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Roflumilast In-Vitro Basophil Release

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00613587
First received: January 30, 2008
Last updated: October 8, 2012
Last verified: September 2012

January 30, 2008
October 8, 2012
August 2007
January 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00613587 on ClinicalTrials.gov Archive Site
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Roflumilast In-Vitro Basophil Release
Effect of Roflumilast In-Vitro on Basophil Histamine, Leukotriene, IL-4 and IL13-release.

This study is looking for allergic asthmatics. Lung and allergy testing will be done to verify. If qualified, blood will be drawn for laboratory studies.

Non-smoking allergic asthmatics will be verified using pulmonary function, skin prick testing, exhaled nitric oxide and serum IgE. If qualified, blood will be drawn, treated with study medication and then stimulated with the allergen to which the subject is allergic. Mediators including Histamine, IL-13, IL-4, and leukotrienes will be measured.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Polymorphal Blood Mononuclar Cells will be stimulated to release various cytokines. The supernatant of the stimulations will be stored for batched analysis.

Probability Sample

Allergic Asthma, non-smoker

  • Allergy
  • Asthma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 19 and above Allergic Asthma Serum IgE greater than 30iu/ml Exhaled Nitric Oxide greater than 17ppb

Exclusion Criteria:

  • smoking history
Both
19 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00613587
RGT2007
No
Creighton University
Creighton University
Takeda
Principal Investigator: Robert G Townley, MD Creighton University
Creighton University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP