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Trial record 9 of 16 for:    AZD 5069

Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis (STRATUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01255592
Recruitment Status : Completed
First Posted : December 7, 2010
Results First Posted : October 8, 2015
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Bronchiectasis
Lung Disease
Respiratory Diseases
Interventions Drug: AZD5069
Drug: Placebo
Enrollment 83
Recruitment Details This multicenter study was conducted in Europe between 27 December 2010 and 13 February 2012.
Pre-assignment Details  
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description AZD5069 80 mg bd Placebo for AZD5069, bd
Period Title: Overall Study
Started 26 26
Completed 20 25
Not Completed 6 1
Reason Not Completed
Adverse Event             5             0
Withdrawal by Subject             1             0
Other             0             1
Arm/Group Title AZD5069 Placebo Total
Hide Arm/Group Description AZD5069 80 mg bd Placebo bd Total of all reporting groups
Overall Number of Baseline Participants 26 26 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 26 participants 52 participants
66  (6.6) 65  (8.8) 65  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Female
16
  61.5%
12
  46.2%
28
  53.8%
Male
10
  38.5%
14
  53.8%
24
  46.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Asian 0 0 0
Black or African American 0 0 0
White 26 26 52
Other 0 0 0
1.Primary Outcome
Title Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline
Hide Description Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time Frame End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo bd
Overall Number of Participants Analyzed 19 24
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ratio
0.31
(0.20 to 0.50)
1.00
(0.66 to 1.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection, and baseline as covariates. The analysis was done on log-transformed data. The results were back-transformed after the analysis on the log scale.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of AZD5069 80 mg to placebo
Estimated Value 0.31
Confidence Interval (2-Sided) 90%
0.17 to 0.59
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Ratio of the Percentage Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline
Hide Description Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time Frame End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 19 24
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ratio
0.66
(0.54 to 0.80)
1.02
(0.86 to 1.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection, and baseline as covariates. The analysis was done on log-transformed data. The results were back-transformed after the analysis on the log scale.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of AZD5069 80 mg to placebo
Estimated Value 0.64
Confidence Interval (2-Sided) 90%
0.49 to 0.84
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Weight of 24-hour Sputum Collection
Hide Description Patients collected all sputum produced during a 24-hour period at baseline and Day 28.
Time Frame Baseline and end of treatment (Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 20 25
Least Squares Mean (Standard Error)
Unit of Measure: grams
3.51  (2.455) -3.26  (2.195)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments The 24-hour sputum weight on Visit 4 was compared between groups using ANCOVA (additive model) with treatment and inhaled corticosteroids/P. aeruginosa infection as fixed effects and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 6.78
Confidence Interval (2-Sided) 90%
1.22 to 12.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.298
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Slow Vital Capacity (SVC)
Hide Description Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. SVC is the measure of the change in volume of gas in the lungs from complete inspiration to complete expiration.
Time Frame Baseline to end of treatment (Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 23 26
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.05  (0.067) -0.05  (0.063)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.284
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.10
Confidence Interval (2-Sided) 90%
-0.05 to 0.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.092
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Forced Vital Capacity (FVC)
Hide Description Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FVC is the maximum volume of air which can be exhaled or inspired during a forced maneuver.
Time Frame Baseline to end of treatment (Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 24 26
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.07  (0.056) 0.06  (0.054)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.929
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.01
Confidence Interval (2-Sided) 90%
-0.12 to 0.14
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.078
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 is the volume expired in the first second of maximal expiration after a full inspiration.
Time Frame Baseline to end of treatment (Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 24 26
Least Squares Mean (Standard Error)
Unit of Measure: liters
-0.01  (0.044) -0.01  (0.043)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.966
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.00
Confidence Interval (2-Sided) 90%
-0.11 to 0.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.062
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75)
Hide Description Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEF25-75 is flow rate during the middle half of forced vital capacity (25%-75% of the total volume (FVC) exhaled).
Time Frame Baseline to end of treatment (Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 24 25
Least Squares Mean (Standard Error)
Unit of Measure: liters/second
-0.04  (0.063) -0.07  (0.062)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.791
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.02
Confidence Interval (2-Sided) 90%
-0.13 to 0.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.090
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Transition Dyspnea Index (TDI) at End of Treatment (Day 28)
Hide Description TDI measures changes in dyspnea severity from the baseline as established by the Baseline Dyspnea Index (BDI). TDI is an interviewer-administered rating of severity of dyspnea that assesses Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort domains on a 7-point scale ranging from -3 (major deterioration) to +3 (major improvement). Total score ranges from -9 to +9. The lower the score, the more deterioration in severity of dyspnea.
Time Frame Baseline to end of treatment (Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 25 25
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1  (0.5) -0  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments The ANCOVA model used TDI as the response variable with treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and BDI as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.433
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1
Confidence Interval (2-Sided) 90%
-1.6 to 0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card
Hide Description The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.
