Efficacy and Safety of Perioperative Use of Breztri Aerosphere to Relieve Cough After Lobectomy

Jianxing He

Status: Not yet enrolling

Conditions: Lung Cancer, Nonsmall Cell; Perioperative; Cough; Drug Effect; Drug Toxicity

Treatments: Drug: Breztri Aerosphere; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05472350

FAH20220717

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups, including a placebo group

Breztri Aerosphere Group

Experimental group

Description:

Participants will receive Breztri Aerosphere twice a day from 3 days before surgery to 14 days after surgery

Treatment:

Drug: Breztri Aerosphere

Placebo Group

Placebo Comparator group

Description:

Participants will receive 0.9% normal saline twice a day from 3 days before surgery to 14 days after surgery

Treatment:

Other: Placebo