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Trial record 33 of 10799 for:    Placebo AND once

A Study in Asthma Patients to Evaluate Efficacy, Safety and Tolerability of 14 Days Once Daily Inhaled Interferon Beta-1a After the Onset of Symptoms of an Upper Respiratory Tract Infection (INEXAS)

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ClinicalTrials.gov Identifier: NCT02491684
Recruitment Status : Completed
First Posted : July 8, 2015
Results First Posted : January 15, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Asthma
Interventions Drug: Interferon beta-1a Nebuliser solution 48 μg/mL
Drug: Placebo
Enrollment 121
Recruitment Details First patient enrolled: 21 July 2015; Last Patient Last Visit: 24 November 2016. The study was performed at 39 sites in 7 countries including Argentina, Australia, Colombia, France, South Korea, Spain and the United Kingdom.
Pre-assignment Details 349 patients enrolled (signed informed consent) and 228 were not randomised. 121 patients met randomisation criteria and entered the pre-treatment phase. Patients were treated after developing symptoms of an upper respiratory tract infection (URTI) if they met all the inclusion criteria and none of the exclusion criteria for the treatment phase.
Arm/Group Title AZD9412 Placebo
Hide Arm/Group Description

Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.

Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the AZD9412 group received 6 Million International Units (MIU) (24 micrograms [mcg] metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an electronic Patient Reported Outcome (ePRO) device at home.

Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Period Title: Pre-treatment Phase
Started 61 60
Completed 61 60
Not Completed 0 0
Period Title: Treatment Phase
Started 61 60
Completed 58 57
Not Completed 3 3
Reason Not Completed
Adverse Event             2             2
Incorrect randomisation             1             0
Investigator and Sponsor decision             0             1
Arm/Group Title AZD9412 Placebo Total
Hide Arm/Group Description

Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.

Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Total of all reporting groups
Overall Number of Baseline Participants 61 60 121
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 60 participants 121 participants
47.8  (12.95) 47.7  (14.10) 47.7  (13.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 60 participants 121 participants
Female
48
  78.7%
43
  71.7%
91
  75.2%
Male
13
  21.3%
17
  28.3%
30
  24.8%
1.Primary Outcome
Title Proportion of Patients With a Severe Asthma Exacerbation During 14 Days of Treatment
Hide Description

Evaluation of the efficacy of inhaled AZD9412 compared to placebo in preventing severe exacerbations during the 14 day treatment phase following the onset of an URTI in asthmatic patients.

A severe exacerbation was defined as worsening asthma symptoms and

  1. use of systemic corticosteroids (or a temporary increase of at least 2-fold in a stable oral corticosteroid background dose) for at least 3 consecutive days and/or
  2. an unscheduled visit or emergency room visit due to asthma symptoms that required at least 1 dose of systemic corticosteroids and/or
  3. an in-patient hospitalisation due to asthma requiring at least 1 dose of systemic corticosteroids.

The number of patients with severe asthma exacerbations with onset during the treatment phase is presented for each treatment group.

Time Frame Day 1 - 14 of the treatment phase.
Hide Outcome Measure Data
Hide Analysis Population Description
The Intention to treat (ITT) analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.
Arm/Group Title AZD9412 Placebo
Hide Arm/Group Description:

Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.

Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Overall Number of Participants Analyzed 61 60
Measure Type: Count of Participants
Unit of Measure: Participants
7
  11.5%
5
   8.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.645
Comments [Not Specified]
Method log-binomial regression model
Comments The ratio of proportions was calculated by back-transforming the estimated treatment effect.
Method of Estimation Estimation Parameter Ratio of proportions
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
0.43 to 3.85
Estimation Comments AZD9412 versus Placebo
2.Secondary Outcome
Title Proportion of Patients With Severe Asthma Exacerbations Within 7 and 30 Days Following Randomisation
Hide Description

Evaluation of the efficacy of inhaled AZD9412 compared to placebo in preventing severe exacerbations within 7 and 30 days after the start of treatment (Day 1).

A severe exacerbation was defined as worsening asthma symptoms and

  1. use of systemic corticosteroids (or a temporary increase of at least 2-fold in a stable oral corticosteroid background dose) for at least 3 consecutive days and/or
  2. an unscheduled visit or emergency room visit due to asthma symptoms that required at least 1 dose of systemic corticosteroids and/or
  3. an in-patient hospitalisation due to asthma requiring at least 1 dose of systemic corticosteroids.

