Clinical trial NCT04509661: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bronchiectasis Adult
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Actue exacerbation
timeFrame: One year
Secondary outcomes:
measure: modified Medical Research Council score
timeFrame: Six months
measure: Leicester Cough Questionnaire
timeFrame: Six months
measure: Questionnaire of life-Bronchiectasis
timeFrame: Six months
measure: FEV1, FVC
timeFrame: Six months
measure: FEV1%
timeFrame: Six months
measure: Incidence of atrial fibrillation
timeFrame: Six months
measure: Incidence of coronary artery disease
timeFrame: Six months
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Jin-fu Xu, MD
role: STUDY_CHAIR
References: