Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations
Status
Unknown
Conditions
Bronchiectasis Adult
Treatments
Other: Usual care
Drug: Clarithromycin
Details and patient eligibility
About
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.
Enrollment
40 estimated patients
Sex
All
Ages
50+ years old
Volunteers
No 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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
40 participants in 2 patient groups, including a placebo group
Treatment
Active Comparator group
Description:
Patients will be given one tab of Clarithromycin 250mg daily.
Treatment:
Drug: Clarithromycin
usual care
Placebo Comparator group
Description:
Patients will receive usual medical care
Treatment:
Other: Usual care
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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