Exercise-induced Arterial HypoxemiaPhase 4NCT05095311
The Effect of Cetirizine HCl on Exercise-induced Arterial Hypoxemia in Highly-trained Swimmers
A Phase 4 study testing Cetirizine HCl in people with Exercise-induced Arterial Hypoxemia, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise-induced Arterial Hypoxemia
- What is being tested?
- Cetirizine HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2021to 27 Apr 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women
- 18-35 years old
- Current collegiate or professional swimmer
- Currently training at least 300 minutes per week
- Self-reported to be healthy
Who cannot join
- Not within defined age range
- Current diagnosis of or using medication for:
- Severe allergies
- Asthma
- Exercise-induced asthma
- Exercise-induced bronchoconstriction
Show all 23Show fewer
- Pulmonary function test considered to be abnormal (defined as forced vital capacity (FVC) <80% of predicted, forced expiratory volume in one second (FEV1) <80% predicted, and/or FEV1/FVC ratio >5% of the predicted ratio)
- Hypertension during screening (systolic blood pressure >139 or diastolic blood pressure >89)
- Current tobacco or electronic cigarette use or consistent use within the last 2 years
- A contraindication for use of nedocromil sodium:
- Previous adverse reaction to nedocromil sodium or a similar medication
- Use of fast-acting, inhaled insulin
- A contraindication for use of cetirizine HCl:
- Previous adverse reaction to cetirizine HCl or a similar medication
- Allergy to the food additives E218 or E216
- An intolerance to or inability to absorb some sugars, such as lactose or sorbitol
- Liver or kidney failure
- Epilepsy or similar condition
- A condition that makes urinating difficult
- Use of midodrine or ritonavir
- Are pregnant or could possibly be pregnant by self-report
- Subjects with current, irregular menstrual cycles (amenorrhea) or who had irregular menstruation patterns for greater than one year
- People who answer 'yes' to any of the pre-participation screening questions on page one of the PAR-Q+ questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
For the first testing session, participants will report to the Indiana University Human Performance Laboratory to complete a medical screening and, if willing, consent to the procedures of the study. The medical screening will include measurements of height, weight, resting heart rate, resting blood pressure, and resting pulmonary function along with a health history questionnaire.
The second testing session consists of an assessment of risk factors for development of EIAH, specifically changes in blood biomarkers pre- and post-swimming exercise. Participants will report to the Counsilman-Billingsley Aquatics Center and complete an exercise protocol designed to elicit an inflammatory response. Venous blood draws will be performed to assess participants' pre-exercise complete blood count and pre- and post-intense exercise concentrations of plasma IL-1β, IL-8, plasma histamine, whole blood histamine, and histamine release. Measurements of hemoglobin concentration and hematocrit will also be performed pre- and post-exercise in order to correct biomarker concentrations for fluid loss during exercise. Swimmers of each sex that exhibit the largest histamine release will be selected for further study until at least four swimmers of each sex complete all three experimental trials.
Twelve swimmers (n = 6 men, n = 6 women) will be selected for further trials. Those selected for further study will visit the Human Performance Laboratory on two occasions separated by at least 48 hours and no more than 60 days. Apart from receiving a placebo (PL) or drug treatment (cetirizine HCl, CH) prior to exercise, participants will perform identical protocols on each visit to the laboratory. Participants will report to the lab and consume either a placebo or CH pill, followed by a health history update questionnaire and their resting pulmonary function will be measured. Participants will then complete a self-selected warm-up that will be standardized across all testing sessions, followed by instrumentation. The exercise protocol beings with a progressive swimming test to maximum aerobic capacity (V̇O2max) in a swimming flume, followed by two constant load work bouts at approximately 70 and 85% of the previously recorded HRmax while peripheral capillary oxyhemoglobin saturation (SpO2) is continuously monitored. Participants will receive a 20-min break between each work bout. Drug treatments will be assigned in a double-blind, randomized crossover fashion such that each participant receives each treatment. Concentrations of plasma histamine, whole blood histamine, and histamine release will be assessed from pre- and post-exercise blood samples.
- Conditions
- Exercise-induced Arterial Hypoxemia
- Being tested
- Cetirizine HCl, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetirizine HClDrug
Also called Zyrtec
Eight participants will be administered 10 mg of cetirizine HCl to examine whether this drug can improve their oxyhemoglobin saturation during exercise.
PlaceboOther
The placebo pill is a sugar-free gelatin pill casing. The placebo inhaler contains isotonic saline.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Drug: Cetirizine HCl; Other: Placebo |
| Selection pool | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Capillary Oxyhemoglobin Saturation
SpO2 percentage measured via a standard bedside pulse oximetry unit
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start19 May 2021
- Primary completion27 Apr 2022
- Study completion27 Apr 2022
Why it stopped: The recruited population was no longer made available to participate in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise-induced Arterial HypoxemiaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Chapman, Indiana University
- Investigators
- Robert F Chapman, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095311
- Sponsor's protocol ID
- 10766
- Status last verified
- Feb 2024
- First submitted
- 19 Jun 2021
- Last updated
- 5 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be published in the form of a dissertation document.
