Cardiovascular Consequences of Inhaled Short-acting Beta-agonist Use

NCT06027606 | Completed Phase 1

• 1 other identifier: Pro00126438
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Pulse wave velocity

  Velocity of blood flow between pulse points

  Up to 3 days following intervention completion

• % Increase in Brachial Artery Diameter (Flow Mediated Dilation (FMD))

  Brachial artery dilation following suprasystolic occlusion

  Up to 3 days following intervention completion

Secondary Outcomes (1)

• Muscle sympathetic nerve activity

  Up to 5 days following intervention completion

Study Arms (3)

Salbutamol

EXPERIMENTAL

Participants are healthy and between the ages of 18-40 years old

Drug: Salbutamol 400mcg

Budesonide-formoterol

EXPERIMENTAL

Participants are healthy and between the ages of 18-40 years old

Drug: Budesonide/formoterol

Placebo

SHAM COMPARATOR

Participants are healthy and between the ages of 18-40 years old

Drug: Placebo

Interventions

Salbutamol 400mcg DRUG

Salbutamol is a short-acting beta-agonist used primarily as a rescue inhaler for respiratory disease such as asthma

Salbutamol

Budesonide/formoterol DRUG

Budesonide/formoterol is a inhaled corticosteroid with long-acting beta-agonist component primarily used as a maintenance inhaler for respiratory conditions such as asthma

Budesonide-formoterol

Placebo DRUG

Practice inhaler primarily used in training scenarios so looks identical to medical inhalers

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Clinical Physiology Laboratory

Edmonton, Alberta, T6G2R3, Canada

Location

MeSH Terms

Interventions

Albuterol; Budesonide, Formoterol Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Formoterol Fumarate; Budesonide; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Tracey Bryan, MD

  University of Alberta

  STUDY DIRECTOR

• Michael K Stickland, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: September 7, 2023
• Study Start: September 1, 2023
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)