Antibiotics as a treatment of repeated asthmatic symptoms in children.A randomized, controlled study within the ABC-cohort (Asthma Begins in Childhood)
- Conditions
- Acute asthma exacerbations in children.MedDRA version: 12.1Level: LLTClassification code 10049868Term: Asthma exacerbation prophylaxis
- Registration Number
- EUCTR2010-018592-16-DK
- Lead Sponsor
- COPSAC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br><br>Duration of each asthmatic episode.<br><br>
- Secondary Outcome Measures
Name Time Method