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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Indacaterol-Glycopyrronium (110ug/50ug QD inhalation) for one year. |
|
| Control group | Placebo Comparator | Placebo treatment for the airway limitation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LABA/LAMA or Placebo inhalation | Drug | Inhaled LABA/LAMA for one year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Actue exacerbation | Times of acute exacerbation | One year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Leicester Cough Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin-fu Xu, MD | Contact | +86 13321922898 | jfxucn@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin-fu Xu, MD | Shanghai Pulmonary Hospital, Shanghai, China | Study Chair |
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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 |
| 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 |
| FEV1, FVC | Forced Expiratory Volume In 1s and Forced Vital Capacity. | Six months |
| FEV1% | The percent of predicted Forced Expiratory Volume In 1s | Six months |
| Incidence of atrial fibrillation | One of common adverse events | Six months |
| Incidence of coronary artery disease | One of common adverse events | Six months |