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NCT05095311 · ClinicalTrials.gov registry record · Phase 4
The Effect of Cetirizine HCl on Exercise-induced Arterial Hypoxemia in Highly-trained Swimmers
A Phase 4 study, sponsored by Indiana University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT05095311: Clinical Trial Phase 4 study, sponsored by Indiana University.
NCT05095311 is a Phase 4 study that was terminated before completion, run by Indiana University. The registered enrollment target is 16 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05095311, a Phase 4 study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study 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.
Primary Outcome
SpO2 percentage measured via a standard bedside pulse oximetry unit
Interventions
- OTHER Placebo
- DRUG Cetirizine HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-05-19 |
| Est. Completion | 2022-04-27 |
| Phase | Phase 4 |
Why NCT05095311 stopped before completion
NCT05095311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05095311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05095311 about?
NCT05095311 is a clinical study titled "The Effect of Cetirizine HCl on Exercise-induced Arterial Hypoxemia in Highly-trained Swimmers". 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 inf...
What is the current status of trial NCT05095311?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2021-05-19. Estimated completion is 2022-04-27.
What interventions are being tested in trial NCT05095311?
The interventions under investigation include: Placebo (OTHER), Cetirizine HCl (DRUG).
Who is sponsoring clinical trial NCT05095311?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05095311's enrollment target sits among peer trials
16 1869th of 2000 higher than 121 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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