Clinical trial NCT06643078: A Study to Evaluate the Safety and Efficacy of HL231 Solution for Inhalation in Patients with COPD
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Sichuan Haisco Pharmaceutical Group Co., Ltd
First posted: 2024-10-15
Enrollment: 474
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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) \&amp;lt; 80% of the predicted normal value, and post-bronchodilator FEV1/FVC (Forced Vital Capacity) \&amp;lt; 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.

Primary outcomes:
measure: Change from baseline in Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment
timeFrame: 26 weeks
Secondary outcomes:
measure: Rate of Moderate to Severe COPD Exacerbations within weeks 26 and 52
timeFrame: 26, 52 weeks
measure: Change from baseline in Trough Forced Expiratory Volume In One Second (FEV1) at week 6,12,18,34,42,52.
timeFrame: 6,12,18,34,42,52 weeks
measure: Standardized FEV1 Area Under the Curve (AUC) From zero to 4 Hours at Day 1 and Week 26
timeFrame: Day 1,week 26
measure: Change from baseline in COPD assessment test (CAT) score at Week 26 and 52.
timeFrame: 26, 52 weeks
measure: Rescue Medication Use: Summary of the Mean Daily Number of Puffs of Rescue Medication within Week 26 and 52.
timeFrame: 26, 52 weeks
measure: Adverse event rate
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References: