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

PHASE3RecruitingINTERVENTIONAL
Enrollment

474

Participants

Timeline

Start Date

December 11, 2023

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
DRUG

HL231 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.

DRUG

Ultibro 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.

Trial Locations (2)

200433

RECRUITING

Shanghai Pulmonary Hospital, Shanghai

610041

RECRUITING

West China Hospital of Sichuan University, Chengdu

All Listed Sponsors
collaborator

Sichuan Haisco Pharmaceutical Group Co., Ltd

INDUSTRY

lead

Haisco Pharmaceutical Group Co., Ltd.

INDUSTRY

NCT06643078 - A Study to Evaluate the Safety and Efficacy of HL231 Solution for Inhalation in Patients with COPD | Biotech Hunter | Biotech Hunter