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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    40
  • sponsor
    Chinese University of Hong Kong
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Updated on 3 November 2021
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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.

Details
Condition Bronchiectasis Adult
Treatment Placebo, Usual Care, clarithromycin
Clinical Study IdentifierNCT04658277
SponsorChinese University of Hong Kong
Last Modified on3 November 2021

Eligibility

 Yes No Not Sure

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
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