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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