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

Study Overview
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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.

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

Conditions
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Bronchiectasis Adult

Intervention / Treatment
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* Drug: Clarithromycin
* Other: Usual care


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>Patients will be given one tab of Clarithromycin 250mg daily. | Drug: Clarithromycin<br>* Patients in the intervention arm will take Clarithromycin 250mg daily.<br>|
| Placebo Comparator: usual care<br>Patients will receive usual medical care | Other: Usual care<br>* Patients will receive usual medical care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of infectious exacerbations |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first exacerbation (Days) |  | 26 weeks | 
| Rate of symptom-based exacerbations (number of events per month) |  | 26 weeks | 
| change of post bronchodilator Forced Expiratory volume in 1 sec and forced vital capacity |  | 26 weeks | 
| change of exercise capacity (flights of stairs) |  | 26 weeks | 
| change of St George Respiratory Questionnaire Score | Scores range from 0 to 100, with higher scores indicating more limitations. | 26 weeks | 
| change of concentration of serum c-reactive protein (mg/L) |  | 26 weeks |