Asthma
Conditions
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
Interventions
OTHERNo drug will be used
Biomarker
Sponsors
MedImmune LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| To assess which markers are associated with sputum eosinophils. | 8 Days | Comparing lung function tests 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 assess which markers are associated with sputum esonophils | 8 Days | Comparing sputum biomarkers bewteen eosinophilic and non-eosinophilic subjects |
| To evaluate transcript expression profiles in whole blood and/or sputum using microarray analyses | 8 Days | — |
Countries
Canada, United States
Outcome results
None listed