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

Primary Purpose

Lung Cancer, Nonsmall Cell, Perioperative, Cough

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Breztri Aerosphere
Placebo
Sponsored by
Jianxing He
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer, Nonsmall Cell

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Breztri Aerosphere Group

    Placebo Group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    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.
    LCQ-MC at 1 month after surgery
    Leicester Cough Questionnaire in Mandarin-Chinese (LCQ-MC) is a useful questionnaire to evaluate cough after surgery
    the number of days the cough lasts
    the number of days the cough lasts
    Cough start time
    Days from surgery to onset of cough
    Inflammatory factor levels in venous blood before and after surgery
    we test the inflammatory factor 3 days before surgery and 1 day after surgery
    Incidence of serious postoperative pneumonia
    we make a chest radiograph after surgery to find the postoperative pneumonia
    length of postoperative hospital stay
    length of postoperative hospital stay

    Full Information

    First Posted
    July 18, 2022
    Last Updated
    July 22, 2022
    Sponsor
    Jianxing He
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05472350
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    August 1, 2023 (Anticipated)
    Study Completion Date
    November 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jianxing He

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer, Nonsmall Cell, Perioperative, Cough, Drug Effect, Drug Toxicity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    128 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Breztri Aerosphere Group
    Arm Type
    Experimental
    Arm Description
    Participants will receive Breztri Aerosphere twice a day from 3 days before surgery to 14 days after surgery
    Arm Title
    Placebo Group
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive 0.9% normal saline twice a day from 3 days before surgery to 14 days after surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Breztri Aerosphere
    Intervention Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    placebo is 0.9% normal saline
    Primary Outcome Measure Information:
    Title
    Incidence of significant cough two weeks after surgery
    Description
    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
    Secondary Outcome Measure Information:
    Title
    The total and sub-scores of the Cough Evaluation Test (CET) score of each day after surgery
    Description
    Cough Evaluation Test (CET) is an easy way to assess the cough condition
    Time Frame
    12 weeks
    Title
    Incidence of significant cough 1 month after surgery
    Description
    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
    Title
    LCQ-MC at 1 month after surgery
    Description
    Leicester Cough Questionnaire in Mandarin-Chinese (LCQ-MC) is a useful questionnaire to evaluate cough after surgery
    Time Frame
    12 weeks
    Title
    the number of days the cough lasts
    Description
    the number of days the cough lasts
    Time Frame
    12 weeks
    Title
    Cough start time
    Description
    Days from surgery to onset of cough
    Time Frame
    12 weeks
    Title
    Inflammatory factor levels in venous blood before and after surgery
    Description
    we test the inflammatory factor 3 days before surgery and 1 day after surgery
    Time Frame
    12 weeks
    Title
    Incidence of serious postoperative pneumonia
    Description
    we make a chest radiograph after surgery to find the postoperative pneumonia
    Time Frame
    12 weeks
    Title
    length of postoperative hospital stay
    Description
    length of postoperative hospital stay
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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 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

    12. IPD Sharing Statement

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

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