Potency of Dog Hair ExtractNCT01343420
Dog Hair Extract Study
A study testing Dog Hair Extract, ALK-Abelló, Inc. in people with Potency of Dog Hair Extract, run by National Jewish Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Potency of Dog Hair Extract
- What is being tested?
- Dog Hair Extract, ALK-Abelló, Inc.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Oct 2011
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dog Hair Evaluation Potency by Prick Skin Testing
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.
Read the 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.
- Conditions
- Potency of Dog Hair Extract
- Being tested
- Dog Hair Extract, ALK-Abelló, Inc.
- Keywords
- Skin tests, Dog Hair, Allergy Extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dog Hair Extract, ALK-Abelló, Inc.Biological
ALK-Abelló dog epithelial 1:10w/v glycerin
| Study group | Role | What they receive |
|---|---|---|
| Dog Hair Extract, ALK-Abelló, Inc. | Active comparator | Not described Receives: Biological: Dog Hair Extract, ALK-Abelló, Inc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-point dilution giving a positive prick skin test in dog allergic subjects.
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.
Measured: Study Completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startNov 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potency of Dog Hair ExtractStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- ALK-Abelló A/S
- Responsible party
- Sponsor
- Investigators
- Harold Nelson, M.D., Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343420
- Sponsor's protocol ID
- ALK-Abelló Dog Allergen
- Status last verified
- Jan 2021
- First submitted
- 26 Apr 2011
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dog Hair Evaluation Potency by Prick Skin Testing
- ClinicalTrials.gov ID
- NCT01343420
- Acronym / sponsor ID
- ALK-Abelló Dog Allergen
- Conditions
- Potency of Dog Hair Extract
- Keywords
- Skin tests, Dog Hair, Allergy Extract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- ALK-Abelló A/S
- Study start
- Nov 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 28 Apr 2011 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dog Hair Extract, ALK-Abelló, Inc. | Active comparator | Biological: Dog Hair Extract, ALK-Abelló, Inc. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dog Hair Extract, ALK-Abelló, Inc.ALK-Abelló dog epithelial 1:10w/v glycerin | Biological | Dog Hair Extract, ALK-Abelló, Inc. |
Primary outcome
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.
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 19 Jan 2021.
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.
Harold Nelson, M.D. principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dog Hair Extract, ALK-Abelló, Inc. in people with Potency of Dog Hair Extract, run by National Jewish Health 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 7 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 19 Jan 2021. 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?
End-point dilution giving a positive prick skin test in dog allergic subjects. (time frame: Study Completion). 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 19 Jan 2021; AzTrials last refreshed its copy on 30 Oct 2026.