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Effect of an H1 Receptor Antagonist on Exercise Performance in Hypoxia

Primary Purpose

Hypoxia, Altitude

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cetirizine
Placebo oral capsule
Hypoxia
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypoxia, Altitude

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Indiana University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Cetirizine/Hypoxia

Placebo/Normoxia

Placebo/Hypoxia

Arm Description

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).

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

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).

Outcomes

Primary Outcome Measures

Performance Time
Time to complete 8km cycling time trial

Secondary Outcome Measures

Plasma Histamine Concentrations at Baseline and Post-Exercise
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.

Full Information

First Posted
June 16, 2017
Last Updated
June 2, 2020
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT03192488
Brief Title
Effect of an H1 Receptor Antagonist on Exercise Performance in Hypoxia
Official Title
Effect of an H1 Receptor Antagonist on Exercise Performance in Hypoxia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 31, 2017 (Actual)
Primary Completion Date
June 6, 2018 (Actual)
Study Completion Date
June 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Altitude

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cetirizine/Hypoxia
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo/Normoxia
Arm Type
Placebo Comparator
Arm Description
Subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).
Arm Title
Placebo/Hypoxia
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Cetirizine
Other Intervention Name(s)
Zyrtec
Intervention Description
Cetirizine tablet 10 mg
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Gelatin placebo
Intervention Type
Other
Intervention Name(s)
Hypoxia
Other Intervention Name(s)
altitude, low-oxygen environment
Intervention Description
Exposure to a 14.3% oxygen environment simulating an altitude of 3,000m/9,000ft
Primary Outcome Measure Information:
Title
Performance Time
Description
Time to complete 8km cycling time trial
Time Frame
Performed 60min after pill ingestion
Secondary Outcome Measure Information:
Title
Plasma Histamine Concentrations at Baseline and Post-Exercise
Description
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.
Time Frame
baseline and immediately post-exercise, same day as pill ingestion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Chapman, PhD
Organizational Affiliation
Indiana University School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD plan

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Effect of an H1 Receptor Antagonist on Exercise Performance in Hypoxia

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