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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bronchiectasis Adult
• Intervention / Treatment: Drug: An'ningpai

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group; oral An'ningpai Enteric Soft Capsules (300 mg,three times daily) for 12 months.	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.; Other Names: Expectorant
NO_INTERVENTION: Control group; No experimental durgs used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2021
• Primary Completion (ANTICIPATED): December 30, 2022
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: April 25, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (ACTUAL): August 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Exacerbation; Hypersecretion; Brochiectasis Adult
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis; Respiratory System Agents; Expectorants
• Other Study ID Numbers: 20200420

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No