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

October 10, 2012 updated by: MedImmune LLC

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Edmonton, Alberta, Canada
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
    • Ontario
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
      • Quebec City, Quebec, Canada
        • Research Site
  • United States
    • Colorado
      • Denver, Colorado, United States
        • Research Site
    • Illinois
      • Normal, Illinois, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • Research Site
    • Minnesota
      • Rochester, Minnesota, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Research Site
    • Ohio
      • Columbus, Ohio, United States
        • Research Site
    • Pennsylvania
      • Pittsburg, Pennsylvania, United States
        • Research Site
    • Texas
      • Galveston, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess which markers are associated with sputum eosinophils.
Time Frame: 8 Days
Comparing lung function tests between eosinophilic and non-eosinophilic subjects.
8 Days
To assess which markers are associated with sputum eosinophils
Time Frame: 8 Days
Comparing blood biomarkers between eosinophilic and non-eosinophilic subjects
8 Days
To assess which markers are associated with sputum esonophils
Time Frame: 8 Days
Comparing sputum biomarkers bewteen eosinophilic and non-eosinophilic subjects
8 Days
To assess which markers are associated with sputum eosinophils.
Time Frame: 8 Days
Comparing patient reported outcomes between eosinophilic and non-eosinophilic subjects.
8 Days
To evaluate transcript expression profiles in whole blood and/or sputum using microarray analyses
Time Frame: 8 Days
8 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedImmune LLC

Investigators

  • Study Director: David Gossage, M.D., MedImmune LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

March 28, 2011

First Submitted That Met QC Criteria

April 12, 2011

First Posted (Estimate)

April 13, 2011

Study Record Updates

Last Update Posted (Estimate)

October 11, 2012

Last Update Submitted That Met QC Criteria

October 10, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MI-CP223

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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