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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00238927
Recruitment Status : Completed
First Posted : October 14, 2005
Last Update Posted : March 27, 2014
Medical Research Council of Canada
Information provided by (Responsible Party):
Francine Ducharme, McGill University Health Centre/Research Institute of the McGill University Health Centre

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 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 Intervention/treatment Phase
Asthma Drug: inhaled fluticasone 750 mcg/day twice daily until 2 days without symptoms (maximum 15 consecutive days) Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Multicenter Randomised Controlled Trial of Episodic Fluticasone Versus Placebo in Viral-induced Asthma in Children
Study Start Date : November 1999
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Primary Outcome Measures :
  1. 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 :
  1. Rate of unscheduled visits for asthma to an acute care setting adjusted for the number of upper respiratory tract infections (URTIs).
  2. Rate of hospital admissions for asthma adjusted for the number of URTIs.
  3. Maximum and mean number of puffs of ß2-agonists/day during URTI illness.
  4. Peak and mean symptom scores during URTI illness
  5. The mean # of days/URTI during which rescue ß2-agonists were used for asthma symptoms.
  6. The mean # of days/URTI during which asthma symptoms were observed
  7. growth velocity from baseline to endpoint
  8. change in bone mineral density between baseline and endpoint
  9. proportion of osteopenia at endpoint
  10. change from baseline in hypothalamo-pituitary adrenal function (basal cortisol) at endpoint
  11. proportion of adrenal suppression at endpoint
  12. proportion of treatment interruption due to perceived ineffectiveness in each group

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00238927

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Canada, Quebec
Hopital Sainte-Justine
Montreal, Quebec, Canada, H1T 3C5
Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Centre Pédiatrique La Courte Échelle
Repentigny, Quebec, Canada, J5Y 3X6
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Medical Research Council of Canada
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Principal Investigator: Francine M. Ducharme, MD, MSc CHUS Ste-Justine Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Francine Ducharme, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre Identifier: NCT00238927    
Other Study ID Numbers: FAP30006
MRC/PMAC program
First Posted: October 14, 2005    Key Record Dates
Last Update Posted: March 27, 2014
Last Verified: March 2014
Keywords provided by Francine Ducharme, McGill University Health Centre/Research Institute of the McGill University Health Centre:
upper respiratory track infection
inhaled corticosteroids
bone mineral density
adrenal function
rescue beta2-agonists
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents