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

Shanghai Pulmonary Hospital, Shanghai, China

Status and phase: Not yet enrolling; Phase 4

Conditions: Bronchiectasis Adult

Treatments: Drug: LABA/LAMA or Placebo inhalation

Study type: Interventional

Funder types: Other

Identifiers

NCT04509661

20200413

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

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

Treatment:

Drug: LABA/LAMA or Placebo inhalation

Control group

Placebo Comparator group

Description:

Placebo treatment for the airway limitation.

Treatment:

Drug: LABA/LAMA or Placebo inhalation