chronic bronchitis
Conditions
Interventions
- Dupilumab 300 mg/2 ml, administered as 1 SC injection q2w
- Placebo 2 ml, administered as 1 SC injection q2w
Sponsors
Genzyme Europe BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Participants with a physician diagnosis of 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-bronchodilator FEV1/FVC ratio 30% and =2 - Patient-reported history of signs and symptoms of chronic bronchitis (chronic productive cough) for 3 months in the year up to screening in the absence of other known causes of chronic cough - Documented history of high exacerbation risk defined as exacerbation history of >=2 moderate* or >=1 severe** within the year prior to inclusion. At least one exacerbation should have occurred while the patient was taking ICS/LAMA/LABA (or LAMA/LABA if ICS is contradicted). Moderate exacerbations are recorded by the Investigator and defined as AECOPD that require either systemic corticosteroids (intramuscular (IM), intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations has to require the use of systemic corticosteroids. Severe exacerbations are recorded by the Investigator and defined as AECOPD requiring hospitalization or observation >24 hours in emergency department/urgent care facility - Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for >=1 month prior to Visit 1; Double therapy LABA + LAMA allowed if ICS is contraindicated - Evidence of Type 2 inflammation: Patients with blood eosinophils >=300 cells/microliter at Visit 1
Exclusion criteria
Exclusion criteria: - COPD diagnosis for less than 12 months prior to randomization - Participants with current diagnosis of asthma according to the Global Initiative for Asthma (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, etc) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts - Cor pulmonale, evidence of right cardiac failure - Long-term treatment with oxygen >4.0 L/min OR if a participant requires more than 2.0 L/min in order to maintain oxygen saturation >88% - Hypercapnia requiring BiPAP - AECOPD as defined in inclusion criteria within 4 weeks prior to or during the screening period - Respiratory tract infection within 4 weeks prior to screening, or during the screening period - History of, or planned pneumonectomy or lung volume reduction surgery. Patients who are participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Annual rate of acute COPD exacerbation (AECOPD) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in SGRQ - Improvement in SGRQ - Change in pre-bronchodilator FEV1 from baseline to Week 52 - Change in pre-bronchodilator FEV1 from baseline to time points up to Week 44 - Change in post-bronchodilator FEV1 lung function - Change in forced expiratory flow (FEF) 25-75% - Annualized rate of severe AECOPD - Time to first AECOPD - Adverse events - Potentially clinically significant abnormality (PCSA) in laboratory tests - Anti-drug antibodies | — |
Countries
Netherlands
Outcome results
None listed