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

NCT06643078 | Recruiting Phase 3

• 1 other identifier: HEISCO-231-301
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment

  26 weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

HL231 Solution for Inhalation

EXPERIMENTAL

Drug: HL231 Solution for Inhalation

Ultibro

ACTIVE COMPARATOR

Drug: Ultibro 110μg/50 μg

Interventions

HL231 Solution for Inhalation DRUG

HL231 Solution for Inhalation, 3ml:261 μg/141μg, once per day via PARI BOY nebulizer, consisting of a fixed dose combination of indacaterol 261µg and glycopyrronium 141µg, treatment period; 52-weeks fixed dose.

HL231 Solution for Inhalation

Ultibro 110μg/50 μg DRUG

Ultibro capsule for inhalation once per day via Breezhaler, consisting of a fixed dose combination of indacaterol 110µg and glycopyrronium 50µg, treatment period; 52-weeks fixed dose.

Ultibro

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead
• Sichuan Haisco Pharmaceutical Group Co., Ltd: collaborator

Study Sites (2)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single blind（Outcomes Assessor）
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 15, 2024
• Study Start: December 11, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)