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

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchiectasis Adult
• Intervention / Treatment: Drug: Clarithromycin; Other: Usual care

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Please Select
    • Hong Kong, Please Select, Hong Kong
      • Recruiting
      • Chinese University of Hong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Treatment; Patients will be given one tab of Clarithromycin 250mg daily.	Drug: Clarithromycin; Patients in the intervention arm will take Clarithromycin 250mg daily.
PLACEBO_COMPARATOR: usual care; Patients will receive usual medical care	Other: Usual care; Patients will receive usual medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of infectious exacerbations	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Scores range from 0 to 100, with higher scores indicating more limitations.	26 weeks
change of concentration of serum c-reactive protein (mg/L)		26 weeks

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ANTICIPATED): September 30, 2023
• Study Completion (ANTICIPATED): September 30, 2023

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: December 6, 2020
• First Posted (ACTUAL): December 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 24, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Clarithromycin
• Other Study ID Numbers: Macrolid/Bronchiectasis/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No