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Roflumilast In-Vitro Basophil Release

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00613587
First Posted: February 13, 2008
Last Update Posted: October 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Takeda
Information provided by (Responsible Party):
Creighton University
  Purpose
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.

Condition
Allergy Asthma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effect of Roflumilast In-Vitro on Basophil Histamine, Leukotriene, IL-4 and IL13-release.

Resource links provided by NLM:


Further study details as provided by Creighton University:

Biospecimen Retention:   Samples Without DNA
Polymorphal Blood Mononuclar Cells will be stimulated to release various cytokines. The supernatant of the stimulations will be stored for batched analysis.

Enrollment: 15
Study Start Date: August 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Allergic Asthma, non-smoker
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • smoking history
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613587


Locations
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Takeda
Investigators
Principal Investigator: Robert G Townley, MD Creighton University
  More Information

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00613587     History of Changes
Other Study ID Numbers: RGT2007
First Submitted: January 30, 2008
First Posted: February 13, 2008
Last Update Posted: October 10, 2012
Last Verified: September 2012

Keywords provided by Creighton University:
Interleukin 13
Interleukin 4
Leukotrienes
Basophil Histamine Release

Additional relevant MeSH terms:
Histamine
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs