Antibiotic Treatment of Recurrent Episodes of Asthma in Children

Childhood Asthma With Acute Exacerbation Clinical Trial

— AB-studie  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01233297
• Other study ID #: 2010-018592-16
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 2010
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: Copenhagen Studies on Asthma in Childhood
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 3 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Asthma
• Childhood Asthma With Acute Exacerbation

Intervention

Drug:
• Azithromycin
10 mg/kg peroral for 3 consecutive days

Other:
• Placebo mixture
Placebo mixture containing no active substance.

Locations

Country	Name	City	State
Denmark	Copsac, DBAC	Gentofte	Copenhagen
Denmark	Copsac, Næstved Hospital, Pediatric Department	Naestved

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen Studies on Asthma in Childhood

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom scoring		1 to 3 years of age
Primary	Duration in days of each asthmatic episode from randomisation start		1 to 3 years of age
Secondary	need for PO steroids during the episode		1 to 3 years of age
Secondary	beta-agonist use during the asthmatic episode		1 to 3 years of age
Secondary	time lapse until the next asthmatic episode		1 to 3 years of age
Secondary	MD assessment of the episode		1 to 3 years of age
Secondary	Family's assessment of the episode		1 to 3 years of age
Secondary	Asthma related health and economic assessment		1 to 3 years of age
Secondary	percentage of time away from kindergarten or, for the parents, away from work		1 to 3 years of age
Secondary	stratification of the above parameters according to bacterial colonisation of the airways		1 to 3 years of age