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

NCT06643078 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 487

Last updated 2026-04-06

No results posted yet for this study

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)

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.

Sponsors & Collaborators

  • Sichuan Haisco Pharmaceutical Group Co., Ltd

    collaborator INDUSTRY

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-11
Primary Completion
2025-05-12
Completion
2025-12-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06643078 on ClinicalTrials.gov