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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01334853
First received: March 28, 2011
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention
Asthma
Other: No drug will be used

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • To identify an optimal prediction rule for classifying sputum eosinophilic and non-eosinophilic asthmatics. [ Time Frame: 8 Days ] [ Designated as safety issue: No ]
    Variables representing lung function tests, patient reported outcomes, and blood biomarkers will be evaluated singly and in various combinations.


Secondary Outcome Measures:
  • To assess which markers are associated with sputum eosinophils. [ Time Frame: 8 Days ] [ Designated as safety issue: No ]
    Comparing lung function tests between eosinophilic and non-eosinophilic subjects.

  • To assess which markers are associated with sputum eosinophils [ Time Frame: 8 Days ] [ Designated as safety issue: No ]
    Comparing blood biomarkers between eosinophilic and non-eosinophilic subjects

  • To assess which markers are associated with sputum esonophils [ Time Frame: 8 Days ] [ Designated as safety issue: No ]
    Comparing sputum biomarkers bewteen eosinophilic and non-eosinophilic subjects

  • To assess which markers are associated with sputum eosinophils. [ Time Frame: 8 Days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood and Sputum


Enrollment: 97
Study Start Date: January 2011
Study Completion Date: September 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort 1
50 eosinophilic subjects to be evaluated
Other: No drug will be used
Biomarker
Cohort 2
50 non-eosinophilic subjects to be evaluated
Other: No drug will be used
Biomarker

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with asthma on stable medium- to high-dose inhaled corticosteroids.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334853

Locations
United States, Colorado
Research Site
Denver, Colorado, United States
United States, Illinois
Research Site
Normal, Illinois, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
United States, Michigan
Research Site
Ann Arbor, Michigan, United States
United States, Minnesota
Research site
Rochester, Minnesota, United States
United States, Missouri
Research Site
St. Louis, Missouri, United States
United States, North Carolina
Research Site
Chapel Hill, North Carolina, United States
United States, Ohio
Research Site
Columbus, Ohio, United States
United States, Pennsylvania
Research Site
Pittsburg, Pennsylvania, United States
United States, Texas
Research Site
Galveston, Texas, United States
Research Site
Houston, Texas, United States
United States, Wisconsin
Research Site
Madison, Wisconsin, United States
Canada, Alberta
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada
Canada, Ontario
Research Site
Toronto, Ontario, Canada
Canada, Quebec
Research Site
Montreal, Quebec, Canada
Research Site
Quebec City, Quebec, Canada
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: David Gossage, M.D. MedImmune LLC
  More Information

Additional Information:
No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01334853     History of Changes
Other Study ID Numbers: MI-CP223
Study First Received: March 28, 2011
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014