Status:
UNKNOWN
Efficacy and Safety of An'Ningpai Expectorant in Non-CF Bronchiectasis
Lead Sponsor:
Shanghai Pulmonary Hospital, Shanghai, China
Conditions:
Bronchiectasis Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 im...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04511897
Start Date
January 1 2021
End Date
June 30 2023
Last Update
December 2 2020
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