The numbers of patients with severe asthma exacerbations with onset during Days 1 - 7 and Days 1 - 30 are presented for each treatment group.

Time Frame Day 1 of treatment phase up to 30 days post-randomisation.
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.
Arm/Group Title AZD9412 Placebo
Hide Arm/Group Description:

Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.

Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Overall Number of Participants Analyzed 61 60
Measure Type: Count of Participants
Unit of Measure: Participants
Days 1 - 7
4
   6.6%
2
   3.3%
Days 1 - 30
8
  13.1%
6
  10.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.411
Comments [Not Specified]
Method log-binomial regression model
Comments The ratio of proportions was calculated by back-transforming the estimated treatment effect.
Method of Estimation Estimation Parameter Ratio of proportions
Estimated Value 1.97
Confidence Interval (2-Sided) 95%
0.39 to 9.89
Estimation Comments AZD9412 versus Placebo for Days 1 - 7
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.659
Comments [Not Specified]
Method log-binomial regression model
Comments The ratio of proportions was calculated by back-transforming the estimated treatment effect.
Method of Estimation Estimation Parameter Ratio of proportions
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
0.46 to 3.41
Estimation Comments AZD9412 versus Placebo for Days 1 - 30
3.Secondary Outcome
Title Proportion of Patients With Moderate Asthma Exacerbation Within 7, 14 and 30 Days Following Randomisation
Hide Description

Evaluation of the efficacy of inhaled AZD9412 compared to placebo in preventing moderate exacerbations within 7, 14 and 30 days after the start of treatment (Day 1).

A moderate exacerbation was defined as a temporary increase in maintenance therapy in order to prevent a severe event supported by a sustained (2 or more days) worsening in at least one key control metric, including asthma score, rescue use, night time awakening or morning peak expiratory flow.

The numbers of patients with moderate exacerbations with onset during Days 1 - 7, Days 1 - 14 and Days 1 - 30 are presented for each treatment group.

With respect to the Day 1-7 analysis, the model did not converge so the analysis could not be performed.

Time Frame Day 1 of treatment phase up to 30 days post-randomisation.
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.
Arm/Group Title AZD9412 Placebo
Hide Arm/Group Description:

Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.

Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Overall Number of Participants Analyzed 61 60
Measure Type: Count of Participants
Unit of Measure: Participants
Days 1 - 7
0
   0.0%
1
   1.7%
Days 1 - 14
1
   1.6%
1
   1.7%
Days 1 - 30
1
   1.6%
1
   1.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.944
Comments [Not Specified]
Method log-binomial regression model
Comments The ratio of proportions was calculated by back-transforming the estimated treatment effect.
Method of Estimation Estimation Parameter Ratio of proportions
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.08 to 15.79
Estimation Comments AZD9412 versus Placebo for Days 1 - 14
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.944
Comments [Not Specified]
Method log-binomial regression model
Comments The ratio of proportions was calculated by back-transforming the estimated treatment effect.
Method of Estimation Estimation Parameter Ratio of proportions
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.08 to 15.79
Estimation Comments AZD9412 versus Placebo for Days 1 - 30
4.Secondary Outcome
Title Time to First Severe Asthma Exacerbation During 30 Days Following Randomisation
Hide Description

The time to first event was calculated as start date of events - date of randomisation + 1.

Patients with no observed event were censored at the date of their last visit, or for lost-to-follow-up patients, at the last time point after which an event could not be assessed.

The median time to first exacerbation was not calculated in either treatment group due to low numbers of events.

Time Frame From Day 1 of treatment phase up to 30 days post-randomisation.
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.
Arm/Group Title AZD9412 Placebo
Hide Arm/Group Description:

Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.

Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Overall Number of Participants Analyzed 61 60
Median (Full Range)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The median time to severe exacerbation was not calculated due to low numbers of events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of time to first severe exacerbation within 30 days of treatment start.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.634
Comments [Not Specified]
Method Regression, Cox
Comments Hazard ratio was calculated adjusting for treatment group and region.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.30
Confidence Interval (2-Sided) 95%
0.45 to 3.77
Estimation Comments AZD9412 versus Placebo
5.Secondary Outcome
Title Time to First Moderate Asthma Exacerbation During 30 Days Following Randomisation
Hide Description

The time to first event was calculated as start date of events - date of randomisation + 1.

