Status:
COMPLETED
Cardiovascular Consequences of Inhaled Short-acting Beta-agonist Use
Lead Sponsor:
University of Alberta
Conditions:
Healthy
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief 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 e...
Detailed Description
Session 1) The first visit is a screening visit where participants will be invited to our Clinical Sciences Building research lab to conduct pulmonary function testing and cardiopulmonary exercise tes...
Eligibility Criteria
Inclusion
- Healthy participants between the ages of 18-40 years free from a medical history of cardiopulmonary disease
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2025
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT06027606
Start Date
September 1 2023
End Date
September 25 2025
Last Update
November 18 2025
Active Locations (1)
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1
Clinical Physiology Laboratory
Edmonton, Alberta, Canada, T6G2R3