NCT06619210

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

A Multicenter, Randomized, Placebo and Active Controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of HL231 Solution for Inhalation in Patients with Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study is a randomized, single-dose, multi-center, two-part, crossover, dose-ranging study of HL231 in the treatment of subjects with COPD. This study is divided into 2 parts. Part A is a 5 treatment period single dose study. Each treatment period will be separated by a washout period of at least 14 days. The primary comparison for bronchodilation was between HL231 doses vs Ultibro or placebo in COPD patients. Part B is a 3 treatment period single dose study. Each treatment period will be separated by a washout period of at least 14 days. The primary comparison for pharmacokinetic profile was between HL231 vs Ultibro in COPD patients.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	HL231 Dose 1/2/3/4	HL231 Solution for Inhalation, dose 1/2/3 (Part A) , dose 2/4（Part B） single dose, oral inhalation by PARI BOY nebulizer

Timeline

• Start date: 2022-01-12
• Primary completion: 2023-05-29
• Completion: 2023-05-29
• First posted: 2024-10-01
• Last updated: 2024-10-16

Locations

1 site across 1 country: China