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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
History of Changes
  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:

MedlinePlus related topics: Allergy Asthma
U.S. FDA Resources

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

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00613587     History of Changes
Other Study ID Numbers: RGT2007
Study First Received: January 30, 2008
Last Updated: October 8, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013