Trial · NCT04636801
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The number of moderate and severe COPD exacerbations occurring during the planned 52-week treatment period. | Up to 52 weeks | Moderate or severe exacerbation is defined by symptomatic worsening of COPD: * Moderate: requiring use of systemic corticosteroid (oral/IV/IM corticosteroids), and/or use of antibiotics * Severe: requiring hospitalisation or resulting in death |
| Secondary | The time to first moderate or severe exacerbation. | Up to 52 weeks | |
| Secondary | The annual rate of severe exacerbation. | Up to 52 weeks | |
| Secondary | The time to first severe exacerbation. | Up to 52 weeks | |
| Secondary | The number of on-treatment severe exacerbations. | Up to 52 weeks | |
| Secondary | Change from baseline (pre-dose visit 2) in pre-dose FEV1 at week 52. | At Week 52 | |
| Secondary | Change from baseline in SGRQ total and domain scores at week 52. | At week 52 | |
| Secondary | SGRQ response (change from baseline SGRQ total score ≤ -4) at week 52. | At week 52 | |
| Secondary | Change from baseline to last inter-visit period (week 40-52) in E-RS Total and subscale scores | Up to 52 weeks | |
| Secondary | E-RS response (change from baseline E-RS Total score ≤ -2) at week 52. | At week 52 | |
| Secondary | Change from baseline to last inter-visit period (week 40-52) in the percentage of days without intake of rescue medication and in the average rescue medication use (number of puffs) | Up to 52 weeks | |
| Secondary | Time to study medication discontinuation for any reason. | Up to 52 weeks | |
| Secondary | Time to moderate or severe exacerbation or study medication discontinuation due to any adverse event, lack of efficacy or death (composite endpoint) and time to study medication discontinuation component. | Up to 52 weeks |
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/NCT04636801/registered