Clinical Trial of Fluticasone Versus Placebo at the Onset of a Cold for Children With Asthma
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.
Drug: inhaled fluticasone 750 mcg/day twice daily until 2 days without symptoms (maximum 15 consecutive days)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Multicenter Randomised Controlled Trial of Episodic Fluticasone Versus Placebo in Viral-Induced Asthma in Children|
- 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.
- 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
|Study Start Date:||November 1999|
|Study Completion Date:||September 2005|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
|Montreal Children's Hospital|
|Montreal, Quebec, Canada, H3H 1P3|
|Montreal, Quebec, Canada|
|Montreal, Quebec, Canada, H1T 3C5|
|Centre Pédiatrique La Courte Échelle|
|Repentigny, Quebec, Canada, J5Y 3X6|
|Centre Hospitalier Universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||Francine M. Ducharme, MD, MSc||Montreal Children's Hospital of McGill University Health Centre|