Overview

This trial is active, not recruiting.

Condition childhood asthma with acute exacerbation
Treatments azithromycin, placebo mixture
Phase phase 2
Sponsor Copenhagen Studies on Asthma in Childhood
Start date November 2010
End date May 2016
Trial size 70 participants
Trial identifier NCT01233297, 2010-018592-16

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Azithromycin (10 mg/kg once a day for 3 days)
azithromycin
10 mg/kg peroral for 3 consecutive days
(Placebo Comparator)
Placebo mixture (once a day for 3 days)
placebo mixture
Placebo mixture containing no active substance.

Primary Outcomes

Measure
Symptom scoring
time frame: 1 to 3 years of age
Duration in days of each asthmatic episode from randomisation start
time frame: 1 to 3 years of age

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 1 year up to 3 years old.

Inclusion Criteria: - Participation in the COPSAC2010 cohort - recurrent wheeze - and others Exclusion Criteria: - Macrolide allergy - Heart, liver or kidney disease. - and others

Additional Information

Official title Antibiotic Treatment of Recurrent Episode of Asthma in Children - a Randomised, Case-controlled Study Within the COPSAC2010 Cohort (Asthma Begins in Childhood)
Principal investigator Hans Bisgaard, MD, DMSc
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Copenhagen Studies on Asthma in Childhood.