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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bronchiectasis Adult
• Intervention / Treatment: Drug: LABA/LAMA or Placebo inhalation

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Investigators: Study Chair: Jin-fu Xu, MD, Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Asthmatic Agents; Respiratory System Agents; Bronchodilator Agents
• Other Study ID Numbers: 20200413

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No