- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00710450
Effect of Montelukast on Basophils, In-vitro
September 22, 2011 updated by: Creighton University
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
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Nebraska
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Omaha, Nebraska, United States, 68131
- Creighton University Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Allergic rhinitis or allergic asthma, age 13+
Description
Inclusion Criteria:
- Allergic asthma or allergic rhinitis
- age 12+
Exclusion Criteria:
- smokers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
1
Allergic Asthma
|
|
2
Allergic Rhinitis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Histamine Release
Time Frame: during the assay portion.
|
during the assay portion.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cytokine release. IL-13, IL-4 and leukotriene
Time Frame: assay portion
|
assay portion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Anticipated)
September 1, 2011
Study Completion (Anticipated)
September 1, 2011
Study Registration Dates
First Submitted
July 1, 2008
First Submitted That Met QC Criteria
July 3, 2008
First Posted (Estimate)
July 4, 2008
Study Record Updates
Last Update Posted (Estimate)
September 23, 2011
Last Update Submitted That Met QC Criteria
September 22, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Otorhinolaryngologic Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Asthma
- Rhinitis
- Rhinitis, Allergic
Other Study ID Numbers
- Townley Merck
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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