Seabreeze STAT COPD
Seabreeze STAT COPD is a multicenter randomized study that evaluates the safety and efficacy of adding the new compound rademikibart to standard therapy for disease flares (exacerbations) in participants with eosinophilic COPD.
About This Study
Summary
Chronic obstructive pulmonary disease (COPD) includes several progressive lung diseases characterized by airway blockage and breathing problems. COPD is primarily due to long-term exposure to air-borne particles like cigarette smoke and air pollution. These particles damage the airways, leading to swelling and irritation (inflammation) of the tissue that lines the airways, coughing, mucus production, and wheezing.
For people who have a COPD flare-up (acute exacerbation), those with the disease type eosinophilic COPD are at increased risk of additional exacerbations. Seabreeze STAT COPD asks whether adding the new compound rademikibart to standard treatment for a flare-up is safe and effective and decreases the chance of later flare-ups in this patient population.
Participants who are enrolled to Seabreeze STAT COPD are randomized (50:50, like a coin toss) to receive either rademikibart plus standard therapy or placebo (something that looks like the study drug but contains no medication) plus standard therapy. Neither the lead scientist nor the participant can choose or will know which treatment they're given. Participants can expect to be involved with study activities (treatment assessment or follow-up) for a total of 56 days.
To be included in Seabreeze STAT COPD, participant must be / have
- Adult (40 to 80 years of age) with diagnosis of COPD for ≥ 12 months
- History of at least 1 COPD exacerbation requiring systemic corticosteroids
- Current acute COPD exacerbation requiring an urgent healthcare visit and systemic corticosteroids as standard-of-care treatment
- Current or former smoker with a history of smoking of at least 10 pack-years
To be included in Seabreeze STAT COPD, participants must not be / have
- Current diagnosis of or history of asthma
- Treatment with oral corticosteroids and/or hospitalization for COPD exacerbation completed within 4 weeks prior to randomization
- Known or suspected history of immunosuppression
- Chronic treatment with long-term oxygen therapy or nocturnal oxygen therapy required for at least 15 hours daily
Keywords
COPD; Eosinophilic COPD; Lungs and breathing; Pulmonary system
For More About This Study or To Ask About Participation
Additional Information
Lead scientist at Carilion Clinic
Dr. Wahid is an experienced clinical trialist and hospital medicine specialist. Her particular research focus is understanding how various nonmedical factors (including socioeconomic status, healthcare access, and environment) influence patient outcomes. Several of her studies address the management of sepsis, thrombosis prevention, and the long-term health of COVID-19 patients.
Official title of study
A phase 2, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the efficacy and safety of rademikibart as an add-on treatment for acute exacerbation in participants with chronic obstructive pulmonary disease and type 2 inflammation.
Funding mechanism
Industry sponsored by Connect Biopharm