Effect of Ensifentrine (MK-5884/RPL554) on Sputum Markers of Inflammation in Chronic Obstructive Pulmonary Disease (COPD) (MK-5884-023/RPL554-CO-207)

Korábbi kezelés

• Hospitalizations for COPD exacerbation, pneumonia, or other respiratory infection in the 12 weeks prior to Screening.
• Not suitable for study supplied once daily COPD Maintenance Therapy per label warnings and contraindications
• Taking prohibited medication
• Prior receipt of Ohtuvayre or blinded nebulized study medication in an ensifentrine (RPL554) study. Note: Other ensifentrine formats (e.g., DPI, MPI) are not exclusionary
• Use of an experimental drug within 30 days or 5 half-lives of Screening, whichever is longer, and/or participation in a study treatment-free follow-up phase of a clinical trial within 30 days prior to Screening
• Use of an experimental medical device or participation in a follow-up phase of an experimental medical device clinical trial within 30 days prior to Screening

Más betegség

• Any clinically diagnosed lung disease other than COPD such as current asthma, diffuse interstitial lung diseases, cystic fibrosis, or clinically significant bronchiectasis as determined by the Investigator
• Human immunodeficiency virus (HIV) infection or other immunodeficiency
• History of cancer within the last 5 years, except for well-treated basal cell carcinoma and squamous cell carcinoma of the skin
• Known history of poor outcomes with sputum induction
• Known hypersensitivity to ensifentrine or other medications used in the study (e.g., albuterol or salmeterol)

Laborértékek

• Alanine aminotransferase (ALT) ≥ 2 x upper limit of normal (ULN), alkaline phosphatase and/or bilirubin > 1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
• Any clinically significant 12-lead electrocardiogram abnormalities at screening or baseline, including corrected QT interval by Fridericia's correction method >450 ms for males or >480 ms for females or history of significant cardiac dysrhythmia, including long QT syndrome
• Any other medical history, chronic uncontrolled diseases that the investigator considers clinically significant, examination or laboratory findings or reason that the Investigator considers makes the patient unsuitable to participate at Screening

• Participants with a history of cigarette smoking ≥10 pack years and an established clinical history of chronic obstructive pulmonary disease (COPD) as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD. 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]
• COPD Severity: Pre- and Post-albuterol/salbutamol Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio of <0.70; Post-albuterol/salbutamol FEV1 ≥30 % and ≤80% of predicted normal calculated using the National Health and Nutrition Examination Survey III
• Regular use of bronchodilator COPD therapy, in any form (e.g., [Long-acting muscarinic antagonist] LAMA, [Long-acting β2-agonist] LABA, LAMA+LABA, LAMA+LABA+ [Inhaled corticosteroid(s)] ICS), for at least 4 weeks prior to Screening and agrees to use study supplied COPD Maintenance Therapy once daily through the final study visit
• Capable of using the jet nebulizer correctly and complying with all study restrictions and procedures
• Ability to perform acceptable spirometry in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
• Ability to produce sputum samples during the induced sputum procedure