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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cough; Drug Effect; Lung Cancer, Nonsmall Cell; Perioperative; Drug Toxicity
• Intervention / Treatment: Drug: Breztri Aerosphere; Other: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects voluntarily participate in this research and abide by the research regulations, understand and comply with and cooperate with the corresponding inspections, comply with the follow-up plan, and voluntarily sign the written informed consent.
2. Outpatients, 18 years old ≤ age ≤ 70 years old, preoperative examination of cardiopulmonary function can tolerate surgery.
3. Patients planning to undergo lobectomy.
4. No obvious cough before surgery.

Exclusion Criteria:

1. Participated in other interventional clinical trials 90 days before enrollment
2. Pregnant and lactating women (budigrafo is not recommended during pregnancy and lactation)
3. Patients with obvious cough before surgery (which affects the evaluation of drug effect)
4. History of alcohol or narcotic drug abuse, or a history of mental illness, confrontational personality, bad motivation, paranoia, or other emotional or intellectual problems that may affect the informed validity of participation in this study
5. Preoperative respiratory infection, allergic rhinitis, bronchial asthma, chronic obstructive pulmonary disease, postnasal drip syndrome, oral ACEI drugs, CVA, EB, obvious acid reflux, heartburn, etc.
6. Patients with severe cardiac insufficiency or heart-related diseases before surgery
7. Diabetes before surgery
8. Severe liver and kidney damage before surgery

8) ACEI/ARB used within 1 month 9) Use of drugs that may cause cough or suppress cough within 1 month 9) Preoperative narrow-angle glaucoma, benign prostatic hyperplasia, or bladder neck obstruction 10) Patients who are using beta2 agonists or acetylcholine receptor antagonists or inhaled glucocorticoids 11) Tumor recurrence 13) Patients with severe infection or obvious pleural effusion found on postoperative chest X-ray

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breztri Aerosphere Group; Participants will receive Breztri Aerosphere twice a day from 3 days before surgery to 14 days after surgery	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).
Placebo Comparator: Placebo Group; Participants will receive 0.9% normal saline twice a day from 3 days before surgery to 14 days after surgery	Other: Placebo; placebo is 0.9% normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of significant cough two weeks after surgery	Cough Evaluation Test (CET) is an easy way to assess the cough condition. A Visual Analogue Scale (VAS) is a cough rating scale. Significnant cough means VAS more than 3 or any item of CET score more than 2.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total and sub-scores of the Cough Evaluation Test (CET) score of each day after surgery	Cough Evaluation Test (CET) is an easy way to assess the cough condition	12 weeks
Incidence of significant cough 1 month after surgery	Cough Evaluation Test (CET) is an easy way to assess the cough condition. A Visual Analogue Scale (VAS) is a cough rating scale. Significnant cough means VAS more than 3 or any item of CET score more than 2.	12 weeks
LCQ-MC at 1 month after surgery	Leicester Cough Questionnaire in Mandarin-Chinese (LCQ-MC) is a useful questionnaire to evaluate cough after surgery	12 weeks
the number of days the cough lasts	the number of days the cough lasts	12 weeks
Cough start time	Days from surgery to onset of cough	12 weeks
Inflammatory factor levels in venous blood before and after surgery	we test the inflammatory factor 3 days before surgery and 1 day after surgery	12 weeks
Incidence of serious postoperative pneumonia	we make a chest radiograph after surgery to find the postoperative pneumonia	12 weeks
length of postoperative hospital stay	length of postoperative hospital stay	12 weeks

Collaborators and Investigators

• Sponsor: Jianxing He

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Respiratory Tract Diseases; Neoplasms; Respiration Disorders; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Signs and Symptoms, Respiratory; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Drug-Related Side Effects and Adverse Reactions; Cough
• Other Study ID Numbers: FAH20220717

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No