Status:
COMPLETED
Clinical Trial of Fluticasone Versus Placebo at the Onset of a Cold for Children With Asthma
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Medical Research Council of Canada
Conditions:
Asthma
Eligibility:
All Genders
1-6 years
Phase:
PHASE4
Brief 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...
Detailed Description
Preschool-aged children, who represent over half of asthmatics presenting to a pediatric emergency department with acute asthma, also account for most hospital admissions for pediatric asthma. More th...
Eligibility Criteria
Inclusion
- (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
- (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.
Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00238927
Start Date
November 1 1999
End Date
September 1 2005
Last Update
March 27 2014
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Hopital Sainte-Justine
Montreal, Quebec, Canada, H1T 3C5
2
Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
3
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
4
Centre Pédiatrique La Courte Échelle
Repentigny, Quebec, Canada, J5Y 3X6