Last updated 6 days ago
A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
218 patients around the world
Available in Argentina, United States
Sanofi
218Patients around the world
This study is for people with
Chronic obstructive pulmonary disease
Copd
Requirements for the patient
To 85 Years
All Gender
Medical requirements
- Participants with a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD) who meet the following criteria at screening.Current or former smokers with a smoking history of ≥10 pack-years.Moderate-to-severe COPD (post-BD FEV1/FVC ratio <0.70 and post-BD FEV1 % predicted >30% and ≤70%).Medical Research Council Dyspnea Scale grade ≥2 or COPD assessment test (CAT) score ≥10.Global Initiative for Chronic Obstructive Lung Disease (GOLD) category E, Frequent or severe exacerbations.Background triple therapy (ICS + LABA + LAMA) for 3 months before randomization with a stable dose of medication for ≥1 month before Visit 1; dual therapy (LABA + LAMA) allowed if ICS is contraindicated.Evidence of Type 2 inflammation: Participants with blood eosinophils ≥300 cells/μL at screening or with blood eosinophils ≥150 cells/μL at Visit 1 (screening) and with a history of blood eosinophils ≥300 cells/μL within the past year during stable state (non-exacerbation).Mucus score cutoff of ≥3.
- A current diagnosis of asthma according to the Global Initiative for Asthma diagnostic (GINA) guidelines, or documented history of asthma.Significant pulmonary disease other than COPD (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.Treatment with oxygen >4.0 L/min for ≥8 hours/day Respiratory tract infection within 4 weeks before screening, or during the screening period.Diagnosis of α-1 anti-trypsin deficiency.Any biologic therapy (including experimental treatments and dupilumab).Participants on treatment with mucolytics unless on stable therapy for >6 months.
StudyAEOLUS
SponsorSanofi
Study typeInterventional
Conditions
Copd
Requirements
To 85 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07053423
