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Bronchodilator
Inhaled Albuterol for Asthma
Phase 4
Waitlist Available
Led By Victor Hoffstein, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Moderate asthma with baseline FEV1 40-75% predicted
Previous use of albuterol (salbutamol)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test if a new way to deliver albuterol to the lungs can reduce the amount of the drug needed while still providing the same benefit, and also reducing side effects.
Who is the study for?
This trial is for adults aged 18-60 with moderate asthma, who have seen improvement from albuterol but are non-smokers for over 6 months. They must not have heart issues, recent changes in asthma treatment, chest infections or intolerance to bronchodilator withdrawal.Check my eligibility
What is being tested?
The study tests a new way of delivering albuterol using Akita's breath control technology. It aims to see if a much smaller dose can be as effective as the standard one by targeting the drug delivery directly to lung areas that need it most.See study design
What are the potential side effects?
While traditional albuterol can cause shakiness and an increased heart rate, this trial expects that by reducing the dose significantly through targeted delivery, these side effects will also be substantially lessened.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My asthma is moderate with specific lung function levels.
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I have used albuterol before.
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My lung function improved by 20% after a nebulizer treatment.
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I am between 18 and 60 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
change in FEV1 expressed as a percent of predicted between baseline and 1 hour post drug administration.
Secondary outcome measures
change in hand tremor compared to standard treatment
change in heart rate compared to standard treatment
duration of effect based on FEV1 at 6 hours post treatment compared to standard treatment
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,465 Previous Clinical Trials
483,679 Total Patients Enrolled
4 Trials studying Asthma
317 Patients Enrolled for Asthma
Victor Hoffstein, MDPrincipal InvestigatorUniversity Health Network, Toronto
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot stop using my inhaler or breathing treatments.I have not changed my asthma treatment in the last 30 days.You have not smoked for more than 6 months.You have a chest x-ray that shows a serious problem.You are allergic to albuterol (salbutamol).My asthma is moderate with specific lung function levels.I have used albuterol before.I have not had a cold or asthma flare-up in the last 2 weeks.My lung function improved by 20% after a nebulizer treatment.I am between 18 and 60 years old.Your oxygen level is above 90%.I have a history of heart problems, including poor blood flow to my heart, irregular heartbeat, or high blood pressure.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrolling in this research still an option for participants?
"Evidently, this experiment is no longer accepting patients. Initially posted on October 1st 2006 and last amended on the 6th of that same month, prospective participants will have to explore other trials as there are 320 such studies currently enrolling volunteers."
Answered by AI
Does my profile conform to the requirements of this research project?
"This trial is open to 10 individuals in the 18-60 age range who have been diagnosed with asthma. Additional prerequisites include being non-smokers for more than 6 months and identifying as male or female."
Answered by AI
Are there any age limitations for joining this clinical trial?
"Potential participants must be of age and under 60 years old to qualify for this trial."
Answered by AI
Are there any associated risks to this therapy?
"There is ample evidence to suggest the safety of this medication, so it has been allocated a score of 3. As this treatment has already reached phase 4 clinical trials, approval seems imminent."
Answered by AI
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