RecruitingPhase 3NCT06643078

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

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)


Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Enrollment

474 participants

Start Date

Dec 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the safety and effectiveness of HL231, a new inhaled medication, in people of Chinese ethnicity with moderate to severe chronic obstructive pulmonary disease (COPD). **You may be eligible if...** - You are of Chinese ethnicity and at least 40 years old - You have been diagnosed with moderate to severe COPD confirmed by breathing tests - Your lung function tests show a significantly reduced FEV1 (air you can forcefully exhale in 1 second) - You experience significant breathlessness (mMRC score of at least 2) **You may NOT be eligible if...** - You have asthma, alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, or certain other lung diseases - You have a history of serious heart disease, uncontrolled diabetes, or narrow-angle glaucoma - You have been hospitalized for COPD or pneumonia in the past 8 weeks - You have had a respiratory infection in the past 4 weeks - You are allergic to anticholinergic inhalers, beta-agonists, or related medicines Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHL231 Solution for Inhalation

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.

DRUGUltibro 110μg/50 μg

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.


Locations(2)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

View Full Details on ClinicalTrials.gov

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NCT06643078


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