NCT04509661

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	LABA/LAMA or Placebo inhalation	Inhaled LABA/LAMA for one year.

Timeline

• Start date: 2020-09-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2020-08-12
• Last updated: 2020-08-12