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Trial · NCT04636814

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryThe 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
SecondaryThe time to first moderate or severe exacerbation.Up to 52 weeksThe time to first moderate or severe exacerbation.
SecondaryThe annual rate of severe exacerbations.Up to 52 weeksThe annual rate of severe exacerbations.
SecondaryThe time to first severe exacerbation.Up to 52 weeksThe time to first severe exacerbation.
SecondaryThe number of all on-treatment severe exacerbations.Up to 52 weeksThe number of all on-treatment severe exacerbations.
SecondaryThe number of all on-treatment exacerbations requiring systemic corticosteroids.Up to 52 weeksThe number of all on-treatment exacerbations requiring systemic corticosteroids.
SecondaryChange from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52.At week 52Change from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52.
SecondaryChange from baseline in Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52.At week 52Change from baseline in Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52.
SecondarySaint Georges Respiratory Questionnaire response (SGRQ) (change from baseline SGRQ total score ≤ -4) at week 52.At week 52Saint Georges Respiratory Questionnaire response (SGRQ) (change from baseline SGRQ total score ≤ -4) at week 52.
SecondaryChange from baseline to last inter-visit period (week 40-52) in EXACT-Respiratory Symptoms (E-RS) Total and subscale scores.Up to 52 weeksChange from baseline to last inter-visit period (week 40-52) in EXACT-Respiratory Symptoms (E-RS) Total and subscale scores.
SecondaryE-RS response (change from baseline E-RS Total score ≤ -2) at week 52.At week 52E-RS response (change from baseline E-RS Total score ≤ -2) at week 52.
SecondaryChange 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 weeksChange from baseline to last inter-visit period (week 40-52) in the percentage of days
SecondaryTime to study medication discontinuation for any reason.Up to 52 weeksTime 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.
SecondaryKey Secondary Variable: Change from baseline in SGRQ Total score at week 52At week 52Key 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.

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GET https://conductscience.org/api/trials/v1/NCT04636814/registered