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

March 17, 2026 updated by: Professor Klaus Bønnelykke, Copenhagen Studies on Asthma in Childhood

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Næstved, Denmark, 4700
        • Copsac, Næstved Hospital, Pediatric Department
    • Copenhagen
      • Gentofte Municipality, Copenhagen, Denmark, 2820
        • Copsac, DBAC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Antibiotics
Azithromycin (10 mg/kg once a day for 3 days)
Drug: Azithromycin
10 mg/kg peroral for 3 consecutive days
Placebo Comparator: Placebo
Placebo mixture (once a day for 3 days)
Other: Placebo mixture
Placebo mixture containing no active substance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptom scoring
Time Frame: 1 to 3 years of age
1 to 3 years of age
Duration in days of each asthmatic episode from randomisation start
Time Frame: 1 to 3 years of age
1 to 3 years of age

Secondary Outcome Measures

Outcome Measure
Time Frame
need for PO steroids during the episode
Time Frame: 1 to 3 years of age
1 to 3 years of age
beta-agonist use during the asthmatic episode
Time Frame: 1 to 3 years of age
1 to 3 years of age
time lapse until the next asthmatic episode
Time Frame: 1 to 3 years of age
1 to 3 years of age
MD assessment of the episode
Time Frame: 1 to 3 years of age
1 to 3 years of age
Family's assessment of the episode
Time Frame: 1 to 3 years of age
1 to 3 years of age
Asthma related health and economic assessment
Time Frame: 1 to 3 years of age
1 to 3 years of age
percentage of time away from kindergarten or, for the parents, away from work
Time Frame: 1 to 3 years of age
1 to 3 years of age
stratification of the above parameters according to bacterial colonisation of the airways
Time Frame: 1 to 3 years of age
1 to 3 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen Studies on Asthma in Childhood

Investigators

  • Principal Investigator: Klaus Bønnelykke, MD, PhD, Copenhagen Studies on Asthma in Childhood

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2033

Study Registration Dates

First Submitted

November 2, 2010

First Submitted That Met QC Criteria

November 2, 2010

First Posted (Estimated)

November 3, 2010

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-018592-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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