- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00613587
Roflumilast In-Vitro Basophil Release
October 8, 2012 updated by: Creighton University
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68131
- Creighton University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Allergic Asthma, non-smoker
Description
Inclusion Criteria:
- Age 19 and above Allergic Asthma Serum IgE greater than 30iu/ml Exhaled Nitric Oxide greater than 17ppb
Exclusion Criteria:
- smoking history
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert G Townley, MD, Creighton University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
January 30, 2008
First Submitted That Met QC Criteria
January 30, 2008
First Posted (Estimate)
February 13, 2008
Study Record Updates
Last Update Posted (Estimate)
October 10, 2012
Last Update Submitted That Met QC Criteria
October 8, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- RGT2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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