Do Common Over-the-counter Antihistamine Medications Modify Thermoregulatory Responses During Passive Heat Stress?

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 39
Healthy Volunteers: t
View:

• Male or Female between ages 19 and 39 years

• Fully vaccinated against COVID-19

• Able to provide informed consent

• Body-mass index under 30

Locations
Other Locations
Canada
Lakehead University C.J Sanders Fieldhouse
RECRUITING
Thunder Bay
Contact Information
Primary
Nicholas Ravanelli, PhD
nravanel@lakeheadu.ca
6132630361
Backup
Douglas Newhouse, HBK
danewho1@lakeheadu.ca
8076201011
Time Frame
Start Date: 2023-12-05
Estimated Completion Date: 2024-06
Participants
Target number of participants: 16
Treatments
Experimental: 50 mg Diphenhydramine
Experimental: 10 mg Loratadine
Experimental: 5 mg Desloratadine
Placebo_comparator: Placebo (Sugar pill)
Related Therapeutic Areas
Sponsors
Leads: Lakehead University

This content was sourced from clinicaltrials.gov