![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsors and Collaborators: |
McGill University Health Center Medical Research Council of Canada |
---|---|
Information provided by: | McGill University Health Center |
ClinicalTrials.gov Identifier: | NCT00238927 |
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 | Intervention | Phase |
---|---|---|
Asthma |
Drug: inhaled fluticasone 750 mcg/day twice daily until 2 days without symptoms (maximum 15 consecutive days) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Multicenter Randomised Controlled Trial of Episodic Fluticasone Versus Placebo in Viral-Induced Asthma in Children |
Estimated Enrollment: | 150 |
Study Start Date: | November 1999 |
Study Completion Date: | September 2005 |
Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 1 Year to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Quebec | |
Montreal Children's Hospital | |
Montreal, Quebec, Canada, H3H 1P3 | |
Centre Hospitalier Universitaire de Sherbrooke | |
Sherbrooke, Quebec, Canada, J1H 5N4 | |
Hopital Maisonneuve-Rosemont | |
Montreal, Quebec, Canada | |
Centre Pédiatrique La Courte Échelle | |
Repentigny, Quebec, Canada, J5Y 3X6 | |
Hopital Sainte-Justine | |
Montreal, Quebec, Canada, H1T 3C5 |
Principal Investigator: | Francine M. Ducharme, MD, MSc | Montreal Children's Hospital of McGill University Health Centre |
Study ID Numbers: | FAP30006, MRC/PMAC program |
Study First Received: | October 12, 2005 |
Last Updated: | January 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00238927 History of Changes |
Health Authority: | Canada: Health Canada |
asthma preschool viral upper respiratory track infection fluticasone inhaled corticosteroids placebo |
exacerbations severity safety growth bone mineral density adrenal function rescue beta2-agonists |
Anti-Inflammatory Agents Bronchial Diseases Asthma Anti-Asthmatic Agents Anti-Allergic Agents Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases |
Lung Diseases Hypersensitivity, Immediate Fluticasone Peripheral Nervous System Agents Epinephrine Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Bronchial Diseases Immune System Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Asthma Anti-Allergic Agents Pharmacologic Actions Lung Diseases, Obstructive Hypersensitivity |
Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Hypersensitivity, Immediate Fluticasone Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents Respiratory Hypersensitivity |