Cough Clinical Trial
Official title:
Efficacy and Safety of Perioperative Use of Breztri Aerosphere to Relieve Cough After Lobectomy: A Prospective, Randomized, Placebo-controlled Single Center Trial
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Jianxing He |
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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