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

This study has been completed.
Sponsor:
Collaborator:
Medical Research Council of Canada
Information provided by (Responsible Party):
Francine Ducharme, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00238927
First received: October 12, 2005
Last updated: March 25, 2014
Last verified: March 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Multicenter Randomised Controlled Trial of Episodic Fluticasone Versus Placebo in Viral-induced Asthma in Children

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Quebec
Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Hopital Sainte-Justine
Montreal, Quebec, Canada, H1T 3C5
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 Center
Medical Research Council of Canada
Investigators
Principal Investigator: Francine M. Ducharme, MD, MSc CHUS Ste-Justine Hospital
  More Information

No publications provided by McGill University Health Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francine Ducharme, Principal Investigator, McGill University Health Center
ClinicalTrials.gov Identifier: NCT00238927     History of Changes
Other Study ID Numbers: FAP30006, MRC/PMAC program
Study First Received: October 12, 2005
Last Updated: March 25, 2014
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:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 26, 2014