NCT00238927

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Nov 1999

Longer than P75 for phase_4 asthma

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1999

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2005

Completed
Last Updated

March 27, 2014

Status Verified

March 1, 2014

Enrollment Period

5.8 years

First QC Date

October 12, 2005

Last Update Submit

March 25, 2014

Conditions

Asthma

Keywords

asthmapreschoolviralupper respiratory track infectionfluticasoneinhaled corticosteroidsplaceboexacerbationsseveritysafetygrowthbone mineral densityadrenal functionrescue beta2-agonists

Outcome Measures

Primary Outcomes (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 Outcomes (12)

  • 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.

  • +7 more secondary outcomes

Interventions

inhaled fluticasone 750 mcg/day twice daily until 2 days without symptoms (maximum 15 consecutive days)DRUG

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • (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

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hopital Sainte-Justine

Montreal, Quebec, H1T 3C5, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Location

Centre Pédiatrique La Courte Échelle

Repentigny, Quebec, J5Y 3X6, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

  • 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. doi: 10.1056/NEJMoa0808907.

    PMID: 19164187DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Francine M. Ducharme, MD, MSc

    CHUS Ste-Justine Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 14, 2005

Study Start

November 1, 1999

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

March 27, 2014

Record last verified: 2014-03

Locations

CA(5)