Time Frame Baseline and Last 7 days on treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 26 25
Least Squares Mean (Standard Error)
Unit of Measure: L/min
Morning PEF -5.3  (5.41) -5.9  (5.53)
Evening PEF -7.3  (4.95) -10.6  (5.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Morning PEF: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.935
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.7
Confidence Interval (2-Sided) 90%
-12.81 to 14.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.03
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Evening PEF: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.654
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.3
Confidence Interval (2-Sided) 90%
-9.02 to 15.64
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.35
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline for the Symptom Scores of the Bronkotest Diary Card
Hide Description The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, number of puffs of inhalers, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.
Time Frame Baseline and Last 7 days on treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 26 25
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Describe your breathing 0.1  (0.10) -0.1  (0.10)
How often do you cough? 0.1  (0.09) 0.0  (0.09)
Night time symptom score 0.4  (0.12) 0.1  (0.12)
What color is your sputum? -0.7  (0.18) -0.3  (0.18)
The amount of sputum you produced 0.1  (0.08) 0.0  (0.09)
Type of sputum -0.3  (0.09) -0.1  (0.09)
How do you feel? 0.2  (0.10) -0.0  (0.10)
Number of puffs of inhalers 0.1  (0.30) 0.2  (0.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Describe your breathing: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.329
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.1
Confidence Interval (2-Sided) 90%
-0.09 to 0.36
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments How often do you cough?: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.664
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.1
Confidence Interval (2-Sided) 90%
-0.16 to 0.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Night time symptom score: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.152
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.3
Confidence Interval (2-Sided) 90%
-0.04 to 0.54
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments What color is your sputum?: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.150
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.4
Confidence Interval (2-Sided) 90%
-0.80 to 0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.25
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments The amount of sputum you produced: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.248
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.1
Confidence Interval (2-Sided) 90%
-0.06 to 0.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Type of sputum: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.2
Confidence Interval (2-Sided) 90%
-0.45 to -0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments How do you feel?: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.179
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.2
Confidence Interval (2-Sided) 90%
-0.04 to 0.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Number of puffs of inhalers: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.942
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.0
Confidence Interval (2-Sided) 90%
-0.75 to 0.68
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.43
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline Total and Domain Scores in St. George’s Respiratory Questionnaire for COPD Patients (SGRQ-C)
Hide Description

SGRQ-C total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). The SGRQ-C contains 3 domains:

Symptom (distress due to respiratory symptoms), Activity (disturbance of physical activity) and Impact (overall impact on daily life and well being). All three domains with scale from 0 (best health status) to 100 (worst possible status).

Time Frame Baseline and end of treatment (Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 25 26
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Total score -1.75  (2.402) -0.09  (2.355)
Symptom domain -3.16  (2.356) 1.72  (2.309)
Activity domain -0.46  (3.216) 0.85  (3.153)
Impact domain -1.83  (2.742) -1.45  (2.689)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Total score: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.625
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.66
Confidence Interval (2-Sided) 90%
-7.32 to 4.00
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.374
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Symptom domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.151
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -4.88
Confidence Interval (2-Sided) 90%
-10.49 to 0.74
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.342
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Activity domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.773
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.31
Confidence Interval (2-Sided) 90%
-8.91 to 6.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.524
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Impact domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.920
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.39
Confidence Interval (2-Sided) 90%
-6.84 to 6.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.845
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Ratio of Interleukin-1 Beta (IL-1β) in Sputum at End of Treatment Compared to Baseline
Hide Description Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time Frame End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 22 25
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ratio
0.63
(0.44 to 0.90)
0.91
(0.65 to 1.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.220
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS means
Estimated Value 0.69
Confidence Interval (2-Sided) 90%
0.42 to 1.14
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Ratio of Interleukin-6 (IL-6) in Sputum at End of Treatment Compared to Baseline
Hide Description Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time Frame End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 22 25
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ratio
3.68
(2.79 to 4.84)
0.82
(0.64 to 1.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS means
Estimated Value 4.46
Confidence Interval (2-Sided) 90%
3.05 to 6.54
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) in Sputum at End of Treatment Compared to Baseline
Hide Description Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time Frame End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 22 25
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ratio
0.99
(0.79 to 1.24)
1.07
(0.87 to 1.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.670
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS means
Estimated Value 0.92
Confidence Interval (2-Sided) 90%
0.68 to 1.26
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) in Sputum at End of Treatment Compared to Baseline
Hide Description Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time Frame End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 22 25
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ratio
0.91
(0.77 to 1.09)
0.92
(0.78 to 1.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.968
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS means
Estimated Value 0.99
Confidence Interval (2-Sided) 90%
0.78 to 1.27
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Sputum at End of Treatment Compared to Baseline
