Cetirizine for Exercise-induced Arterial Hypoxemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if cetirizine HCl, a common allergy medication, can improve oxygen levels in the blood during intense swimming for highly-trained swimmers. Researchers seek to understand whether swimmers experience low blood oxygen while exercising and if this is linked to histamine, a chemical involved in allergies. Participants will receive different treatments, including a placebo, cetirizine, and nedocromil sodium (an anti-inflammatory medication), to assess any improvement in oxygen levels during swimming. The trial seeks collegiate or professional swimmers who train at least 300 minutes a week and are generally healthy. As a Phase 4 trial, cetirizine is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using medication for severe allergies, asthma, or exercise-induced asthma. If you have any of these conditions, you would not be eligible for the trial.
What is the safety track record for cetirizine HCl and nedocromil sodium?
Research has shown that cetirizine HCl is generally safe for use. This antihistamine often treats allergies and has FDA approval for this purpose, indicating safety when used as directed. Studies have found that cetirizine HCl can cause mild side effects like drowsiness or dry mouth, but serious side effects are rare.
Specific information about cetirizine HCl's safety for swimmers with exercise-induced breathing issues is lacking, but its common use for allergies suggests general safety. Always consult healthcare professionals before starting any new treatment.12345Why are researchers enthusiastic about this study treatment?
Unlike the standard treatments for exercise-induced arterial hypoxemia, which typically involve bronchodilators or corticosteroids, cetirizine HCl offers a unique approach as an antihistamine. Researchers are excited about cetirizine because it targets histamine receptors, which may help reduce inflammation and improve oxygen levels in highly-trained swimmers during intense exercise. This novel mechanism could provide a new way to manage symptoms without the side effects associated with steroids or bronchodilators.
What evidence suggests that cetirizine HCl and nedocromil sodium could be effective for exercise-induced arterial hypoxemia?
Research has shown that cetirizine HCl effectively reduces symptoms caused by histamine, common in allergies. It often surpasses other allergy medications in alleviating reactions like rashes and stuffy noses. Cetirizine blocks histamine, a chemical that causes swelling and other symptoms. This action may improve breathing during exercise by reducing lung inflammation. In this trial, some participants will receive cetirizine HCl to explore its potential benefits for swimmers who experience breathing difficulties during intense exercise.678910
Who Is on the Research Team?
Robert F Chapman, PhD
Principal Investigator
Professor
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Testing
Assessment of risk factors for EIAH and blood biomarker changes pre- and post-swimming exercise
Experimental Trials
Participants undergo swimming tests with placebo or cetirizine HCl treatment in a double-blind, randomized crossover design
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cetirizine HCl
- Nedocromil Sodium
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor