A Study to Assess Selected Biomarkers in Subjects Requiring Daily Inhaled Corticosteroids for Persistent Asthma

Completed

Conditions studied: Asthma

In brief

The rationale for conducting this study is to explore potential clinical and peripheral biomarkers in subjects requiring daily medium to high dose inhaled corticosteroids for persistent asthma

Key facts

Study ID

NCT01334853

Run by

MedImmune LLC

People needed

97

Starts

2011-01-01

Expected to finish

2012-09-01

Last updated by the study team

2012-10-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 through 75 at the time of screening
• 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

You may not qualify if…

• Any medical condition that, in the opinion of the investigator or medical monitor, would interfere with interpretation of subject safety or study results
• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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