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
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
Published Research Related to This Trial
Citations
Focus on the cetirizine use in clinical practice - PubMed Central
Oral cetirizine 10 mg is more effective than other antihistamines in inhibiting the histamine-induced wheal and flare [9]. The increase in nasal ...
Cetirizine - StatPearls - NCBI Bookshelf
Cetirizine is a relatively safe and effective medication for treating allergic rhinitis, urticaria, and allergic conjunctivitis. As cetirizine is also available ...
Cetirizine: Uses, Interactions, Mechanism of Action
The clinical efficacy of cetirizine for allergic respiratory diseases has been well established in numerous trials. Effects on urticaria/anti-inflammatory ...
211415Orig1s000 - accessdata.fda.gov
ETTAU-03 is a double-blind, randomized, active- controlled, noninferiority efficacy trial comparing IV cetirizine to IV diphenhydramine in 262 adults with acute ...
High‐risks drug adverse events associated with Cetirizine ...
It is worth noting that several studies have pointed out that Cetirizine was more effective than Loratadine in clinical treatment responses when ...
SAFETY DATA SHEET
Precautionary Statements. Prevention. Wash face, hands and any exposed skin thoroughly after handling. Do not eat, drink or smoke when using ...
Material Safety Data Sheet
Additional Hazard Information: Short Term: Active ingredient may be harmful if swallowed. Accidental ingestion may cause effects similar.
Safety Data Sheet
Hazards not otherwise classified. There are no adverse physical or health effects known that are not covered by the hazard classes of the.
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sigmaaldrich.com
sigmaaldrich.com/KR/ko/sds/sigma/c3618?srsltid=AfmBOorAxhb_Ln2nnE4q3SVkYmZ2eayP2LFGjlc-iXkKlSY4E2dxXW4RSAFETY DATA SHEET
P301 + P312 + P330. IF SWALLOWED: Call a POISON CENTER/ doctor if you feel unwell. Rinse mouth. P501. Dispose of contents/ container to an ...
Cetirizine (hydrochloride) SAFETY DATA SHEET
P202: Do not handle until all safety precautions have been read and understood. P261: Avoid breathing {dust/fume/gas/mist/vapors/spray}. P264: ...
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