Your session is about to expire
← Back to Search
The Effect of Cetirizine HCl on Exercise-induced Arterial Hypoxemia in Highly-trained Swimmers
Phase 4
Waitlist Available
Led By Robert F Chapman, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial tests whether cetirizine HCl, an antihistamine, can help highly-trained swimmers who experience low oxygen levels during intense exercise by reducing inflammation.
Eligible Conditions
- Exercise-induced Arterial Hypoxemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Peripheral Capillary Oxyhemoglobin Saturation
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental groupExperimental Treatment2 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 poolActive Control1 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.
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
1,040 Previous Clinical Trials
1,220,048 Total Patients Enrolled
Robert F Chapman, PhDPrincipal InvestigatorProfessor