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

Not Applicable

• Conditions: Bronchiectasis Adult
• Interventions: Other: Usual care; Drug: Clarithromycin

• Registration Number: NCT04658277
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-31
• Study Start: 2020-10-01
• Study First Submitted QC: 2020-12-06
• Study First Posted: 2020-12-08
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-24
• Last Update Posted: 2021-10-29
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usual care	Usual care	Patients will receive usual medical care
Treatment	Clarithromycin	Patients will be given one tab of Clarithromycin 250mg daily.

Primary Outcome Measures

Name	Time	Method
number of infectious exacerbations	26 weeks

Secondary Outcome Measures

Name	Time	Method
change of St George Respiratory Questionnaire Score	26 weeks	Scores range from 0 to 100, with higher scores indicating more limitations.
Time to first exacerbation (Days)	26 weeks
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
change of exercise capacity (flights of stairs)	26 weeks
change of concentration of serum c-reactive protein (mg/L)	26 weeks

Trial Locations

Locations (1)

Chinese University of Hong; 🇭🇰 Hong Kong, Please Select, Hong Kong