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Antihistamine
Role of Desloratadine in Reducing Inflammation From Occupational Heat Strain
N/A
Waitlist Available
Led By Lynneth Stuart-Hill, PhD
Research Sponsored by University of Victoria
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before, immediately following, and 2-hours following exertional heat strain
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Summary
This trial investigates whether desloratadine can reduce inflammation in firefighters exposed to high heat. Firefighters often face extreme temperatures that can cause harmful inflammation. Desloratadine, typically used for allergies, may help by stabilizing certain cells in the body. Desloratadine also has anti-inflammatory activity.
Eligible Conditions
- Firefighter PPE
- Inflammation
- Heat Exhaustion
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before, immediately following, and 24, 48, and 72-hours following exertional heat strain
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before, immediately following, and 24, 48, and 72-hours following exertional heat strain
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Body Weight Changes
Change in serum cortisol
Body Weight Changes
+1 moreSecondary study objectives
Change in body mass
Differences in core body heat storage
Other study objectives
Differences in Cerebral Blood Flow
Differences in brain blood oxygenation of prefrontal cortex
Differences in heart rate (HR) and heart rate variability (HRV)
Side effects data
From 2007 Phase 4 trial • 886 Patients • NCT002643038%
Headache
7%
Somnolence
4%
Fatigue
2%
Abdominal pain upper
1%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Levocetirizine 5 mg
Desloratadine 5 mg
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
3Treatment groups
Experimental Treatment
Group I: No InterventionExperimental Treatment1 Intervention
No intervention: neither drug nor placebo
Group II: Inert PlaceboExperimental Treatment1 Intervention
Placebo 10mg compounded to oral pill
Group III: DesloratadineExperimental Treatment1 Intervention
Desloratadine (Aerius) 10mg compounded to oral pill
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Desloratadine
FDA approved
Find a Location
Who is running the clinical trial?
University of VictoriaLead Sponsor
57 Previous Clinical Trials
11,626 Total Patients Enrolled
Lynneth Stuart-Hill, PhDPrincipal InvestigatorUniversity of Victoria