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

• Status: Recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Clarithromycin

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.