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

NCT05472350 | Unknown

• 1 other identifier: FAH20220717
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The total and sub-scores of the Cough Evaluation Test (CET) score of each day after surgery

  12 weeks

• Incidence of significant cough 1 month after surgery

  12 weeks

• LCQ-MC at 1 month after surgery

  12 weeks

• the number of days the cough lasts

  12 weeks

• Cough start time

  12 weeks

Study Arms (2)

Breztri Aerosphere Group

EXPERIMENTAL

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

Drug: Breztri Aerosphere

Placebo Group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Breztri Aerosphere 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).

Breztri Aerosphere Group

Placebo OTHER

placebo is 0.9% normal saline

Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Outpatients, 18 years old ≤ age ≤ 70 years old, preoperative examination of cardiopulmonary function can tolerate surgery.
• Patients planning to undergo lobectomy.
• No obvious cough before surgery.

You may not qualify if:

• Participated in other interventional clinical trials 90 days before enrollment
• Pregnant and lactating women (budigrafo is not recommended during pregnancy and lactation)
• Patients with obvious cough before surgery (which affects the evaluation of drug effect)
• 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
• Preoperative respiratory infection, allergic rhinitis, bronchial asthma, chronic obstructive pulmonary disease, postnasal drip syndrome, oral ACEI drugs, CVA, EB, obvious acid reflux, heartburn, etc.
• Patients with severe cardiac insufficiency or heart-related diseases before surgery
• Diabetes before surgery
• Severe liver and kidney damage before surgery
• \) 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

Sponsors & Collaborators

• Jianxing He: lead

Related Publications (1)

• 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.

  PMID: 40386713 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Cough; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 25, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 25, 2022

Record last verified: 2022-07