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Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations

Primary Purpose

Bronchiectasis Adult

Status

Unknown status

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

Clarithromycin

Usual care

About this trial

This is an interventional treatment trial for Bronchiectasis Adult

Eligibility Criteria

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

Inclusion Criteria:

Patients aged 50 years or older
At least 2 or more exacerbation requiring antibiotic treatment in the past year Clinically stable for at least 4 weeks prior to enrollment (defined as no symptoms of exacerbation, no requirement for supplemental antibiotic therapy)
Diagnosis of bronchiectasis defined by high-resolution computed tomography (CT) scan

Exclusion Criteria:

History of cystic fibrosis; hypogammaglobulinemia; allergic bronchopulmonary aspergilosis,
Cigarette smoking within 6 months
A positive culture of non-tuberculosis mycobacteria in the past 2 years or at screening
Macrolide treatment for more than 3 months in the past 6 months
Oral or intravenous courses of corticosteroids within 30 days of screening
Any antimicrobial treatment for lower respiratory tract infection in the last 2 weeks
Unstable arrhythmia
History of coronary artery disease, or symptoms of heart disease
Known allergy or intolerance to macrolides
Patients with liver disease or with elevated transaminanse (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels equal to or greater than the upper limit of the normal)
Concurrent medication: Colchicine, calcium channel blocker, statins, amiodarone, amitriptyline, trazodone, citalopram, disopyramide, itraconazole, saquinavir, ritaonavir, atazanavir, sildenafil, tadalafil, vardenafil, theophylline, carbamazepine.

Sites / Locations

Chinese University of HongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment

usual care

Arm Description

Patients will be given one tab of Clarithromycin 250mg daily.

Patients will receive usual medical care

Outcomes

Primary Outcome Measures

number of infectious exacerbations

Secondary Outcome Measures

Time to first exacerbation (Days)

Rate of symptom-based exacerbations (number of events per month)

change of post bronchodilator Forced Expiratory volume in 1 sec and forced vital capacity

change of exercise capacity (flights of stairs)

change of St George Respiratory Questionnaire Score

Scores range from 0 to 100, with higher scores indicating more limitations.

change of concentration of serum c-reactive protein (mg/L)

Full Information

NCT ID

NCT04658277

First Posted

August 31, 2020

Last Updated

October 24, 2021

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT04658277

Brief Title

Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations

Official Title

Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

clarithromycin may reduce the exacerbations in middle-aged and elderly patients with non-CF bronchiectasis. The study is aimed to (A) investigate the etiologies and clinical features of patients with bronchiectasis, (B) compare the effect of clarithromycin 250mg daily on the frequency of exacerbations, quality of life and lung function, stratified according to the degree of bronchiectasis severity.

6. Conditions and Keywords

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

Bronchiectasis Adult

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Active Comparator

Arm Description

Patients will be given one tab of Clarithromycin 250mg daily.

Arm Title

usual care

Arm Type

Placebo Comparator

Arm Description

Patients will receive usual medical care

Intervention Type

Drug

Intervention Name(s)

Clarithromycin

Intervention Description

Patients in the intervention arm will take Clarithromycin 250mg daily.

Intervention Type

Other

Intervention Name(s)

Usual care

Intervention Description

Patients will receive usual medical care

Primary Outcome Measure Information:

Title

number of infectious exacerbations

Time Frame

26 weeks

Secondary Outcome Measure Information:

Title

Time to first exacerbation (Days)

Time Frame

26 weeks

Title

Rate of symptom-based exacerbations (number of events per month)

Time Frame

26 weeks

Title

change of post bronchodilator Forced Expiratory volume in 1 sec and forced vital capacity

Time Frame

26 weeks

Title

change of exercise capacity (flights of stairs)

Time Frame

26 weeks

Title

change of St George Respiratory Questionnaire Score

Description

Scores range from 0 to 100, with higher scores indicating more limitations.

Time Frame

26 weeks

Title

change of concentration of serum c-reactive protein (mg/L)

Time Frame

26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients aged 50 years or older At least 2 or more exacerbation requiring antibiotic treatment in the past year Clinically stable for at least 4 weeks prior to enrollment (defined as no symptoms of exacerbation, no requirement for supplemental antibiotic therapy) Diagnosis of bronchiectasis defined by high-resolution computed tomography (CT) scan Exclusion Criteria: History of cystic fibrosis; hypogammaglobulinemia; allergic bronchopulmonary aspergilosis, Cigarette smoking within 6 months A positive culture of non-tuberculosis mycobacteria in the past 2 years or at screening Macrolide treatment for more than 3 months in the past 6 months Oral or intravenous courses of corticosteroids within 30 days of screening Any antimicrobial treatment for lower respiratory tract infection in the last 2 weeks Unstable arrhythmia History of coronary artery disease, or symptoms of heart disease Known allergy or intolerance to macrolides Patients with liver disease or with elevated transaminanse (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels equal to or greater than the upper limit of the normal) Concurrent medication: Colchicine, calcium channel blocker, statins, amiodarone, amitriptyline, trazodone, citalopram, disopyramide, itraconazole, saquinavir, ritaonavir, atazanavir, sildenafil, tadalafil, vardenafil, theophylline, carbamazepine.

Facility Information:

Facility Name

Chinese University of Hong

City

Hong Kong

State/Province

Please Select

Country

Hong Kong

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Susanna SS Ng, MBChB

Phone

(852) 35053493

ssng@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations

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