ClinicaliQ Trial Snapshot
- A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease — Recruiting • Phase III • Respiratory / COPD / Asthma • NCT05595642.
- This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.
- Sponsor: Hoffmann-La Roche.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.
Eligibility Snapshot
- * Documented COPD diagnosis for ≥ 12 months * History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening * Post-bronchodilator FEV1 ≥ 20% and < 80% of predicted at screening * Post-bronchodilator FEV1/FVC < 0.70 at screening * Modified Medical Research Council (dyspnea scale) (mMRC) score ≥ 2 * Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years * On optimized COPD maintenance therapy as defined below for ≥ 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA * Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.