Cardiovascular Consequences of Inhaled Short-acting Beta-agonist Use

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical trial is to test the impact inhalers have on blood vessels in young healthy individuals. The main question it aims to answer is if long term use of asthma inhalers have any effect on the blood vessels and heart. Participants will be asked to:

• Perform lung function and exercise tests

• Have ultrasound images taken of the artery in their arm

• Use an inhaler for 4 weeks

• Visit the lab for testing on 4-6 different occasions

Researchers will compare two different inhalers (Ventolin and Symbicort) with a placebo to see if the inhalers have any effect on the blood vessels over the 4 week period.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alberta
• Treatments: Albuterol; Budesonide; Formoterol Fumarate

Criteria

Inclusion Criteria:

• Healthy participants between the ages of 18-40 years free from a medical history of cardiopulmonary disease

Exclusion Criteria:

• Absolute contraindication to exercise testing or an orthopedic condition that may limit exercise testing as identified by standardized health screening tool (PAR-Q+).

• Abnormal findings during the pulmonary function test and/or cardiopulmonary exercise test including pulmonary function values below the lower limit of normal, decrease in FEV1 following exercise (>10%), tachycardia (>100bpm at rest), and resting hypertension (>140/90 mmHg).

• Pre-existing cardiac conditions (heart failure, congenital heart defect, valvular disease) that may limit exercise testing.

• Comorbidities such as diabetes, dyslipidemia, liver disease, neuromuscular disease, renal disease, and respiratory disease

• Prescription of medical inhaler

• History of inhalants usage for greater than 1 year including but not limited to cigarettes, marijuana, and vaporizers.

• Pregnancy or lactation

• Women of childbearing potential must be willing to use an acceptable method of contraception to avoid pregnancy throughout the study. Acceptable methods of contraception include tubal ligation, oral contraceptive, and barrier methods. Abstinence is an acceptable form of contraception, only insofar as patients agree to use another acceptable method of birth control, preferably a barrier method, if they become sexually active.

• Medication usage of monoamine oxidase inhibitors, tricyclic antidepressants, beta-blockers, diuretics, digoxin, other inhaled sympathomimetric bronchodilators or epinephrine, ritonavir, ketoconazole, itraconazole, cytochrome P450 sA4 inhibitors, xanthine derivatives, steroids, non-potassium sparing diuretics, L-Dopa, L-thyroxine, and oxytocin.