An interventional study of Breztri Aerosphere and Placebo in Lung Cancer, Nonsmall Cell, Perioperative and Cough, sponsored by Jianxing He. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-25.
Sponsored by Jianxing He · Not applicable, Interventional, and Treatment
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 128 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Jianxing He is the lead sponsor of 11 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Participants will receive Breztri Aerosphere twice a day from 3 days before surgery to 14 days after surgery
Drug: Breztri Aerosphere
Participants will receive 0.9% normal saline twice a day from 3 days before surgery to 14 days after surgery
Other: Placebo
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 is 0.9% normal saline
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.
Time frame: 12 weeks
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
Time frame: 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.
Time frame: 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
Time frame: 12 weeks
the number of days the cough lasts
the number of days the cough lasts
Time frame: 12 weeks
Cough start time
Days from surgery to onset of cough
Time frame: 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
Time frame: 12 weeks
Incidence of serious postoperative pneumonia
we make a chest radiograph after surgery to find the postoperative pneumonia
Time frame: 12 weeks
length of postoperative hospital stay
length of postoperative hospital stay
Time frame: 12 weeks
No study locations are listed for this record.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Jianxing He