Cross-sectional Study for Identification and Description of Severe Asthma Patients



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:10/14/2017
Start Date:December 2014
End Date:May 2015

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Identification and Description of Severe Asthma Patients in a Cross-sectional Study—the IDEAL Study

This will be a non-drug interventional cross-sectional study, where the screening visit and
study visit can occur on the same day. Investigational product will not be administered.
Approximately 790 subjects with severe asthma will be screened to achieve a total of at least
750 evaluable study subjects. The study will not include a run-in or follow-up period. This
study will provide a more reliable description of the severe asthma patient landscape with
respect to the potential eligibility for treatment with mepolizumab, omalizumab, and
reslizumab. This study aims to estimate the potential overlap of patients eligible for
treatment with mepolizumab and those eligible for treatment with omalizumab and/or
reslizumab. Additionally, the current study will also ascertain and describe reslizumab
eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient
population.


Inclusion Criteria:

- At least 12 years of age at study visit.

- Participants eligible for enrolment and entry into the study must meet the following
definition of severe asthma, which is based on the definition of severe asthma
described in the European Respiratory Society/ American Thoracic Society (ERS/ATS)
Guidelines for severe asthma: Asthma which requires treatment with guideline suggested
medications for Global Initiative for Asthma (GINA) steps 4-5 asthma for the previous
year (i.e., at least 12 months).

Patients must be treated with high dose ICS PLUS at least one of the following: LABA,
leukotriene modifier, theophylline, or continuous or near continuous systemic
corticosteroid (i.e., maintenance systemic corticosteroid for ≥50% of the previous year).

SPECIAL CIRCUMSTANCE: If patient is on a fixed dose combination medication, then the
maximum recommended dose of the ICS/LABA combination per local label is acceptable.

- Able to give written informed consent prior to participation in the study, which will
include the ability to comply with the requirements and restrictions listed in the
consent form. Participants must be able to read, comprehend, and write at a level
sufficient to complete study related materials. A parent or legal guardian must
provide informed consent for participants less than 18 years of age at study visit (or
less than minimum age to be considered an adult per local laws).

Exclusion Criteria:

Participants who have participated in an interventional clinical trial for asthma within
the past 12 months prior to Visit 1 (NOTE: subjects participating in an observational study
where an investigational product or procedure is not administered will not be subject to
this exclusion criteria)
We found this trial at
22
sites
Baltimore, Maryland 21201
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Charlotte, North Carolina 28203
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Charlotte, NC
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Cincinnati, Ohio 45229
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Cincinnati, OH
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Coffs Harbour, New South Wales 2450
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Coffs Harbour,
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Columbia, Maryland 21044
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Columbia, MD
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Corning, New York 14830
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Corning, NY
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Fresno, California 93720
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Fresno, CA
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Greenville, South Carolina 29615
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Greenville, SC
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Little Rock, Arkansas 72205
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Little Rock, AR
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Los Angeles, California 90025
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Los Angeles, CA
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Medford, Oregon 97504
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Medford, OR
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Minneapolis, Minnesota 55404
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Minneapolis, MN
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Newport Beach, California 92663
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Newport Beach, CA
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Owensboro, Kentucky 42303
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Owensboro, KY
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Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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Plymouth, Minnesota 55441
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Plymouth, MN
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Riverside, California 92506
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Riverside, CA
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Rolling Hills Estates, California 90274
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Rolling Hills Estates, CA
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San Diego, California 92111
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San Diego, CA
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Shelby, North Carolina 28152
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Shelby, NC
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Tallahassee, Florida 32308
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Tallahassee, FL
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Upland, California 91786
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Upland, CA
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