Clinical trial NCT05472350: Efficacy and Safety of Perioperative Use of Breztri Aerosphere to Relieve Cough After Lobectomy
Official title: Efficacy and Safety of Perioperative Use of Breztri Aerosphere to Relieve Cough After Lobectomy: A Prospective, Randomized, Placebo-controlled Single Center Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer, Nonsmall Cell
Perioperative
Cough
Drug Effect
Drug Toxicity
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of significant cough two weeks after surgery
timeFrame: 12 weeks
Secondary outcomes:
measure: The total and sub-scores of the Cough Evaluation Test (CET) score of each day after surgery
timeFrame: 12 weeks
measure: Incidence of significant cough 1 month after surgery
timeFrame: 12 weeks
measure: LCQ-MC at 1 month after surgery
timeFrame: 12 weeks
measure: the number of days the cough lasts
timeFrame: 12 weeks
measure: Cough start time
timeFrame: 12 weeks
measure: Inflammatory factor levels in venous blood before and after surgery
timeFrame: 12 weeks
measure: Incidence of serious postoperative pneumonia
timeFrame: 12 weeks
measure: length of postoperative hospital stay
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References: