Effect of an H1 Receptor Antagonist on Exercise Performance in Hypoxia

• ClinicalTrials.gov Identifier: NCT03192488
• Recruitment Status: Completed
• First Posted: June 20, 2017
• Results First Posted: June 16, 2020
• Last Update Posted: June 16, 2020
• Sponsor: Indiana University
• Information provided by (Responsible Party): Robert Chapman, Indiana University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypoxia, Altitude	Drug: Cetirizine; Drug: Placebo oral capsule; Other: Hypoxia	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Effect of an H1 Receptor Antagonist on Exercise Performance in Hypoxia
• Actual Study Start Date: August 31, 2017
• Actual Primary Completion Date: June 6, 2018
• Actual Study Completion Date: June 6, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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).	Drug: Cetirizine; Cetirizine tablet 10 mg; Other Name: Zyrtec; Other: Hypoxia; Exposure to a 14.3% oxygen environment simulating an altitude of 3,000m/9,000ft; Other Name: altitude, low-oxygen environment
Placebo Comparator: Placebo/Normoxia; Subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).	Drug: Placebo oral capsule; Gelatin placebo
Placebo Comparator: 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).	Drug: Placebo oral capsule; Gelatin placebo; Other: Hypoxia; Exposure to a 14.3% oxygen environment simulating an altitude of 3,000m/9,000ft; Other Name: altitude, low-oxygen environment

Outcome Measures

Primary Outcome Measures :

1. Performance Time [ Time Frame: Performed 60min after pill ingestion ]
   Time to complete 8km cycling time trial

Secondary Outcome Measures :

1. Plasma Histamine Concentrations at Baseline and Post-Exercise [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Indiana

Indiana University

Bloomington, Indiana, United States, 47401

Sponsors and Collaborators

Indiana University

Investigators

• Principal Investigator: Robert Chapman, PhD; Indiana University School of Public Health

  Study Documents (Full-Text)

Documents provided by Robert Chapman, Indiana University:

Study Protocol and Statistical Analysis Plan  [PDF] May 1, 2017

More Information

• Responsible Party: Robert Chapman, Associate Professor, Indiana University
• ClinicalTrials.gov Identifier: NCT03192488
• Other Study ID Numbers: 1702396373
• First Posted: June 20, 2017
• Results First Posted: June 16, 2020
• Last Update Posted: June 16, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No IPD plan

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Altitude Sickness; Hypoxia; Signs and Symptoms, Respiratory; Respiration Disorders; Respiratory Tract Diseases; Cetirizine; Anti-Allergic Agents; Histamine H1 Antagonists, Non-Sedating; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs