Summary:
This clinical study is testing an investigational treatment for adults with chronic obstructive pulmonary disease (COPD) who remain symptomatic despite standard therapy. The study will assess whether the treatment can reduce COPD flare-ups and improve breathing and quality of life compared with placebo. Participant safety and treatment tolerability will be monitored throughout the study period.
1. Age 40–80 years
2. BMI 18–40 kg/m², weight ≥40 kg
3. History of physician-diagnosed COPD ≥1 year
4. Current or former smokers (≥10 pack-years)
5. History of ≥2 moderate or ≥1 severe exacerbations in the past year
Moderate exacerbations: defined as exacerbations/flare up that requires either systemic (Oral/ IV) corticosteroids for at least 3 days and/or antibiotics. At least 1 of the 2 required moderate exacerbations must involve the use of systemic corticosteroids.
Severe exacerbations: defined as exacerbations/flare up of COPD requiring hospitalization or emergency room (or urgent care facility) visit lasting >24 hours
6. On stable triple therapy (LABA + LAMA + ICS) ≥12 weeks. (Could be single or combination inhalers)
7. At least one of the required exacerbations must have happened while on the current triple therapy regimen
8. At least one of the COPD exacerbations/ flare up must have happened while on the current triple therapy regimen
Key Exclusions (short list):
- History of cancer within 5 years (except certain skin cancers like completely treated basal and squamous or treated cervical carcinoma in situ)
- Active cancer
- Pregnant or breastfeeding
- 24-hour oxygen dependency is an exclusion
Qualified Participants May Receive:
Stipend from $100 to $200 per visit.
Mileage will be reimbursed.