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

NCT05095311 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 10766
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Peripheral Capillary Oxyhemoglobin Saturation

  SpO2 percentage measured via a standard bedside pulse oximetry unit

  In the final minute of the aerobic capacity test and each of the two (70% and 85% of max) constant load trials in Visits 3 and 4 of the study

Study Arms (2)

Experimental group

EXPERIMENTAL

This subset of 12 individuals will complete all experimental study visits, and will ingest either 1) a placebo pill and placebo inhaler contents or 2) a cetirizine HCl pill (10 mg) and placebo inhaler contents in a randomized order and double-blind fashion.

Drug: Cetirizine HCl; Other: Placebo

Selection pool

NO INTERVENTION

Twenty-four total individuals will be recruited for the initial portion of the study, and the aforementioned 12 (6 men, 6 women) will be a subset of the initial 24. The other 12 participants will not take part in further study.

Interventions

Cetirizine HCl DRUG

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

Also known as: Zyrtec

Experimental group

Placebo OTHER

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women
• years old
• Current collegiate or professional swimmer
• Currently training at least 300 minutes per week
• Self-reported to be healthy

You may not qualify if:

• Not within defined age range
• Current diagnosis of or using medication for:
• Severe allergies
• Asthma
• Exercise-induced asthma
• Exercise-induced bronchoconstriction
• Pulmonary function test considered to be abnormal (defined as forced vital capacity (FVC) \<80% of predicted, forced expiratory volume in one second (FEV1) \<80% predicted, and/or FEV1/FVC ratio \>5% of the predicted ratio)
• Hypertension during screening (systolic blood pressure \>139 or diastolic blood pressure \>89)
• Current tobacco or electronic cigarette use or consistent use within the last 2 years
• A contraindication for use of nedocromil sodium:
• Previous adverse reaction to nedocromil sodium or a similar medication
• Use of fast-acting, inhaled insulin
• A contraindication for use of cetirizine HCl:
• Previous adverse reaction to cetirizine HCl or a similar medication
• Allergy to the food additives E218 or E216

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

1025 E Seventh St

Bloomington, Indiana, 47405, United States

Location

Related Publications (1)

• Coyle MA, Goss CS, Manz WJ, Greenshields JT, Chapman RF, Stager JM. Nedocromil sodium and diphenhydramine HCl ameliorate exercise-induced arterial hypoxemia in highly trained athletes. Physiol Rep. 2022 Jan;10(1):e15149. doi: 10.14814/phy2.15149.

  PMID: 35001564 RESULT

MeSH Terms

Interventions

Cetirizine

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Curtis Goss, Student Investigator
• Organization: Indiana University

csgoss13@gmail.com

8178080085

Study Officials

• Robert F Chapman, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2021
• First Posted: October 27, 2021
• Study Start: May 19, 2021
• Primary Completion: April 27, 2022
• Study Completion: April 27, 2022
• Last Updated: March 5, 2024
• Results First Posted: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available upon degree certification (anticipated May 2022) and will be available indefinitely.
• Access Criteria: The dissertation document will be publicly available.

Locations

US (1)