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

NCT ID: NCT05472350

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-11-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Breztri Aerosphere Group

Participants will receive Breztri Aerosphere twice a day from 3 days before surgery to 14 days after surgery

Group Type: EXPERIMENTAL

Breztri Aerosphere

Intervention Type: DRUG

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 Group

Participants will receive 0.9% normal saline twice a day from 3 days before surgery to 14 days after surgery

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

placebo is 0.9% normal saline

Interventions

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).

Intervention Type: DRUG

Placebo

placebo is 0.9% normal saline

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jianxing He

OTHER

Sponsor Role: lead

Responsible Party

Jianxing He

Director

Responsibility Role: SPONSOR_INVESTIGATOR

References

Dong J, Jiang S, Qiu Y, Li J, Cui F, Liang H, Lao S, Xie Z, Huang J, Hao Z, He H, Xv X, Zhang M, He M, Zhang Y, He J, Wang W. Budesonide/glycopyrronium/formoterol fumarate co-suspension metered dose inhaler relieves cough after lobectomy: a randomized controlled study. Transl Lung Cancer Res. 2025 Apr 30;14(4):1290-1300. doi: 10.21037/tlcr-24-905. Epub 2025 Apr 27.

Reference Type: DERIVED

PMID: 40386713 (View on PubMed)

Other Identifiers

FAH20220717

Identifier Type: -

Identifier Source: org_study_id