Effect of Montelukast on Basophils, in-Vitro

This study is ongoing, but not recruiting participants.

First Received: July 1, 2008 Last Updated: January 19, 2009 History of Changes

Sponsors and Collaborators:	Creighton University Merck
Information provided by:	Creighton University
ClinicalTrials.gov Identifier:	NCT00710450

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, leukotriends, IL-13 and IL-3. These are chemicals responsible for allergy symptoms.

Condition
Allergic Asthma Allergic Rhinitis

MedlinePlus related topics: Asthma

Drug Information available for: Histamine Montelukast sodium Montelukast

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	The Effect of Montelukast in-Vitro on Basophil Histamine and Leukotriene, IL-4 Adn IL-13 Release in Subjhects With Allergic Rhinitis or Allergic Asthma

Further study details as provided by Creighton University:

Primary Outcome Measures:

Histamine Release [ Time Frame: during the assay portion. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cytokine release. IL-13, IL-4 and leukotriene [ Time Frame: assay portion ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Supernatents from stimulation assays will be kept for batch assay.

Estimated Enrollment:	15
Study Start Date:	May 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Allergic Asthma
2 Allergic Rhinitis

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710450

Locations

United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131

Sponsors and Collaborators

Creighton University

Merck

More Information

No publications provided

Responsible Party:	Creighton University ( Robert G. Townley, MD )
Study ID Numbers:	Townley Merck
Study First Received:	July 1, 2008
Last Updated:	January 19, 2009
ClinicalTrials.gov Identifier:	NCT00710450 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Creighton University:

IL13
leukotriene
histamine
IL4
Must be allergic asthma or allergic rhinitis

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Bronchial Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Asthma
Rhinitis
Hormones
Leukotriene Antagonists
Histamine

Montelukast
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Hypersensitivity, Immediate
Histamine phosphate
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Otorhinolaryngologic Diseases
Bronchial Diseases
Immune System Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Asthma
Rhinitis
Pharmacologic Actions

Nose Diseases
Leukotriene Antagonists
Montelukast
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009