Clinical Trial of Fluticasone Versus Placebo at the Onset of a Cold for Children With Asthma
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ClinicalTrials.gov Identifier: NCT00238927
Recruitment Status :
First Posted : October 14, 2005
Last Update Posted : March 27, 2014
McGill University Health Centre/Research Institute of the McGill University Health Centre
Medical Research Council of Canada
Information provided by (Responsible Party):
Francine Ducharme, McGill University Health Centre/Research Institute of the McGill University Health Centre
The purpose of this study is to determine, in children aged 1 to 6 years with recurrent asthma induced by upper respiratory tract infections (URTI), whether the administration of high doses of inhaled fluticasone started at the onset of symptoms of a cold will result in a reduced severity and shorter duration of asthma exacerbations and will not be associated with reduced growth velocity, osteopenia, and adrenal suppression.
Condition or disease
Drug: inhaled fluticasone 750 mcg/day twice daily until 2 days without symptoms (maximum 15 consecutive days)
The proportion of upper respiratory tract infections (URTIs) in each group requiring treatment with systemic corticosteroids as confirmed by review of medical records and pharmacy records of prescriptions dispensed.
Secondary Outcome Measures :
Rate of unscheduled visits for asthma to an acute care setting adjusted for the number of upper respiratory tract infections (URTIs).
Rate of hospital admissions for asthma adjusted for the number of URTIs.
Maximum and mean number of puffs of ß2-agonists/day during URTI illness.
Peak and mean symptom scores during URTI illness
The mean # of days/URTI during which rescue ß2-agonists were used for asthma symptoms.
The mean # of days/URTI during which asthma symptoms were observed
growth velocity from baseline to endpoint
change in bone mineral density between baseline and endpoint
proportion of osteopenia at endpoint
change from baseline in hypothalamo-pituitary adrenal function (basal cortisol) at endpoint
proportion of adrenal suppression at endpoint
proportion of treatment interruption due to perceived ineffectiveness in each group
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Layout table for eligibility information
Ages Eligible for Study:
1 Year to 6 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
(1) Children aged 1-6 years,
(2) they had at least 2 documented episodes of URTI-induced asthma requiring systemic (i.e., oral, intravenous, or intramuscular) corticosteroids in the previous 12 months or 1 episode in the previous 6 months,
(3) no intercurrent symptoms (i.e., cough, wheezing, or observed dyspnea) documented for at least 7 days between wheezing episodes,
(4) no suspicion of allergy to pollen or perennial allergens, and
(5) caregivers have a good understanding of French or English
(a) other chronic diseases such as cystic fibrosis, bronchopulmonary dysplasia, cardiac disease, kidney disease, gastro-oesophageal reflux requiring treatment,
(b) intake, in the 21 days preceding randomization, of inhaled, nasal, or oral corticosteroids, leukotriene antagonists, cromolyn, nedocromyl, or ketotifen, -(c) prior intubation for an asthma exacerbation.