In a subgroup of patients with COPD, there is an elevation in blood eosinophils. The Dupilumab study is designed to investigate the efficacy and safety of Dupilumab over one year in patients with COPD and Type II inflammation in need of additional treatment added to their current management.
This study is a multinational, RCT PHASE 3 to assess the efficacy, safety, and tolerability of Dupilumab in patients with moderate-or-severe COPD with Type II inflammation on triple therapy unless ICS contraindicated.
Contact Roel-Rolando Almario to enroll patients:
INCLUSION CRITERIA
* ≥40 to ≤80 yrs of age
* ≥10 pack-years smoking history
* Triple therapy (unless ICS is contraindicated) for min of 3 mo’s
* FEV1/FVC ratio <0.70
* FEV1 >30% and ≤70% pct predicted
* Chronic Bronchitis
* COPDE hx within the last year
* 1 severe exacerbation; hospitalization or >24 hrs in ED/urgent care facility OR
* 2 moderate exacerbations; either steroids or abx (but one requires steroid use)
KEY EXCLUSION CRITERIA
* Hx of Asthma
* Other active significant pulm dz
* Cor Pulmonale, right sided heart failure
* > 12 hrs of O2/day
* MI or Stroke within the last 6 mo’s
* Heart Failure (Class III or IV)
* Other exclusion criteria to be reviewed by the research coordinator