Over-the-Counter Antihistamines & Heat Stress

Last updated: January 11, 2024
Sponsor: Lakehead University
Overall Status: Active - Recruiting

Phase

4

Condition

Allergies & Asthma

Common Cold

Acute Rhinitis

Treatment

5 mg Desloratadine

50 mg Diphenhydramine

10 mg Loratadine

Clinical Study ID

NCT06217367
100241
273752
  • Ages 19-39
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Allergic rhinitis (AR) currently affects ~25% of Canadians, and due to factors of climate change, this number is expected to increase over the coming decade. AR symptoms can significantly impact individuals' quality of life by compromising sleep, productivity, and social interactions. To alleviate AR symptoms, North Americans tend to rely on H1 antihistamine medications available over-the-counter (OTC) at most pharmacies. However, public health authorities currently suggest restraining all antihistamines during heat waves due to beliefs that M3 muscarinic receptor and H1 receptor antagonism, independent pharmacological mechanisms of H1 antihistamines, might suppress thermoregulatory responses to heat stress and increase individuals' susceptibility to heat-related illness/injury. To date, studies using supramaximal doses of antihistamines have demonstrated reductions in sweating, however these doses and administration routes are not the typical use case. Additional studies utilizing fexofenadine, a second-generation H1 antihistamine, have linked H1 receptor antagonism to reductions in skin blood flow, potentially impacting thermoregulation by reducing peripheral blood redistribution. Empirical evidence supporting OTC H1 antihistamines impacting thermoregulatory control at recommended doses is scarce. Thus, this study aims to systematically assess whether three common OTC H1 antihistamines, taken as prescribed, alter thermoregulatory responses during thermal stress.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or Female between ages 19 and 39 years
  • Fully vaccinated against COVID-19
  • Able to provide informed consent
  • Body-mass index under 30

Exclusion

Exclusion Criteria:

  • Body-mass index over 30
  • Currently taking sedative or autonomic nervous system depressant medication
  • Hypersensitivity to diphenhydramine, loratadine, or desloratadine
  • History of cardiovascular disease, cancer, type 1 or 2 diabetes, chronic obstructivepulmonary disorder, or cystic fibrosis
  • Have smoked tobacco products less than 12 months prior to participation
  • Pregnant/Breastfeeding

Study Design

Total Participants: 16
Treatment Group(s): 4
Primary Treatment: 5 mg Desloratadine
Phase: 4
Study Start date:
December 05, 2023
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • Lakehead University C.J Sanders Fieldhouse

    Thunder Bay, Ontario P7B5E1
    Canada

    Active - Recruiting

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