Efficacy and Safety of Perioperative Use of Breztri Aerosphere to Relieve Cough After Lobectomy: A Prospective, Randomized, Placebo-controlled Single Center Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 128
- 主要终点
- Incidence of significant cough two weeks after surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Breztri Aerosphere Group
Participants will receive Breztri Aerosphere twice a day from 3 days before surgery to 14 days after surgery
干预措施: Breztri Aerosphere (Drug)
Placebo Group
Participants will receive 0.9% normal saline twice a day from 3 days before surgery to 14 days after surgery
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of significant cough two weeks after surgery
时间窗: 12 weeks
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.
次要结局
- 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)
- Inflammatory factor levels in venous blood before and after surgery(12 weeks)
- length of postoperative hospital stay(12 weeks)
- Incidence of serious postoperative pneumonia(12 weeks)
研究者
Jianxing He
Director
The First Affiliated Hospital of Guangzhou Medical University