Antibiotics as a treatment of repeated asthmatic symptoms in children. A randomized, controlled study within the ABC-cohort (Asthma Begins in Childhood)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018592-16-DK

Enrollment

Registered

2010-10-04

Start date

2010-10-15

Completion date

Unknown

Last updated

2016-09-26

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

Conditions

Acute asthma exacerbations in children. MedDRA version: 12.1 Level: LLT Classification code 10049868 Term: Asthma exacerbation prophylaxis

Interventions

Trade Name: Azithromycin (Teva) Pharmaceutical Form: Oral suspension Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40- Pharmaceutical form of the pl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participant in the ABC-cohort study. Resident of Copenhagen, Sjælland, Møn, Lolland or Falster. Both parents are Danish speaking. Parents agree to enroll the child. The child is at least one year old. Has had one of the following asthma symptoms: 5 episodes within 6 mdr. (1 episode: 3 consecutive days with lower airway symptoms) or 4 weeks daily lung symptoms or acute severe asthma. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Allergy towards macrolide antibiotics, low liver function, low kidney function, neurological or psyciatric illness, congenital or documented prolonged QT-interval, clinically relevant bradycardia, heart arythmia or other serious heart conditions.

Design outcomes

Primary

Measure	Time frame
Main Objective: In the patient group 1-3 years of age, will treatment with antibiotics (azithromycin) significantly reduce the number and severity of asthmatic episodes compared to placebo?;Secondary Objective: No secondary objective;Primary end point(s): Changes in symptom score from day 1 until termination of each asthmatic episode during the age of 1-3 years. Duration of each asthmatic episode.	—

Measure

Time frame

Main Objective: In the patient group 1-3 years of age, will treatment with antibiotics (azithromycin) significantly reduce the number and severity of asthmatic episodes compared to placebo?;Secondary Objective: No secondary objective;Primary end point(s): Changes in symptom score from day 1 until termination of each asthmatic episode during the age of 1-3 years. Duration of each asthmatic episode.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026