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

Overseen By Curtis S Goss, MS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Indiana University

Must not be taking: Asthma medications, Midodrine, Ritonavir

Disqualifiers: Severe allergies, Asthma, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

16 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests whether cetirizine HCl, an antihistamine, can help highly-trained swimmers who experience low oxygen levels during intense exercise by reducing inflammation.

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 data supports the effectiveness of the drug Cetirizine HCl and Nedocromil Sodium?

Research shows that Nedocromil Sodium is effective in treating allergic rhinitis (a condition where the inside of the nose becomes inflamed due to an allergen) by reducing symptoms like sneezing and runny nose. It was found to be more effective than a placebo, with fewer symptoms and less need for additional antihistamines. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

Cetirizine, a common antihistamine, is generally safe for humans with few side effects like headache, nausea, and dry mouth. It has minimal effects on the brain, does not cause significant sedation, and is well tolerated even in elderly patients. ^{6 7 8 9 10}

How does the drug nedocromil sodium differ from other treatments for allergic rhinitis?

Nedocromil sodium is unique because it is a nasal spray that works by stabilizing mast cells (cells involved in allergic reactions) to prevent symptoms like runny nose and sneezing. Unlike some other treatments, it has a rapid onset and is effective in reducing the need for additional antihistamines, with minimal systemic absorption and no significant side effects reported. ^{1 3 4 11 12}

Research Team

Robert F Chapman, PhD

Principal Investigator

Professor

Eligibility Criteria

Inclusion Criteria

Men and women

18-35 years old

Current collegiate or professional swimmer

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 session

1 visit (in-person)

Initial Testing

Assessment of risk factors for EIAH and blood biomarker changes pre- and post-swimming exercise

1 session

1 visit (in-person)

Experimental Trials

Participants undergo swimming tests with placebo or cetirizine HCl treatment in a double-blind, randomized crossover design

2 sessions

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cetirizine HCl
• Nedocromil Sodium

Participant Groups

Group I: Experimental group Experimental Treatment 2 Interventions

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.

Group II: Selection pool Active Control 1 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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Findings from Research

In a double-blind, placebo-controlled trial with 104 patients, intranasal nedocromil sodium (1%) significantly relieved symptoms of ragweed allergic rhinitis within 2 hours of the first dose, showing its rapid efficacy.

The relief of symptoms was sustained throughout a 2-day exposure to pollen and was maintained even after leaving the study site, indicating that nedocromil can effectively manage allergic rhinitis symptoms during peak allergy seasons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nedocromil sodium is rapidly effective in the therapy of seasonal allergic rhinitis. Donnelly, A., Casale, TB.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intranasal nedocromil sodium in the treatment of ragweed-allergic rhinitis. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Double-blind comparison of nedocromil sodium (1% nasal spray) and placebo in rhinitis caused by birch pollen. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Nedocromil sodium is rapidly effective in the therapy of seasonal allergic rhinitis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The effect of nedocromil sodium on nasal provocation with allergen. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Nedocromil sodium. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Cetirizine: a new, nonsedating antihistamine. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Cetirizine-associated delusions and depression in an 18-year-old woman. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Review of cetirizine hydrochloride for the treatment of allergic disorders. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Cetirizine: antiallergic therapy beyond traditional H1 antihistamines. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Central effects of the H1-antihistamine, cetirizine. [2013]

11. Denmark pubmed.ncbi.nlm.nih.gov

A clinical overview of Tilarin. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Treatment of chronic urticaria with cetirizine dihydrochloride a non-sedating antihistamine. [2019]