Desloratadine for Inflammation

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the allergy medication desloratadine can reduce inflammation caused by heat stress in firefighters wearing protective gear. Researchers compare this medication to a placebo (a pill with no active drug) and a group with no treatment to determine its effectiveness in managing heat-related inflammation. The study seeks male firefighters in good health, not currently using certain medications, and who can swallow a special capsule to measure body temperature. This trial may suit those who frequently work in high-heat environments and are interested in new ways to manage heat strain. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve heat strain management in high-risk professions.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that desloratadine is generally safe for people. Commonly used for allergies, this medication doesn't present any special safety concerns. Studies have found that even with long-term use, desloratadine doesn't cause harmful effects, suggesting it is safe for most individuals. Its approval by health authorities for other uses further supports confidence in its safety. However, like any medication, some individuals might experience mild side effects. Consulting a healthcare provider before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for inflammation from occupational heat strain focus on cooling techniques or hydration strategies. However, desloratadine, commonly known as Aerius, is unique because it's an antihistamine that may reduce inflammation through a different pathway. Unlike traditional approaches, desloratadine could potentially lower inflammation by blocking histamine receptors, which play a role in the body's inflammatory response. Researchers are excited about exploring this because it offers a novel way to address heat-related inflammation, possibly leading to more effective management strategies for those exposed to high temperatures at work.

What evidence suggests that desloratadine could be effective for reducing inflammatory responses to heat stress in firefighters?

Research has shown that desloratadine, which participants in this trial may receive, helps reduce symptoms of long-term nasal allergies, known as perennial allergic rhinitis. In various studies, desloratadine significantly lessened symptoms like stuffy nose and itching. It worked quickly and remained effective for several weeks. Although these studies focused on allergies, desloratadine's ability to reduce swelling might also aid other inflammation-related issues, such as heat stress. However, specific data on desloratadine's effectiveness for heat-related inflammation is not yet available. ^{4 6 7 8 9}

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.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/12642846/

Efficacy and safety of desloratadine in the treatment ...

Desloratadine rapidly and safely reduced the symptoms of perennial allergic rhinitis, and its efficacy did not diminish during 4 weeks of treatment.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00817076

Study of the Effectiveness and Safety of Desloratadine ...

The doctor also rated how much relief the patient got from treatment and recorded any side effects.

3.

ema.europa.eu

ema.europa.eu/en/documents/scientific-discussion/aerius-epar-scientific-discussion_en.pdf

Aerius, INN-desloratadine - European Medicines Agency

The data showed that 5 mg desloratadine was effective in reducing the symptoms of AR compared to placebo. Data provided in a Type II variation was found to ...

4.

jacionline.org

jacionline.org/article/S0091-6749(02)91487-9/fulltext

Efficacy and safety of desloratadine in the treatment ...

Results: Six hundred thirty-four patients completed the study. Desloratadine consistently diminished perennial allergic rhinitis symptoms, reducing the morning- ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2721966/

Desloratadine for the Relief of Nasal and Non- ...

Efficacy. The data showed that nasal, ocular, and dermal symptoms all improved significantly following desloratadine treatment (P < 0.001). Nasal Symptoms.

6.

fishersci.com

fishersci.com/store/msds?partNumber=AC462920010&productDescription=DESLORATADINE+1GR&vendorId=VN00032119&countryCode=US&language=en

SAFETY DATA SHEET

Handle in accordance with good industrial hygiene and safety practice. Page 4. Desloratadine. Revision Date 24-Dec-2021.

7.

ema.europa.eu

ema.europa.eu/en/documents/product-information/aerius-epar-product-information_en.pdf

Aerius, INN-desloratadine - EMA

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic ...

8.

organon.com

organon.com/docs/product/safety-data-sheets/Desloratadine%20Solid%20Formulation_HH_NO_6N.pdf

Desloratadine Solid Formulation

P201 Obtain special instructions before use. P273 Avoid release to the environment. P280 Wear protective gloves/ protective clothing/ eye ...

9.

organon.com

organon.com/docs/product/safety-data-sheets/Desloratadine%20Solid%20Formulation_IN_6N.pdf

SAFETY DATA SHEET Desloratadine Solid Formulation

Species. : Mouse. Application Route. : Oral. Exposure time. : 2 Years. Result. : negative. Species. : Rat. Page 11. SAFETY DATA SHEET according ...