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

Bronchiectasis Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04658277
• Other study ID #: Macrolid/Bronchiectasis/2019
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis
• Bronchiectasis Adult

Intervention

Drug:
• Clarithromycin
Patients in the intervention arm will take Clarithromycin 250mg daily.

Other:
• Usual care
Patients will receive usual medical care

Locations

Country	Name	City	State
Hong Kong	Chinese University of Hong	Hong Kong	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of infectious exacerbations		26 weeks
Secondary	Time to first exacerbation (Days)		26 weeks
Secondary	Rate of symptom-based exacerbations (number of events per month)		26 weeks
Secondary	change of post bronchodilator Forced Expiratory volume in 1 sec and forced vital capacity		26 weeks
Secondary	change of exercise capacity (flights of stairs)		26 weeks
Secondary	change of St George Respiratory Questionnaire Score	Scores range from 0 to 100, with higher scores indicating more limitations.	26 weeks
Secondary	change of concentration of serum c-reactive protein (mg/L)		26 weeks