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

Phase 3

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: HL231 Solution for Inhalation; Drug: Ultibro 110μg/50 μg

• Registration Number: NCT06643078
• Lead 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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-11
• Study First Submitted: 2024-09-29
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-14
• Last Update Submitted: 2024-10-14
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-15
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 474

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HL231 Solution for Inhalation	HL231 Solution for Inhalation	-
Ultibro	Ultibro 110μg/50 μg	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment	26 weeks

Secondary Outcome Measures

Name	Time	Method
Rate of Moderate to Severe COPD Exacerbations within weeks 26 and 52	26, 52 weeks
Change from baseline in Trough Forced Expiratory Volume In One Second (FEV1) at week 6,12,18,34,42,52.	6,12,18,34,42,52 weeks
Standardized FEV1 Area Under the Curve (AUC) From zero to 4 Hours at Day 1 and Week 26	Day 1,week 26
Change from baseline in COPD assessment test (CAT) score at Week 26 and 52.	26, 52 weeks
Rescue Medication Use: Summary of the Mean Daily Number of Puffs of Rescue Medication within Week 26 and 52.	26, 52 weeks
Adverse event rate	52 weeks	Adverse events are summarized according to the system organ classification and standard name, and the system organ classification and standard name are arranged in descending order of the frequency of the tested preparation group

Trial Locations

Locations (2)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China