Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-29 @ 3:19 AM
Study NCT ID:
NCT05472350
Status:
UNKNOWN
Last Update Posted:
2022-07-25
First Post:
2022-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Perioperative Use of Breztri Aerosphere to Relieve Cough After Lobectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D003371', 'term': 'Cough'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-22', 'studyFirstSubmitDate': '2022-07-18', 'studyFirstSubmitQcDate': '2022-07-22', 'lastUpdatePostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of significant cough two weeks after surgery', 'timeFrame': '12 weeks', '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.'}], 'secondaryOutcomes': [{'measure': 'The total and sub-scores of the Cough Evaluation Test (CET) score of each day after surgery', 'timeFrame': '12 weeks', 'description': 'Cough Evaluation Test (CET) is an easy way to assess the cough condition'}, {'measure': 'Incidence of significant cough 1 month after surgery', 'timeFrame': '12 weeks', '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.'}, {'measure': 'LCQ-MC at 1 month after surgery', 'timeFrame': '12 weeks', 'description': 'Leicester Cough Questionnaire in Mandarin-Chinese (LCQ-MC) is a useful questionnaire to evaluate cough after surgery'}, {'measure': 'the number of days the cough lasts', 'timeFrame': '12 weeks', 'description': 'the number of days the cough lasts'}, {'measure': 'Cough start time', 'timeFrame': '12 weeks', 'description': 'Days from surgery to onset of cough'}, {'measure': 'Inflammatory factor levels in venous blood before and after surgery', 'timeFrame': '12 weeks', 'description': 'we test the inflammatory factor 3 days before surgery and 1 day after surgery'}, {'measure': 'Incidence of serious postoperative pneumonia', 'timeFrame': '12 weeks', 'description': 'we make a chest radiograph after surgery to find the postoperative pneumonia'}, {'measure': 'length of postoperative hospital stay', 'timeFrame': '12 weeks', 'description': 'length of postoperative hospital stay'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer, Nonsmall Cell', 'Perioperative', 'Cough', 'Drug Effect', 'Drug Toxicity']}, 'referencesModule': {'references': [{'pmid': '40386713', 'type': 'DERIVED', 'citation': 'Dong J, Jiang S, Qiu Y, Li J, Cui F, Liang H, Lao S, Xie Z, Huang J, Hao Z, He H, Xv X, Zhang M, He M, Zhang Y, He J, Wang W. Budesonide/glycopyrronium/formoterol fumarate co-suspension metered dose inhaler relieves cough after lobectomy: a randomized controlled study. Transl Lung Cancer Res. 2025 Apr 30;14(4):1290-1300. doi: 10.21037/tlcr-24-905. Epub 2025 Apr 27.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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.\n2. Outpatients, 18 years old ≤ age ≤ 70 years old, preoperative examination of cardiopulmonary function can tolerate surgery.\n3. Patients planning to undergo lobectomy.\n4. No obvious cough before surgery.\n\nExclusion Criteria:\n\n1. Participated in other interventional clinical trials 90 days before enrollment\n2. Pregnant and lactating women (budigrafo is not recommended during pregnancy and lactation)\n3. Patients with obvious cough before surgery (which affects the evaluation of drug effect)\n4. 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\n5. Preoperative respiratory infection, allergic rhinitis, bronchial asthma, chronic obstructive pulmonary disease, postnasal drip syndrome, oral ACEI drugs, CVA, EB, obvious acid reflux, heartburn, etc.\n6. Patients with severe cardiac insufficiency or heart-related diseases before surgery\n7. Diabetes before surgery\n8. Severe liver and kidney damage before surgery\n\n8\\) 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'}, 'identificationModule': {'nctId': 'NCT05472350', 'briefTitle': 'Efficacy and Safety of Perioperative Use of Breztri Aerosphere to Relieve Cough After Lobectomy', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'Efficacy and Safety of Perioperative Use of Breztri Aerosphere to Relieve Cough After Lobectomy: A Prospective, Randomized, Placebo-controlled Single Center Trial', 'orgStudyIdInfo': {'id': 'FAH20220717'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breztri Aerosphere Group', 'description': 'Participants will receive Breztri Aerosphere twice a day from 3 days before surgery to 14 days after surgery', 'interventionNames': ['Drug: Breztri Aerosphere']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Participants will receive 0.9% normal saline twice a day from 3 days before surgery to 14 days after surgery', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Breztri Aerosphere', 'type': 'DRUG', '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).', 'armGroupLabels': ['Breztri Aerosphere Group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'placebo is 0.9% normal saline', 'armGroupLabels': ['Placebo Group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jianxing He', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Jianxing He', 'investigatorAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}}}}