The Effects of Nedocromil Sodium and Cetirizine HCl on Exercise-induced Arterial Hypoxemia in Highly-trained Swimmers

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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 nedocromil sodium (NS), a mast cell stabilizer, and cetirizine HCl (CH), an H1-receptor competitive inhibitor, can improve oxyhemoglobin saturation during submaximal and maximal swimming exercise. Twenty-six (13 men, 13 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indiana University
• Treatments: Cetirizine; Nedocromil

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Not within defined age range

• Current diagnosis of or using medication for:

• Severe allergies

• Asthma

• Exercise-induced asthma

• Exercise-induced bronchoconstriction

• 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.