Ensifentrine (MK-5884) Study for the Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in Adults With a History of Moderate or Severe Exacerbations While Receiving Standard of Care (SOC) (MK-5884-031/RPL554/ENHANCE-3)

Korábbi kezelés

• Is receiving long-term oxygen therapy defined as >15 hours per day
• Is currently using or has used a biologic therapy (e.g., dupilumab, mepolizumab, or tozorakimab) within 6 months prior to Screening Visit

Más betegség

• Has a history of intubation for respiratory failure within 1 year of Screening
• Uses chronic bilevel positive airway pressure for treatment of respiratory condition unless for treatment of sleep apnea at a stable pressure for at least 3 months
• Has history of or current malignancy of any organ system, treated or untreated within the past 5 years, except for localized basal or squamous cell carcinoma of the skin.

• Has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) that was made ≥12 months prior to randomization
• Has been on the stable treatment with the same standard of care (SOC) with long-acting muscarinic antagonist (LAMA)/long-acting beta-2 agonist (LABA)/inhaled corticosteroid (ICS) or LAMA/LABA (if ICS is not appropriate), for at least 2 months prior to Screening
• Has a documented history of ≥1 moderate or severe COPD exacerbation while on standard of care (SOC) within 1 year of Screening
• Is a current or former cigarette smoker with a history of cigarette smoking ≥10 packyears at Screening (number of pack-years = [number of cigarettes per day/20] × number of years smoked [e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]). Pipe, cigar, and/or e-cigarette/vape use cannot be used to calculate pack-year history.
• Has post-bronchodilator forced expiratory volume 1 (FEV1) ≥25% and <70% of Predicted Normal Value