Desloratadine for Firefighter PPE

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Firefighter PPE+2 MoreDesloratadine - Drug
Eligibility
19 - 50
Male
What conditions do you have?
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Study Summary

This trial will compare the effects of the antihistamine drug desloratadine on firefighters' inflammatory responses to heat stress.

Eligible Conditions
  • Firefighter PPE
  • Heat Exhaustion
  • Inflammation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 2 Secondary · Reporting Duration: Before and immediately after exertional heat strain

Before and immediately after (following assessment of outcome 8 and 9) exertional heat strain
Differences in Cerebral Blood Flow
Before and immediately after exertional heat strain
Change in body mass
Differences in brain blood oxygenation of prefrontal cortex
Differences in core body heat storage
Differences in heart rate (HR) and heart rate variability (HRV)
Before, immediately following, and 2-hours following exertional heat strain
Change in serum cortisol
Body Weight Changes
Change in serum tumor necrosis factor alpha
Before, immediately following, and 24, 48, and 72-hours following exertional heat strain
Body Weight Changes

Trial Safety

Safety Progress

1 of 3

Side Effects for

Levocetirizine 5 mg
8%Headache
7%Somnolence
4%Fatigue
2%Abdominal pain upper
1%Nausea
This histogram enumerates side effects from a completed 2007 Phase 4 trial (NCT00264303) in the Levocetirizine 5 mg ARM group. Side effects include: Headache with 8%, Somnolence with 7%, Fatigue with 4%, Abdominal pain upper with 2%, Nausea with 1%.

Trial Design

3 Treatment Groups

Desloratadine
1 of 3
Inert Placebo
1 of 3
No Intervention
1 of 3

Experimental Treatment

12 Total Participants · 3 Treatment Groups

Primary Treatment: Desloratadine · Has Placebo Group · N/A

Desloratadine
Drug
Experimental Group · 1 Intervention: Desloratadine · Intervention Types: Drug
Inert Placebo
Drug
Experimental Group · 1 Intervention: Placebo · Intervention Types: Drug
No Intervention
Other
Experimental Group · 1 Intervention: No Intervention · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Desloratadine
2002
Completed Phase 4
~7040

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: before and immediately after exertional heat strain

Who is running the clinical trial?

University of VictoriaLead Sponsor
47 Previous Clinical Trials
10,262 Total Patients Enrolled
Lynneth Stuart-Hill, PhDPrincipal InvestigatorUniversity of Victoria

Eligibility Criteria

Age 19 - 50 · Male Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a biological male aged 19-50.