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Trial · NCT01329029

Results by group74

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

OutcomeGroupCategoryValueSpreadUnits
Rate of Moderate or Severe COPD Exacerbations Per Patient Per YearRoflumilast 500 µg0.80595% Confidence Interval 0.724 to 0.895exacerbations per patient per year
Rate of Moderate or Severe COPD Exacerbations Per Patient Per YearPlacebo0.92795% Confidence Interval 0.843 to 1.020exacerbations per patient per year
Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First Second (FEV1)Roflumilast 500 µg0.052Standard Error 0.0064liters
Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First Second (FEV1)Placebo-0.004Standard Error 0.0062liters
Rate of Severe COPD Exacerbations Per Patient Per YearRoflumilast 500 µg0.23995% Confidence Interval 0.201 to 0.283exacerbations per patient per year
Rate of Severe COPD Exacerbations Per Patient Per YearPlacebo0.31595% Confidence Interval 0.270 to 0.368exacerbations per patient per year
Rate of COPD Exacerbations Per Patient Per Year All CategoriesRoflumilast 500 µgModerate0.57495% Confidence Interval 0.508 to 0.648exacerbations per patient per year
Rate of COPD Exacerbations Per Patient Per Year All CategoriesPlaceboModerate0.62795% Confidence Interval 0.561 to 0.702exacerbations per patient per year
Rate of COPD Exacerbations Per Patient Per Year All CategoriesRoflumilast 500 µgMild, Moderate or Severe3.07895% Confidence Interval 2.723 to 3.479exacerbations per patient per year
Rate of COPD Exacerbations Per Patient Per Year All CategoriesPlaceboMild, Moderate or Severe3.87995% Confidence Interval 3.492 to 4.310exacerbations per patient per year
Rate of COPD Exacerbations Per Patient Per Year All CategoriesRoflumilast 500 µgLeading to Hospitalisation0.23895% Confidence Interval 0.200 to 0.283exacerbations per patient per year
Rate of COPD Exacerbations Per Patient Per Year All CategoriesPlaceboLeading to Hospitalisation0.31395% Confidence Interval 0.268 to 0.365exacerbations per patient per year
Rate of COPD Exacerbations Per Patient Per Year All CategoriesRoflumilast 500 µgGlucocorticosteroids and/or Antibiotics treatment0.79495% Confidence Interval 0.716 to 0.88exacerbations per patient per year
Rate of COPD Exacerbations Per Patient Per Year All CategoriesPlaceboGlucocorticosteroids and/or Antibiotics treatment0.92995% Confidence Interval 0.847 to 1.019exacerbations per patient per year
Rate of COPD Exacerbations Per Patient Per Year All CategoriesRoflumilast 500 µgModerate or Severe and/or treated with Antibiotics1.01295% Confidence Interval 0.922 to 1.110exacerbations per patient per year
Rate of COPD Exacerbations Per Patient Per Year All CategoriesPlaceboModerate or Severe and/or treated with Antibiotics1.21095% Confidence Interval 1.115 to 1.313exacerbations per patient per year
Percentage of Participants Experiencing at Least 1 COPD ExacerbationRoflumilast 500 µg55.2percentage of participants
Percentage of Participants Experiencing at Least 1 COPD ExacerbationPlacebo60.5percentage of participants
Time to First COPD Exacerbation All CategoriesRoflumilast 500 µg218.095% Confidence Interval 189.0 to 259.0days
Time to First COPD Exacerbation All CategoriesPlacebo180.095% Confidence Interval 147.0 to 200.0days

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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