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The objective of this study was to assess whether the long-term use of oral An'Ningpai Enteric Soft Capsuleson (300 mg, three times daily, 12 months) might reduce the incidence of exacerbations and improve the quality of life in patients with Non-CF bronchiectasis.
Mucus hypersecretion plays an essential role in bronchiectasis. It has been deduced that reducing the production of mucus or improving the clearance of sputum in the airway is the key to break down this "vicious cycle" and enhance the therapeutic efficacy for bronchiectasis.
The investgators aimed to assess whether the long-term use of oral An'Ningpai Enteric Soft Capsules (300 mg, three times daily) might reduce the rate of exacerbations and improve the quality of life in patients with bronchiectasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | oral An'ningpai Enteric Soft Capsules (300 mg,three times daily) for 12 months. |
|
| Control group | No Intervention | No experimental durgs used. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| An'ningpai | Drug | An'ningpai Enteric Soft Capsules was a kind of expectorant, comprised with Eucalyptol, Limonene and Pinene. 300 mg, oral, three times daily for 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of acute exacerbation | one year |
| Measure | Description | Time Frame |
|---|---|---|
| The time to first exacerbation | one year | |
| The volume of 24h sputum | Six months | |
| Leicester Cough Questionnaire |
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Inclusion Criteria:
1) subjects older than 18 ; 2)a diagnosis of bronchiectasis was according to the 2010 British Thoracic Society guidelines; 3) with hypersecretion :high viscous sputum symptoms (sputum traits score 2-3 points) ;4) patients had least two exacerbations in the past year and were in a state for at least 4 weeks prior to randomization
Exclusion Criteria:
1) cystic fibrosis or other etiologies (such as immunodeficiency, allergic bronchopulmonary aspergillosis, traction bronchiectasis caused by emphysema, advanced pulmonary fibrosis, etc.); 2)primary diagnosis of COPD or asthma; 3)a history of severe cardiovascular disease; 4)comorbidity with liver disease, kidney disease, malignant tumor, gastric ulcer, or intestinal malabsorption; 5)a known allergy to Eucalyptol , Limonene and Pinene Enteric Soft Capsules; 6)pregnancy or lactation (for women);7)a history of prior macrolide use of more than 1 week; 8)and poor compliance
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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 | Principal Investigator |
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| ID | Term |
|---|---|
| D005100 | Expectorants |
| ID | Term |
|---|---|
| D019141 | Respiratory System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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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 | Questionnaire for the life of bronchiectasis. The minimum value is 0 and maximum value is 100; higher scores indicate better health-related quality of life. | Six months |
| Incidence of diarrhea | One of common adverse events | Six months |