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SUNRISE Trial Summary
This trial is testing the effectiveness of a new drug, tezepelumab, in reducing the amount of oral corticosteroids needed for people with asthma who are dependent on them.
SUNRISE 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 • NCT03406078SUNRISE Trial Design
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Who is running the clinical trial?
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- I am a current smoker or have a history of heavy smoking, or I use vaping products.I've needed more asthma medication or steroids in the last 30 days.I have been treated for tuberculosis within the last year.I had skin or cervical cancer treated over a year ago, or any cancer treated over 5 years ago.I do not have an active COVID-19 infection.I received a COVID-19 vaccine within the last 28 days.I haven't taken any experimental drugs or biologics recently.I have a lung condition that is not asthma.I have been on a medium or high dose of prescribed inhaler steroids for over a year.I have been using additional asthma control medications for at least 3 months.I have been on prescribed LABA and high dose ICS for at least 3 months.I have had an asthma attack in the last 2 years.I have asthma confirmed by tests in the last 5 years.I have a worm infection diagnosed in the last 6 months that hasn't improved with standard treatment.My asthma is controlled with a very low or high steroid dose, or after reducing my medication dose 3 times.I have been using a short-acting asthma inhaler regularly for the last month.I have been diagnosed with asthma for over a year.I am between 18 and 80 years old.I have been taking oral steroids for asthma for at least 6 months and have been on a stable dose for the last month.I have been on a stable dose of oral corticosteroids for at least 2 weeks.I finished treatment for a serious infection less than 2 weeks ago.You have shown good response to bronchodilator test in the past 5 years or have documented airway hyperresponsiveness in the past 5 years.
- Group 1: Placebo
- Group 2: Tezepelumab
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
Does this research restrict participation to adults over 30?
"This study is looking for individuals that fall between 18-80 years old."
Are there any vacancies in this clinical trial for new patients?
"The clinical trial mentioned is still open and looking for participants, with the original posting on 8/9/2022. The most recent update to the listing was on 11/14/2022."
Is Tezepelumab known to have negative effects on patients?
"There is existing clinical data that supports the safety of Tezepelumab, thus it received a score of 3."
Which patients does this clinical trial target?
"This study is seeking 207 participants with asthma between the ages of 18 and 80. Candidates should meet the following criteria: Participant must be 18 to 80 years of age., Participants must have received a physician-prescribed medium- or high-dose ICS for at least 12 months prior to Visit 1., Participants must have received OCS for the treatment of asthma for at least 6 months prior to Visit 1 and on a stable dose of between ≥7.5 to ≤ 30 mg (prednisone or prednisolone) daily or daily equivalent for at least 1 month prior to Visit 1., Morning pre- bronchod"
Is this research being conducted in a number of different locations across Canada?
"To make participation more logistically feasible, this clinical trial offers 17 different sites. They are situated in Kingwood, Hazelwood, Bronx and 14 other locations."
How many volunteers are helping with this research project?
"Yes, the listed information on clinicaltrials.gov affirms that the trial is actively recruiting patients. The trial was first posted on August 9th, 2022 and has since been updated on November 14th, 2022. They are looking for a total of 207 participants from 17 different locations."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
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