Clinical trial NCT01334853: A Study to Assess Selected Biomarkers in Subjects Requiring Daily Inhaled Corticosteroids for Persistent Asthma
Official title: A Prospective Observational Study to Assess the Role of Selected Biomarkers in Subjects Requiring Daily Medium- to High-dose Inhaled Corticosteroids for Persistent Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2011-04-13
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with asthma on stable medium- to high-dose inhaled corticosteroids.

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: To identify an optimal prediction rule for classifying sputum eosinophilic and non-eosinophilic asthmatics.
timeFrame: 8 Days
Secondary outcomes:
measure: To assess which markers are associated with sputum eosinophils.
timeFrame: 8 Days
measure: To assess which markers are associated with sputum eosinophils
timeFrame: 8 Days
measure: To assess which markers are associated with sputum esonophils
timeFrame: 8 Days
measure: To assess which markers are associated with sputum eosinophils.
timeFrame: 8 Days
measure: To evaluate transcript expression profiles in whole blood and/or sputum using microarray analyses
timeFrame: 8 Days
Other outcomes:
Locations:
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Normal
country: United States
facility: Research Site
state: Illinois
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Rochester
country: United States
facility: Research site
state: Minnesota
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Pittsburg
country: United States
facility: Research Site
state: Pennsylvania
city: Galveston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Madison
country: United States
facility: Research Site
state: Wisconsin
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Quebec City
country: Canada
facility: Research Site
state: Quebec
Study officials:
affiliation: MedImmune LLC
name: David Gossage, M.D.
role: STUDY_DIRECTOR
References: