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

NCT04658277 | Unknown

• 1 other identifier: Macrolid/Bronchiectasis/2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis Adult

Outcome Measures

Primary Outcomes (1)

• number of infectious exacerbations

  26 weeks

Secondary Outcomes (6)

• 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 St George Respiratory Questionnaire Score

  26 weeks

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Patients will be given one tab of Clarithromycin 250mg daily.

Drug: Clarithromycin

usual care

PLACEBO COMPARATOR

Patients will receive usual medical care

Other: Usual care

Interventions

Clarithromycin DRUG

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

Treatment

Usual care OTHER

Patients will receive usual medical care

usual care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong

Hong Kong, Please Select, Hong Kong

RECRUITING

MeSH Terms

Interventions

Clarithromycin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: December 8, 2020
• Study Start: October 1, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)