Trial · NCT02345161
Outcomes49
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 49
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24 | Baseline to Week 24 | ITT Population | Liters (L) | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 52 | Baseline to Week 52 | Extension Population; Only participants with analyzable data at the given time point were analyzed. | Liters (L) | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in St George's Respiratory Questionnaire-Chronic Obstructive Pulmonary Disease (COPD; SGRQ) Total Score for COPD Participants at Week 24 | Baseline to Week 24 | ITT Population; Only participants with analyzable data at the given time point were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in St George's Respiratory Questionnaire-COPD; SGRQ Total Score for COPD Participants at Week 52 | Baseline to Week 52 | Extension Population; Only participants with analyzable data at the given time point were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Transitional Dyspnea Index (TDI) Focal Score Expressed as Least Square Mean at Week 24 | Week 24 | ITT Population; Only participants with analyzable data at the given time point were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Transitional Dyspnea Index (TDI) Focal Score Expressed as Least Square Mean at Week 52 | Week 52 | Extension Population; Only participants with analyzable data at the given time point were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Daily Activity Question Percentage of Days Reporting a Score of 2 up to Week 24 | Up to Week 24 | ITT Population; Only participants with analyzable data at the given time point were analyzed. | Percentage of days | LEAST_SQUARES_MEAN |
| SECONDARY | Daily Activity Question Percentage of Days Reporting a Score of 2 up to Week 52 | Up to Week 52 | Extension Population; Only participants with analyzable data at the given time point were analyzed. | Percentage of days | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Annual On-treatment Moderate and/or Severe COPD Exacerbations up to Week 24 | Up to Week 24 | ITT Population; Only participants with analyzable data at the given time point were analyzed. | Exacerbations per participant per year | MEAN |
| SECONDARY | Mean Annual On-treatment Moderate and/or Severe COPD Exacerbations up to Week 52 | Up to Week 52 | Extension Population; Only participants with analyzable data at the given time point were analyzed. | Exacerbations per participant per year | MEAN |
| SECONDARY | Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24 | Baseline to Week 24 | ITT Population | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52 | Baseline to Week 52 | Extension Population | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Any On-treatment Adverse Event (AE) and Serious Adverse Event (SAE) in the Treatment Period | Up to Week 24 | ITT Population | Participants | NUMBER |
| SECONDARY | Number of Participants With Any On-treatment AE/SAEs in the Extension Part of the Study | Up to Week 52 | Extension Population | Participants | NUMBER |
| SECONDARY | Number of Participants With an On-treatment Penumonia Event in the Treatment Period | Up to Week 24 | ITT Population. | Participants | NUMBER |
| SECONDARY | Number of Participants With an On-treatment Penumonia Event in the Extension Part of the Study | Up to Week 52 | Extension Population | Participants | NUMBER |
| SECONDARY | Number of Participants With Any On-treatment Cardiovascular (CV) Events (Including Supraventricular Arrhythmia and Non Fatal Myocardial Infarction) in the Treatment Period | Up to Week 24 | ITT Population | Participants | NUMBER |
| SECONDARY | Number of Participants With Any On-treatment CV Events (Including Supraventricular Arrhythmia and Non Fatal Myocardial Infarction) in the Extension Part of the Study | Up to Week 52 | Extension Population | Participants | NUMBER |
| SECONDARY | Change From Baseline in Heart Rate at Week 24 | Baseline and Week 24 | ITT Population; Only participants with analyzable data at the given time point were analyzed. | Beats per minute (Bpm) | MEAN |
| SECONDARY | Change From Baseline in Heart Rate at Week 52 | Baseline and Week 52 | Extension Population; Only participants with analyzable data at the given time point were analyzed. | Bpm | 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/NCT02345161/outcomes