Allergic RhinitisPhase 1/2NCT01989897
Effect of HSA or Saline Diluent on Immunotherapy Extract Stability as Determined by Graded ID Skin Tests
A Phase 1/2 study testing saline with 1mg/ml Histamine base and diluent, saline with HSA--phenol in people with Allergic Rhinitis, run by Bryan Martin, DO at 1 site in United States.
Trial summary
This is a double-blind study with respect to the diluents used, with patients known to be allergic to the specific allergen tested. Three study sites will be involved, each testing one allergen (Cat, Mite, Timothy grass pollen). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- saline with 1mg/ml Histamine base and diluent, saline with HSA--phenol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Nov 2015
- Phase
- Phase 1/2
- 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
- 1. Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- 2. Subjects of either gender, ages 18-60 years, with a history of allergic rhinitis related to exposure to the allergen of interest.
- 3. Previous positive routine skin test to the allergen to be tested: minimum 5mm wheal diameter with 10,000BAU/mL cat or minimum 5mm wheal diameter with 10,000AU/mL Dermatophagoides farinae or minimum 8mm wheal diameter with timothy 100,000BAU/mL.
- 4. AND (in addition to #3) sum of erythema after SPT of at least 50mm or erythema in largest diameter of at least 30mm.
- 5. Subject's skin coloring should permit evaluation of erythema. 6. Ability to stop medication that might interfere with the results of the skin prick test.
Who cannot join
- 1. Spirometry with FEV1 below 80% of predicted normal value and/or poorly controlled asthma 2. Known pregnancy 3. Patients with a history of anaphylaxis or severe allergic reactions. 4. Patients with absolute necessity of antihistamines to control their allergies 5. Patients with active and extensive atopic dermatitis. 6. Patients that take psychotropic medication. 7. General skin hyperreactivity (Negative control greater than 3 mm wheal diameter) or with known tendency for dermatographic urticaria.
- 8. Patients currently under allergen immunotherapy treatment or with a history of immunotherapy treatment within the last 5 years to the extract to be tested in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Martha Morehouse Medical Plaza, 2050 Kenny Rd,Suite 2200 and Suite 2600
Columbus, Ohio, 43221
About this study
This is a double-blind study with respect to the diluents used, with patients known to be allergic to the specific allergen tested. Three study sites will be involved, each testing one allergen (Cat, Mite, Timothy grass pollen). Subjects who are known to be allergic to the allergen in question will be tested with serial three-fold dilutions to determine the ID 50 and relative extract potency using the method described by Turkeltaub.
Read the detailed description
The specific objective of this study is to determine the stability of immunotherapy extract dilutions. Higher dilutions (lower potency) have been shown in vitro to decrease in potency over time more rapidly than less dilute preparations. The investigators hope to determine whether there is a detectable difference in skin test reaction of dilutions of three common antigens (Cat, Timothy Grass, Dust Mite). The diluents used strongly affect the strength when extract potency is tested in vitro. Therefore, the investigators expect to find a detectable difference in skin test potency based on the diluents used (Saline vs. HSA Saline [300mcg/ml]).
- Conditions
- Allergic Rhinitis
- Being tested
- saline with 1mg/ml Histamine base, diluent, saline with HSA--phenol
- Keywords
- diluent, rhinitis, allergic
- Medical subject headings
- Rhinitis, Allergic, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saline with 1mg/ml Histamine baseDrug
diluent, saline with HSA--phenolDrug
Also called HSA 300mcg/ml (0.03%) and Saline
| Study group | Role | What they receive |
|---|---|---|
| diluents | Experimental | Negative control = diluent, saline with HSA--phenol Positive control = saline with 1mg/ml Histamine base Receives: Drug: saline with 1mg/ml Histamine base; Drug: diluent, saline with HSA--phenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the stability of immunotherapy extract dilutions
Subjects who are known to be allergic to the allergen in question will be tested with serial three-fold dilutions to determine the ID 50 and relative extract potency using the method described by Turkeltaub. This will be done by measuring skin test results in mm the goal of the testing is to get an area of redness (erythema) that is approximately 50mm
Measured: The participants will be at the study site for one visit, the visit will last approximately three (3) hours. There will be one short follow-up phone call.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Funding for the trial was lost so study was ended. No participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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 1/2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bryan Martin, DO
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Allergy, Asthma and Immunology
- Responsible party
- Sponsor-investigator, Bryan Martin, DO, Ohio State University
- Investigators
- Bryan Martin, DO, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989897
- Sponsor's protocol ID
- 2012H0217
- Status last verified
- Oct 2021
- First submitted
- 11 Jun 2013
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of HSA or Saline Diluent on Immunotherapy Extract Stability as Determined by Graded ID Skin Tests
- ClinicalTrials.gov ID
- NCT01989897
- Acronym / sponsor ID
- 2012H0217
- Conditions
- Allergic Rhinitis
- Keywords
- diluent, rhinitis, allergic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding for the trial was lost so study was ended. No participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bryan Martin, DOUniversity, hospital or other
- Collaborators
- American College of Allergy, Asthma and Immunology
- Study start
- Mar 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Nov 2013 (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.
