Effect of an H1 Receptor Antagonist on Exercise Performance in Hypoxia

Phase 4

Completed

Conditions: Hypoxia, Altitude

Interventions: Drug: Placebo oral capsule
Drug: Cetirizine
Other: Hypoxia

Registration Number: NCT03192488

Lead Sponsor: Indiana University

Brief 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.

Detailed Description: 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. Non-invasive techniques (pulse oximetry, near-infrared spectroscopy \[NIRS\]) will be utilized to measure changes in arterial oxyhemoglobin saturation and skeletal muscle oxygenation at the level of the microvasculature during exercise. It is expected that after Cetirizine, blood and muscle microvascular oxygenation during heavy exercise will improve compared to placebo, ultimately improving exercise performance at altitude. Subjects will be asked to report to the laboratory on a three occasions, separated by a minimum of 48 hours and a maximum of 14 days. For each subject, all testing sessions will be performed at the same time of day. Prior to each testing session, subjects will be asked to abstain from caffeine consumption for 12 hours. Subjects will also be asked to avoid alcohol consumption for 24 hours before testing, be at least 3-hour post prandial and avoid high-intensity exercise during the 24 hours leading to the exercise testing. Finally, subjects will be asked to consume a similar diet the night before, and the morning of, Sessions 2 and 3.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 13

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo/Normoxia	Placebo oral capsule	Subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).
Cetirizine/Hypoxia	Hypoxia	Subjects orally ingested 10 mg of Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
Placebo/Hypoxia	Hypoxia	Subjects orally ingested a 10 mg Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
Placebo/Hypoxia	Placebo oral capsule	Subjects orally ingested a 10 mg Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
Cetirizine/Hypoxia	Cetirizine	Subjects orally ingested 10 mg of Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).

Primary Outcome Measures

Name	Time	Method
Performance Time	Performed 60min after pill ingestion	Time to complete 8km cycling time trial

Secondary Outcome Measures

Name	Time	Method
Plasma Histamine Concentrations at Baseline and Post-Exercise	baseline and immediately post-exercise, same day as pill ingestion	Plasma histamine concentrations (ng/mL) were determined baseline and post-exercise for each experimental condition. Baseline measures were taken immediately prior to exercise and the post-exercise measures were taken 5-10 minutes after the cessation of exercise.