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

NCT ID: NCT01063985

Last Updated: 2011-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 39 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-09-30

Brief 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.

Conditions

Mouse Allergies; Mouse Sensitization

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.
• Patients with any nasal condition that could confound the efficacy or safety assessments, for example nasal polyposis, nasal ulcers, nasal surgery 6 weeks prior to study or tumors.
• Patients with any past or current clinically significant condition that may affect the patient's participation or the outcome of the study to the discretion of the investigator. These include, but are not limited to, anaphylaxis with cardio-respiratory symptoms (to any known or unknown source including mice exposure), chronic urticaria and angioedema unless related to mouse exposure, severe atopic dermatitis, malignancy, cardiovascular, hepatic, renal, hematological, neurological, immunological, and endocrine disease.
• Hyper responsiveness to glycerin control on nasal challenge as defined by a non-cumulative score of 5 on the nasal challenge symptom score.
• Although fetal risk is not expected to be high, women of childbearing potential who may be pregnant or who are not on adequate contraceptives will be excluded from the study (as defined in inclusions). In addition pregnant or breastfeeding women will also be excluded from the study.
• Study staff, investigators, sub-investigators, as well as their children or spouses and family members of all study staff should not be enrolled in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Vanderbilt University Medical Center

Principal Investigators

Ryszard Dworski, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Allison Norton, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Clinical Research Center at Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

091213

Identifier Type: -

Identifier Source: org_study_id