Effects of over-the-counter antihistamines on heat stress
Do Common Over-the-counter Antihistamine Medications Modify Thermoregulatory Responses During Passive Heat Stress?
PHASE4 · Lakehead University · NCT06217367
This study tests whether common allergy medications can affect how well young adults handle heat stress and sweating during hot weather.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 19 Years to 39 Years |
| Sex | All |
| Sponsor | Lakehead University (other) |
| Locations | 1 site (Thunder Bay, Ontario) |
| Trial ID | NCT06217367 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of over-the-counter antihistamines on individuals experiencing heat stress and allergic rhinitis. It aims to determine whether commonly used antihistamines, such as diphenhydramine, loratadine, and desloratadine, affect thermoregulation and sweating during heat exposure. Participants aged 19 to 39 will be administered either antihistamines or a placebo to assess their physiological responses to heat stress. The study seeks to clarify public health concerns regarding antihistamine use during heat waves.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy males and females aged 19 to 39 with a body mass index under 30 who are fully vaccinated against COVID-19.
Not a fit: Patients with a body mass index over 30 or those with certain medical histories, such as cardiovascular disease or diabetes, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence supporting the safe use of antihistamines during heat waves, improving quality of life for individuals with allergic rhinitis.
How similar studies have performed: While previous studies have shown that high doses of antihistamines can reduce sweating, this study explores their effects in typical over-the-counter dosages, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 obstructive pulmonary disorder, or cystic fibrosis * Have smoked tobacco products less than 12 months prior to participation * Pregnant/Breastfeeding
Where this trial is running
Thunder Bay, Ontario
- Lakehead University C.J Sanders Fieldhouse — Thunder Bay, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: Nicholas Ravanelli, PhD
- Email: nravanel@lakeheadu.ca
- Phone: 6132630361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heat Illness, Allergic Rhinitis, Heat Injury, Sudomotor Sympathetic Dysfunction, H1 antihistamine, Sweating, Heat stress, Thermoregulation