Patients with no observed event were censored at the date of their last visit, or for lost-to-follow-up patients, at the last time point after which an event could not be assessed.

The median time to first exacerbation was not calculated in either treatment group due to low numbers of events.

Time Frame From Day 1 of treatment phase up to 30 days post-randomisation.
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.
Arm/Group Title AZD9412 Placebo
Hide Arm/Group Description:

Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.

Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Overall Number of Participants Analyzed 61 60
Median (Full Range)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The median time to moderate exacerbation was not calculated due to low numbers of events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of time to first moderate exacerbation within 30 days of treatment start.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.973
Comments [Not Specified]
Method Regression, Cox
Comments Hazard ratio was calculated adjusting for treatment group and region.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.07 to 16.78
Estimation Comments AZD9412 versus Placebo
6.Secondary Outcome
Title Duration of Moderate or Severe Exacerbations
Hide Description

The duration of each individual moderate or severe exacerbation was calculated as:

Cessation date of exacerbation - Start date of exacerbation + 1.

The start date of a severe exacerbation was defined as the start date of systemic corticosteroids or increase of systemic corticosteroids or emergency room visit or hospital admission, whichever occurred first. The stop date was defined as the last day of systemic corticosteroids/increase of systemic corticosteroids or hospital discharge, whichever occurred last.

The start date of a moderate exacerbation was defined as the first day of increase in temporary maintenance therapy. The stop date was defined as the last day of this treatment.

The mean duration of moderate or severe exacerbations is presented for each treatment group.

Time Frame Day 1 of treatment phase up to 30 days post-randomisation.
Hide Outcome Measure Data
Hide Analysis Population Description

The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.

The number of patients in the analysis are those with at least 1 exacerbation.

Arm/Group Title AZD9412 Placebo
Hide Arm/Group Description:

Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.

Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Overall Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: Days
10  (7.7) 8  (4.5)
7.Secondary Outcome
Title Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6)
Hide Description

The ACQ-6 consists of 6 questions to assess asthma control, each question measured on a 7-point scale scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 total score is computed as the un-weighted mean of the responses to the 6 questions. Baseline assessments were taken as the last non-missing assessment prior to randomisation.

The change from baseline at Visit 4 (Day 7 +/- 1), at Visit 6 (Day 14 +/- 1) and at Visit 8 (Day 30) is presented for the total score and for each of the 6 questions.

Time Frame From baseline up to 30 days after start of treatment phase.
Hide Outcome Measure Data
Hide Analysis Population Description

The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.

Patients with non-missing values were included in the analysis.

Arm/Group Title AZD9412 Placebo
Hide Arm/Group Description:

Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.

Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Overall Number of Participants Analyzed 61 60
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
ACQ-6 Total Score, Visit 4 Number Analyzed 53 participants 54 participants
0.02  (0.11) -0.07  (0.12)
ACQ-6 Total Score, Visit 6 Number Analyzed 57 participants 55 participants
-0.15  (0.14) -0.21  (0.14)
ACQ-6 Total Score, Visit 8 Number Analyzed 55 participants 56 participants
-0.42  (0.15) -0.35  (0.15)
Q1: Woken by Asthma, Visit 4 Number Analyzed 53 participants 54 participants
0.09  (0.18) -0.09  (0.18)
Q1: Woken by Asthma, Visit 6 Number Analyzed 57 participants 55 participants
0.15  (0.20) -0.28  (0.21)
Q1: Woken by Asthma, Visit 8 Number Analyzed 55 participants 56 participants
-0.50  (0.18) -0.32  (0.18)
Q2: Symptoms at Awakening, Visit 4 Number Analyzed 53 participants 54 participants
0.06  (0.18) -0.17  (0.18)
Q2: Symptoms at Awakening, Visit 6 Number Analyzed 57 participants 55 participants
-0.40  (0.16) -0.33  (0.17)
Q2: Symptoms at Awakening, Visit 8 Number Analyzed 55 participants 56 participants
-0.76  (0.19) -0.47  (0.19)
Q3: Limited in Activities, Visit 4 Number Analyzed 53 participants 54 participants
0.04  (0.15) 0.06  (0.15)
Q3: Limited in Activities, Visit 6 Number Analyzed 57 participants 55 participants
-0.12  (0.17) 0.16  (0.18)
Q3: Limited in Activities, Visit 8 Number Analyzed 55 participants 56 participants
-0.43  (0.18) -0.33  (0.18)
Q4: Shortness of Breath, Visit 4 Number Analyzed 53 participants 54 participants
-0.13  (0.15) -0.11  (0.16)
Q4: Shortness of Breath, Visit 6 Number Analyzed 57 participants 55 participants
-0.34  (0.19) -0.38  (0.21)
Q4: Shortness of Breath, Visit 8 Number Analyzed 55 participants 56 participants
-0.46  (0.18) -0.37  (0.19)
Q5: Wheeze, Visit 4 Number Analyzed 53 participants 54 participants
0.13  (0.17) 0.08  (0.17)
Q5: Wheeze, Visit 6 Number Analyzed 57 participants 55 participants
-0.17  (0.17) -0.17  (0.18)
Q5: Wheeze, Visit 8 Number Analyzed 55 participants 56 participants
-0.33  (0.21) -0.42  (0.21)
Q6: Puffs of Short-Acting Bronchodilator; Visit 4 Number Analyzed 53 participants 54 participants
0.06  (0.13) 0.00  (0.14)
Q6: Puffs of Short-Acting Bronchodilator; Visit 6 Number Analyzed 57 participants 55 participants
0.07  (0.14) -0.11  (0.15)
Q6: Puffs of Short-Acting Bronchodilator; Visit 8 Number Analyzed 55 participants 56 participants
0.04  (0.14) -0.03  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of change from baseline in total score at Visit 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.495
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline is analysed using an Analysis of Covariance (ANCOVA) model with treatment and region as factors and baseline value as covariate.
Method of Estimation Estimation Parameter Least Squares (LS) Mean difference
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.17 to 0.35
Estimation Comments AZD9412 versus Placebo for change from baseline in total score at Visit 4.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of change from baseline in total score at Visit 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.715
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.26 to 0.38
Estimation Comments AZD9412 versus Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of change from baseline in total score at Visit 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.687
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.42 to 0.28
Estimation Comments AZD9412 versus Placebo
8.Secondary Outcome
Title AUC for Change in Daytime and Night-time Asthma Symptom Score From Baseline up to 30 Days
Hide Description Asthma symptoms during night-time and daytime were recorded by the patient each morning and evening in the Asthma Daily Diary on a daily basis. Symptoms were recorded using a scale of 0 to 3 where 0 indicates no asthma symptoms up to an absolute score of 3. Baseline assessments were taken as the last non-missing assessment prior to randomisation. The total daily asthma symptom score was calculated by taking the sum of the night-time and daytime asthma scores recorded each day. The outcome variable is the area under the curve (AUC) for change from baseline in day-time, night-time and total daily asthma symptom scores over Days 1-14, Days 1-7, Days 8-14 and Days 15-30.
Time Frame From baseline up to 30 days after start of treatment phase.
Hide Outcome Measure Data
Hide Analysis Population Description

The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.

Patients with non-missing values were included in the analysis.

Arm/Group Title AZD9412 Placebo
Hide Arm/Group Description:

Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.

Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Overall Number of Participants Analyzed 61 60
Least Squares Mean (Standard Error)
Unit of Measure: Units on Scale
Total asthma score, Days 1-14 Number Analyzed 47 participants 46 participants
-0.20  (0.16) -0.31  (0.16)
Total asthma score, Days 1-7 Number Analyzed 48 participants 50 participants
-0.11  (0.13) -0.22  (0.13)
Total asthma score, Days 8-14 Number Analyzed 54 participants 49 participants
-0.40  (0.15) -0.41  (0.16)
Total asthma score, Days 15-30 Number Analyzed 55 participants 55 participants
-0.77  (0.16) -0.77  (0.16)
Daytime asthma score, Days 1-14 Number Analyzed 56 participants 56 participants
-0.22  (0.07) -0.26  (0.07)
Daytime asthma score, Days 1-7 Number Analyzed 56 participants 58 participants
-0.17  (0.06) -0.17  (0.06)
Daytime asthma score, Days 8-14 Number Analyzed 58 participants 57 participants
-0.23  (0.07) -0.27  (0.07)
Daytime asthma score, Days 15-30 Number Analyzed 60 participants 59 participants
-0.44  (0.07) -0.41  (0.07)
Night-time asthma score, Days 1-14 Number Analyzed 53 participants 50 participants
-0.17  (0.07) -0.16  (0.08)
Night-time asthma score, Days 1-7 Number Analyzed 54 participants 52 participants
-0.10  (0.06) -0.09  (0.07)
Night-time asthma score, Days 8-14 Number Analyzed 55 participants 53 participants
-0.20  (0.07) -0.17  (0.08)
Night-time asthma score, Days 15-30 Number Analyzed 57 participants 55 participants
-0.44  (0.09) -0.39  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline in total score over Days 1-14.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.516
Comments [Not Specified]
Method ANCOVA
Comments AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.23 to 0.45
Estimation Comments AZD9412 versus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline in total score over Days 1-7.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.417
Comments [Not Specified]
Method ANCOVA
Comments AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.16 to 0.37
Estimation Comments AZD9412 versus Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline in total score over Days 8-14.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.954
Comments [Not Specified]
Method ANCOVA
Comments AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.34 to 0.36
Estimation Comments AZD9412 versus Placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline in total score over Days 15-30.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.985
Comments [Not Specified]
Method ANCOVA
Comments AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.35 to 0.35
Estimation Comments AZD9412 versus Placebo
9.Secondary Outcome
Title Change in the Proportion of Night-time Awakening Using the ePRO Questionnaire From Baseline up to 30 Days
Hide Description

