NCT05446480

Role of Desloratadine in Reducing Inflammation From Occupational Heat Strain

Potential Off-label Use of Desloratadine to Mitigate Inflammation Caused by PPE-induced Heat Stress

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Victoria · Academic / Other
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The aim of this initial investigational study is to compare the effect of desloratadine on the inflammatory responses to heat stress in firefighters exercising in their personal protective equipment.

Detailed description

Significant heat strain where temperatures approach and exceed 39.0 degrees celsius is known to increase intestinal permeability and induce a graded systemic inflammatory response which includes increases in interleukin-6, tumor necrosis factor alpha, and c-reactive protein. Recent data examining firefighters found fire service instructors possessed greater resting levels of inflammatory markers and that 18-29% of the variation in these markers could be explained by frequency of heat strain. Firefighters themselves are susceptible to core temperatures ranging between 38.5 and 39.0C in as little as 2-3 work cycles. Considering resource limitation in the fire service, such workloads is a realistic possibility when at structural fires, particularly for first alarm apparatus. Though there is a well-defined role of the inflammatory response in adaptive changes, elevated resting levels begs the question of whether such frequency of exposure and acute inflammatory flux in fire service workers may contribute to chronic elevations of inflammatory markers and altered disease risk. Elevations in c-reactive protein are associated with cardiovascular risk with studies indicating a causative role of monomeric c-reactive protein in platelet activation and thrombus growth. Cooling methods save for cryotherapy have demonstrated limited to mild effectiveness for mitigating the inflammatory responses to heat strain resulting in no solution to attenuate acute inflammatory responses. The mast-cell stabilizing properties of desloratadine and its safety profile make it an interesting candidate for investigating its use in this context. This study seeks to determine whether 10mg desloratadine taken before and 24h after exertional heat strain to a core temperature to a core temperature of 39.5 degrees celsius reduces the associated inflammatory response measured over a 72-hour period.

Conditions

• Heat Stress, Exertional
• Inflammatory Response
• Firefighter Personal Protective Equipment

Interventions

Type	Name	Description
DRUG	Desloratadine	Oral ingestion 10mg pill 2 hours prior to heat strain trial. Second 10mg dose 24-hours later.
DRUG	Placebo	Oral ingestion 10mg inert pill 2 hours prior to heat strain trial. Second dose 24-hours later.
OTHER	No Intervention	No pill ingestion during the trial - to discern the presence of a placebo effect from baseline inflammatory response

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2022-07-06
• Last updated: 2022-07-06

Locations

1 site across 1 country: Canada