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AB-studie: Antibiotic Treatment of Recurrent Episodes of Asthma in Children

Sponsor
Copenhagen Studies on Asthma in Childhood (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01233297
Collaborator
(none)
70
Enrollment
2
Locations
2
Arms
140
Duration (Months)
35
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Antibiotic Treatment of Recurrent Episode of Asthma in Children - a Randomised, Case-controlled Study Within the COPSAC2010 Cohort (Asthma Begins in Childhood)
Study Start Date :
Nov 1, 2010
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Symptom scoring [1 to 3 years of age]

  2. Duration in days of each asthmatic episode from randomisation start [1 to 3 years of age]

Secondary Outcome Measures

  1. need for PO steroids during the episode [1 to 3 years of age]

  2. beta-agonist use during the asthmatic episode [1 to 3 years of age]

  3. time lapse until the next asthmatic episode [1 to 3 years of age]

  4. MD assessment of the episode [1 to 3 years of age]

  5. Family's assessment of the episode [1 to 3 years of age]

  6. Asthma related health and economic assessment [1 to 3 years of age]

  7. percentage of time away from kindergarten or, for the parents, away from work [1 to 3 years of age]

  8. stratification of the above parameters according to bacterial colonisation of the airways [1 to 3 years of age]

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 3 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Participation in the COPSAC2010 cohort

  • recurrent wheeze

  • and others

Exclusion Criteria:

  • Macrolide allergy

  • Heart, liver or kidney disease.

  • and others

Contacts and Locations

Locations

Site City State Country Postal Code
1 Copsac, DBAC Gentofte Copenhagen Denmark 2820
2 Copsac, Næstved Hospital, Pediatric Department Naestved Denmark 4700

Sponsors and Collaborators

  • Copenhagen Studies on Asthma in Childhood

Investigators

  • Principal Investigator: Hans Bisgaard, MD, DMSc, Copenhagen Studies on Asthma in Childhood

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Professor Hans Bisgaard, MD, DMSc, Copenhagen Studies on Asthma in Childhood
ClinicalTrials.gov Identifier:
NCT01233297
Other Study ID Numbers:
  • 2010-018592-16
First Posted:
Nov 3, 2010
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Keywords provided by Professor Hans Bisgaard, MD, DMSc, Copenhagen Studies on Asthma in Childhood
wheeze
infections
Additional relevant MeSH terms:
Asthma
Azithromycin

Study Results

No Results Posted as of Mar 9, 2022