Effect of Montelukast on Basophils, In-vitro
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
1 other identifier
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 1, 2008
CompletedFirst Posted
Study publicly available on registry
July 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedSeptember 23, 2011
September 1, 2011
3.3 years
July 1, 2008
September 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Histamine Release
during the assay portion.
Secondary Outcomes (1)
Cytokine release. IL-13, IL-4 and leukotriene
assay portion
Study Arms (2)
1
Allergic Asthma
2
Allergic Rhinitis
Eligibility Criteria
Allergic rhinitis or allergic asthma, age 13+
You may qualify if:
- Allergic asthma or allergic rhinitis
- age 12+
You may not qualify if:
- smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Creighton Universitylead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Biospecimen
Supernatents from stimulation assays will be kept for batch assay.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2008
First Posted
July 4, 2008
Study Start
May 1, 2008
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
September 23, 2011
Record last verified: 2011-09