Efficacy and Safety of An'Ningpai Expectorant in Non-CF Bronchiectasis

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Efficacy and Safety of An'Ningpai Enteric Soft Capsuleson in Stable Non-CF Bronchiectasis With Hypersecretion: a Open-label Randomized Controlled Trial

Conditions
-----------------
Bronchiectasis Adult

Intervention / Treatment
-----------------
* Drug: An'ningpai


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>oral An'ningpai Enteric Soft Capsules (300 mg,three times daily) for 12 months. | Drug: An'ningpai<br>* 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.<br>* Other names: Expectorant;|
| No Intervention: Control group<br>No experimental durgs used. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of acute exacerbation |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to first exacerbation |  | one year | 
| The volume of 24h sputum |  | Six months | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brochiectasis Adult, Hypersecretion, Exacerbation