Clinical trial NCT04658277: Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations
Official title: Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchiectasis Adult
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: number of infectious exacerbations
timeFrame: 26 weeks
Secondary outcomes:
measure: Time to first exacerbation (Days)
timeFrame: 26 weeks
measure: Rate of symptom-based exacerbations (number of events per month)
timeFrame: 26 weeks
measure: change of post bronchodilator Forced Expiratory volume in 1 sec and forced vital capacity
timeFrame: 26 weeks
measure: change of exercise capacity (flights of stairs)
timeFrame: 26 weeks
measure: change of St George Respiratory Questionnaire Score
timeFrame: 26 weeks
measure: change of concentration of serum c-reactive protein (mg/L)
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong
state: Please Select
Study officials:
References: