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

NCT04511897 | Unknown Phase 4

• 1 other identifier: 20200420
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bronchiectasis Adult

Keywords

Brochiectasis Adult; Hypersecretion; Exacerbation

Outcome Measures

Primary Outcomes (1)

• Numbers of acute exacerbation

  one year

Secondary Outcomes (5)

• The time to first exacerbation

  one year

• The volume of 24h sputum

  Six months

• Leicester Cough Questionnaire

  Six months

• Questionnaire of life-Bronchiectasis

  Six months

• Incidence of diarrhea

  Six months

Study Arms (2)

Experimental group

EXPERIMENTAL

oral An'ningpai Enteric Soft Capsules (300 mg,three times daily) for 12 months.

Drug: An'ningpai

Control group

NO INTERVENTION

No experimental durgs used.

Interventions

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.

Also known as: Expectorant

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

MeSH Terms

Interventions

Expectorants

Intervention Hierarchy (Ancestors)

Respiratory System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Jin-fu Xu, MD

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin-fu Xu, MD

CONTACT

+86 13321922898; jfxucn@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: August 13, 2020
• Study Start: January 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: December 2, 2020

Record last verified: 2020-11