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Role of Desloratadine in Reducing Inflammation From Occupational Heat Strain

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Desloratadine
Placebo
No Intervention
Sponsored by
University of Victoria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heat Stress, Exertional

Eligibility Criteria

19 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Demonstrated willingness to participate in the study and adhere to procedures by signing a written informed consent
  • Biological males aged 19-50
  • Successful Physical Activity Readiness Questionnaire (PAR-Q)
  • Ability to swallow core temperature capsule
  • VO2Max >35 mL/kg/min
  • No allergy or current dosage of H1 histamine receptor antagonists
  • Participants must be in good health with no 'Category A' diseases/conditions outlined in National Fire Protection Association (NFPA) 1582 (https://www.iafc.org/docs/default-source/1vcos/vws_rrkit_nfpa-1582.pdf?sfvrsn=ca9b9f0d_2)

Exclusion Criteria:

  • Biological females
  • Males below age of 19, and 51-years or older
  • Unsuccessful PAR-Q
  • VO2Max below 35 mL/kg/min
  • Allergy to H1 histamine receptor antagonists
  • Esophageal constriction (inability to swallow core temperature capsule)
  • Any condition or disease listed as 'Category A' in NFPA 1582 that would disqualify a person as a firefighter.
  • Current use of NSAIDS or steroid drugs (oral or nasal).
  • Consumption of caffeine, nicotine, or alcohol in the preceding 12-hours.
  • Dehydration (urine specific gravity over 1.030)
  • Recent cold/flu (at least 7-days clear of symptom resolution)
  • No use of antibiotics in preceding 14-days.
  • Dosing of medication that is known to exhibit adverse reactions with desloratadine dosing.

Sites / Locations

  • University of VictoriaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Desloratadine

Inert Placebo

No Intervention

Arm Description

Desloratadine (Aerius) 10mg compounded to oral pill

Placebo 10mg compounded to oral pill

No intervention: neither drug nor placebo

Outcomes

Primary Outcome Measures

Change in serum cortisol
Assessment of changes in serum cortisol within and between interventions measured via venipuncture and ELISA
Change in serum interleukin-6 and ELISA
Assessment of changes in serum interleukin-6 within and between interventions measured via venipuncture and ELISA
Change in serum c-reactive protein
Assessment of changes in serum c-reactive protein within and between interventions measured via venipuncture and ELISA
Change in serum tumor necrosis factor alpha
Assessment of changes in serum tumor necrosis factor alpha within and between interventions measured via venipuncture and ELISA.

Secondary Outcome Measures

Change in body mass
Trial arm differences in fluid loss estimated via differences between before-after body mass.
Differences in core body heat storage
Trial arm differences in the change in core body temperature during heating.

Full Information

First Posted
June 13, 2022
Last Updated
July 4, 2022
Sponsor
University of Victoria
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1. Study Identification

