Expired Study
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Omaha, Nebraska 68131


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.


Criteria:

Inclusion Criteria: - Allergic asthma or allergic rhinitis - age 12+ Exclusion Criteria: - smokers


Study is Available At:


Original ID:

Townley Merck


NCT ID:

NCT00710450


Secondary ID:


Study Acronym:


Brief Title:

Effect of Montelukast on Basophils, In-vitro


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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

12 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Creighton University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

15


Enrollment Type:

Anticipated


Study Dates

Start Date:May 2008
Completion Date:September 2011
Completion Type:Anticipated
Primary Completion Date:September 2011
Primary Completion Type:Anticipated
Verification Date:September 2011
Last Changed Date:September 22, 2011
First Received Date:July 1, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Cytokine release. IL-13, IL-4 and leukotriene
Time Frame:assay portion
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Histamine Release
Time Frame:during the assay portion.
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:1
Description:Allergic Asthma
Study Arm Type:Other
Arm Name:2
Description:Allergic Rhinitis

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Creighton University
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Merck

Samples and Retentions

Sample Retention:Samples Without DNA
Description: Supernatents from stimulation assays will be kept for batch assay.
Study Population: Allergic rhinitis or allergic asthma, age 13+
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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