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

NCT ID: NCT04658277

Last Updated: 2021-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchiectasis Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

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

Group Type ACTIVE_COMPARATOR

Clarithromycin

Intervention Type DRUG

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

usual care

Patients will receive usual medical care

Group Type PLACEBO_COMPARATOR

Usual care

Intervention Type OTHER

Patients will receive usual medical care

Interventions

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Clarithromycin

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

Intervention Type DRUG

Usual care

Patients will receive usual medical care

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Susanna SS Ng

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chinese University of Hong

Hong Kong, Please Select, Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Facility Contacts

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Susanna SS Ng, MBChB

Role: primary

Other Identifiers

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Macrolid/Bronchiectasis/2019

Identifier Type: -

Identifier Source: org_study_id