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

This study is currently recruiting participants.
Verified June 2012 by Copenhagen Studies on Asthma in Childhood
Sponsor:
Information provided by (Responsible Party):
Professor Hans Bisgaard, Copenhagen Studies on Asthma in Childhood
ClinicalTrials.gov Identifier:
NCT01233297
First received: November 2, 2010
Last updated: June 18, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Childhood Asthma With Acute Exacerbation
 Drug: Azithromycin
Other: Placebo mixture
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Asthma
U.S. FDA Resources

Further study details as provided by Copenhagen Studies on Asthma in Childhood:

Primary Outcome Measures:
  • Symptom scoring [ Time Frame: 1 to 3 years of age ] [ Designated as safety issue: No ]
  • Duration in days of each asthmatic episode from randomisation start [ Time Frame: 1 to 3 years of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • need for PO steroids during the episode [ Time Frame: 1 to 3 years of age ] [ Designated as safety issue: No ]
  • beta-agonist use during the asthmatic episode [ Time Frame: 1 to 3 years of age ] [ Designated as safety issue: No ]
  • time lapse until the next asthmatic episode [ Time Frame: 1 to 3 years of age ] [ Designated as safety issue: No ]
  • MD assessment of the episode [ Time Frame: 1 to 3 years of age ] [ Designated as safety issue: No ]
  • Family's assessment of the episode [ Time Frame: 1 to 3 years of age ] [ Designated as safety issue: No ]
  • Asthma related health and economic assessment [ Time Frame: 1 to 3 years of age ] [ Designated as safety issue: No ]
  • percentage of time away from kindergarten or, for the parents, away from work [ Time Frame: 1 to 3 years of age ] [ Designated as safety issue: No ]
  • stratification of the above parameters according to bacterial colonisation of the airways [ Time Frame: 1 to 3 years of age ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: November 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   1 Year to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233297

Contacts
Contact: Jakob Stokholm, MD (45)56514348 jakob.stokholm@dbac.dk

Locations
Denmark
Copsac, DBAC Recruiting
Gentofte, Copenhagen, Denmark, 2820
Contact         jakob.stokholm@dbac.dk    
Sub-Investigator: Nilo Følsgaard, MD            
Copsac, Næstved Hospital, Pediatric Department Recruiting
Naestved, Denmark, 4700
Contact: Jakob Stokholm     +45 56514348     jakob.stokholm@dbac.dk    
Sub-Investigator: Jakob Stokholm, MD            
Sponsors and Collaborators
Copenhagen Studies on Asthma in Childhood
Investigators
Principal Investigator: Hans Bisgaard, MD, DMSc Copenhagen Studies on Asthma in Childhood
  More Information

No publications provided

Responsible Party: Professor Hans Bisgaard, MD, DMSc, Copenhagen Studies on Asthma in Childhood
ClinicalTrials.gov Identifier: NCT01233297     History of Changes
Other Study ID Numbers: 2010-018592-16
Study First Received: November 2, 2010
Last Updated: June 18, 2012
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by Copenhagen Studies on Asthma in Childhood:
wheeze
infections

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Anti-Bacterial Agents
Azithromycin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013