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Effect of an H1 Receptor Antagonist on Exercise Performance in Hypoxia

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ClinicalTrials.gov Identifier: NCT03192488
Recruitment Status : Unknown
Verified August 2017 by Robert Chapman, Indiana University.
Recruitment status was:  Recruiting
First Posted : June 20, 2017
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Robert Chapman, 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.

Condition or disease Intervention/treatment Phase
Exercise Intolerance at Altitude Drug: Cetirizine Drug: Placebo oral capsule 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 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
Estimated Study Start Date : September 15, 2017
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cetirizine
10 mg of Cetirizine given 60 min before exercise
Drug: Cetirizine
Cetirizine tablet 10 mg

Placebo Comparator: Placebo
Placebo given 60 min prior to exercise
Drug: Placebo oral capsule
Gelatin placebo




Primary Outcome Measures :
  1. Performance time [ Time Frame: Performed 60min after pill ingestion ]
    cycle ergometry time to completion of 5km distance


Secondary Outcome Measures :
  1. histamine [ Time Frame: baseline and immediately post-exercise, same day as pill ingestion ]
    change in plasma histamine level from pre- to post-exercise



Information from the National Library of Medicine

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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192488


Contacts
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Contact: Robert Chapman, {hD 8128562452 rfchapma@indiana.edu

Locations
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United States, Indiana
Indiana University Recruiting
Bloomington, Indiana, United States, 47401
Contact: Robert Chapman, PhD    812-856-2452    rfchapma@indiana.edu   
Sponsors and Collaborators
Indiana University

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Responsible Party: Robert Chapman, Associate Professor, Indiana University
ClinicalTrials.gov Identifier: NCT03192488     History of Changes
Other Study ID Numbers: 1702396373
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD plan

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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:
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Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms
Cetirizine
Histamine H1 Antagonists
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs