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

Study Overview
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Brief Summary
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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

Official Title
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A Prospective Observational Study to Assess the Role of Selected Biomarkers in Subjects Requiring Daily Medium- to High-dose Inhaled Corticosteroids for Persistent Asthma

Conditions
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Asthma

Intervention / Treatment
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* Other: No drug will be used
* Other: No drug will be used


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>50 eosinophilic subjects to be evaluated | Other: No drug will be used<br>* Biomarker<br>|
| Cohort 2<br>50 non-eosinophilic subjects to be evaluated | Other: No drug will be used<br>* Biomarker<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess which markers are associated with sputum eosinophils. | Comparing lung function tests between eosinophilic and non-eosinophilic subjects. | 8 Days | 
| To assess which markers are associated with sputum eosinophils | Comparing blood biomarkers between eosinophilic and non-eosinophilic subjects | 8 Days | 
| To assess which markers are associated with sputum esonophils | Comparing sputum biomarkers bewteen eosinophilic and non-eosinophilic subjects | 8 Days | 
| To assess which markers are associated with sputum eosinophils. | 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 |  | 8 Days |