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Trial · NCT02224157

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Annual Severe Asthma Exacerbation Rate - Non-inferiority AnalysisPlacebo Bid + Symbicort 'as Needed' (Experimental)0.1195% Confidence Interval 0.10 to 0.13exacerbations per participant year
Annual Severe Asthma Exacerbation Rate - Non-inferiority AnalysisPulmicort Bid + Terbutaline 'as Needed' (Active Comparator)0.1295% Confidence Interval 0.10 to 0.14exacerbations per participant year
Number of Participants Experiencing at Least One Severe Asthma ExacerbationPlacebo Bid + Symbicort 'as Needed' (Experimental)177Participants
Number of Participants Experiencing at Least One Severe Asthma ExacerbationPulmicort Bid + Terbutaline 'as Needed' (Active Comparator)184Participants
Average Change From Baseline in Pre-bronchodilator FEV1Placebo Bid + Symbicort 'as Needed' (Experimental)104.095% Confidence Interval 88.5 to 119.6mL
Average Change From Baseline in Pre-bronchodilator FEV1Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator)136.695% Confidence Interval 121.1 to 152.2mL
Number of Participants With Study Specific Asthma Related DiscontinuationPlacebo Bid + Symbicort 'as Needed' (Experimental)0Participants
Number of Participants With Study Specific Asthma Related DiscontinuationPulmicort Bid + Terbutaline 'as Needed' (Active Comparator)4Participants
Average Change From Baseline in 'as Needed' UsePlacebo Bid + Symbicort 'as Needed' (Experimental)-0.8495% Confidence Interval -0.86 to -0.81Number of inhalations per day
Average Change From Baseline in 'as Needed' UsePulmicort Bid + Terbutaline 'as Needed' (Active Comparator)-0.8795% Confidence Interval -0.89 to -0.84Number of inhalations per day
Change From Baseline in Percent of 'as Needed' Free DaysPlacebo Bid + Symbicort 'as Needed' (Experimental)41.0195% Confidence Interval 39.90 to 42.12Percentage of 'as needed' free days
Change From Baseline in Percent of 'as Needed' Free DaysPulmicort Bid + Terbutaline 'as Needed' (Active Comparator)47.8695% Confidence Interval 46.75 to 48.98Percentage of 'as needed' free days
Percentage of Controller Use DaysPlacebo Bid + Symbicort 'as Needed' (Experimental)30.4595% Confidence Interval 29.20 to 31.70Percentage of days
Percentage of Controller Use DaysPulmicort Bid + Terbutaline 'as Needed' (Active Comparator)67.9295% Confidence Interval 66.67 to 69.17Percentage of days
Average Change From Baseline in Asthma Control Questionnaire (5-item Version) - ACQ-5 ScorePlacebo Bid + Symbicort 'as Needed' (Experimental)-0.3595% Confidence Interval -0.38 to -0.32Score
Average Change From Baseline in Asthma Control Questionnaire (5-item Version) - ACQ-5 ScorePulmicort Bid + Terbutaline 'as Needed' (Active Comparator)-0.4695% Confidence Interval -0.49 to -0.43Score
Average Change From Baseline in Asthma Quality of Life Questionnaire Standardised Version - AQLQ(S) ScorePlacebo Bid + Symbicort 'as Needed' (Experimental)0.33595% Confidence Interval 0.305 to 0.366AQLQ(S) overall score
Average Change From Baseline in Asthma Quality of Life Questionnaire Standardised Version - AQLQ(S) ScorePulmicort Bid + Terbutaline 'as Needed' (Active Comparator)0.43195% Confidence Interval 0.400 to 0.461AQLQ(S) overall score
Annual Severe Asthma Exacerbation Rate - Superiority AnalysisPlacebo Bid + Symbicort 'as Needed' (Experimental)0.1195% Confidence Interval 0.10 to 0.13exacerbations per participant year
Annual Severe Asthma Exacerbation Rate - Superiority AnalysisPulmicort Bid + Terbutaline 'as Needed' (Active Comparator)0.1295% Confidence Interval 0.10 to 0.14exacerbations per participant year

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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