Efficacy and Safety of Inhaled Bronchodilator in Non-CF Bronchiectasis With Airflow Limitation
1 other identifier
interventional
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2020
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2020
CompletedFirst Posted
Study publicly available on registry
August 12, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedAugust 12, 2020
April 1, 2020
3.8 years
April 22, 2020
August 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Actue exacerbation
Times of acute exacerbation
One year
Secondary Outcomes (7)
modified Medical Research Council score
Six months
Leicester Cough Questionnaire
Six months
Questionnaire of life-Bronchiectasis
Six months
FEV1, FVC
Six months
FEV1%
Six months
- +2 more secondary outcomes
Study Arms (2)
Experimental group
EXPERIMENTALIndacaterol-Glycopyrronium (110ug/50ug QD inhalation) for one year.
Control group
PLACEBO COMPARATORPlacebo treatment for the airway limitation.
Interventions
Inhaled LABA/LAMA for one year.
Eligibility Criteria
You may qualify if:
- Idiopathic bronchiectasis with FEV1/FVC \< 70%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- STUDY CHAIR
Jin-fu Xu, MD
Shanghai Pulmonary Hospital, Shanghai, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Department of Pulmonary and Critical Care Medicine
Study Record Dates
First Submitted
April 22, 2020
First Posted
August 12, 2020
Study Start
September 1, 2020
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
August 12, 2020
Record last verified: 2020-04