Clinical Trial of Fluticasone Versus Placebo at the Onset of a Cold for Children With Asthma

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborator: Medical Research Council of Canada
• Treatments: Fluticasone

Criteria

Inclusion Criteria:

• (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

Exclusion Criteria:

• (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.