Heat Stress, ExertionalNCT05446480
Role of Desloratadine in Reducing Inflammation From Occupational Heat Strain
A study testing Desloratadine in people with Heat Stress, Exertional and Inflammatory Response, run by University of Victoria at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heat Stress, Exertional, Inflammatory Response, Firefighter Personal Protective Equipment
- What is being tested?
- Desloratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2022to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Victoria
Victoria, British Columbia, V8P 5C2
Thomas W Service, MSc, 2508964682, service1@uvic.ca
Lynneth A Stuart-Hill, PhD, 250-721-7884, lstuhill@uvic.ca
About this study
Official title: Potential Off-label Use of Desloratadine to Mitigate Inflammation Caused by PPE-induced Heat Stress
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.
Read the 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.
- Being tested
- Desloratadine, Placebo, No Intervention
- Medical subject headings
- Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesloratadineDrug
Also called Desloratadine (Aerius)
Oral ingestion 10mg pill 2 hours prior to heat strain trial. Second 10mg dose 24-hours later.
PlaceboDrug
Also called Inert Placebo
Oral ingestion 10mg inert pill 2 hours prior to heat strain trial. Second dose 24-hours later.
No InterventionOther
Also called Neither Drug nor Placebo
No pill ingestion during the trial - to discern the presence of a placebo effect from baseline inflammatory response
| Study group | Role | What they receive |
|---|---|---|
| Desloratadine | Experimental | Desloratadine (Aerius) 10mg compounded to oral pill Receives: Drug: Desloratadine |
| Inert Placebo | Experimental | Placebo 10mg compounded to oral pill Receives: Drug: Placebo |
| No Intervention | Experimental | No intervention: neither drug nor placebo Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum cortisol
Assessment of changes in serum cortisol within and between interventions measured via venipuncture and ELISA
Measured: 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
Measured: 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
Measured: 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.
Measured: Before, immediately following, and 2-hours following exertional heat strain
Secondary outcomes (2)
Change in body mass
Trial arm differences in fluid loss estimated via differences between before-after body mass.
Measured: Before and immediately after exertional heat strain
Differences in core body heat storage
Trial arm differences in the change in core body temperature during heating.
Measured: Before and immediately after exertional heat strain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat Stress, ExertionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Victoria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lynneth Stuart-Hill, PhD, Principal investigator, University of Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446480
- Sponsor's protocol ID
- 21-0616
- Status last verified
- May 2022
- First submitted
- 13 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data, if used in a publication, may be available in a data repository with all identifiers removed.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Off-label Use of Desloratadine to Mitigate Inflammation Caused by PPE-induced Heat Stress
- ClinicalTrials.gov ID
- NCT05446480
- Acronym / sponsor ID
- 21-0616
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of VictoriaUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Desloratadine | Experimental | Drug: DesloratadineDesloratadine (Aerius) 10mg compounded to oral pill |
| Inert Placebo | Experimental | Drug: PlaceboPlacebo 10mg compounded to oral pill |
| No Intervention | Experimental | Other: No InterventionNo intervention: neither drug nor placebo |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesloratadineAlso: Desloratadine (Aerius)Oral ingestion 10mg pill 2 hours prior to heat strain trial. Second 10mg dose 24-hours later. | Drug | Desloratadine |
| PlaceboAlso: Inert PlaceboOral ingestion 10mg inert pill 2 hours prior to heat strain trial. Second dose 24-hours later. | Drug | Inert Placebo |
| No InterventionAlso: Neither Drug nor PlaceboNo pill ingestion during the trial - to discern the presence of a placebo effect from baseline inflammatory response | Other | No Intervention |
Primary outcome
Change in serum cortisol
Time frame: Before, immediately following, and 2-hours following exertional heat strain
Assessment of changes in serum cortisol within and between interventions measured via venipuncture and ELISA
Change in serum interleukin-6 and ELISA
Time frame: Before, immediately following, and 2-hours following exertional heat strain
Assessment of changes in serum interleukin-6 within and between interventions measured via venipuncture and ELISA
Change in serum c-reactive protein
Time frame: Before, immediately following, and 24, 48, and 72-hours following exertional heat strain
Assessment of changes in serum c-reactive protein within and between interventions measured via venipuncture and ELISA
Change in serum tumor necrosis factor alpha
Time frame: Before, immediately following, and 2-hours following exertional heat strain
Assessment of changes in serum tumor necrosis factor alpha within and between interventions measured via venipuncture and ELISA.
2 secondary outcomes
Change in body mass
Time frame: Before and immediately after exertional heat strain
Differences in core body heat storage
Time frame: Before and immediately after exertional heat strain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: No. Data, if used in a publication, may be available in a data repository with all identifiers removed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynneth Stuart-Hill, PhD principal investigator
University of Victoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desloratadine in people with Heat Stress, Exertional and Inflammatory Response, run by University of Victoria at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas W Service, MSc (2508964682, service1@uvic.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum cortisol (time frame: Before, immediately following, and 2-hours following exertional heat strain). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.