Trial · NCT02443688
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference From Placebo in Absolute Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted (ppFEV1) | Baseline, Week 48 | Difference from Placebo in absolute change from Baseline at Week 48 was assessed for FEV1 percent predicted. |
| Secondary | Number of Pulmonary Exacerbations Through 48 Weeks | Week 48 | Rate of protocol-defined pulmonary exacerbations reported through the Week 48/Early Termination visit will be annualized where a year is defined by 52 weeks and will be analyzed using a negative binomial regression. |
| Secondary | Hazard Ratio Pulmonary Exacerbation While in the Study | Week 48 | Hazard Ratio of pulmonary exacerbation versus placebo for all subjects. Pulmonary exacerbations are defined as treatment with oral, inhaled, or intravenous antibiotic(s) for ≥4 of symptoms/signs per the modified Fuchs criteria. |
| Secondary | Subjects Without a Pulmonary Exacerbation While in the Study | Week 48 | Subjects who did not experience a protocol-defined pulmonary exacerbation during the study |
| Secondary | Relative Change (Percent Change) From Baseline in ppFEV1 | Baseline, Week 48 | Percent change from Baseline for ppFEV1 at 48 weeks was assessed. |
| Secondary | Change From Baseline at 48 Weeks for Forced Vital Capacity Percent Predicted (FVC) and FEF25-75% (Forced Expiratory Flow During the Middle Half of the Forced Vital Capacity) Percent Predicted | Baseline, Week 48 | |
| Secondary | Change From Baseline for Specified Biomarkers | Baseline, Week 48 | Results were only calculated in subjects who had a verifiable result at the Baseline and Week 48 visits. |
| Secondary | Change From Baseline for C-reactive Protein (Hs-CRP) | Baseline, Week 48 | Results were only calculated in subjects who had a verifiable result at the Baseline and Week 48 visits. |
| Other | Number of Pulmonary Exacerbation Per Year for Participants With ppFEV1 >75 at Baseline | Week 48 | Rate of protocol-defined pulmonary exacerbations reported through the Week 48/Early Termination visit will be annualized where a year is defined by 52 weeks and will be analyzed using a negative binomial regression. |
| Other | Hazard Ratio Pulmonary Exacerbation for Participants With ppFEV1 >75 at Baseline | Week 48 | Hazard ratio of pulmonary exacerbation versus placebo for all subjects |
| Other | Subjects Without a Pulmonary Exacerbation by Participants With ppFEV1 >75 at Baseline | Week 48 | Subjects who did not experience a protocol-defined pulmonary exacerbation during the study. |
| Other | Number of Pulmonary Exacerbation by Subjects if Taking CFTR-Modulator Therapy at Baseline | Week 48 | Rate of protocol-defined pulmonary exacerbations reported through the Week 48/Early Termination visit will be annualized where a year is defined by 52 weeks and will be analyzed using a negative binomial regression. |
| Other | Hazard Ratio Pulmonary Exacerbation by Subjects if Taking CFTR-Modulator Therapy at Baseline | Week 48 | Hazard Ratio pulmonary exacerbation versus placebo for all subjects taking CFTR-modulating therapy at Baseline |
| Other | Subjects Without a Pulmonary Exacerbation by Subjects if Taking CFTR-Modulator Therapy at Baseline | Week 48 | Subjects who did not experience a protocol-defined pulmonary exacerbation during the study. |
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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GET https://conductscience.org/api/trials/v1/NCT02443688/registered