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Tezepelumab for Severe Asthma (WAYFINDER Trial)
WAYFINDER Trial Summary
This trial will test whether Tezepelumab can help reduce oral steroid use in people with severe asthma, who are already taking them with or without other asthma medications.
WAYFINDER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowWAYFINDER Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 150 Patients • NCT03406078WAYFINDER Trial Design
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Who is running the clinical trial?
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- You have a history of heavy drinking or drug use within the past year before starting the study.I have been on daily steroids for asthma, between 5 and 40 mg, for the last 3 months.I have tested positive for hepatitis B or C.I haven't taken any experimental drugs or biologics recently.I haven't taken immune-suppressing drugs in the last 12 weeks, except for asthma.You have had a severe allergic reaction or immune system-related disease after taking a biologic therapy.I am between 18 and 80 years old.It seems like the criterion is incomplete. Could you please provide more details or context so I can assist you accurately?I have had at least one asthma attack in the last year.There are additional requirements for participation in the study, as outlined in the study protocol.Other requirements listed in the study guidelines must also be met.I haven't had major surgery in the last 8 weeks nor plan to during the study.I have been on a stable dose of oral corticosteroids for at least 4 weeks.I have a lung or systemic disease, but it's not asthma with high EOS counts.I finished treatment for a serious infection less than 2 weeks ago.I was diagnosed with a worm infection in the last 6 months that hasn't improved with standard treatment.I am on long-term oral steroids for an inflammatory condition.I have had at least one asthma attack in the last year.I have been on daily steroids for asthma, between 5mg and 40mg, for the last 3 months.I have been on a stable dose of oral corticosteroids for at least 4 weeks.I have had at least one asthma attack in the last year.I have been treated for tuberculosis within the last year.I have had cancer in the past.I currently smoke or have a history of smoking equivalent to 10 pack-years or more, or I use vaping products.I am between 18 and 80 years old.I have been on high-dose asthma medication for at least 6 months.
- Group 1: Tezepelumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
How many people are participating in this trial at any given time?
"Yes, as the listing on clinicaltrials.gov indicates, this study is recruiting patients. The trial was originally posted on May 17th, 2022 and has been edited most recently on November 4th of the same year. Currently, 8 different locations are looking for a total of 323 participants."
Are there any participants needed for this clinical trial at the moment?
"Yes, the information on clinicaltrials.gov suggests that this study is recruiting patients as of the most recent update on 11/4/2022. The trial was first posted 5/17/2022 and is enrolling 323 participants between 8 locations."
Who meets the requirements to be a test subject in this experiment?
"This trial is recruiting 323 participants who have asthma and are between the ages of 18 and 80. The following criteria must be met in order to be eligible for the study: - Age 18-80 years- Documented long-term OCS therapy for asthma, equivalent to a daily dose of at least 5 mg and up to 40 mg of prednisone/prednisolone for at least 3 continuous months directly preceding Visit 1- Participant should be on a stable OCS dose for at least 4 weeks prior to Visit 1- Documented history of at least 1 asthma exacerbation event within 12 months prior"
Could you please elaborate on the potential risks of Tezepelumab?
"Tezepelumab is a medication that has completed Phase 3 clinical trials. This means there is available data which supports its efficacy and multiple rounds of data supporting safety. Our team at Power estimates the safety of Tezepelumab to be a 3 on a scale from 1 to 3."
Is this clinical trial happening at more than one hospital in the state?
"Currently, this trial is running at 8 sites. They are situated in Ann Arbor, Riverdale and Newark as well as 5 other locations. If you want to participate, it would be advantageous to choose the location nearest to you so that travelling isn't an inconvenience."
For this particular test, is the age limit set at 45 years or above?
"Enrolment for this study is open to patients aged between 18-80 years old. There are 117 clinical trials available for minors and 202 for senior citizens."
What goals does this research hope to achieve?
"The primary outcome that will be assessed at Week 52 is the percentage of patients who are able to reduce their daily maintenance oral corticosteroid dose to 5 mg/day or below without loss of asthma control. Additionally, researchers will also monitor the rate of hospitalization and emergency room visits due to exacerbations, as well as the overall number of exacerbations over the course of the trial."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Most responsive sites:
- Research Site: < 48 hours
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