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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05472350
Other study ID # FAH20220717
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2022
Est. completion date November 1, 2023

Study information

Verified date July 2022
Source The First Affiliated Hospital of Guangzhou Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 128
Est. completion date November 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Jianxing He

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary the number of days the cough lasts the number of days the cough lasts 12 weeks
Secondary Cough start time Days from surgery to onset of cough 12 weeks
Secondary 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
Secondary Incidence of serious postoperative pneumonia we make a chest radiograph after surgery to find the postoperative pneumonia 12 weeks
Secondary length of postoperative hospital stay length of postoperative hospital stay 12 weeks
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