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Effect of Montelukast on Basophils, In-vitro

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ClinicalTrials.gov Identifier: NCT00710450
Recruitment Status : Unknown
Verified September 2011 by Creighton University.
Recruitment status was:  Active, not recruiting
First Posted : July 4, 2008
Last Update Posted : September 23, 2011
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Creighton University

Brief Summary:
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.

Condition or disease
Allergic Asthma Allergic Rhinitis

Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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
Study Start Date : May 2008
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast

Group/Cohort
1
Allergic Asthma
2
Allergic Rhinitis



Primary Outcome Measures :
  1. Histamine Release [ Time Frame: during the assay portion. ]

Secondary Outcome Measures :
  1. Cytokine release. IL-13, IL-4 and leukotriene [ Time Frame: assay portion ]

Biospecimen Retention:   Samples Without DNA
Supernatents from stimulation assays will be kept for batch assay.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Allergic rhinitis or allergic asthma, age 13+
Criteria

Inclusion Criteria:

  • Allergic asthma or allergic rhinitis
  • age 12+

Exclusion Criteria:

  • smokers

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): NCT00710450


Locations
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Merck Sharp & Dohme Corp.

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00710450     History of Changes
Other Study ID Numbers: Townley Merck
First Posted: July 4, 2008    Key Record Dates
Last Update Posted: September 23, 2011
Last Verified: September 2011

Keywords provided by Creighton University:
IL13
leukotriene
histamine
IL4
Must be allergic asthma or allergic rhinitis

Additional relevant MeSH terms:
Asthma
Rhinitis
Rhinitis, Allergic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Montelukast
Histamine
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Histamine Agonists
Histamine Agents
Neurotransmitter Agents