A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.

Korábbi kezelés

• Treatment with oxygen >4.0 L/min for ≥8 hours/day Respiratory tract infection within 4 weeks before screening, or during the screening period
• Any biologic therapy (including experimental treatments and dupilumab)
• Participants on treatment with mucolytics unless on stable therapy for >6 months
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Más betegség

• A current diagnosis of asthma according to the Global Initiative for Asthma diagnostic (GINA) guidelines, or documented history of asthma

Laborértékek

• 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

Egyéb

• Diagnosis of α-1 anti-trypsin deficiency

• 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