Night-time awakenings due to asthma symptoms were recorded by the patient in the Asthma Daily Diary each morning by answering the question whether he/she woke up during the night due to asthma symptoms with a 'yes' or 'no' response.

Biweekly means were calculated as the percentages of times the subject answered 'yes' over a period of 14 sequential days. Biweekly means are presented for the periods over Days 2-15 and Days 16-30.

Time Frame From baseline up to 30 days after start of treatment phase.
Hide Outcome Measure Data
Hide Analysis Population Description

The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.

Patients with non-missing values were included in the analysis.

Arm/Group Title AZD9412 Placebo
Hide Arm/Group Description:

Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.

Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Overall Number of Participants Analyzed 61 60
Mean (Standard Deviation)
Unit of Measure: Percentage of 'yes' responses
Days 2-15 Number Analyzed 61 participants 60 participants
22.3  (30.42) 24.8  (29.77)
Days 16-30 Number Analyzed 60 participants 59 participants
15.2  (26.79) 15.9  (26.34)
10.Secondary Outcome
Title Change in Health-related Quality of Life as Measured by the Asthma Quality of Life Questionnaire (AQLQ[S]) From Baseline up to 30 Days
Hide Description

The AQLQ(S) was used to assess health-related quality of life and consisted of 32 questions. Patients were asked to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The questions were allocated to 4 domains assessing:

  1. activity limitation,
  2. symptoms,
  3. emotional function, and
  4. environmental stimuli

The overall score was calculated as the mean of the responses to all questions. The mean change in overall score from baseline at Visit 6 (Day 14+/-1) and Visit 8 (Day 30) are presented.

Time Frame From baseline up to 30 days after start of treatment phase.
Hide Outcome Measure Data
Hide Analysis Population Description

The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.

Patients with non-missing values were included in the analysis.

Arm/Group Title AZD9412 Placebo
Hide Arm/Group Description:

Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.

Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Overall Number of Participants Analyzed 61 60
Least Squares Mean (Standard Error)
Unit of Measure: Units on Scale
Overall Score Visit 6 Number Analyzed 57 participants 56 participants
0.28  (0.13) 0.35  (0.14)
Overall Score Visit 8 Number Analyzed 55 participants 57 participants
0.43  (0.16) 0.53  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of change from baseline in overall score at Visit 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.660
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.38 to 0.24
Estimation Comments AZD9412 versus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of change from baseline in overall score at Visit 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.624
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.48 to 0.29
Estimation Comments AZD9412 versus Placebo
11.Secondary Outcome
Title AUC for Change in Daytime and Night-time Reliever Medication Use From Baseline up to 14 Days
Hide Description

Patients recorded the number of reliever medication inhalations taken twice daily in the Asthma Daily Diary. The number of inhalations taken between the morning and evening lung function assessments were recorded in the evening. The number of inhalations taken between the evening and morning lung function assessments were recorded in the morning. Baseline assessments were taken as the last non-missing assessment prior to randomisation.

The AUC for change from baseline over Days 1-14 (inclusive of Days 1 and 14) is presented.

Time Frame From baseline up to Day 14 of treatment phase.
Hide Outcome Measure Data
Hide Analysis Population Description

The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.

