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Effect of Montelukast on Basophils, In-vitro

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Creighton University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00710450
First Posted: July 4, 2008
Last Update Posted: October 12, 2017
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:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Creighton University
  Purpose
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
Allergic Asthma Allergic Rhinitis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Creighton University:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 15
Study Start Date: May 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Allergic Asthma
2
Allergic Rhinitis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
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
  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): NCT00710450


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

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00710450     History of Changes
Other Study ID Numbers: Townley Merck
First Submitted: July 1, 2008
First Posted: July 4, 2008
Last Update Posted: October 12, 2017
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