Effect of an H1 Receptor Antagonist on Exercise Performance in Hypoxia

NCT03192488 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 1702396373
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to determine whether a simple, single intervention of Cetirizine / Zyrtec® use can improve exercise performance of active individuals when acutely exposed to altitude. For this project, healthy subjects will perform steady state and progressive work rate exercise, endurance performance time trials, and repeated sprint performance time trials in the laboratory at a simulated altitude of 3000m (9900ft) after dosing with 10 mg of Cetirizine or a placebo in a repeated measures design.

Conditions

Hypoxia, Altitude

Outcome Measures

Primary Outcomes (1)

• Performance Time

  Time to complete 8km cycling time trial

  Performed 60min after pill ingestion

Secondary Outcomes (1)

• Plasma Histamine Concentrations at Baseline and Post-Exercise

  baseline and immediately post-exercise, same day as pill ingestion

Study Arms (3)

Cetirizine/Hypoxia

EXPERIMENTAL

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).

Drug: Cetirizine; Other: Hypoxia

Placebo/Normoxia

PLACEBO COMPARATOR

Subjects orally ingested a 10 mg gelatin Placebo 60 min before exercising in a normoxic (room-air) environment (20.9% oxygen).

Drug: Placebo oral capsule

Placebo/Hypoxia

PLACEBO COMPARATOR

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).

Drug: Placebo oral capsule; Other: Hypoxia

Interventions

Cetirizine DRUG

Cetirizine tablet 10 mg

Also known as: Zyrtec

Cetirizine/Hypoxia

Placebo oral capsule DRUG

Gelatin placebo

Placebo/Hypoxia; Placebo/Normoxia

Hypoxia OTHER

Exposure to a 14.3% oxygen environment simulating an altitude of 3,000m/9,000ft

Also known as: altitude, low-oxygen environment

Cetirizine/Hypoxia; Placebo/Hypoxia

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Physically active a minimum of 120 minutes a week, as determined by questionnaire
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Bloomington, Indiana, 47401, United States

Location

MeSH Terms

Conditions

Altitude Sickness

Interventions

Cetirizine; Altitude

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Results Point of Contact

• Title: Robert Chapman
• Organization: Indiana University

rfchapma@indiana.edu

812-856-2452

Study Officials

• Robert Chapman, PhD

  Indiana University School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 20, 2017
• Study Start: August 31, 2017
• Primary Completion: June 6, 2018
• Study Completion: June 6, 2018
• Last Updated: June 16, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)