Recruiting

Desloratadine

Sponsor:

University of Victoria

Code:

NCT05446480

Conditions

Heat Stress, Exertional

Inflammatory Response

Firefighter Personal Protective Equipment

Eligibility Criteria

Sex: Male

Age: 19 - 50

Healthy Volunteers: Accepted

Interventions

Desloratadine

Placebo

No Intervention

Study Details

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

Study ID

NCT05446480

Start date

Jul, 2022

Status verified date

May, 2022

Completion date

Aug, 2023

Anticipated

Primary completion date

Aug, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 19 - 50

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Desloratadine

Desloratadine (Aerius) 10mg compounded to oral pill

experimental: Inert Placebo

Placebo 10mg compounded to oral pill

experimental: No Intervention

No intervention: neither drug nor placebo

Interventions

Desloratadine

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

Placebo

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

No Intervention

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

Primary outcome measure

  • Change in serum cortisol [ Time Frame: Before, immediately following, and 2-hours following exertional heat strain ]
  • Change in serum interleukin-6 and ELISA [ Time Frame: Before, immediately following, and 2-hours following exertional heat strain ]
  • Change in serum c-reactive protein [ Time Frame: Before, immediately following, and 24, 48, and 72-hours following exertional heat strain ]
  • Change in serum tumor necrosis factor alpha [ Time Frame: Before, immediately following, and 2-hours following exertional heat strain ]

Central Contacts and Locations

Central contacts

Thomas W Service, MSc

2508964682service1@uvic.ca

Locations

University of Victoria

Recruiting

Victoria, British Columbia, Canada, V8P 5C2

Contacts

Thomas W Service, MSc

2508964682service1@uvic.ca

Lynneth A Stuart-Hill, PhD

250-721-7884lstuhill@uvic.ca

More Information

Sponsor

University of Victoria

Last update posted

Jul 6, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Victoria on 2022-07-06.