Effect of Montelukast on Basophils, In-vitro
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Creighton University.
Recruitment status was Active, not recruiting
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
First received: July 1, 2008
Last updated: September 22, 2011
Last verified: September 2011
Subjects with either allergic asthma or allergic rhinitis will be recruited to obtain blood. This blood will be used to be stimulated with to whatever the patient allergic. In the laboratory, this stimulated blood will be measured for histamine, leukotrienes, IL-13 and IL-3. These are chemicals responsible for allergy symptoms.
||Observational Model: Case-Only
Time Perspective: Prospective
||The Effect of Montelukast In-vitro on Basophil Histamine and Leukotriene, IL-4 Adn IL-13 Release in Subjects With Allergic Rhinitis or Allergic Asthma
Primary Outcome Measures:
- Histamine Release [ Time Frame: during the assay portion. ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Secondary Outcome Measures:
- Cytokine release. IL-13, IL-4 and leukotriene [ Time Frame: assay portion ] [ Designated as safety issue: No ]
Supernatents from stimulation assays will be kept for batch assay.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2011 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||12 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Allergic rhinitis or allergic asthma, age 13+
- Allergic asthma or allergic rhinitis
- age 12+
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710450
|Creighton University Medical Center
|Omaha, Nebraska, United States, 68131 |
Merck Sharp & Dohme Corp.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 1, 2008
||September 22, 2011
||United States: Institutional Review Board
Keywords provided by Creighton University:
Must be allergic asthma or allergic rhinitis
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 19, 2014
Rhinitis, Allergic, Perennial
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Infections
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs