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
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00710450
First received: July 1, 2008
Last updated: September 22, 2011
Last verified: September 2011
  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. ] [ 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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00710450     History of Changes
Other Study ID Numbers: Townley Merck
Study First Received: July 1, 2008
Last Updated: September 22, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Asthma
Rhinitis
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
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014