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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334853
• Other study ID #: MI-CP223
• Status: Completed
• Phase: N/A
• First received: March 28, 2011
• Last updated: October 10, 2012
• Start date: January 2011
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: September 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• No drug will be used
Biomarker
• No drug will be used
Biomarker

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify an optimal prediction rule for classifying sputum eosinophilic and non-eosinophilic asthmatics.	Variables representing lung function tests, patient reported outcomes, and blood biomarkers will be evaluated singly and in various combinations.	8 Days	No
Secondary	To assess which markers are associated with sputum eosinophils.	Comparing lung function tests between eosinophilic and non-eosinophilic subjects.	8 Days	No
Secondary	To assess which markers are associated with sputum eosinophils	Comparing blood biomarkers between eosinophilic and non-eosinophilic subjects	8 Days	No
Secondary	To assess which markers are associated with sputum esonophils	Comparing sputum biomarkers bewteen eosinophilic and non-eosinophilic subjects	8 Days	No
Secondary	To assess which markers are associated with sputum eosinophils.	Comparing patient reported outcomes between eosinophilic and non-eosinophilic subjects.	8 Days	No
Secondary	To evaluate transcript expression profiles in whole blood and/or sputum using microarray analyses		8 Days	No

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