Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619210
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
A Trial to Evaluate the Safety and Efficacy of HL231 Solution for Inhalation in Patients with COPD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None