Dog Hair Extract Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01343420
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : March 29, 2017
ALK-Abelló A/S
Information provided by (Responsible Party):
Jennifer Brandorff, National Jewish Health

Brief Summary:

Liquid allergen extracts contain proteins, such as (but not limited to) tree, weed, cat, cockroach, and nuts, and are used to identify allergies by observing the body's reaction to the introduction of extract underneath the skin. There are a few dog allergen extracts commercially available in the US for allergy testing; however, none of these products are standardized, meaning they are not required to be the same strength. Because some extracts are not as potent (strong) as others, it's possible that some patients' allergies are misdiagnosed. Typically, the most potent (strong), but safe extract should be used so that allergic patients are correctly diagnosed.

The purpose of this study is to compare the safety and potency of an investigational (not approved for use by the United States Food and Drug Administration [FDA]) dog allergen extract with two commercially available dog extracts, which are of differing potencies.

Condition or disease Intervention/treatment
Potency of Dog Hair Extract Biological: Dog Hair Extract, ALK-Abelló, Inc.

Detailed Description:
This study is designed to assess the potency of a modified dog hair and dander extract in comparison with the two commercially available dog hair and dander extracts. This is a pilot study to estimate a target strength of dog extract in order to proceed to further studies.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Dog Hair Evaluation Potency by Prick Skin Testing
Study Start Date : November 2010
Primary Completion Date : October 2011
Study Completion Date : October 2011

Arm Intervention/treatment
Active Comparator: Dog Hair Extract, ALK-Abelló, Inc. Biological: Dog Hair Extract, ALK-Abelló, Inc.
ALK-Abelló dog epithelial 1:10w/v glycerin

Primary Outcome Measures :
  1. End-point dilution giving a positive prick skin test in dog allergic subjects. [ Time Frame: Study Completion ]
    The concentration of each allergen extract which produced a 5 mm wheal for each subject will be calculated. From this, the relative potency of each extract will be calculated.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must sign informed consent before completing any study procedure.
  • Age 18 years and ≤60 years.
  • Dog-sensitized patients as indicated by a mean wheal > 5 mm with the AP dog extract.
  • Females of child-bearing potential must have a negative pregnancy test the day of skin testing.
  • Patients who are able to understand the information given and be compliant with the protocol.

Exclusion Criteria:

  • Asthma requiring treatment with medications other than beta-2 inhaled agonists and montelukast inhibitors.
  • Patients with a history of asthma or wheezing with an FEV1 <80%.
  • Subjects who have taken an ocular or nasal antihistamine within 5 days prior to the procedures.
  • Patients who have received any desensitization for dog allergen in the past 5 years.
  • 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, chronic urticaria and angioedema unless related to dog exposure, severe atopic dermatitis, malignancy, cardiovascular, hepatic, renal, hematological, neurological, immunological, and endocrine disease.
  • Subjects taking beta blockers, ace inhibitors, continuous systemic corticotherapy, immunosuppressive drugs or monoamine oxidase inhibitors.
  • Use of H1 antagonists, tricyclic antidepressants and phenothiazines within 5 days prior to the testing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01343420

United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
ALK-Abelló A/S
Principal Investigator: Harold Nelson, M.D. National Jewish Health

Responsible Party: Jennifer Brandorff, Regulatory Manager, National Jewish Health Identifier: NCT01343420     History of Changes
Other Study ID Numbers: ALK-Abelló Dog Allergen
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by Jennifer Brandorff, National Jewish Health:
Skin tests
Dog Hair
Allergy Extract