Trial · NCT04636814
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The number of moderate and severe 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 corticosteroids (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 | The time to first moderate or severe exacerbation. |
| Secondary | The annual rate of severe exacerbations. | Up to 52 weeks | The annual rate of severe exacerbations. |
| Secondary | The time to first severe exacerbation. | Up to 52 weeks | The time to first severe exacerbation. |
| Secondary | The number of all on-treatment severe exacerbations. | Up to 52 weeks | The number of all on-treatment severe exacerbations. |
| Secondary | The number of all on-treatment exacerbations requiring systemic corticosteroids. | Up to 52 weeks | The number of all on-treatment exacerbations requiring systemic corticosteroids. |
| Secondary | Change from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52. | At week 52 | Change from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52. |
| Secondary | Change from baseline in Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52. | At week 52 | Change from baseline in Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52. |
| Secondary | Saint Georges Respiratory Questionnaire response (SGRQ) (change from baseline SGRQ total score ≤ -4) at week 52. | At week 52 | Saint Georges Respiratory Questionnaire response (SGRQ) (change from baseline SGRQ total score ≤ -4) at week 52. |
| Secondary | Change from baseline to last inter-visit period (week 40-52) in EXACT-Respiratory Symptoms (E-RS) Total and subscale scores. | Up to 52 weeks | Change from baseline to last inter-visit period (week 40-52) in EXACT-Respiratory Symptoms (E-RS) Total and subscale scores. |
| Secondary | E-RS response (change from baseline E-RS Total score ≤ -2) at week 52. | At week 52 | E-RS response (change from baseline E-RS Total score ≤ -2) 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 | Change from baseline to last inter-visit period (week 40-52) in the percentage of days |
| Secondary | Time to study medication discontinuation for any reason. | Up to 52 weeks | Time to study medication discontinuation for any reason. |
| 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 | 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. |
| Secondary | Time to first moderate/severe exacerbation or study medication discontinuation due to any class-related AE, lack of efficacy, or death (composite endpoint) and time to study medication discontinuation component. | Up to 52 weeks | Time to first moderate/severe exacerbation or study medication discontinuation due to any class-related AE, lack of efficacy, or death (composite endpoint) and time to study medication discontinuation component. |
| Secondary | Key Secondary Variable: Change from baseline in SGRQ Total score at week 52 | At week 52 | Key Secondary Variable: Change from baseline in SGRQ Total score at week 52 |
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/NCT04636814/registered