Efficacy and Safety of Inhaled Bronchodilator in Non-CF Bronchiectasis With Airflow Limitation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Inhaled Bronchodilator in Non-cystic Fibrosis Bronchiectasis Patients With Airflow Limitation: a Multicenter, Open-label Randomized Controlled Trial

Conditions
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Bronchiectasis Adult

Intervention / Treatment
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* Drug: LABA/LAMA or Placebo inhalation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Indacaterol-Glycopyrronium (110ug/50ug QD inhalation) for one year. | Drug: LABA/LAMA or Placebo inhalation<br>* Inhaled LABA/LAMA for one year.<br>* Other names: Inhaled dual Bronchodilator;|
| Placebo Comparator: Control group<br>Placebo treatment for the airway limitation. | Drug: LABA/LAMA or Placebo inhalation<br>* Inhaled LABA/LAMA for one year.<br>* Other names: Inhaled dual Bronchodilator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actue exacerbation | Times of acute exacerbation | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Medical Research Council score | 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. | Six months | 
| Leicester Cough Questionnaire | Cough Questionnaire for the degree of cough. The minimum value is 1 and maximum value is 21. Higher scores mean a better outcome. | Six months | 
| Questionnaire of life-Bronchiectasis | 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. | Six months | 
| FEV1, FVC | Forced Expiratory Volume In 1s and Forced Vital Capacity. | Six months | 
| FEV1% | The percent of predicted Forced Expiratory Volume In 1s | Six months | 
| Incidence of atrial fibrillation | One of common adverse events | Six months | 
| Incidence of coronary artery disease | One of common adverse events | Six months |