Patients with non-missing values were included in the analysis.

Arm/Group Title AZD9412 Placebo
Hide Arm/Group Description:

Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.

Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Overall Number of Participants Analyzed 52 48
Least Squares Mean (Standard Error)
Unit of Measure: Inhalations
-0.12  (0.46) -0.67  (0.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline over Days 1-14.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.309
Comments [Not Specified]
Method ANCOVA
Comments AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
-0.51 to 1.59
Estimation Comments AZD9412 versus Placebo
12.Secondary Outcome
Title AUC for Change in the Morning Peak Expiratory Flow (PEF) From Baseline to up to 30 Days
Hide Description

Patients measured morning PEF at home and recorded the results using the ePRO device. Baseline assessments were taken as the last non-missing assessment prior to randomisation.

The mean AUC for change from baseline is presented for the periods Days 1-14, 1-7, 8-14 and 15-30.

Time Frame From baseline up to 30 days after start of treatment phase.
Hide Outcome Measure Data
Hide Analysis Population Description

The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.

Patients with non-missing values were included in the analysis.

Arm/Group Title AZD9412 Placebo
Hide Arm/Group Description:

Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.

Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Overall Number of Participants Analyzed 61 60
Least Squares Mean (Standard Error)
Unit of Measure: litres/minute (l/min)
Days 1-14 Number Analyzed 55 participants 57 participants
9.56  (14.02) -7.42  (13.91)
Days 1-7 Number Analyzed 56 participants 59 participants
19.66  (9.66) 0.31  (9.11)
Days 8-14 Number Analyzed 57 participants 57 participants
7.03  (15.90) -7.35  (15.80)
Days 15-30 Number Analyzed 59 participants 59 participants
32.75  (15.35) 13.49  (14.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline over Days 1-14.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments [Not Specified]
Method ANCOVA
Comments Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 16.98
Confidence Interval (2-Sided) 95%
-0.63 to 34.60
Estimation Comments AZD9412 versus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline over Days 1-7.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method ANCOVA
Comments Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 19.35
Confidence Interval (2-Sided) 95%
4.66 to 34.05
Estimation Comments AZD9412 versus Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline over Days 8-14.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.153
Comments [Not Specified]
Method ANCOVA
Comments Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 14.38
Confidence Interval (2-Sided) 95%
-5.44 to 34.20
Estimation Comments AZD9412 versus Placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline over Days 15-30.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.096
Comments [Not Specified]
Method ANCOVA
Comments Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 19.26
Confidence Interval (2-Sided) 95%
-3.44 to 41.97
Estimation Comments AZD9412 versus Placebo
13.Secondary Outcome
Title AUC for Change in the Morning Forced Expiratory Volume in 1 Second (FEV1) From Baseline up to 30 Days
Hide Description

Patients measured morning FEV1 at home and recorded the results using the ePRO device. Baseline assessments were taken as the last non-missing assessment prior to randomisation.

The mean AUC for change from baseline is presented for the periods Days 1-14, 1-7, 8-14 and 15-30.

Time Frame From baseline up to 30 days after start of treatment phase.
Hide Outcome Measure Data
Hide Analysis Population Description

The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.

Patients with non-missing values were included in the analysis.

Arm/Group Title AZD9412 Placebo
Hide Arm/Group Description:

Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.

Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Overall Number of Participants Analyzed 61 60
Least Squares Mean (Standard Error)
Unit of Measure: litres
Days 1-14 Number Analyzed 55 participants 57 participants
-0.00  (0.08) -0.08  (0.08)
Days 1-7 Number Analyzed 56 participants 59 participants
0.10  (0.06) 0.02  (0.06)
Days 8-14 Number Analyzed 57 participants 57 participants
-0.03  (0.08) -0.09  (0.08)
Days 15-30 Number Analyzed 59 participants 59 participants
0.15  (0.09) 0.04  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline over Days 1-14.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.161
Comments [Not Specified]
Method ANCOVA
Comments Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.03 to 0.17
Estimation Comments AZD9412 versus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline over Days 1-7.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments [Not Specified]
Method ANCOVA
Comments Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.01 to 0.17
Estimation Comments AZD9412 versus Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline over Days 8-14.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.280
Comments [Not Specified]
Method ANCOVA
Comments Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.05 to 0.16
Estimation Comments AZD9412 versus Placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline over Days 15-30.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.086
Comments [Not Specified]
Method ANCOVA
Comments Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.02 to 0.24
Estimation Comments AZD9412 versus Placebo
14.Secondary Outcome
Title AUC for Change in the Evening PEF From Baseline to up to 30 Days
Hide Description

Patients measured evening PEF at home and recorded the results using the ePRO device. Baseline assessments were taken as the last non-missing assessment prior to randomisation.

