Trial · NCT06082037
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent change from baseline to Week 26 in forced expiratory volume in 1 second (FEV1) | Baseline to Week 26 | |
| Secondary | Response rate at Week 26 | Baseline to Week 26 | Defined as the proportion of participants with ≤10% decline in FEV1 at Week 26 compared with baseline |
| Secondary | Absolute change from baseline to Week 26 in FEV1 | Baseline to Week 26 | |
| Secondary | Absolute change from baseline to Week 26 in percent predicted FEV1 | Baseline to Week 26 | |
| Secondary | Percent change from baseline to Week 26 in forced vital capacity (FVC) | Baseline to Week 26 | |
| Secondary | Absolute change from baseline to Week 26 in FVC | Baseline to Week 26 | |
| Secondary | Absolute change from baseline to Week 26 in percent predicted FVC | Baseline to Week 26 | |
| Secondary | Time to CLAD progression during the double-blind treatment period | Baseline to Week 26 | Defined as the first of the following events: \>10% decline in FEV1 compared with baseline, or change in CLAD stage, or re-transplantation, or death |
| Secondary | Time to re-transplantation or death | Up to 7 days after the administration of last dose of study drug | |
| Secondary | Percent change from baseline to Week 26 in 6-minute walk distance | Baseline to Week 26 | |
| Secondary | Absolute change from baseline to Week 26 in 6-minute walk distance | Baseline to Week 26 | |
| Secondary | Change from baseline to Week 26 in Saint George Respiratory Questionnaire (SGRQ) | Baseline to Week 26 | Total score and scores by domain |
| Secondary | Change from baseline to Week 26 in EQ-5D-5L | Baseline to Week 26 | Visual analogue scale and individual dimensions |
| Secondary | Change from baseline to Week 26 in Patient-Reported Outcomes Measurement Information System-29 profile version 2.1 | Baseline to Week 26 | Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) profile V2.1 (domain scores) |
| Secondary | Number of participants with adverse events (AEs) and serious adverse events (SAEs) | Up to 7 days after the administration of last dose of study drug | Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), as well as laboratory abnormalities during the double-blind treatment period and the open-label extensions |
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/NCT06082037/registered