Publications
Coyle MA, Goss CS, Manz WJ, Greenshields JT, Chapman RF, Stager JM. Nedocromil sodium and diphenhydramine HCl ameliorate exercise-induced arterial hypoxemia in highly trained athletes. Physiol Rep. 2022 Jan;10(1):e15149. doi: 10.14814/phy2.15149.
PubMed 35001564
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cetirizine HCl on Exercise-induced Arterial Hypoxemia in Highly-trained Swimmers
- ClinicalTrials.gov ID
- NCT05095311
- Acronym / sponsor ID
- 10766
- Conditions
- Exercise-induced Arterial Hypoxemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruited population was no longer made available to participate in the study.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Posted 5 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For the first testing session, participants will report to the Indiana University Human Performance Laboratory to complete a medical screening and, if willing, consent to the procedures of the study. The medical screening will include measurements of height, weight, resting heart rate, resting blood pressure, and resting pulmonary function along with a health history questionnaire.
The second testing session consists of an assessment of risk factors for development of EIAH, specifically changes in blood biomarkers pre- and post-swimming exercise. Participants will report to the Counsilman-Billingsley Aquatics Center and complete an exercise protocol designed to elicit an inflammatory response. Venous blood draws will be performed to assess participants' pre-exercise complete blood count and pre- and post-intense exercise concentrations of plasma IL-1β, IL-8, plasma histamine, whole blood histamine, and histamine release. Measurements of hemoglobin concentration and hematocrit will also be performed pre- and post-exercise in order to correct biomarker concentrations for fluid loss during exercise. Swimmers of each sex that exhibit the largest histamine release will be selected for further study until at least four swimmers of each sex complete all three experimental trials.
Twelve swimmers (n = 6 men, n = 6 women) will be selected for further trials. Those selected for further study will visit the Human Performance Laboratory on two occasions separated by at least 48 hours and no more than 60 days. Apart from receiving a placebo (PL) or drug treatment (cetirizine HCl, CH) prior to exercise, participants will perform identical protocols on each visit to the laboratory. Participants will report to the lab and consume either a placebo or CH pill, followed by a health history update questionnaire and their resting pulmonary function will be measured. Participants will then complete a self-selected warm-up that will be standardized across all testing sessions, followed by instrumentation. The exercise protocol beings with a progressive swimming test to maximum aerobic capacity (V̇O2max) in a swimming flume, followed by two constant load work bouts at approximately 70 and 85% of the previously recorded HRmax while peripheral capillary oxyhemoglobin saturation (SpO2) is continuously monitored. Participants will receive a 20-min break between each work bout. Drug treatments will be assigned in a double-blind, randomized crossover fashion such that each participant receives each treatment. Concentrations of plasma histamine, whole blood histamine, and histamine release will be assessed from pre- and post-exercise blood samples.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Cetirizine HCl, Other: PlaceboThis 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. |
| Selection pool | No 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 may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women
- 18-35 years old
- Current collegiate or professional swimmer
- Currently training at least 300 minutes per week
- Self-reported to be healthy
Key exclusion criteria (23 listed)
- Not within defined age range
- Current diagnosis of or using medication for:
- Pulmonary function test considered to be abnormal (defined as forced vital capacity (FVC) <80% of predicted, forced expiratory volume in one second (FEV1) <80% predicted, and/or FEV1/FVC ratio >5% of the predicted ratio)
- Hypertension during screening (systolic blood pressure >139 or diastolic blood pressure >89)
- Current tobacco or electronic cigarette use or consistent use within the last 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetirizine HClAlso: ZyrtecEight participants will be administered 10 mg of cetirizine HCl to examine whether this drug can improve their oxyhemoglobin saturation during exercise. | Drug | Experimental group |
| PlaceboThe placebo pill is a sugar-free gelatin pill casing. The placebo inhaler contains isotonic saline. | Other | Experimental group |
Primary outcome
Peripheral Capillary Oxyhemoglobin Saturation
Time frame: 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
SpO2 percentage measured via a standard bedside pulse oximetry unit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35001564Coyle MA, Goss CS, Manz WJ, Greenshields JT, Chapman RF, Stager JM. Nedocromil sodium and diphenhydramine HCl ameliorate exercise-induced arterial hypoxemia in highly trained athletes. Physiol Rep. 2022 Jan;10(1):e15149. doi: 10.14814/phy2.15149.
- Individual participant dataSharing planned: Yes. IPD will be published in the form of a dissertation document.
Related trials for Exercise-induced Arterial Hypoxemia
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Interstitial Lung Disease, Chronic Obstructive Pulmonary Disease
Recruiting
Effects of Oxygen Supplementation During the 6-Minute Walk Test in Chronic Respiratory Failure or Exertional Hypoxemia
Chronic Respiratory Failure, Hypoxemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert F Chapman, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cetirizine HCl in people with Exercise-induced Arterial Hypoxemia, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral Capillary Oxyhemoglobin Saturation (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05095311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.