Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-12 @ 9:51 AM
Study NCT ID:
NCT04509661
Status:
UNKNOWN
Last Update Posted:
2020-08-12
First Post:
2020-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Inhaled Bronchodilator in Non-CF Bronchiectasis With Airflow Limitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2020-04-22', 'studyFirstSubmitQcDate': '2020-08-11', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Actue exacerbation', 'timeFrame': 'One year', 'description': 'Times of acute exacerbation'}], 'secondaryOutcomes': [{'measure': 'modified Medical Research Council score', 'timeFrame': 'Six months', 'description': 'modified Medical Research Council score for the degree of dyspnea. The minimum value is 0 and maximum value is 4. Higher scores mean a worse outcome.'}, {'measure': 'Leicester Cough Questionnaire', 'timeFrame': 'Six months', 'description': 'Cough Questionnaire for the degree of cough. The minimum value is 1 and maximum value is 21. Higher scores mean a better outcome.'}, {'measure': 'Questionnaire of life-Bronchiectasis', 'timeFrame': 'Six months', 'description': 'Including eight scales: respiratory symptoms; physical, role, emotional, and social functioning; vitality; health perceptions; and treatment burden. For each scale, scores are standardized on a 0-to-100-point scale; higher scores indicate better health-related quality of life.'}, {'measure': 'FEV1, FVC', 'timeFrame': 'Six months', 'description': 'Forced Expiratory Volume In 1s and Forced Vital Capacity.'}, {'measure': 'FEV1%', 'timeFrame': 'Six months', 'description': 'The percent of predicted Forced Expiratory Volume In 1s'}, {'measure': 'Incidence of atrial fibrillation', 'timeFrame': 'Six months', 'description': 'One of common adverse events'}, {'measure': 'Incidence of coronary artery disease', 'timeFrame': 'Six months', 'description': 'One of common adverse events'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchiectasis Adult']}, 'descriptionModule': {'briefSummary': 'Airflow limitation is common exist in idiopathic bronchiectasis patients. However, there are few evidence on the treatment of bronchodilator in bronchiectasis with airflow limitation. The efficacy and safety of dual bronchodilator in idiopathic bronchiectasis with airflow limitation are still unclear. Thus, the investigators conduct a multicenter, open-label randomized controlled trial to investigate the efficacy and safety of dual bronchodilator in idiopathic bronchiectasis with airflow limitation.', 'detailedDescription': 'Airflow limitation is common exist in idiopathic bronchiectasis patients. Our previous studies showed that FEV1\\<50% is one of the major risk factors for poor prognosis and high incidence of acute exacerbation in patients with bronchiectasis. However, there are few evidence on the treatment of bronchodilator in bronchiectasis with airflow limitation, and there is no recommendation in bronchiectasis guidelines. Moreover, because of the high risk of infection and bacterial colonization in bronchiectasis, there is still unclear whether inhaled corticosteroids or bronchodilators affect the parameters of bronchiectasis. Thus, there is urgent need to optimize the treatment of bronchiectasis with airflow limitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Idiopathic bronchiectasis with FEV1/FVC \\< 70%\n\nExclusion Criteria:\n\n* With Asthma\n* α-1 antitrypsin deficiency\n* Turculosis\n* Lung cancer\n* Sarcoidosis\n* Idiopathic pulmonary fibrosis\n* Primary pulmonary hypertension\n* Uncontrolled sleep apnea\n* Bronchiectasis accepted long-term low dose macrolides\n* Pulmonary surgery within 6 months\n* Lower respiratory tract infections require antibiotic treatment in 6 weeks\n* Upper respiratory tract infection did not recover for at least 7 days\n* With Glaucoma or severe prostate hyperplasia that can not use Indacaterol\n* Patients allergic to experimental drugs\n* Women pregnant, breast-feeding or who planned a pregnancy during the study'}, 'identificationModule': {'nctId': 'NCT04509661', 'briefTitle': 'Efficacy and Safety of Inhaled Bronchodilator in Non-CF Bronchiectasis With Airflow Limitation', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Pulmonary Hospital, Shanghai, China'}, 'officialTitle': 'Efficacy and Safety of Inhaled Bronchodilator in Non-cystic Fibrosis Bronchiectasis Patients With Airflow Limitation: a Multicenter, Open-label Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '20200413'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Indacaterol-Glycopyrronium (110ug/50ug QD inhalation) for one year.', 'interventionNames': ['Drug: LABA/LAMA or Placebo inhalation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Placebo treatment for the airway limitation.', 'interventionNames': ['Drug: LABA/LAMA or Placebo inhalation']}], 'interventions': [{'name': 'LABA/LAMA or Placebo inhalation', 'type': 'DRUG', 'otherNames': ['Inhaled dual Bronchodilator'], 'description': 'Inhaled LABA/LAMA for one year.', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jin-fu Xu, MD', 'role': 'CONTACT', 'email': 'jfxucn@163.com', 'phone': '+86 13321922898'}], 'overallOfficials': [{'name': 'Jin-fu Xu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Pulmonary Hospital, Shanghai, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Pulmonary Hospital, Shanghai, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Department of Pulmonary and Critical Care Medicine', 'investigatorFullName': 'Jin-Fu Xu', 'investigatorAffiliation': 'Shanghai Pulmonary Hospital, Shanghai, China'}}}}