Beta-Agonist Inhalers for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
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 occasionsResearchers 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.
Will I have to stop taking my current medications?
Yes, you will need to stop taking certain medications to participate in this trial. The trial excludes participants who are using specific medications like monoamine oxidase inhibitors, tricyclic antidepressants, beta-blockers, and several others.
Is the combination of budesonide/formoterol and salbutamol safe for humans?
How is the drug budesonide/formoterol different from other asthma treatments?
Budesonide/formoterol is unique because it combines a corticosteroid (budesonide) and a long-acting beta-agonist (formoterol) in a single inhaler, providing both anti-inflammatory effects and long-term bronchodilation, which can be more convenient and effective for patients not adequately controlled with separate medications.12346
What data supports the effectiveness of the drug Budesonide/formoterol?
Research shows that Budesonide/formoterol is effective in improving lung function and quality of life in patients with chronic obstructive pulmonary disease (COPD) and asthma. It helps maintain lung function, reduces the number of exacerbations (worsening of symptoms), and is more effective than using either component alone or a placebo.12478
Who Is on the Research Team?
Tracey Bryan, MD
Principal Investigator
University of Alberta
Michael K Stickland, PhD
Principal Investigator
University of Alberta
Are You a Good Fit for This Trial?
This trial is for healthy individuals aged 18-40 without heart or lung diseases. Participants should not be using medical inhalers, have abnormal exercise test results, pre-existing cardiac conditions, or be pregnant/lactating. Women must use contraception if they can bear children.Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo baseline assessments including pulmonary function testing, cardiopulmonary exercise testing, and cardiovascular function measurements.
Treatment
Participants use an inhaler for 4 weeks and complete weekly symptom questionnaires.
Post-Treatment Assessment
Participants replicate baseline assessments to evaluate the impact of the inhaler use.
Follow-up
Participants are monitored for safety and effectiveness after treatment.
What Are the Treatments Tested in This Trial?
Interventions
- Budesonide/formoterol
- Placebo
- Salbutamol
Budesonide/formoterol is already approved in European Union, United States, Canada, Japan for the following indications:
- Asthma
- Chronic Obstructive Pulmonary Disease (COPD)
- Asthma
- COPD
- Asthma
- COPD
- Asthma
- COPD
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor