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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01334853
First Posted: April 13, 2011
Last Update Posted: October 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MedImmune LLC
March 28, 2011
April 13, 2011
October 11, 2012
January 2011
April 2012   (Final data collection date for primary outcome measure)
To identify an optimal prediction rule for classifying sputum eosinophilic and non-eosinophilic asthmatics. [ Time Frame: 8 Days ]
Variables representing lung function tests, patient reported outcomes, and blood biomarkers will be evaluated singly and in various combinations.
Same as current
Complete list of historical versions of study NCT01334853 on ClinicalTrials.gov Archive Site
  • To assess which markers are associated with sputum eosinophils. [ Time Frame: 8 Days ]
    Comparing lung function tests between eosinophilic and non-eosinophilic subjects.
  • To assess which markers are associated with sputum eosinophils [ Time Frame: 8 Days ]
    Comparing blood biomarkers between eosinophilic and non-eosinophilic subjects
  • To assess which markers are associated with sputum esonophils [ Time Frame: 8 Days ]
    Comparing sputum biomarkers bewteen eosinophilic and non-eosinophilic subjects
  • To assess which markers are associated with sputum eosinophils. [ Time Frame: 8 Days ]
    Comparing patient reported outcomes between eosinophilic and non-eosinophilic subjects.
  • To evaluate transcript expression profiles in whole blood and/or sputum using microarray analyses [ Time Frame: 8 Days ]
Same as current
Not Provided
Not Provided
 
A Study to Assess Selected Biomarkers in Subjects Requiring Daily Inhaled Corticosteroids for Persistent Asthma
A Prospective Observational Study to Assess the Role of Selected Biomarkers in Subjects Requiring Daily Medium- to High-dose Inhaled Corticosteroids for Persistent Asthma
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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Blood and Sputum
Non-Probability Sample
Adults with asthma on stable medium- to high-dose inhaled corticosteroids.
Asthma
Other: No drug will be used
Biomarker
  • Cohort 1
    50 eosinophilic subjects to be evaluated
    Intervention: Other: No drug will be used
  • Cohort 2
    50 non-eosinophilic subjects to be evaluated
    Intervention: Other: No drug will be used
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
September 2012
April 2012   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01334853
MI-CP223
No
Not Provided
Not Provided
MedImmune LLC
MedImmune LLC
Not Provided
Study Director: David Gossage, M.D. MedImmune LLC
MedImmune LLC
October 2012