Trial · NCT01329029
Outcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year | 52 weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | exacerbations per patient per year | MEAN |
| SECONDARY | Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First Second (FEV1) | Baseline and Week 52 | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | liters | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Severe COPD Exacerbations Per Patient Per Year | 52 weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | exacerbations per patient per year | MEAN |
| SECONDARY | Rate of COPD Exacerbations Per Patient Per Year All Categories | 52 weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | exacerbations per patient per year | MEAN |
| SECONDARY | Percentage of Participants Experiencing at Least 1 COPD Exacerbation | 52 weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | percentage of participants | NUMBER |
| SECONDARY | Time to First COPD Exacerbation All Categories | 52 Weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized. | days | MEDIAN |
| SECONDARY | Time to Second Moderate or Severe COPD Exacerbation | 52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis) | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized. | days | MEDIAN |
| SECONDARY | Time to Third Moderate or Severe COPD Exacerbation | 52 Weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized. | days | MEDIAN |
| SECONDARY | Number of Patients Needed to Treat to Avoid 1 Moderate or Severe COPD Exacerbation Derived From Exacerbation Per Patient Per Year | 52 Weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | participants | NUMBER |
| SECONDARY | Number of Moderate or Severe COPD Exacerbation Days | 52 Weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | days | MEAN |
| SECONDARY | Duration of Moderate or Severe COPD Exacerbations Per Participant | 52 Weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. n in each of the categories is the number of participants with exacerbations. | days | MEAN |
| SECONDARY | Change From Baseline in Post-Bronchodilator Forced Vital Capacity (FVC) | 52 weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | liters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Post-Bronchodilator Forced Expiratory Flow at 25% to 75% of Vital Capacity (FEF25-75%) | 52 weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | liters/second | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First 6 Seconds (FEV6) | 52 weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | liters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Post-Bronchodilator FEV1/FVC | 52 weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | percent | MEAN |
| SECONDARY | Change From Baseline in Use of Rescue Medication From Daily Diary | Baseline and Week 52 | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data included in the repeated measurements analysis. | puffs per day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in COPD Symptom Score From Daily Diary | 52 weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Symptom-Free Days | 52 Weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | percentage of days | MEAN |
| SECONDARY | Percentage of Rescue Medication-Free Days | 52 Weeks | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | percentage of days | MEAN |
| SECONDARY | Change From Baseline in COPD Assessment Test (CAT) Total Score | Baseline and Week 52 | Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. | score on a scale | MEAN |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01329029/outcomes