Trial · NCT01782326
Outcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of COPD Exacerbations | 52 weeks | The per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Only PPS patients with non-missing values for all terms in negative binomial model are included. | COPD Exacerbations/year | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First COPD Exacerbation. | 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included. | Days | MEDIAN |
| SECONDARY | Rate of Moderate to Severe COPD Exacerbations. | 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included. | COPD Exacerbation/year | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Moderate to Severe COPD Exacerbation. | 52 weeks. | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in the Cox regression model are included. | Days | MEDIAN |
| SECONDARY | Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids | 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included. | COPD Exacerbation/year | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics | 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Only FAS patients with non-missing values for all terms in negative binomial model are included. | COPD Exacerbation/year | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Moderate to Severe COPD Exacerbations Requiring Hospitalization. COPD Exacerbations Starting Between First Dose and One Day After Last Treatment Are Included. | 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included. | COPD Exacerbation/year | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days | 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included. | COPD Exacerbation/year | MEAN |
| SECONDARY | Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids | 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included. | Days | MEDIAN |
| SECONDARY | Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics | 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included. | Days | MEDIAN |
| SECONDARY | Time to First Moderate to Severe COPD Exacerbations Requiring Hospitalization | 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included. | Days | MEDIAN |
| SECONDARY | Time to First Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days | 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included. | Days | MEDIAN |
| SECONDARY | Forced Expiratory Volume in 1 Second | Baseline, day 1 (30 min and one hour post dose) | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and did not have any major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included. | Liters | LEAST_SQUARES_MEAN |
| SECONDARY | Forced Expiratory Volume in 1 Second | Baseline, 4 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included. | Liters | LEAST_SQUARES_MEAN |
| SECONDARY | Forced Expiratory Volume in 1 Second | Baseline, 12 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included. | Liters | LEAST_SQUARES_MEAN |
| SECONDARY | Forced Expiratory Volume in 1 Second | Baseline, 26 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included. | Liters | LEAST_SQUARES_MEAN |
| SECONDARY | Forced Expiratory Volume in 1 Second | Baseline, 38 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included. | Liters | LEAST_SQUARES_MEAN |
| SECONDARY | Forced Expiratory Volume in 1 Second | Baseline, 52 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included. | Liters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Forced Expiratory Volume in 1 Second AUC (0-12h) | Baseline, 52 weeks | Serial spirometry set - Serial spirometry set includes the patients who performed additional serial spirometry, a subset of FAS. Only patients with non-missing values for all terms in MMRM are included. | Liters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total St. George's Respiratory Questionnaire Score | Baseline, 4 weeks | The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Only FAS patients with non-missing values for all terms in MMRM are included. | Score on a scale | LEAST_SQUARES_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/NCT01782326/outcomes