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NCT06643078 | RECRUITING | Chronic Obstructive Pulmonary Disease (COPD)

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

Haisco Pharmaceutical Group Co., Ltd.

Brief Summary:

To evaluate the efficacy and safety of HL231 Solution for Inhalation vs Ultibro in Chinese patients with moderate to very severe COPD

Condition or disease

Chronic Obstructive Pulmonary Disease (COPD)

Intervention/treatment

HL231 Solution for Inhalation

Ultibro 110μg/50 μg

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 474 participants
Masking : SINGLE
Masking Description : single blind（Outcomes Assessor）
Primary Purpose : TREATMENT
Official Title : A Multicenter, Randomized, Single-blind, Active-controlled, Parallel-designed Phase III Clinical Study to Evaluate the Efficacy and Safety of HL231 Solution for Inhalation in Patients with Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date : 2023-12-11
Estimated Primary Completion Date : 2025-10
Estimated Study Completion Date : 2025-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Males and females of Chinese ethnicity, at least 40 years of age.
  • 2. Patients with with a clinical diagnosis of moderate to severe COPD confirmed by spirometry according to according to GOLD criteria 2023.
  • 3. 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.
  • 4. Modified Medical Research Council (mMRC) grade of at least 2 at visit 1.
Exclusion Criteria
  • 1. 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.
  • 2. Patients with a history of serious cardiovascular disease;
  • 3. Patients with Type I or uncontrolled Type II diabetes;
  • 4. 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;
  • 5. Patients who have had hospitalized due to COPD or pneumonia within 8 weeks prior to screening (Visit 1) or screening.
  • 6. 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.
  • 7. 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).
  • 8. 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.
A Study to Evaluate the Safety and Efficacy of HL231 Solution for Inhalation in Patients with COPD

Location Details

NCT06643078

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How to Participate

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Locations

RECRUITING

China, Shanghai Municipality

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China, 200433

RECRUITING

China, Sichuan

West China Hospital of Sichuan University

Chengdu, Sichuan, China, 610041