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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breztri Aerosphere Group | Experimental | Participants will receive Breztri Aerosphere twice a day from 3 days before surgery to 14 days after surgery |
|
| Placebo Group | Placebo Comparator | Participants will receive 0.9% normal saline twice a day from 3 days before surgery to 14 days after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40386713 | Derived | 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. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D003371 | Cough |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Placebo | Other | placebo is 0.9% normal saline |
|
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 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064419 | Chemically-Induced Disorders |