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

Primary Purpose

Bronchiectasis Adult

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

An'ningpai

About this trial

This is an interventional treatment trial for Bronchiectasis Adult focused on measuring Brochiectasis Adult, Hypersecretion, Exacerbation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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

No experimental durgs used.

Outcomes

Primary Outcome Measures

Numbers of acute exacerbation

Secondary Outcome Measures

The time to first exacerbation

The volume of 24h sputum

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

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.

Incidence of diarrhea

One of common adverse events

Full Information

NCT ID

NCT04511897

First Posted

April 25, 2020

Last Updated

November 30, 2020

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

1. Study Identification

Unique Protocol Identification Number

NCT04511897

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2021 (Anticipated)

Primary Completion Date

December 30, 2022 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchiectasis Adult

Keywords

Brochiectasis Adult, Hypersecretion, Exacerbation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

No Intervention

Arm Description

No experimental durgs used.

Intervention Type

Drug

Intervention Name(s)

An'ningpai

Other Intervention Name(s)

Expectorant

Intervention Description

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.

Primary Outcome Measure Information:

Title

Numbers of acute exacerbation

Time Frame

one year

Secondary Outcome Measure Information:

Title

The time to first exacerbation

Time Frame

one year

Title

The volume of 24h sputum

Time Frame

Six months

Title

Leicester Cough Questionnaire

Description

Cough Questionnaire for the degree of cough. The minimum value is 1 and maximum value is 21. Higher scores mean a better outcome

Time Frame

Six months

Title

Questionnaire of life-Bronchiectasis

Description

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.

Time Frame

Six months

Title

Incidence of diarrhea

Description

One of common adverse events

Time Frame

Six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jin-fu Xu, MD

Phone

+86 13321922898

jfxucn@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jin-fu Xu, MD

Organizational Affiliation

Shanghai Pulmonary Hospital, Shanghai, China

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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