Loading clinical trials...

A Comparison of Skin Prick Tests, Clinical Symptoms, and Nasal Challenge Using a New Mouse Extract | Clinical Trials | Clareo Health

COMPLETED

A Comparison of Skin Prick Tests, Clinical Symptoms, and Nasal Challenge Using a New Mouse Extract

A Comparison of Skin Prick Tests, Clinical Symptoms and Nasal Challenge Using a New Mouse Extract

NCT01063985•Vanderbilt University

View on ClinicalTrials.gov

Summary

The purpose of this study is to test a new mouse skin test extract on people who work with mice in a lab or through animal care. It has a higher level of the major allergen and therefore may be better at diagnosing mouse allergies in this population.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Exposure to mouse on a regular basis through occupation or animal care. Patients must sign informed consent before completing any study procedure.
•Healthy subjects age \>18 years and \<60 years
•Females with no child bearing potential. Females are considered not to have child bearing potential before their menarche, at least 2 years after menopause or if they have had a total hysterectomy or bilateral oophorectomy
•Females with child bearing potential if they fulfill the following criteria: Use of a medically accepted contraceptive method (hormone birth control \[orally, injectable, or implant for at least 2 months prior to enrollment\], intrauterine device, spermicide used with a male condom, bilateral tubal ligation, diaphragm with spermicide, female condom), and have a negative pregnancy test
•Patients who are able to understand the information given, be compliant with the protocol including investigational product administration and visit schedules as well as recording information requested by the investigators.

Exclusion Criteria

•Present history of tobacco smoking (within the past 12 months or ex-smoker with \>10 pack years).
•Illicit drug use.
•Asthma requiring treatment with medications other than beta-2 inhaled agonists and leukotriene inhibitors.
•Patients with a history of asthma or wheezing with an FEV1 \<80%
•Subjects who have taken a nasal adrenergic agonist the day of the procedure
•Use of H1 antagonists, leukotriene inhibitors, tricyclic antidepressants, phenothiazines, nasal antihistamines, or ocular antihistamines within 5 days prior to the testing.
•Subjects who are on nasal, oral steroids, or ketotifen within 2 weeks of the procedure
•Subjects taking beta blockers, ace inhibitors, continuous systemic corticotherapy, immunosuppressive drugs, reserpine, clonidine or monoamine oxidase inhibitors.
•Patients who have received any desensitization for mouse allergen in the past 5 years
•Ongoing immunotherapy with any other allergen.
+5 more criteria

Locations (1)

Clinical Research Center at Vanderbilt University

Nashville, Tennessee, United States

Key Dates

Start Date

May 1, 2010

Primary Completion Date

September 1, 2010

Completion Date

September 1, 2010

Last Updated

July 27, 2011

Enrollment

ACTUAL participants

Conditions

Mouse AllergiesMouse Sensitization