Clinical Trial of Fluticasone Versus Placebo at the Onset of a Cold for Children With Asthma - Full Text View

Sponsor:	McGill University Health Center
Collaborator:	Medical Research Council of Canada
Information provided by:	McGill University Health Center
ClinicalTrials.gov Identifier:	NCT00238927

Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma Minerals

Drug Information available for: Fluticasone propionate Fluticasone

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:

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:

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

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)

Show Detailed Description

Eligibility

Ages Eligible for Study:	1 Year to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238927

Locations

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

Sponsors and Collaborators

McGill University Health Center

Medical Research Council of Canada

Investigators

Principal Investigator:

Francine M. Ducharme, MD, MSc

Montreal Children's Hospital of McGill University Health Centre

More Information

No publications provided by McGill University Health Center

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Ducharme FM, Lemire C, Noya FJ, Davis GM, Alos N, Leblond H, Savdie C, Collet JP, Khomenko L, Rivard G, Platt RW. Preemptive use of high-dose fluticasone for virus-induced wheezing in young children. N Engl J Med. 2009 Jan 22;360(4):339-53.

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

Keywords provided by McGill University Health Center:

asthma
preschool
viral
upper respiratory track infection
fluticasone
inhaled corticosteroids
placebo

exacerbations
severity
safety
growth
bone mineral density
adrenal function
rescue beta2-agonists

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 08, 2010