Trial · NCT04053634
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized rate of moderate or severe COPD exacerbations | Over first 56 weeks | Moderate or severe COPD exacerbation is defined by symptomatic worsening of COPD requiring: * Use of systemic corticosteroids for at least 3 days; and/or * Use of antibiotics; and/or * An inpatient hospitalization or death due to COPD |
| Secondary | Annualized rate of severe COPD exacerbations | Minimum of 1 year and an average of 2 years | A severe COPD exacerbation is defined by symptomatic worsening of COPD requiring an inpatient hospitalization or results in death due to COPD |
| Secondary | Annualized rate of COPD exacerbations that are associated with an emergency room/emergency department visit or a hospitalization | Minimum of 1 year and an average of 2 years | |
| Secondary | Time to first COPD exacerbation | During first 56 weeks | |
| Secondary | Change from baseline in SGRQ total and domain scores | up to 56 weeks | St. George's Respiratory Questionnaire (SGRQ) |
| Secondary | Change from baseline in E-RS:COPD total and domain scores | up to 56 weeks | Evaluating Respiratory Symptoms in COPD (E-RS:COPD) |
| Secondary | Change from baseline in pre-dose/pre-bronchodilator FEV1 | up to 56 weeks | FEV1 is the Forced expiratory volume in one second at study site |
| Secondary | All cause and respiratory-related mortality rate | Minimum of 1 year and an average of 2 years | |
| Secondary | Annual rate of hospitalizations due to COPD | Minimum of 1 year and an average of 2 years | |
| Secondary | Serum benralizumab concentration as a measure of pharmacokinetics | up to 56 weeks | |
| Secondary | Anti-drug antibodies (ADA) as a measure of immunogenicity | up to 56 weeks | |
| Secondary | Change from baseline in CAT total score | up to 56 weeks | Chronic Obstructive Pulmonary Disease assessment tool (CAT) |
| Secondary | Length of hospital stay | Minimum of 1 year and an average of 2 years | |
| Secondary | ICU (Intensive Care Unit) days | Minimum of 1 year and an average of 2 years | |
| Secondary | Annual rate of hospitalizations and emergency department visits combined | Minimum of 1 year and an average of 2 years | |
| Secondary | Annual rate of unscheduled outpatient visits including unscheduled visits to study sites | Minimum of 1 year and an average of 2 years | |
| Secondary | Annual rate of unscheduled healthcare encounters | Minimum of 1 year and and average of 2 years | |
| Other | Safety and tolerability of benralizumab in patients with moderate to very severe COPD | Minimum of 1 year and average of 2 years | AEs, vital signs, clinical laboratory, and ECG |
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/NCT04053634/registered