Phase 4
Completed N=11
Effect of an H1 Receptor Antagonist on Exercise Performance in Hypoxia
Hypoxia, Altitude
Source: ClinicalTrials.gov NCT03192488 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Performance Time — 17.03; 18.08; 16.32 minutes — p=0.047
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study seeks to determine whether a simple, single intervention of Cetirizine / Zyrtec® use can improve exercise performance of active individuals when acutely exposed to altitude. For this project, healthy subjects will perform steady state and progressive work rate exercise, endurance performance time trials, and repeated sprint performance time trials in the laboratory at a simulated altitude of 3000m (9900ft) after dosing with 10 mg of Cetirizine or a placebo in a repeated measures design.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance Time |
17.03; 18.08; 16.32 | 0.047 sig |
| SECONDARY Plasma Histamine Concentrations at Baseline and Post-Exercise |
.36; .49; .56; .61; .37; .47 | 0.327 |
Eligibility Criteria
Inclusion Criteria
- Physically active a minimum of 120 minutes a week, as determined by questionnaire
- 18-35 years of age
- Classified as low risk, based on the modified PAR-Q questionnaire, BMI, and non-smoking status
- No history of pulmonary disease and pulmonary function classified as normal, as defined by the following measurements being 80% of predicted values: forced vital capacity (FVC), forced expired volume in one second (FEV1) and FEV1/FVC, according to the American Thoracic Society standards.
Exclusion Criteria
- Current smoker
- Women who are pregnant or could possibly be pregnant
- BMI > 25 kg/m2
- A 'yes' answer to any of the 14 questions on the PAR-Q pre-participation questionnaire
- History of pulmonary disease or <80% of predicted FCV, FEV1 and/or FEV1/FVC.
- A history of renal or liver disease, due to possible interaction effect with Cetirizine
- Currently taking any prescription or over the counter medications for the treatment of allergies, or taking any of the below listed drugs known to have a moderate or higher interaction effect with Cetirizine:
isocarboxazid tranylcypromine bosutinib clobazam crizotinib daclatasvir eliglustat hyaluronidase lomitapide lurasidone ombitasvir/paritaprevir/ritonavir phenelzine ponatinib ritonavir vemurafenib
Data sourced from ClinicalTrials.gov (NCT03192488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.