Antibiotic Treatment of Recurrent Episodes of Asthma in Children (AB-studie)

Copenhagen Studies on Asthma in Childhood

Status and phase: Active, not recruiting; Phase 2

Conditions: Childhood Asthma With Acute Exacerbation

Treatments: Other: Placebo mixture; Drug: Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01233297

2010-018592-16

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 1 to 3 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Antibiotics

Active Comparator group

Description:

Azithromycin (10 mg/kg once a day for 3 days)

Treatment:

Drug: Azithromycin

Placebo

Placebo Comparator group

Description:

Placebo mixture (once a day for 3 days)

Treatment:

Other: Placebo mixture