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

Overview

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.

Full Title of Study: “Efficacy and Safety of An’Ningpai Enteric Soft Capsuleson in Stable Non-CF Bronchiectasis With Hypersecretion: a Open-label Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 30, 2022

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.

Interventions

  • Drug: An’ningpai
    • 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.

Arms, Groups and Cohorts

  • Experimental: Experimental group
    • oral An’ningpai Enteric Soft Capsules (300 mg,three times daily) for 12 months.
  • No Intervention: Control group
    • No experimental durgs used.

Clinical Trial Outcome Measures

Primary Measures

  • Numbers of acute exacerbation
    • Time Frame: one year

Secondary Measures

  • The time to first exacerbation
    • Time Frame: one year
  • The volume of 24h sputum
    • Time Frame: Six months
  • Leicester Cough Questionnaire
    • Time Frame: Six months
    • Cough Questionnaire for the degree of cough. The minimum value is 1 and maximum value is 21. Higher scores mean a better outcome
  • Questionnaire of life-Bronchiectasis
    • Time Frame: Six months
    • 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.
  • Incidence of diarrhea
    • Time Frame: Six months
    • One of common adverse events

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Pulmonary Hospital, Shanghai, China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jin-Fu Xu, Chief of Department of Pulmonary and Critical Care Medicine – Shanghai Pulmonary Hospital, Shanghai, China
  • Overall Official(s)
    • Jin-fu Xu, MD, Principal Investigator, Shanghai Pulmonary Hospital, Shanghai, China
  • Overall Contact(s)
    • Jin-fu Xu, MD, +86 13321922898, jfxucn@163.com

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