A Study to Assess Selected Biomarkers in Subjects Requiring Daily Inhaled Corticosteroids for Persistent Asthma
NCT ID: NCT01334853
Last Updated: 2012-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
97 participants
OBSERVATIONAL
2011-01-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1
50 eosinophilic subjects to be evaluated
No drug will be used
Biomarker
Cohort 2
50 non-eosinophilic subjects to be evaluated
No drug will be used
Biomarker
Interventions
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No drug will be used
Biomarker
No drug will be used
Biomarker
Eligibility Criteria
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Inclusion Criteria
* Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
* History of physician-diagnosed asthma for at least 12 months prior to screening
* Stable Medium- to high-dose ICS divided twice daily as outlined by the NHLBI Asthma Guidelines, 2007
Exclusion Criteria
* Concurrent enrollment in another clinical study
* Use of immunosuppressive medication within 3 months prior to screening
* Acute upper or lower respiratory infections requiring antibiotics or antiviral medications with in 30 days prior to screening or during screning period.
* Receipt of immunoglobulin or blood products within 30 days prior to screening or during the screening period
* Receipt of any investigational non-biological drug therapy within 30 days or 5 half-lives prior to screening whichever is longer; or receipt of any marketed or investigational biologic within 6 months or 5 half-lives prior to screening whichever is longer
* Pregnant, lactating, or breastfeeding woman
* Diagnosis of lung disease other than persistent asthma
* History of smoking ≥10 pack years or any smoking within 12 months prior to screening
* History of active, infectious hepatitis A, B, C or human immunodeficiency virus (HIV)
18 Years
75 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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David Gossage, M.D.
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
Denver, Colorado, United States
Research Site
Normal, Illinois, United States
Research Site
Baltimore, Maryland, United States
Research Site
Ann Arbor, Michigan, United States
Research site
Rochester, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Columbus, Ohio, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Galveston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Madison, Wisconsin, United States
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Countries
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Other Identifiers
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MI-CP223
Identifier Type: -
Identifier Source: org_study_id