Brief Title
Efficacy and Safety of Inhaled Bronchodilator in Non-CF Bronchiectasis With Airflow Limitation
Official Title
Efficacy and Safety of Inhaled Bronchodilator in Non-cystic Fibrosis Bronchiectasis Patients With Airflow Limitation: a Multicenter, Open-label Randomized Controlled Trial
Brief Summary
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.
Detailed Description
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Actue exacerbation
Secondary Outcome
modified Medical Research Council score
Condition
Bronchiectasis Adult
Intervention
LABA/LAMA or Placebo inhalation
Study Arms / Comparison Groups
Experimental group
Description: Indacaterol-Glycopyrronium (110ug/50ug QD inhalation) for one year.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
200
Start Date
September 1, 2020
Completion Date
June 1, 2024
Primary Completion Date
June 1, 2024
Eligibility Criteria
Inclusion Criteria: - Idiopathic bronchiectasis with FEV1/FVC < 70% Exclusion Criteria: - With Asthma - α-1 antitrypsin deficiency - Turculosis - Lung cancer - Sarcoidosis - Idiopathic pulmonary fibrosis - Primary pulmonary hypertension - Uncontrolled sleep apnea - Bronchiectasis accepted long-term low dose macrolides - Pulmonary surgery within 6 months - Lower respiratory tract infections require antibiotic treatment in 6 weeks - Upper respiratory tract infection did not recover for at least 7 days - With Glaucoma or severe prostate hyperplasia that can not use Indacaterol - Patients allergic to experimental drugs - Women pregnant, breast-feeding or who planned a pregnancy during the study
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jin-fu Xu, MD, +86 13321922898, [email protected]
Administrative Informations
NCT ID
NCT04509661
Organization ID
20200413
Responsible Party
Principal Investigator
Study Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Study Sponsor
Jin-fu Xu, MD, Study Chair, Shanghai Pulmonary Hospital, Shanghai, China
Verification Date
April 2020