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

Completed

• Conditions: Asthma
• Interventions: Other: No drug will be used

• Registration Number: NCT01334853
• Lead Sponsor: MedImmune LLC

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-04-12
• Study First Posted: 2011-04-13
• Primary Completion: 2012-04
• Study Completion: 2012-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-10
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	No drug will be used	50 eosinophilic subjects to be evaluated
Cohort 2	No drug will be used	50 non-eosinophilic subjects to be evaluated

Primary Outcome Measures

Name	Time	Method
To identify an optimal prediction rule for classifying sputum eosinophilic and non-eosinophilic asthmatics.	8 Days	Variables representing lung function tests, patient reported outcomes, and blood biomarkers will be evaluated singly and in various combinations.

Secondary Outcome Measures

Name	Time	Method
To assess which markers are associated with sputum esonophils	8 Days	Comparing sputum biomarkers bewteen eosinophilic and non-eosinophilic subjects
To assess which markers are associated with sputum eosinophils.	8 Days	Comparing patient reported outcomes between eosinophilic and non-eosinophilic subjects.
To assess which markers are associated with sputum eosinophils	8 Days	Comparing blood biomarkers between eosinophilic and non-eosinophilic subjects
To evaluate transcript expression profiles in whole blood and/or sputum using microarray analyses	8 Days

Trial Locations

Locations (2)

Research site; 🇺🇸 Rochester, Minnesota, United States

Research Site; 🇨🇦 Quebec City, Quebec, Canada