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A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo (CHASE 1)

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ClinicalTrials.gov Identifier: NCT01136382
Recruitment Status : Completed
First Posted : June 3, 2010
Results First Posted : July 21, 2014
Last Update Posted : August 1, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: budesonide
Drug: placebo
Enrollment 304

Recruitment Details This multicenter study was conducted in Bulgaria, Hungary, Latvia, Poland, Slovakia, South Africa, and the United States between 07 August 2011 and 05 April 2013.
Pre-assignment Details The study consisted of a screening visit (Visit 1), an enrollment visit (Visit 2), a 7- to 21-day run-in/qualification period, a randomization visit (Visit 3), and 6 further weekly visits during a treatment period of 6 weeks. A telephone follow-up was conducted approximately 2 weeks after the final study visit.
Arm/Group Title Placebo Budesonide
Hide Arm/Group Description Placebo pMDI bid Budesonide pMDI 160 mcg bid
Period Title: Overall Study
Started 152 152
Completed 92 121
Not Completed 60 31
Reason Not Completed
Not Specified             8             3
Study-Specific Withdrawal Criteria             48             25
Severe Non-Compliance to Protocol             0             2
Withdrawal by Subject             4             1
Arm/Group Title Placebo Budesonide Total
Hide Arm/Group Description Placebo pMDI bid Budesonide pMDI 160 mcg bid Total of all reporting groups
Overall Number of Baseline Participants 152 152 304
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 152 participants 152 participants 304 participants
9.0  (1.62) 9.0  (1.63) 9.0  (1.62)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 152 participants 304 participants
6 to <8 years 33 33 66
8 to- <12 years 119 119 238
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 152 participants 304 participants
Female
58
  38.2%
54
  35.5%
112
  36.8%
Male
94
  61.8%
98
  64.5%
192
  63.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 152 participants 304 participants
Hispanic or Latino 10 11 21
Native Hawaiian/Pacific Islander 1 0 1
African American 7 9 16
Asian (other than Chinese and Japanese) 0 2 2
Not Applicable 128 126 254
Other 6 4 10
Forced expiratory volume in 1 second (FEV1)  
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 152 participants 152 participants 304 participants
1.70  (0.416) 1.69  (0.388) 1.70  (0.401)
1.Primary Outcome
Title Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average
Hide Description The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Time Frame Baseline to 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
Arm/Group Title Placebo Budesonide
Hide Arm/Group Description:
Placebo pMDI bid
Budesonide pMDI 160 mcg bid
Overall Number of Participants Analyzed 151 151
Least Squares Mean (Standard Error)
Unit of Measure: liters/minute
4.1  (3.19) 17.8  (3.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Budesonide
Comments Change from baseline to treatment period average was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments To address multiplicity, a step-down procedure was used. If the treatment difference for the primary variable, morning PEF, was statistically significant (p<0.05), then the key secondary variable, FEV1, was tested at the 0.05 level of significance.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 13.6
Confidence Interval (2-Sided) 95%
7.5 to 19.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.10
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average
Hide Description FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Time Frame Baseline to 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
Arm/Group Title Placebo Budesonide
Hide Arm/Group Description:
Placebo pMDI bid
Budesonide pMDI 160 mcg bid
Overall Number of Participants Analyzed 149 152
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.00  (0.023) 0.06  (0.023)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Budesonide
Comments Change from baseline to treatment period average was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0047
Comments To address multiplicity, a step-down procedure was used. If the treatment difference for the primary variable, morning PEF, was statistically significant (p<0.05), then the key secondary variable, FEV1, was tested at the 0.05 level of significance.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
0.02 to 0.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.022
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Evening PEF From Baseline to the Treatment Period Average
Hide Description The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Time Frame Baseline to 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
Arm/Group Title Placebo Budesonide
Hide Arm/Group Description:
Placebo pMDI bid
Budesonide pMDI 160 mcg bid
Overall Number of Participants Analyzed 150 151
Least Squares Mean (Standard Error)
Unit of Measure: liters/minute
4.0  (3.08) 14.7  (3.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Budesonide
Comments Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
4.9 to 16.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.00
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average
Hide Description FVC is the total volume of air expired after a full inspiration. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Time Frame Baseline to 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
Arm/Group Title Placebo Budesonide
Hide Arm/Group Description:
Placebo pMDI bid
Budesonide pMDI 160 mcg bid
Overall Number of Participants Analyzed 149 152
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.00  (0.021) 0.04  (0.021)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Budesonide
Comments Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0673
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
0.00 to 0.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.020
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average
Hide Description FEF25-75 is the average rate of airflow during the midportion of the forced vital capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.
Time Frame Baseline to 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
Arm/Group Title Placebo Budesonide
Hide Arm/Group Description:
Placebo pMDI bid
Budesonide pMDI 160 mcg bid
Overall Number of Participants Analyzed 149 152
Least Squares Mean (Standard Error)
Unit of Measure: liters/second
0.01  (0.045) 0.11  (0.045)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Budesonide
Comments Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0216
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
0.01 to 0.19
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.044
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average
Hide Description Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep.
Time Frame Baseline to 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
Arm/Group Title Placebo Budesonide
Hide Arm/Group Description:
Placebo pMDI bid
Budesonide pMDI 160 mcg bid
Overall Number of Participants Analyzed 151 152
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Daytime asthma symptom score -0.2  (0.06) -0.4  (0.06)
Total asthma symptom score -0.5  (0.11) -0.8  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Budesonide
Comments Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments Analysis for change in daytime asthma symptom score from baseline to treatment period average.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.31 to -0.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Budesonide
Comments Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0015
Comments Analysis for change in total asthma symptom score from baseline to treatment period average.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.55 to -0.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average
Hide Description Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep.
