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

Bronchiectasis Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04509661
• Other study ID #: 20200413
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 1, 2020
• Est. completion date: June 1, 2024

Study information

• Verified date: April 2020
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Jin-fu Xu, MD
• Phone: +86 13321922898
• Email: jfxucn[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Idiopathic bronchiectasis with FEV1/FVC < 70%

Exclusion Criteria:

• With Asthma

• a-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

Related Conditions & MeSH terms

• Bronchiectasis
• Bronchiectasis Adult

Intervention

Drug:
• LABA/LAMA or Placebo inhalation
Inhaled LABA/LAMA for one year.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actue exacerbation	Times of acute exacerbation	One year
Secondary	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
Secondary	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
Secondary	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
Secondary	FEV1, FVC	Forced Expiratory Volume In 1s and Forced Vital Capacity.	Six months
Secondary	FEV1%	The percent of predicted Forced Expiratory Volume In 1s	Six months
Secondary	Incidence of atrial fibrillation	One of common adverse events	Six months
Secondary	Incidence of coronary artery disease	One of common adverse events	Six months