Unique Protocol Identification Number
NCT05446480
Brief Title
Role of Desloratadine in Reducing Inflammation From Occupational Heat Strain
Official Title
Potential Off-label Use of Desloratadine to Mitigate Inflammation Caused by PPE-induced Heat Stress
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Victoria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heat Stress, Exertional, Inflammatory Response, Firefighter Personal Protective Equipment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Own-control study - all participants perform each trial arm/intervention separated by a washout period. Order of trials is randomized for each participant.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Desloratadine
Arm Type
Experimental
Arm Description
Desloratadine (Aerius) 10mg compounded to oral pill
Arm Title
Inert Placebo
Arm Type
Experimental
Arm Description
Placebo 10mg compounded to oral pill
Arm Title
No Intervention
Arm Type
Experimental
Arm Description
No intervention: neither drug nor placebo
Intervention Type
Drug
Intervention Name(s)
Desloratadine
Other Intervention Name(s)
Desloratadine (Aerius)
Intervention Description
Oral ingestion 10mg pill 2 hours prior to heat strain trial. Second 10mg dose 24-hours later.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Inert Placebo
Intervention Description
Oral ingestion 10mg inert pill 2 hours prior to heat strain trial. Second dose 24-hours later.
Intervention Type
Other
Intervention Name(s)
No Intervention
Other Intervention Name(s)
Neither Drug nor Placebo
Intervention Description
No pill ingestion during the trial - to discern the presence of a placebo effect from baseline inflammatory response
Primary Outcome Measure Information:
Title
Change in serum cortisol
Description
Assessment of changes in serum cortisol within and between interventions measured via venipuncture and ELISA
Time Frame
Before, immediately following, and 2-hours following exertional heat strain
Title
Change in serum interleukin-6 and ELISA
Description
Assessment of changes in serum interleukin-6 within and between interventions measured via venipuncture and ELISA
Time Frame
Before, immediately following, and 2-hours following exertional heat strain
Title
Change in serum c-reactive protein
Description
Assessment of changes in serum c-reactive protein within and between interventions measured via venipuncture and ELISA
Time Frame
Before, immediately following, and 24, 48, and 72-hours following exertional heat strain
Title
Change in serum tumor necrosis factor alpha
Description
Assessment of changes in serum tumor necrosis factor alpha within and between interventions measured via venipuncture and ELISA.
Time Frame
Before, immediately following, and 2-hours following exertional heat strain
Secondary Outcome Measure Information:
Title
Change in body mass
Description
Trial arm differences in fluid loss estimated via differences between before-after body mass.
Time Frame
Before and immediately after exertional heat strain
Title
Differences in core body heat storage
Description
Trial arm differences in the change in core body temperature during heating.
Time Frame
Before and immediately after exertional heat strain
Other Pre-specified Outcome Measures:
Title
Differences in Cerebral Blood Flow
Description
Within and between intervention differences in cerebral blood flow changes via vascular duplex ultrasound and hypercapnia
Time Frame
Before and immediately after (following assessment of outcome 8 and 9) exertional heat strain
Title
Differences in heart rate (HR) and heart rate variability (HRV)
Description
Within and between intervention differences in HR and HRV
Time Frame
Before and immediately after exertional heat strain
Title
Differences in brain blood oxygenation of prefrontal cortex
Description
Within and between intervention differences in prefrontal cortex oxygenation via near-infrared spectroscopy
Time Frame
Before and immediately after exertional heat strain

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Demonstrated willingness to participate in the study and adhere to procedures by signing a written informed consent Biological males aged 19-50 Successful Physical Activity Readiness Questionnaire (PAR-Q) Ability to swallow core temperature capsule VO2Max >35 mL/kg/min No allergy or current dosage of H1 histamine receptor antagonists Participants must be in good health with no 'Category A' diseases/conditions outlined in National Fire Protection Association (NFPA) 1582 (https://www.iafc.org/docs/default-source/1vcos/vws_rrkit_nfpa-1582.pdf?sfvrsn=ca9b9f0d_2) Exclusion Criteria: Biological females Males below age of 19, and 51-years or older Unsuccessful PAR-Q VO2Max below 35 mL/kg/min Allergy to H1 histamine receptor antagonists Esophageal constriction (inability to swallow core temperature capsule) Any condition or disease listed as 'Category A' in NFPA 1582 that would disqualify a person as a firefighter. Current use of NSAIDS or steroid drugs (oral or nasal). Consumption of caffeine, nicotine, or alcohol in the preceding 12-hours. Dehydration (urine specific gravity over 1.030) Recent cold/flu (at least 7-days clear of symptom resolution) No use of antibiotics in preceding 14-days. Dosing of medication that is known to exhibit adverse reactions with desloratadine dosing.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas W Service, MSc
Phone
2508964682
Email
service1@uvic.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynneth Stuart-Hill, PhD
Organizational Affiliation
University of Victoria
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Victoria
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8P 5C2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas W Service, MSc
Phone
2508964682
Email
service1@uvic.ca
First Name & Middle Initial & Last Name & Degree
Lynneth A Stuart-Hill, PhD
Phone
250-721-7884
Email
lstuhill@uvic.ca

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data, if used in a publication, may be available in a data repository with all identifiers removed.

Learn more about this trial

Role of Desloratadine in Reducing Inflammation From Occupational Heat Strain

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