Role of Desloratadine in Reducing Inflammation From Occupational Heat Strain

Overseen By Thomas W Service, MSc

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: University of Victoria

Must not be taking: NSAIDs, Steroids, Antibiotics, others

Disqualifiers: Females, Age, NFPA 1582, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 1 week

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether desloratadine can reduce inflammation in firefighters exposed to high heat. Firefighters often face extreme temperatures that can cause harmful inflammation. Desloratadine, typically used for allergies, may help by stabilizing certain cells in the body. Desloratadine also has anti-inflammatory activity.

Will I have to stop taking my current medications?

The trial requires that you stop taking NSAIDs, steroid drugs, and any medication that could have adverse reactions with desloratadine. You also need to avoid antibiotics for 14 days before the trial.

What data supports the effectiveness of the drug Desloratadine?

Desloratadine is effective in treating seasonal allergic rhinitis (hay fever), perennial allergic rhinitis, and chronic idiopathic urticaria (hives) by reducing symptoms like nasal congestion and improving quality of life. It works as a nonsedating antihistamine, meaning it blocks the effects of histamine (a chemical in the body that causes allergy symptoms) without causing drowsiness. ^{1 2 3 4 5}

Who Is on the Research Team?

Lynneth Stuart-Hill, PhD

Principal Investigator

University of Victoria

Are You a Good Fit for This Trial?

Inclusion Criteria

Biological males aged 19-50

Demonstrated willingness to participate in the study and adhere to procedures by signing a written informed consent

Successful Physical Activity Readiness Questionnaire (PAR-Q)

Exclusion Criteria

Biological females

VO2Max below 35 mL/kg/min

You are allergic to medications that block H1 histamine receptors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10mg desloratadine before and 24 hours after exertional heat strain to assess inflammatory response

1 week

3 visits (in-person)

Follow-up

Participants are monitored for changes in inflammatory markers and other physiological responses after treatment

1 week

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Desloratadine
• No Intervention
• Placebo

How Is the Trial Designed?

Group I: No Intervention Experimental Treatment 1 Intervention

No intervention: neither drug nor placebo

Group II: Inert Placebo Experimental Treatment 1 Intervention

Placebo 10mg compounded to oral pill

Group III: Desloratadine Experimental Treatment 1 Intervention

Desloratadine (Aerius) 10mg compounded to oral pill

Who Is Running the Clinical Trial?

University of Victoria

Lead Sponsor

Trials

59

Recruited

12,000+

Citations

1. New Zealand pubmed.ncbi.nlm.nih.gov

Desloratadine: an update of its efficacy in the management of allergic disorders. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A pharmacokinetic profile of desloratadine in healthy adults, including elderly. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Desloratadine demonstrates dose proportionality in healthy adults after single doses. [2018]

4. Denmark pubmed.ncbi.nlm.nih.gov

The pharmacologic profile of desloratadine: a review. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Pharmacology and clinical efficacy of desloratadine as an anti-allergic and anti-inflammatory drug. [2019]