Effect of an H1 Receptor Antagonist on Exercise Performance in Hypoxia
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ClinicalTrials.gov Identifier: NCT03192488 |
Recruitment Status :
Completed
First Posted : June 20, 2017
Results First Posted : June 16, 2020
Last Update Posted : June 16, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypoxia, Altitude | Drug: Cetirizine Drug: Placebo oral capsule Other: Hypoxia | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | Effect of an H1 Receptor Antagonist on Exercise Performance in Hypoxia |
Actual Study Start Date : | August 31, 2017 |
Actual Primary Completion Date : | June 6, 2018 |
Actual Study Completion Date : | June 6, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Cetirizine/Hypoxia
Subjects orally ingested 10 mg of Cetirizine 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
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Drug: Cetirizine
Cetirizine tablet 10 mg
Other Name: Zyrtec Other: Hypoxia Exposure to a 14.3% oxygen environment simulating an altitude of 3,000m/9,000ft
Other Name: altitude, low-oxygen environment |
Placebo Comparator: Placebo/Normoxia
Subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).
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Drug: Placebo oral capsule
Gelatin placebo |
Placebo Comparator: Placebo/Hypoxia
Subjects orally ingested a 10 mg Placebo 60 min before exercising in a normobaric hypoxic environment (14.3% oxygen simulating an altitude of 3,000m/9,000ft).
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Drug: Placebo oral capsule
Gelatin placebo Other: Hypoxia Exposure to a 14.3% oxygen environment simulating an altitude of 3,000m/9,000ft
Other Name: altitude, low-oxygen environment |
- Performance Time [ Time Frame: Performed 60min after pill ingestion ]Time to complete 8km cycling time trial
- Plasma Histamine Concentrations at Baseline and Post-Exercise [ Time Frame: baseline and immediately post-exercise, same day as pill ingestion ]Plasma histamine concentrations (ng/mL) were determined baseline and post-exercise for each experimental condition. Baseline measures were taken immediately prior to exercise and the post-exercise measures were taken 5-10 minutes after the cessation of exercise.

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Physically active a minimum of 120 minutes a week, as determined by questionnaire
- 18-35 years of age
- Classified as low risk, based on the modified PAR-Q questionnaire, BMI, and non-smoking status
- No history of pulmonary disease and pulmonary function classified as normal, as defined by the following measurements being 80% of predicted values: forced vital capacity (FVC), forced expired volume in one second (FEV1) and FEV1/FVC, according to the American Thoracic Society standards.
Exclusion Criteria:
- Current smoker
- Women who are pregnant or could possibly be pregnant
- BMI > 25 kg/m2
- A 'yes' answer to any of the 14 questions on the PAR-Q pre-participation questionnaire
- History of pulmonary disease or <80% of predicted FCV, FEV1 and/or FEV1/FVC.
- A history of renal or liver disease, due to possible interaction effect with Cetirizine
- Currently taking any prescription or over the counter medications for the treatment of allergies, or taking any of the below listed drugs known to have a moderate or higher interaction effect with Cetirizine:
isocarboxazid tranylcypromine bosutinib clobazam crizotinib daclatasvir eliglustat hyaluronidase lomitapide lurasidone ombitasvir/paritaprevir/ritonavir phenelzine ponatinib ritonavir vemurafenib

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192488
United States, Indiana | |
Indiana University | |
Bloomington, Indiana, United States, 47401 |
Principal Investigator: | Robert Chapman, PhD | Indiana University School of Public Health |
Documents provided by Robert Chapman, Indiana University:
Responsible Party: | Robert Chapman, Associate Professor, Indiana University |
ClinicalTrials.gov Identifier: | NCT03192488 |
Other Study ID Numbers: |
1702396373 |
First Posted: | June 20, 2017 Key Record Dates |
Results First Posted: | June 16, 2020 |
Last Update Posted: | June 16, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | No IPD plan |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Altitude Sickness Hypoxia Signs and Symptoms, Respiratory Respiration Disorders Respiratory Tract Diseases Cetirizine Anti-Allergic Agents |
Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |