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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
10 mg/kg peroral for 3 consecutive days
Placebo mixture containing no active substance.
Copsac, DBAC
Gentofte Municipality, Copenhagen, Denmark
Copsac, Næstved Hospital, Pediatric Department
Næstved, Denmark
Symptom scoring
Time frame: 1 to 3 years of age
Duration in days of each asthmatic episode from randomisation start
Time frame: 1 to 3 years of age
need for PO steroids during the episode
Time frame: 1 to 3 years of age
beta-agonist use during the asthmatic episode
Time frame: 1 to 3 years of age
time lapse until the next asthmatic episode
Time frame: 1 to 3 years of age
MD assessment of the episode
Time frame: 1 to 3 years of age
Family's assessment of the episode
Time frame: 1 to 3 years of age
Asthma related health and economic assessment
Time frame: 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
stratification of the above parameters according to bacterial colonisation of the airways
Time frame: 1 to 3 years of age
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