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

NCT ID: NCT04509661

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2024-06-01

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.

Conditions

Bronchiectasis Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Indacaterol-Glycopyrronium (110ug/50ug QD inhalation) for one year.

Group Type: EXPERIMENTAL

LABA/LAMA or Placebo inhalation

Intervention Type: DRUG

Inhaled LABA/LAMA for one year.

Control group

Placebo treatment for the airway limitation.

Group Type: PLACEBO_COMPARATOR

LABA/LAMA or Placebo inhalation

Intervention Type: DRUG

Inhaled LABA/LAMA for one year.

Interventions

LABA/LAMA or Placebo inhalation

Inhaled LABA/LAMA for one year.

Intervention Type: DRUG

Other Intervention Names

Inhaled dual Bronchodilator

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: lead

Responsible Party

Jin-Fu Xu

Chief of Department of Pulmonary and Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin-fu Xu, MD

Role: STUDY_CHAIR

Shanghai Pulmonary Hospital, Shanghai, China

Central Contacts

Jin-fu Xu, MD

Role: CONTACT

jfxucn@163.com

+86 13321922898

Other Identifiers

20200413

Identifier Type: -

Identifier Source: org_study_id