Time Frame Baseline to 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
Arm/Group Title Placebo Budesonide
Hide Arm/Group Description:
Placebo pMDI bid
Budesonide pMDI 160 mcg bid
Overall Number of Participants Analyzed 152 152
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.3  (0.06) -0.4  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Budesonide
Comments Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0079
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.26 to -0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.06
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average
Hide Description Patients, with the help of their caregiver, were asked to respond to a standard question each morning as they completed their eDiary. The question to be answered was, “Did your asthma cause you to wake-up last night?” If yes, patients were asked, “Did you need to use your reliever medication (albuterol/salbutamol inhaler) before you went back to sleep?” Baseline is defined as the percentage of days where patient experienced nighttime awakenings out of all available days where data was collected during the last 7 days of the run-in period.
Time Frame Baseline to 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
Arm/Group Title Placebo Budesonide
Hide Arm/Group Description:
Placebo pMDI bid
Budesonide pMDI 160 mcg bid
Overall Number of Participants Analyzed 152 152
Least Squares Mean (Standard Error)
Unit of Measure: percentage of days with awakenings
Nighttime awakenings -9.8  (1.81) -14.5  (1.84)
Nighttime awakenings with reliever use -6.1  (1.17) -10.0  (1.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Budesonide
Comments Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0095
Comments Analysis for change in nighttime awakenings from baseline to treatment period average.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -4.7
Confidence Interval (2-Sided) 95%
-8.2 to -1.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.78
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Budesonide
Comments Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments Analysis for change in nighttime awakenings with reliever medication use from baseline to treatment period average.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-6.2 to -1.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.15
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average
Hide Description The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, “How many albuterol/salbutamol inhalations since last diary entry?”
Time Frame Baseline to 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
Arm/Group Title Placebo Budesonide
Hide Arm/Group Description:
Placebo pMDI bid
Budesonide pMDI 160 mcg bid
Overall Number of Participants Analyzed 151 152
Least Squares Mean (Standard Error)
Unit of Measure: inhalations per day
Daytime reliever medication use -0.1  (0.07) -0.4  (0.07)
Total reliever medication use -0.3  (0.11) -0.7  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Budesonide
Comments Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments Analysis for change in daytime reliever medication use from baseline to treatment period average.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.4 to -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Budesonide
Comments Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Analysis for change in total reliever medication use from baseline to treatment period average.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-0.7 to -0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average
Hide Description The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, “How many albuterol/salbutamol inhalations since last diary entry?”
Time Frame Baseline to 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
Arm/Group Title Placebo Budesonide
Hide Arm/Group Description:
Placebo pMDI bid
Budesonide pMDI 160 mcg bid
Overall Number of Participants Analyzed 152 152
Least Squares Mean (Standard Error)
Unit of Measure: inhalations per day
-0.1  (0.06) -0.4  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Budesonide
Comments Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.3 to -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.06
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Withdrawals Due to Pre-defined Asthma Events
Hide Description Patients were considered to have experienced a “pre-defined asthma event” if any of the following conditions were met during the study: 1. At each visit or follow-up visit, a decrease in morning pre-dose FEV1 >=20% from the Visit 3 (randomization visit) morning pre-dose FEV1 or a decrease to <65% of predicted normal value; 2. The use of >=8 actuations of albuterol/salbutamol per day on 3 or more days within any period of 7 consecutive days following randomization; 3. A decrease in morning PEF >=20% from baseline on 3 or more days within any period of 7 consecutive days after randomization; 4. Two or more nights with an awakening due to asthma, which required the use of reliever medication within any period of 7 consecutive days after randomization; 5. A clinical exacerbation requiring emergency treatment, hospitalization, or use of an asthma medication not allowed by the study protocol.
Time Frame Baseline to 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.
Arm/Group Title Placebo Budesonide
Hide Arm/Group Description:
Placebo pMDI bid
Budesonide pMDI 160 mcg bid
Overall Number of Participants Analyzed 152 152
Measure Type: Number
Unit of Measure: participants
50 25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Budesonide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Budesonide pMDI 160mcg b.i.d. Placebo pMDI b.i.d.
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Budesonide pMDI 160mcg b.i.d. Placebo pMDI b.i.d.
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Budesonide pMDI 160mcg b.i.d. Placebo pMDI b.i.d.
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/152 (0.00%)      0/152 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Budesonide pMDI 160mcg b.i.d. Placebo pMDI b.i.d.
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/152 (17.76%)      40/152 (26.32%)    
Infections and infestations     
INFLUENZA  1  4/152 (2.63%)  5 4/152 (2.63%)  5
NASOPHARYNGITIS  1  12/152 (7.89%)  12 9/152 (5.92%)  11
PHARYNGITIS  1  5/152 (3.29%)  5 8/152 (5.26%)  8
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  3/152 (1.97%)  3 8/152 (5.26%)  9
Respiratory, thoracic and mediastinal disorders     
ASTHMA  1  1/152 (0.66%)  1 11/152 (7.24%)  11
OROPHARYNGEAL PAIN  1  3/152 (1.97%)  3 4/152 (2.63%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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: Geoff Gilmartin
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01136382     History of Changes
Other Study ID Numbers: D589GC00001
First Submitted: June 1, 2010
First Posted: June 3, 2010
Results First Submitted: March 25, 2014
Results First Posted: July 21, 2014
Last Update Posted: August 1, 2014