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OpenTrials
Completed

NCT Number: NCT01334853

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No drug will be used

Other

Biomarker

Primary outcomes

  1. To identify an optimal prediction rule for classifying sputum eosinophilic and non-eosinophilic asthmatics.

    Time frame: 8 Days

    Variables representing lung function tests, patient reported outcomes, and blood biomarkers will be evaluated singly and in various combinations.

Secondary outcomes

  1. To assess which markers are associated with sputum eosinophils.

    Time frame: 8 Days

    Comparing lung function tests between eosinophilic and non-eosinophilic subjects.

  2. To assess which markers are associated with sputum eosinophils

    Time frame: 8 Days

    Comparing blood biomarkers between eosinophilic and non-eosinophilic subjects

  3. To assess which markers are associated with sputum esonophils

    Time frame: 8 Days

    Comparing sputum biomarkers bewteen eosinophilic and non-eosinophilic subjects

  4. To assess which markers are associated with sputum eosinophils.

    Time frame: 8 Days

    Comparing patient reported outcomes between eosinophilic and non-eosinophilic subjects.

  5. To evaluate transcript expression profiles in whole blood and/or sputum using microarray analyses

    Time frame: 8 Days

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 13, 2011
Registry last updated
Oct 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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