Hide Description Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time Frame End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 22 25
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ratio
1.29
(0.93 to 1.80)
0.91
(0.67 to 1.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.193
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS means
Estimated Value 1.43
Confidence Interval (2-Sided) 90%
0.91 to 2.24
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Ratio of Growth-related Oncogene-α (GRO-α) in Sputum at End of Treatment Compared to Baseline
Hide Description Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time Frame End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 22 25
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ratio
2.77
(2.08 to 3.67)
0.85
(0.65 to 1.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS means
Estimated Value 3.24
Confidence Interval (2-Sided) 90%
2.19 to 4.79
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Ratio of Interleukin-8 (IL-8) in Sputum at End of Treatment Compared to Baseline
Hide Description Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time Frame End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 22 26
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ratio
0.81
(0.62 to 1.07)
0.80
(0.62 to 1.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.917
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS means
Estimated Value 1.02
Confidence Interval (2-Sided) 90%
0.71 to 1.48
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Ratio of Neutrophil Elastase Activity in Sputum at End of Treatment Compared to Baseline
Hide Description Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time Frame End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 4 5
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ratio
0.34
(0.09 to 1.28)
1.95
(0.59 to 6.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.111
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS means
Estimated Value 0.17
Confidence Interval (2-Sided) 90%
0.03 to 1.08
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Ratio of Serum Amyloid A (SAA) in Serum at End of Treatment Compared to Baseline
Hide Description Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time Frame End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 24 24
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ratio
1.18
(0.82 to 1.72)
0.89
(0.61 to 1.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.367
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS means
Estimated Value 1.33
Confidence Interval (2-Sided) 90%
0.79 to 2.26
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Ratio of C-reactive Protein (CRP) in Serum at End of Treatment Compared to Baseline
Hide Description Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time Frame End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 24 24
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ratio
1.28
(0.94 to 1.76)
0.83
(0.61 to 1.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.112
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS means
Estimated Value 1.54
Confidence Interval (2-Sided) 90%
0.98 to 2.40
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Serum at End of Treatment Compared to Baseline
Hide Description Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time Frame End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 24 24
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ratio
1.02
(0.97 to 1.06)
0.97
(0.92 to 1.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.241
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS means
Estimated Value 1.05
Confidence Interval (2-Sided) 90%
0.98 to 1.12
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Ratio of Growth-related Oncogene-α (GRO-α) in Serum at End of Treatment Compared to Baseline
Hide Description Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time Frame End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 16 24
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ratio
5.45
(4.42 to 6.73)
0.99
(0.84 to 1.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS means
Estimated Value 5.50
Confidence Interval (2-Sided) 90%
4.18 to 7.23
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Ratio of Interleukin-6 (IL-6) in Serum at End of Treatment Compared to Baseline
Hide Description Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time Frame End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 24 24
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ratio
1.13
(0.96 to 1.34)
0.97
(0.82 to 1.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.281
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS means
Estimated Value 1.16
Confidence Interval (2-Sided) 90%
0.92 to 1.47
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Ratio of Interleukin-1 Beta (IL-1β) in Serum at End of Treatment Compared to Baseline
Hide Description Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time Frame End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 24 24
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ratio
1.45
(1.25 to 1.67)
0.93
(0.80 to 1.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS means
Estimated Value 1.56
Confidence Interval (2-Sided) 90%
1.28 to 1.91
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Ratio of Interleukin-8 (IL-8) in Serum at End of Treatment Compared to Baseline
Hide Description Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Time Frame End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description:
AZD5069 80 mg bd
Placebo for AZD5069, bd
Overall Number of Participants Analyzed 24 24
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ratio
5.90
(4.74 to 7.34)
0.97
(0.78 to 1.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069, Placebo
Comments Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS means
Estimated Value 6.07
Confidence Interval (2-Sided) 90%
4.42 to 8.35
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZD5069 Placebo
Hide Arm/Group Description 80 mg bd Placebo for AZD5069 bd
All-Cause Mortality
AZD5069 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AZD5069 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/26 (3.85%)   0/26 (0.00%) 
Infections and infestations     
Infective Exacerbation Of Bronchiectasis  1  1/26 (3.85%)  0/26 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZD5069 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   22/26 (84.62%)   16/26 (61.54%) 
Gastrointestinal disorders     
Diarrhoea  1  3/26 (11.54%)  0/26 (0.00%) 
Dyspepsia  1  2/26 (7.69%)  2/26 (7.69%) 
Vomiting  1  2/26 (7.69%)  0/26 (0.00%) 
General disorders     
Non-Cardiac Chest Pain  1  2/26 (7.69%)  2/26 (7.69%) 
Infections and infestations     
Nasopharyngitis  1  3/26 (11.54%)  5/26 (19.23%) 
Infective Exacerbation Of Bronchiectasis  1  1/26 (3.85%)  2/26 (7.69%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  1/26 (3.85%)  2/26 (7.69%) 
Musculoskeletal Chest Pain  1  2/26 (7.69%)  1/26 (3.85%) 
Pain In Extremity  1  0/26 (0.00%)  2/26 (7.69%) 
Nervous system disorders     
Headache  1  5/26 (19.23%)  3/26 (11.54%) 
Somnolence  1  0/26 (0.00%)  2/26 (7.69%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  6/26 (23.08%)  1/26 (3.85%) 
Rhinorrhoea  1  4/26 (15.38%)  1/26 (3.85%) 
Dyspnoea  1  0/26 (0.00%)  3/26 (11.54%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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: Gerard Lynch
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01255592     History of Changes
Other Study ID Numbers: D3550C00014
First Submitted: December 2, 2010
First Posted: December 7, 2010
Results First Submitted: June 25, 2015
Results First Posted: October 8, 2015
Last Update Posted: October 8, 2015