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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04509661
Other study ID # 20200413
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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