Effect of an H1 Receptor Antagonist on Exercise Performance in Hypoxia

NCT ID: NCT03192488

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-31
• Study Completion Date: 2018-06-06

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.

Conditions

Hypoxia, Altitude

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Cetirizine/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).

Group Type: EXPERIMENTAL

Cetirizine

Intervention Type: DRUG

Cetirizine tablet 10 mg

Hypoxia

Intervention Type: OTHER

Exposure to a 14.3% oxygen environment simulating an altitude of 3,000m/9,000ft

Placebo/Normoxia

Subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

Gelatin placebo

Placebo/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).

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

Gelatin placebo

Hypoxia

Intervention Type: OTHER

Exposure to a 14.3% oxygen environment simulating an altitude of 3,000m/9,000ft

Interventions

Cetirizine

Cetirizine tablet 10 mg

Intervention Type: DRUG

Placebo oral capsule

Gelatin placebo

Intervention Type: DRUG

Hypoxia

Exposure to a 14.3% oxygen environment simulating an altitude of 3,000m/9,000ft

Intervention Type: OTHER

Other Intervention Names

Zyrtec; altitude, low-oxygen environment

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Robert Chapman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Chapman, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Public Health

Locations

Indiana University

Bloomington, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1702396373

Identifier Type: -

Identifier Source: org_study_id