Antibiotic Treatment of Recurrent Episodes of Asthma in Children

Phase 2

Active, not recruiting

• Conditions: Childhood Asthma With Acute Exacerbation
• Interventions: Other: Placebo mixture; Drug: Azithromycin

• Registration Number: NCT01233297
• Lead Sponsor: Copenhagen Studies on Asthma in Childhood

Brief Summary

Copsac has discovered that asthmatic exacerbations are as closely linked to bacterial as to viral infection. The current study will examine whether treatment of asthmatic exacerbations with macrolide antibiotics - in the abscence of clear clinical bacterial infection which would in any case precipitate antibiotic treatment - has an effect on either the particular episode, or subsequently. Macrolide antibiotics are chosen for ease of administration ensuring high compliance, antibiotic appropriacy, and anti-inflammatory properties.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-02
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-03
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-16
• Primary Completion: 2027-10
• Study Completion: 2033-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Participation in the COPSAC2010 cohort
• recurrent wheeze
• and others

Exclusion Criteria

• Macrolide allergy
• Heart, liver or kidney disease.
• and others

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo mixture	Placebo mixture (once a day for 3 days)
Antibiotics	Azithromycin	Azithromycin (10 mg/kg once a day for 3 days)

Primary Outcome Measures

Name	Time	Method
Symptom scoring	1 to 3 years of age
Duration in days of each asthmatic episode from randomisation start	1 to 3 years of age

Secondary Outcome Measures

Name	Time	Method
MD assessment of the episode	1 to 3 years of age
Family's assessment of the episode	1 to 3 years of age
Asthma related health and economic assessment	1 to 3 years of age
need for PO steroids during the episode	1 to 3 years of age
beta-agonist use during the asthmatic episode	1 to 3 years of age
stratification of the above parameters according to bacterial colonisation of the airways	1 to 3 years of age
time lapse until the next asthmatic episode	1 to 3 years of age
percentage of time away from kindergarten or, for the parents, away from work	1 to 3 years of age

Trial Locations

Locations (2)

Copsac, DBAC; 🇩🇰 Gentofte, Copenhagen, Denmark

Copsac, Næstved Hospital, Pediatric Department; 🇩🇰 Naestved, Denmark