Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-29 @ 3:19 AM
Study NCT ID:
NCT05472350
Status:
UNKNOWN
Last Update Posted:
2022-07-25
First Post:
2022-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Perioperative Use of Breztri Aerosphere to Relieve Cough After Lobectomy
Sponsor:
Jianxing He
Organization:
Study Overview
Official Title:
Efficacy and Safety of Perioperative Use of Breztri Aerosphere to Relieve Cough After Lobectomy: A Prospective, Randomized, Placebo-controlled Single Center Trial
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cough after lobectomy is common. The prevention and treatment of cough after lobectomy is not standardized. Breztri Aerosphere is often used to relieve cough. Therefore, we conduct a single center placebo-controlled study to evaluate the efficacy and safety of perioperative use of Breztri Aerosphere in relieving cough after lobectomy.
Detailed Description:
This study is a single-center, prospective, randomized, controlled clinical trial to understand the efficacy and safety of perioperative use of Breztri in relieving cough after lobectomy. This study plans to include 128 subjects from the Department of Thoracic Surgery of the First Affiliated Hospital of Guangzhou Medical University. Participants will be randomly divided into according Breztri group and placebo group to the ratio of 1:1. Participants in Placebo group will receive 0.9% normal saline for 3 days before operation and 14 days after operation (n=64). Participants in Breztri group will receive Breztri for 3 days before operation and 14 days after operation (n=64). All patients will undergo screening and baseline visits. After sugery, they will be followed up for 2 months.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: