Antibiotic Treatment of Recurrent Episodes of Asthma in Children - Full Text View

Sponsor:	Copenhagen Studies on Asthma in Childhood
Information provided by (Responsible Party):	Professor Hans Bisgaard, Copenhagen Studies on Asthma in Childhood
ClinicalTrials.gov Identifier:	NCT01233297

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	Phase 2

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

Drug Information available for: Azithromycin Azithromycin dihydrate Azithromycin monohydrate

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
Placebo Comparator: Antibiotics asthma treatment Azithromycin	Drug: Azithromycin 10 mg/kg peroral for 3 consecutive days

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:	February 8, 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 24, 2012