Mouse AllergiesNCT01063985
A Comparison of Skin Prick Tests, Clinical Symptoms, and Nasal Challenge Using a New Mouse Extract
An observational study of Mouse Allergies and Mouse Sensitization, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Mouse Allergies, Mouse Sensitization
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy individuals between the ages of 18-60 who are exposed to mice through occupation or animal care.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center at Vanderbilt University
Nashville, Tennessee
About this study
Official title: A Comparison of Skin Prick Tests, Clinical Symptoms and Nasal Challenge Using a New Mouse Extract
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
- Keywords
- Skin testing for mouse allergies
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the optimal concentration of mouse extract based on the skin prick test using the nasal challenge and clinical symptoms to confirm their true mouse allergic status in a sample of people exposed to mice.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mouse AllergiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Investigators
- Ryszard Dworski, MD, Principal investigator, Vanderbilt UniversityAllison Norton, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063985
- Sponsor's protocol ID
- 091213
- Status last verified
- Jul 2011
- First submitted
- 4 Feb 2010
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Skin Prick Tests, Clinical Symptoms and Nasal Challenge Using a New Mouse Extract
- ClinicalTrials.gov ID
- NCT01063985
- Acronym / sponsor ID
- 091213
- Conditions
- Mouse Allergies, Mouse Sensitization
- Keywords
- Skin testing for mouse allergies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 5 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy individuals between the ages of 18-60 who are exposed to mice through occupation or animal care.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the optimal concentration of mouse extract based on the skin prick test using the nasal challenge and clinical symptoms to confirm their true mouse allergic status in a sample of people exposed to mice.
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2011.
Related trials for Mouse Allergies
RecruitingObservational study
Personalized Patient Derived Xenograft (pPDX) Modeling to Test Drug Response in Matching Host
Colorectal Neoplasms, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryszard Dworski, MD principal investigator
Vanderbilt University
Allison Norton, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mouse Allergies and Mouse Sensitization, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the optimal concentration of mouse extract based on the skin prick test using the nasal challenge and clinical symptoms to confirm their true mouse allergic status in a sample of people exposed to mice. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2011.