A prospective, real-world, interventional study to evaluate the effect of mepolizumab on achieving clinical remission in participants with severe asthma.
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StatusAccepting Candidates
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Age18 Years - NA Years
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SexesAll
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Healthy Volunteers
Description
This study is being done to better understand how well the medication mepolizumab (NUCALA) is working in routine medical practice to treat a sub-population of adult patients with severe asthma who have what is termed an eosinophilic phenotype (SA-EP). Participants will come to the clinic for regular scheduled visits as decided with the doctor and also at specified timepoints (enrollment in the study, 6 months, 12 months, and 24 months after enrollment). At visits, participants will be asked to complete questionnaires about their asthma and its impact on their life as well as, at some visits, to do breathing tests by blowing into equipment to measure their lung function. Taking part in this research will last up to 24 months.
Details
Protocol number | 219871 |
Eligibility
Inclusion
Adults aged 18 years or over Participant has a confirmed asthma diagnosis with physician decision to initiate treatment with NUCALA Participants with 60% predicted FEV1 and 4 exacerbations per year, as confirmed by the physician Written informed consent
Exclusion
Investigator concerns about participants willingness to adhere to biologic treatment for any reason (e.g., cost, behavior, difficulty with access to healthcare) Any NUCALA use in the 6 months prior to enrollment Participants currently on mOCS or intramuscular corticosteroids Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within the 6 months prior to enrollment Participating in an interventional study with a treatment intervention Other clinically significant respiratory conditions (e.g., bronchiectasis, pulmonary fibrosis) Current smokers
Lead researcher
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Vandana K Seeram, MDPulmonologist, Critical Care Medicine Physician
Participate in a study
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
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Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.