Allergic Rhinitis Clinical Trial
Official title:
Do Common Over-the-counter Antihistamine Medications Modify Thermoregulatory Responses During Passive Heat Stress?
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.
Status | Recruiting |
Enrollment | 16 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 39 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Lakehead University C.J Sanders Fieldhouse | Thunder Bay | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lakehead University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Whole-Body Sweat Losses | Difference in participants' pre/post body mass | For each study arm (all completed within 4 months), measurements taken immediately before heating protocol & immediately following the heating protocol | |
Primary | Skin Blood Flow | Measured using laser-doppler skin blood blow sensor affixed to forearm | For each study arm (all completed within 4 months), measured before heating, and at every 0.25C increase in core temperature (+0.25C, +0.50C, +0.75C, +1.0C, +1.25C, and +1.5C), or every ~15 minutes of (up to ~90 minutes) and immediately after heating | |
Primary | Heart Rate | Measured using electrocardiogram | For each study arm (all completed within 4 months), measured before heating, and at every 0.25C increase in core temperature (+0.25C, +0.50C, +0.75C, +1.0C, +1.25C, and +1.5C), or every ~15 minutes of (up to ~90 minutes) and immediately after heating | |
Primary | Mean Arterial Pressure | Measured using brachial blood pressure cuff | For each study arm (all completed within 4 months), measurements taken at baseline before heating, and every 10 minutes throughout heating protocol (up to ~ 90 minutes), and immediately after heating | |
Primary | Local Sweat Rate | Measured using ventilated sweat capsules affixed to forearm and chest | For each study arm (all completed within 4 months), measured before heating, and at every 0.25C increase in core temperature (+0.25C, +0.50C, +0.75C, +1.0C, +1.25C, and +1.5C), or every ~15 minutes of (up to ~90 minutes) and immediately after heating | |
Secondary | Thermal Sensation | Self-assessments of thermal sensation using a 7-point analog scale where -3 is "Cold" and +3 is "Hot". | For each study arm (all completed within 4 months), measured before heating, and at every 0.25C increase in core temperature (+0.25C, +0.50C, +0.75C, +1.0C, +1.25C, and +1.5C), or every ~15 minutes of (up to ~90 minutes) and immediately after heating | |
Secondary | Thermal Comfort | Self-assessments of thermal comfort using four-point analog scale where 1 is "Not uncomfortable" and 4 is "Very uncomfortable" | For each study arm (all completed within 4 months), measured before heating, and at every 0.25C increase in core temperature (+0.25C, +0.50C, +0.75C, +1.0C, +1.25C, and +1.5C), or every ~15 minutes of (up to ~90 minutes) and immediately after heating | |
Secondary | Mental Acuity | Indexed with digital Stroop test | For each study arm (all completed within 4 months), measurements taken 2 hours before heating (pre-pill ingestion), 5-minutes before initiating heating, and within 5-minutes after the heating protocol | |
Secondary | Sleepiness/Fatigue level | Measured using Stanford Sleepiness Scale (min: 1, max: 7 (more fatigued)) | For each study arm (all completed within 4 months), measurements taken 2 hours before heating (pre-pill ingestion), 5-minutes before initiating heating, and within 5-minutes after the heating protocol |
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