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

Shanghai Pulmonary Hospital, Shanghai, China200 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Bronchiectasis Adult

Interventions

LABA/LAMA or Placebo inhalationDRUG

Inhaled LABA/LAMA for one year.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Actue exacerbation

Times of acute exacerbation

Time frame: One year

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Six months

FEV1, FVC

Forced Expiratory Volume In 1s and Forced Vital Capacity.

Time frame: Six months

FEV1%

The percent of predicted Forced Expiratory Volume In 1s

Time frame: Six months

Incidence of atrial fibrillation

One of common adverse events

Time frame: Six months

Incidence of coronary artery disease

One of common adverse events

Central Contacts

Jin-fu Xu, MD

CONTACT

+86 13321922898 jfxucn@163.com

Data from ClinicalTrials.gov

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