The mean AUC for change from baseline is presented for the periods Days 1-14, 1-7, 8-14 and 15-30.

Time Frame From baseline up to 30 days after start of treatment phase.
Hide Outcome Measure Data
Hide Analysis Population Description

The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.

Patients with non-missing values were included in the analysis.

Arm/Group Title AZD9412 Placebo
Hide Arm/Group Description:

Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.

Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Overall Number of Participants Analyzed 61 60
Least Squares Mean (Standard Error)
Unit of Measure: l/min
Days 1-14 Number Analyzed 52 participants 51 participants
10.96  (12.58) -0.73  (11.88)
Days 1-7 Number Analyzed 53 participants 53 participants
8.78  (9.87) -2.41  (9.30)
Days 8-14 Number Analyzed 53 participants 52 participants
8.49  (13.09) -2.66  (12.55)
Days 15-30 Number Analyzed 56 participants 54 participants
11.88  (15.70) -5.25  (15.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline over Days 1-14.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.211
Comments [Not Specified]
Method ANCOVA
Comments Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 11.69
Confidence Interval (2-Sided) 95%
-6.76 to 30.14
Estimation Comments AZD9412 versus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline over Days 1-7.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.125
Comments [Not Specified]
Method ANCOVA
Comments Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 11.19
Confidence Interval (2-Sided) 95%
-3.18 to 25.56
Estimation Comments AZD9412 versus Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline over Days 8-14.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.277
Comments [Not Specified]
Method ANCOVA
Comments Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 11.14
Confidence Interval (2-Sided) 95%
-9.08 to 31.36
Estimation Comments AZD9412 versus Placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline over Days 15-30.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.161
Comments [Not Specified]
Method ANCOVA
Comments Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 17.13
Confidence Interval (2-Sided) 95%
-6.92 to 41.18
Estimation Comments AZD9412 versus Placebo
15.Secondary Outcome
Title AUC for Change in the Evening FEV1 From Baseline up to 30 Days
Hide Description

Patients measured evening FEV1 at home and recorded the results using the ePRO device. Baseline assessments were taken as the last non-missing assessment prior to randomisation.

The mean AUC for change from baseline is presented for the periods Days 1-14, 1-7, 8-14 and 15-30.

Time Frame From baseline up to 30 days after start of treatment phase.
Hide Outcome Measure Data
Hide Analysis Population Description

The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.

Patients with non-missing values were included in the analysis.

Arm/Group Title AZD9412 Placebo
Hide Arm/Group Description:

Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.

Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

Overall Number of Participants Analyzed 61 60
Least Squares Mean (Standard Error)
Unit of Measure: litres
Days 1-14 Number Analyzed 52 participants 51 participants
-0.01  (0.07) -0.07  (0.07)
Days 1-7 Number Analyzed 53 participants 53 participants
0.01  (0.07) -0.03  (0.07)
Days 8-14 Number Analyzed 53 participants 52 participants
-0.02  (0.07) -0.08  (0.07)
Days 15-30 Number Analyzed 56 participants 54 participants
0.02  (0.08) -0.08  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline over Days 1-14.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.287
Comments [Not Specified]
Method ANCOVA
Comments Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.05 to 0.16
Estimation Comments AZD9412 versus Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline over Days 1-7.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.457
Comments [Not Specified]
Method ANCOVA
Comments Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.06 to 0.14
Estimation Comments AZD9412 versus Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline over Days 8-14.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.315
Comments [Not Specified]
Method ANCOVA
Comments Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.05 to 0.16
Estimation Comments AZD9412 versus Placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection AZD9412, Placebo
Comments Analysis of AUC for change from baseline over Days 15-30.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments [Not Specified]
Method ANCOVA
Comments Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.03 to 0.22
Estimation Comments AZD9412 versus Placebo
Time Frame Treatment emergent adverse events were collected from the first day of study treatment up to the last date of follow-up (approximately 30 days).
Adverse Event Reporting Description The safety analysis set consisted of all randomised patients who received at least 1 dose of investigational product and with post-dose data available.
 
Arm/Group Title AZD9412 Placebo
Hide Arm/Group Description

Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase.

Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the AZD9412 group received 6 Million International Units (MIU) (24 micrograms [mcg] metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an electronic Patient Reported Outcome (ePRO) device at home.

Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.

Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.

Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.

All-Cause Mortality
AZD9412 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AZD9412 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/61 (4.92%)      0/60 (0.00%)    
Respiratory, thoracic and mediastinal disorders     
Asthma  1  3/61 (4.92%)  4 0/60 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AZD9412 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/61 (44.26%)      20/60 (33.33%)    
Blood and lymphatic system disorders     
Eosinophilia  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Iron deficiency anaemia  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Lymphadenopathy  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Cardiac disorders     
Palpitations  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Ear and labyrinth disorders     
Vertigo  1  1/61 (1.64%)  3 0/60 (0.00%)  0
Eye disorders     
Blepharospasm  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Periorbital oedema  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Gastrointestinal disorders     
Constipation  1  2/61 (3.28%)  2 0/60 (0.00%)  0
Diarrhoea  1  2/61 (3.28%)  2 0/60 (0.00%)  0
Gastritis  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Gastrooesophageal reflux disease  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Mouth ulceration  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Nausea  1  1/61 (1.64%)  1 1/60 (1.67%)  1
Odynophagia  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Vomiting  1  1/61 (1.64%)  1 1/60 (1.67%)  1
General disorders     
Asthenia  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Fatigue  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Influenza like illness  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Injury associated with device  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Oedema peripheral  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Infections and infestations     
Bronchitis  1  5/61 (8.20%)  5 1/60 (1.67%)  1
Conjunctivitis bacterial  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Ear infection  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Gastroenteritis  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Laryngitis  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Nasopharyngitis  1  2/61 (3.28%)  2 1/60 (1.67%)  1
Rhinitis  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Sinusitis  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Tooth infection  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Upper respiratory tract infection  1  1/61 (1.64%)  1 1/60 (1.67%)  1
Urinary tract infection  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Injury, poisoning and procedural complications     
Mouth injury  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Muscle strain  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Investigations     
Alanine aminotransferase increased  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Aspartate aminotransferase increased  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Blood creatine phosphokinase increased  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Blood pressure decreased  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Glycosylated haemoglobin increased  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Pulmonary function test decreased  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Metabolism and nutrition disorders     
Diabetic ketoacidosis  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Hypocalcaemia  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Hypokalaemia  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/61 (1.64%)  1 1/60 (1.67%)  1
Back pain  1  1/61 (1.64%)  2 0/60 (0.00%)  0
Musculoskeletal pain  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Osteoarthritis  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Pain in jaw  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Tendonitis  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Nervous system disorders     
Headache  1  2/61 (3.28%)  2 3/60 (5.00%)  3
Paraesthesia  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Tremor  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Psychiatric disorders     
Depressed mood  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Emotional distress  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Insomnia  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Mood altered  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Panic attack  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/61 (1.64%)  1 4/60 (6.67%)  5
Bronchospasm  1  1/61 (1.64%)  2 0/60 (0.00%)  0
Cough  1  1/61 (1.64%)  3 1/60 (1.67%)  1
Dysphonia  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Dyspnoea  1  1/61 (1.64%)  1 2/60 (3.33%)  2
Hiccups  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Nasal congestion  1  2/61 (3.28%)  2 0/60 (0.00%)  0
Oropharyngeal pain  1  2/61 (3.28%)  2 0/60 (0.00%)  0
Rhinitis allergic  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Sinus pain  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Throat irritation  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Upper-airway cough syndrome  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Wheezing  1  1/61 (1.64%)  1 1/60 (1.67%)  2
Skin and subcutaneous tissue disorders     
Eczema  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Pruritus  1  1/61 (1.64%)  1 1/60 (1.67%)  1
Pruritus generalised  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 19.1
The study was terminated early due to the lower than expected rate of severe exacerbations in the study as a whole, and due to the observed lack of differential effect at interim analysis.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Medical Science Director
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02491684     History of Changes
Other Study ID Numbers: D6230C00001
First Submitted: June 16, 2015
First Posted: July 8, 2015
Results First Submitted: July 23, 2018
Results First Posted: January 15, 2019
Last Update Posted: February 12, 2019