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Bronchodilator

Beta-Agonist Inhalers for Healthy Subjects

Phase 1
Recruiting
Led By Michael K Stickland, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy participants between the ages of 18-40 years free from a medical history of cardiopulmonary disease
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 days following intervention completion
Awards & highlights

Study Summary

This trial tests if long-term use of asthma inhalers affects blood vessels & heart in young, healthy individuals. Participants will have tests & use inhalers over 4 weeks & researchers will compare results to a placebo.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects from the inhalers may include increased heart rate, shakiness, headaches, throat irritation and possible impact on blood pressure or heart rhythm as seen with typical beta-agonist usage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18-40 years old and have no heart or lung diseases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 days following intervention completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 days following intervention completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
% Increase in Brachial Artery Diameter (Flow Mediated Dilation (FMD))
Pulse wave velocity
Secondary outcome measures
Muscle sympathetic nerve activity

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Budesonide/formoterol
2016
Completed Phase 2
~460

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,087 Total Patients Enrolled
Michael K Stickland, PhDPrincipal InvestigatorUniversity of Alberta
9 Previous Clinical Trials
4,453 Total Patients Enrolled
Tracey Bryan, MDStudy DirectorUniversity of Alberta

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available for the clinical research?

"According to clinicaltrials.gov, this investigation is in the process of enrolling participants and was originally announced on September 1st 2023 with its last edit occurring four days later."

Answered by AI

What is the current roster for participants in this examination?

"Affirmative, the information available on clinicaltrials.gov verifies that this investigation is presently searching for volunteers. The medical trial was initially published in September 1st 2023 and its most recent update occurred 5 days later. 90 patients need to be enrolled at one site."

Answered by AI

Is the scope of this experiment restricted to those over 65 years old?

"This clinical trial is specifically for participants aged between 18 and 40. Patients under the age of 18 have 63 trials to choose from, while those over 65 are offered 404 options."

Answered by AI

Might I be a viable candidate for this research program?

"Eligible candidates for this clinical investigation should be between 18 and 40 years old with no known, underlying health issues. At the current moment in time approximately 90 participants are required to participate in this trial."

Answered by AI

Has the U.S. Food and Drug Administration permitted Salbutamol to be used?

"The degree of safety associated with Salbutamol is marked as a 1, since this first-phase trial only provides scant evidence that it is both effective and safe."

Answered by AI
~25 spots leftby Aug 2024