NCT05472350

Efficacy and Safety of Perioperative Use of Breztri Aerosphere to Relieve Cough After Lobectomy

Efficacy and Safety of Perioperative Use of Breztri Aerosphere to Relieve Cough After Lobectomy: A Prospective, Randomized, Placebo-controlled Single Center Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Jianxing He · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer, Nonsmall Cell
• Perioperative
• Cough
• Drug Effect
• Drug Toxicity

Interventions

Type	Name	Description
DRUG	Breztri Aerosphere	Breztri Aerosphere is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema).
OTHER	Placebo	placebo is 0.9% normal saline

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-08-01
• Completion: 2023-11-01
• First posted: 2022-07-25
• Last updated: 2022-07-25