Bronchiectasis Adult
Conditions
Brief 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.
Interventions
DRUGClarithromycin
Patients in the intervention arm will take Clarithromycin 250mg daily.
OTHERUsual care
Patients will receive usual medical care
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of infectious exacerbations | 26 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Time to first exacerbation (Days) | 26 weeks | — |
| change of St George Respiratory Questionnaire Score | 26 weeks | Scores range from 0 to 100, with higher scores indicating more limitations. |
| change of concentration of serum c-reactive protein (mg/L) | 26 weeks | — |
| change of exercise capacity (flights of stairs) | 26 weeks | — |
Countries
Hong Kong
Outcome results
None listed