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Experimental group for Exercise-induced Arterial Hypoxemia

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

Study Summary

This trial is testing whether two drugs can improve oxygen saturation in the blood of highly-trained swimmers during intense exercise. The drugs being tested are nedocromil sodium (NS), a mast cell stabilizer, and cetirizine HCl (CH), an H1-receptor competitive inhibitor.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Peripheral Capillary Oxyhemoglobin Saturation

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.

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Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

982,966 Total Patients Enrolled

Robert F Chapman, PhDPrincipal InvestigatorProfessor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who qualifies as an eligible participant for this research project?

"Eligibility into this trial requires that patients are of legal age and have anoxia. 26 participants must be recruited in order to complete the study, with ages ranging from 18-35."

Answered by AI

Has Nedocromil Sodium been sanctioned by the Food and Drug Administration?

"The safety of Nedocromil Sodium is thought to be highly reliable, with a rating of 3. This conclusion can be drawn as the drug has already completed Phase 4 trials and been sanctioned for use in medical treatments."

Answered by AI

How original is this clinical trial compared to similar research initiatives?

"Currently, 4 ongoing studies for Nedocromil Sodium are being held in 9 cities and 6 countries. This drug's history dates back to a 2020 trial sponsored by Genentech Inc., which involved 52 individuals that completed Phase 3 of the approval process. Since then, 18378 further experiments have taken place."

Answered by AI

Is enrollment available at this time for this research project?

"According to the data from clinicaltrials.gov, this trial is still open for enrollment and has been since May 19th 2021. It was last updated on January 18th 2022."

Answered by AI

Could you provide more information regarding past investigations concerning Nedocromil Sodium?

"Currently, 4 clinical trials involving Nedocromil Sodium are active with one in its final stage. Most of the studies occur within Bloomington, Indiana but 21 other sites are also running these experiments."

Answered by AI

How many individuals can participate in this medical experiment at one time?

"Affirmative. According to clinicaltrials.gov, this scientific trial was initially uploaded on May 19th 2021 and the most recent update occured on January 18th 2022. The study is currently seeking 26 patients from a single medical centre for participation."

Answered by AI

Are adolescents eligible for inclusion in this clinical trial?

"As per the regulations of this trial, individuals must fall within a range of 18-35 years old to be eligible for enrollment."

Answered by AI

What health concerns are typically addressed with Nedocromil Sodium?

"Nedocromil Sodium is often administered to patients with chronic idiopathic urticaria, yet this medication can also alleviate symptoms of eye allergy, animal dander and perennial allergic rhinitis."

Answered by AI

Recent research and studies

Physiological ReportsJournal

Nedocromil Sodium and Diphenhydramine Hcl Ameliorate Exercise‐induced Arterial Hypoxemia in Highly Trained Athletes

Coyle, Michael A., Curtis S. Goss, Wesley J. Manz, Joel T. Greenshields, Robert F. Chapman, and Joel M. Stager. 2022. “Nedocromil Sodium and Diphenhydramine Hcl Ameliorate Exercise‐induced Arterial Hypoxemia in Highly Trained Athletes”. Physiological Reports. Wiley. doi:10.14814/phy2.15149.

clinicaltrials.govStudy

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

Robert Chapman 2021. "The Effect of Cetirizine HCl on Exercise-induced Arterial Hypoxemia in Highly-trained Swimmers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05095311.