CompletedNCT01334853Updated Oct 11, 2012

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

An observational study in Asthma, sponsored by MedImmune LLC. Completed at 18 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-10-11.

Sponsored by MedImmune LLC · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 97
Ages: 18 Years to 75 Years
Sex: All

Study 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

Conditions studied

Asthma

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Asthma 3,921

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 97 is below the median of 150 across 970 observational studies indexed under Asthma.

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Lead sponsor

MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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

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

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
Enrollment: 97 participants (actual)
Biospecimen retention: Samples without dna

Groups and cohorts

Cohort 1
50 eosinophilic subjects to be evaluated
Other: No drug will be used
Cohort 2
50 non-eosinophilic subjects to be evaluated
Other: No drug will be used

Interventions

OtherNo drug will be used
Biomarker
OtherNo drug will be used
Biomarker

What researchers measure

Primary outcomes

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.
Time frame: 8 Days

Secondary outcomes

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

Study locations

18 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01334853
Lead sponsor: MedImmune LLC
Responsible party: Sponsor
First posted: Apr 13, 2011
Start date: Jan 2011
Primary completion: Apr 2012
Completion: Sep 2012
Last update: Oct 11, 2012

Study contacts

David Gossage, M.D.

study director · MedImmune LLC

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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