A Study to Evaluate the Safety and Efficacy of HL231 Solution for Inhalation in Patients With COPD

Prior treatment

• Patients who have had hospitalized due to COPD or pneumonia within 8 weeks prior to screening (Visit 1) or screening.
• Patients who have had an acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, pharyngitis or urinary tract infections within 4 weeks prior to screening (Visit 1) or screening.
• Patients who have had a COPD exacerbation that required treatment with systemic steroids, hospitalization or emergency treatment in the 8 weeks prior to screening (Visit 1).
• Patients with conditions contraindicated for treatment with or having a history of allergy or hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof: Anticholinergic/muscarinic receptor antagonist, Long- or short-acting β2-agonists, Sympathomimetic amines, Lactose/milk proteins, or any of the other excipients of the delivery system.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Other illness

• Patients with any of the following diseases:α-1 antitrypsin deficiency, asthma, active pulmonary tuberculosis, lung cancer, pulmonary edema, cystic fibrosis, obliterated bronchiolitis, sarcoidosis, or other diseases that the investigator considers to be at risk of safety/efficacy for the patient, e.g lung fibrosis, pulmonary hypertension, interstitial lung disorder, active bronchiectasis.
• Patients with a history of serious cardiovascular disease;
• Patients with Type I or uncontrolled Type II diabetes;
• Patients with paradoxical bronchospasm, narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (benign prostatic hyperplasia patients who were stable on treatment could have been considered), bladder-neck obstruction, severe renal impairment, or urinary retention, or any other medical history, which, in the opinion of the investigator, would contraindicate the use of an anticholinergic agent;

• Males and females of Chinese ethnicity, at least 40 years of age.
• Patients with with a clinical diagnosis of moderate to severe COPD confirmed by spirometry according to according to GOLD criteria 2023.
• Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) \< 80% of the predicted normal value, and post-bronchodilator FEV1/FVC (Forced Vital Capacity) \< 0.70 at visit 1.
• Modified Medical Research Council (mMRC) grade of at least 2 at visit 1.