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Antibiotic Treatment of Recurrent Episodes of Asthma in Children

Antibiotic Treatment of Recurrent Episode of Asthma in Children - a Randomised, Case-controlled Study Within the COPSAC2010 Cohort (Asthma Begins in Childhood)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01233297
Acronym
AB-studie
Enrollment
70
Registered
2010-11-03
Start date
2010-11-01
Completion date
2033-10-01
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Asthma With Acute Exacerbation

Keywords

wheeze, infections

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.

Interventions

DRUGAzithromycin

10 mg/kg peroral for 3 consecutive days

Placebo mixture containing no active substance.

Sponsors

Copenhagen Studies on Asthma in Childhood
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Years to 3 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Symptom scoring1 to 3 years of age
Duration in days of each asthmatic episode from randomisation start1 to 3 years of age

Secondary

MeasureTime frame
need for PO steroids during the episode1 to 3 years of age
beta-agonist use during the asthmatic episode1 to 3 years of age
time lapse until the next asthmatic episode1 to 3 years of age
MD assessment of the episode1 to 3 years of age
Family's assessment of the episode1 to 3 years of age
Asthma related health and economic assessment1 to 3 years of age
percentage of time away from kindergarten or, for the parents, away from work1 to 3 years of age
stratification of the above parameters according to bacterial colonisation of the airways1 to 3 years of age

Countries

Denmark

Contacts

PRINCIPAL_INVESTIGATORKlaus Bønnelykke, MD, PhD

Copenhagen Studies on Asthma in Childhood

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026