Trial · NCT02443688
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference From Placebo in Absolute Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted (ppFEV1) | Baseline, Week 48 | Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. The primary analysis was based upon the pooled results of the 100mg and 50mg doses. | FEV1 percent predicted | MEAN |
| SECONDARY | Number of Pulmonary Exacerbations Through 48 Weeks | Week 48 | Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled. | pulmonary exacerbations per year | MEAN |
| SECONDARY | Hazard Ratio Pulmonary Exacerbation While in the Study | Week 48 | Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled. | hazard ratio | NUMBER |
| SECONDARY | Subjects Without a Pulmonary Exacerbation While in the Study | Week 48 | Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Relative Change (Percent Change) From Baseline in ppFEV1 | Baseline, Week 48 | Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. (Observed Data). The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled. | percent change from baseline | MEAN |
| 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 | Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. (Observed Data). The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled. | absolute change of percent predicted | MEAN |
| SECONDARY | Change From Baseline for Specified Biomarkers | Baseline, Week 48 | Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment and who had results at Baseline and Week 48. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled. | log10(mcg/mL) | MEAN |
| SECONDARY | Change From Baseline for C-reactive Protein (Hs-CRP) | Baseline, Week 48 | Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment and who had results at Baseline and Week 48. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled. | mg/dL | MEAN |
| OTHER_PRE_SPECIFIED | Number of Pulmonary Exacerbation Per Year for Participants With ppFEV1 >75 at Baseline | Week 48 | Population of subjects with Baseline ppFEV1 \>75. The statistical analysis plans states the two active doses will be compared to placebo individually as well as combined. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled. | pulmonary exacerbations per year | MEAN |
| OTHER_PRE_SPECIFIED | Hazard Ratio Pulmonary Exacerbation for Participants With ppFEV1 >75 at Baseline | Week 48 | Population of subjects with Baseline ppFEV1 \>75. The statistical analysis plan states the two active doses will be compared to placebo individually as well as pooled. | hazard ratio | NUMBER |
| OTHER_PRE_SPECIFIED | Subjects Without a Pulmonary Exacerbation by Participants With ppFEV1 >75 at Baseline | Week 48 | Population of subjects with Baseline ppFEV1 \>75. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Pulmonary Exacerbation by Subjects if Taking CFTR-Modulator Therapy at Baseline | Week 48 | Population of subjects taking CFTR modulating therapy at Baseline. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled. | pulmonary exacerbations per year | MEAN |
| OTHER_PRE_SPECIFIED | Hazard Ratio Pulmonary Exacerbation by Subjects if Taking CFTR-Modulator Therapy at Baseline | Week 48 | Population of subjects taking CFTR modulating therapy at Baseline. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled. | hazard ratio | NUMBER |
| OTHER_PRE_SPECIFIED | Subjects Without a Pulmonary Exacerbation by Subjects if Taking CFTR-Modulator Therapy at Baseline | Week 48 | Population of subjects taking CFTR modulating therapy at Baseline. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Number of Pulmonary Exacerbation by Baseline FEV1 Percent Predicted at Week 48 | Week 48 | Subject's FEV1 percent predicted at screening are presented below. | pulmonary exacerbations per year | 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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02443688/outcomes