Impact of asthma inhalers on blood vessels in healthy young adults

Cardiovascular Consequences of Prolonged Inhaled Short-acting Beta-agonist Use in Healthy Participants

This study is testing if using certain asthma inhalers affects blood vessel health in healthy young adults aged 18-40.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: University of Alberta (Academic / other)
• Locations: 1 site (Edmonton, Alberta)
• Trial ID: NCT06027606 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the cardiovascular effects of inhaled short-acting beta-agonists in healthy individuals aged 18-40. Participants will undergo lung function and exercise tests, receive ultrasound imaging of their arteries, and use either salbutamol, budesonide-formoterol, or a placebo inhaler over a four-week period. The study aims to determine if these inhalers affect blood vessel function and heart health. Participants will attend multiple lab visits for comprehensive testing and monitoring.

Who should consider this trial

Good fit: Ideal candidates are healthy individuals aged 18-40 with no history of cardiopulmonary disease.

Not a fit: Patients with pre-existing cardiac conditions or those who have used inhalers for more than one year may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the cardiovascular safety of commonly used asthma inhalers in young adults.

How similar studies have performed: While the specific focus on inhalers' cardiovascular effects in healthy individuals is novel, related studies have explored the impacts of inhalers on other populations.

Eligibility 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.

Where this trial is running

Edmonton, Alberta

• Clinical Physiology Laboratory — Edmonton, Alberta, Canada (Recruiting)

Study contacts

• Principal investigator: Michael K Stickland, PhD — University of Alberta
• Study coordinator: Desi P Fuhr, MSc

Conditions Healthy