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The Effect of Cetirizine HCl on Exercise-induced Arterial Hypoxemia in Highly-trained Swimmers

NCT05095311 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-03-05

Study results available
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Summary

Exercise-induced arterial hypoxemia (EIAH), a reduced amount of oxygen in the arterial blood during exercise, has been observed in otherwise healthy, highly-trained endurance athletes during exercise at sea level. The extent of the arterial deoxygenation may be influenced by a histamine-mediated inflammatory response at the pulmonary capillary-alveolar membrane limiting oxygen diffusion. Moreover, while EIAH has been routinely explored in running and cycling, swimming is understudied despite potential mechanistic avenues which may put swimmers at further risk for EIAH. The purpose of this study is threefold: 1) to determine whether highly-trained swimmers experience EIAH during submaximal and maximal exercise, 2) to determine the extent to which histamine release influences oxyhemoglobin saturation during swimming exercise, and 3) to determine whether cetirizine HCl (CH), an H1-receptor competitive inhibitor, can improve oxyhemoglobin saturation during submaximal and maximal swimming exercise. Twenty-four (12 men, 12 women) highly-trained swimmers will complete an intense swimming protocol to assess the histamine response to intense exercise. A subset with the highest histamine responses will participate in three additional sessions (placebo, NS, and CH conditions) which will include a swimming aerobic capacity test and 5-minutes of swimming at both 70 and 85% of their maximal oxygen uptake.

Conditions

  • Exercise-induced Arterial Hypoxemia

Interventions

DRUG

Cetirizine HCl

Eight participants will be administered 10 mg of cetirizine HCl to examine whether this drug can improve their oxyhemoglobin saturation during exercise.

OTHER

Placebo

The placebo pill is a sugar-free gelatin pill casing. The placebo inhaler contains isotonic saline.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Robert F Chapman, PhD · Professor

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-19
Primary Completion
2022-04-27
Completion
2022-04-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05095311 on ClinicalTrials.gov