Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT01233297

Antibiotic Treatment of Recurrent Episodes of Asthma in Children

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Childhood Asthma With Acute Exacerbation Infections Pathological Conditions, Signs and Symptoms Respiratory Sounds Signs and Symptoms Signs and Symptoms, Respiratory

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Copsac, DBAC, Gentofte Municipality, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Azithromycin

Drug

10 mg/kg peroral for 3 consecutive days

Placebo mixture

Other

Placebo mixture containing no active substance.

Primary outcomes

  1. Symptom scoring

    Time frame: 1 to 3 years of age

  2. Duration in days of each asthmatic episode from randomisation start

    Time frame: 1 to 3 years of age

Secondary outcomes

  1. need for PO steroids during the episode

    Time frame: 1 to 3 years of age

  2. beta-agonist use during the asthmatic episode

    Time frame: 1 to 3 years of age

  3. time lapse until the next asthmatic episode

    Time frame: 1 to 3 years of age

  4. MD assessment of the episode

    Time frame: 1 to 3 years of age

  5. Family's assessment of the episode

    Time frame: 1 to 3 years of age

  6. Asthma related health and economic assessment

    Time frame: 1 to 3 years of age

  7. percentage of time away from kindergarten or, for the parents, away from work

    Time frame: 1 to 3 years of age

  8. stratification of the above parameters according to bacterial colonisation of the airways

    Time frame: 1 to 3 years of age

Sponsors and collaborators

Lead sponsor

Copenhagen Studies on Asthma in Childhood

Other

Registry information

Official study title

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

Acronym: AB-studie

Important dates

Study start
2010
Primary completion
2027
Study completion
2033
First posted
Nov 3, 2010
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.