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

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT04658277
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
35.9
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. number of infectious exacerbations [26 weeks]

Secondary Outcome Measures

  1. Time to first exacerbation (Days) [26 weeks]

  2. Rate of symptom-based exacerbations (number of events per month) [26 weeks]

  3. change of post bronchodilator Forced Expiratory volume in 1 sec and forced vital capacity [26 weeks]

  4. change of exercise capacity (flights of stairs) [26 weeks]

  5. change of St George Respiratory Questionnaire Score [26 weeks]

    Scores range from 0 to 100, with higher scores indicating more limitations.

  6. change of concentration of serum c-reactive protein (mg/L) [26 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chinese University of Hong Hong Kong Please Select Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Susanna SS Ng, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04658277
Other Study ID Numbers:
  • Macrolid/Bronchiectasis/2019
First Posted:
Dec 8, 2020
Last Update Posted:
Oct 29, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Bronchiectasis
Clarithromycin

Study Results

No Results Posted as of Oct 29, 2021