Role of Desloratadine in Reducing Inflammation From Occupational Heat Strain

NCT05446480 | Unknown

• 1 other identifier: 21-0616
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Change in serum cortisol

  Assessment of changes in serum cortisol within and between interventions measured via venipuncture and ELISA

  Before, immediately following, and 2-hours following exertional heat strain

• Change in serum interleukin-6 and ELISA

  Assessment of changes in serum interleukin-6 within and between interventions measured via venipuncture and ELISA

  Before, immediately following, and 2-hours following exertional heat strain

• Change in serum c-reactive protein

  Assessment of changes in serum c-reactive protein within and between interventions measured via venipuncture and ELISA

  Before, immediately following, and 24, 48, and 72-hours following exertional heat strain

• 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.

  Before, immediately following, and 2-hours following exertional heat strain

Secondary Outcomes (2)

• Change in body mass

  Before and immediately after exertional heat strain

• Differences in core body heat storage

  Before and immediately after exertional heat strain

Other Outcomes (3)

• Differences in Cerebral Blood Flow

  Before and immediately after (following assessment of outcome 8 and 9) exertional heat strain

• Differences in heart rate (HR) and heart rate variability (HRV)

  Before and immediately after exertional heat strain

• Differences in brain blood oxygenation of prefrontal cortex

  Before and immediately after exertional heat strain

Study Arms (3)

Desloratadine

EXPERIMENTAL

Desloratadine (Aerius) 10mg compounded to oral pill

Drug: Desloratadine

Inert Placebo

EXPERIMENTAL

Placebo 10mg compounded to oral pill

Drug: Placebo

No Intervention

EXPERIMENTAL

No intervention: neither drug nor placebo

Other: No Intervention

Interventions

Desloratadine DRUG

Oral ingestion 10mg pill 2 hours prior to heat strain trial. Second 10mg dose 24-hours later.

Also known as: Desloratadine (Aerius)

Desloratadine

Placebo DRUG

Oral ingestion 10mg inert pill 2 hours prior to heat strain trial. Second dose 24-hours later.

Also known as: Inert Placebo

Inert Placebo

No Intervention OTHER

No pill ingestion during the trial - to discern the presence of a placebo effect from baseline inflammatory response

Also known as: Neither Drug nor Placebo

No Intervention

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Victoria: lead

Study Sites (1)

University of Victoria

Victoria, British Columbia, V8P 5C2, Canada

RECRUITING

MeSH Terms

Conditions

Heat Stress Disorders

Interventions

desloratadine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Lynneth Stuart-Hill, PhD

  University of Victoria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas W Service, MSc

CONTACT

2508964682; service1@uvic.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Own-control study - all participants perform each trial arm/intervention separated by a washout period. Order of trials is randomized for each participant.

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: July 6, 2022
• Study Start: July 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: July 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)