90 Participants Needed

Beta-Agonist Inhalers for Healthy Subjects

DP
AR
Overseen ByAndrew R Brotto, MSc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

Studies have shown that both budesonide/formoterol and salbutamol are generally safe for treating asthma, with similar improvements in lung function. However, salbutamol may cause a slightly higher pulse rate compared to budesonide/formoterol.12345

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?

TB

Tracey Bryan, MD

Principal Investigator

University of Alberta

MK

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

I have abnormal lung or heart test results, like low lung function, fast heart rate, or high blood pressure.
I am not taking specific medications like MAOIs, beta-blockers, or steroids.
Absolute contraindication to exercise testing or an orthopedic condition that may limit exercise testing as identified by standardized health screening tool (PAR-Q+).
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Baseline Assessment

Participants undergo baseline assessments including pulmonary function testing, cardiopulmonary exercise testing, and cardiovascular function measurements.

1 week
2 visits (in-person)

Treatment

Participants use an inhaler for 4 weeks and complete weekly symptom questionnaires.

4 weeks
Home use with electronic monitoring

Post-Treatment Assessment

Participants replicate baseline assessments to evaluate the impact of the inhaler use.

1 week
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment.

1 week
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Budesonide/formoterol
  • Placebo
  • Salbutamol
Trial Overview The study tests the effects of two asthma inhalers (Ventolin and Symbicort) versus a placebo on blood vessels over four weeks in young adults. It involves lung function tests, exercise tests, ultrasound imaging of an artery, and multiple lab visits.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: SalbutamolExperimental Treatment1 Intervention
Participants are healthy and between the ages of 18-40 years old
Group II: Budesonide-formoterolExperimental Treatment1 Intervention
Participants are healthy and between the ages of 18-40 years old
Group III: PlaceboPlacebo Group1 Intervention
Participants are healthy and between the ages of 18-40 years old

Budesonide/formoterol is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Symbicort for:
  • Asthma
  • Chronic Obstructive Pulmonary Disease (COPD)
🇺🇸
Approved in United States as Symbicort for:
  • Asthma
  • COPD
🇨🇦
Approved in Canada as Symbicort for:
  • Asthma
  • COPD
🇯🇵
Approved in Japan as Symbicort for:
  • Asthma
  • COPD

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

Published Research Related to This Trial

In a study of 373 patients with moderate persistent asthma, Symbicort (budesonide/formoterol) significantly improved lung function compared to fluticasone propionate, with greater increases in morning peak expiratory flow (PEF) and fewer asthma exacerbations.
Symbicort also led to better overall asthma control, as indicated by a higher percentage of symptom-free days and reduced reliance on reliever medication, while both treatments were well tolerated.
Combination therapy with single inhaler budesonide/formoterol compared with high dose of fluticasone propionate alone in patients with moderate persistent asthma.Bateman, ED., Bantje, TA., João Gomes, M., et al.[2019]
Budesonide formoterol (BF) Spiromax® is pharmacokinetically equivalent to BF Turbohaler®, as demonstrated in two studies with 90 healthy volunteers each, showing similar absorption and peak drug concentrations for both inhalers.
Both inhalers were well tolerated, with only a few minor treatment-emergent adverse events reported, indicating that BF Spiromax is a safe alternative to BF Turbohaler.
Bioequivalence of budesonide plus formoterol (BF) Spiromax® and BF Turbohaler® (with and without charcoal block) in healthy volunteers.Weisfeld, L., Shu, Y., Shah, TP.[2015]
In a study of 207 patients with acute asthma, budesonide/formoterol (Symbicort) showed similar efficacy to salbutamol in improving lung function (FEV1) after treatment, with both showing about a 30% increase from baseline.
Budesonide/formoterol had a better safety profile, as it resulted in a lower mean pulse rate compared to salbutamol, indicating less cardiovascular stimulation, while both treatments were well tolerated.
Efficacy and safety of budesonide/formoterol compared with salbutamol in the treatment of acute asthma.Balanag, VM., Yunus, F., Yang, PC., et al.[2015]

Citations

Combination therapy with single inhaler budesonide/formoterol compared with high dose of fluticasone propionate alone in patients with moderate persistent asthma. [2019]
Bioequivalence of budesonide plus formoterol (BF) Spiromax® and BF Turbohaler® (with and without charcoal block) in healthy volunteers. [2015]
Efficacy and safety of budesonide/formoterol compared with salbutamol in the treatment of acute asthma. [2015]
Maintenance therapy with budesonide and formoterol in chronic obstructive pulmonary disease. [2022]
A comparison of budesonide/formoterol maintenance and reliever therapy vs. conventional best practice in asthma management. [2021]
[symbol: see text] Seretide and [symbol: see text] Symbicort in asthma management. [2017]
Budesonide and formoterol in a single inhaler improves asthma control compared with increasing the dose of corticosteroid in adults with mild-to-moderate asthma. [2019]
Evaluation of inhaler technique and achievement and maintenance of mastery of budesonide/formoterol Spiromax® compared with budesonide/formoterol Turbuhaler® in adult patients with asthma: the Easy Low Instruction Over Time (ELIOT) study. [2019]
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