This is a double-blind study with respect to the diluents used, with patients known to be allergic to the specific allergen tested. Three study sites will be involved, each testing one allergen (Cat, Mite, Timothy grass pollen). Subjects who are known to be allergic to the allergen in question will be tested with serial three-fold dilutions to determine the ID 50 and relative extract potency using the method described by Turkeltaub.
Detailed description
The specific objective of this study is to determine the stability of immunotherapy extract dilutions. Higher dilutions (lower potency) have been shown in vitro to decrease in potency over time more rapidly than less dilute preparations. The investigators hope to determine whether there is a detectable difference in skin test reaction of dilutions of three common antigens (Cat, Timothy Grass, Dust Mite). The diluents used strongly affect the strength when extract potency is tested in vitro. Therefore, the investigators expect to find a detectable difference in skin test potency based on the diluents used (Saline vs. HSA Saline [300mcg/ml]).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diluents | Experimental | Drug: saline with 1mg/ml Histamine base, Drug: diluent, saline with HSA--phenolNegative control = diluent, saline with HSA--phenol Positive control = saline with 1mg/ml Histamine base |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- 2. Subjects of either gender, ages 18-60 years, with a history of allergic rhinitis related to exposure to the allergen of interest.
- 3. Previous positive routine skin test to the allergen to be tested: minimum 5mm wheal diameter with 10,000BAU/mL cat or minimum 5mm wheal diameter with 10,000AU/mL Dermatophagoides farinae or minimum 8mm wheal diameter with timothy 100,000BAU/mL.
- 4. AND (in addition to #3) sum of erythema after SPT of at least 50mm or erythema in largest diameter of at least 30mm.
- 5. Subject's skin coloring should permit evaluation of erythema. 6. Ability to stop medication that might interfere with the results of the skin prick test.
Key exclusion criteria (2 listed)
- 1. Spirometry with FEV1 below 80% of predicted normal value and/or poorly controlled asthma 2. Known pregnancy 3. Patients with a history of anaphylaxis or severe allergic reactions. 4. Patients with absolute necessity of antihistamines to control their allergies 5. Patients with active and extensive atopic dermatitis. 6. Patients that take psychotropic medication. 7. General skin hyperreactivity (Negative control greater than 3 mm wheal diameter) or with known tendency for dermatographic urticaria.
- 8. Patients currently under allergen immunotherapy treatment or with a history of immunotherapy treatment within the last 5 years to the extract to be tested in this study
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 |
|---|---|---|
| saline with 1mg/ml Histamine base | Drug | diluents |
| diluent, saline with HSA--phenolAlso: HSA 300mcg/ml (0.03%) and Saline | Drug | diluents |
Primary outcome
to determine the stability of immunotherapy extract dilutions
Time frame: The participants will be at the study site for one visit, the visit will last approximately three (3) hours. There will be one short follow-up phone call.
Subjects who are known to be allergic to the allergen in question will be tested with serial three-fold dilutions to determine the ID 50 and relative extract potency using the method described by Turkeltaub. This will be done by measuring skin test results in mm the goal of the testing is to get an area of redness (erythema) that is approximately 50mm
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
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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.
Bryan Martin, DO principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing saline with 1mg/ml Histamine base and diluent, saline with HSA--phenol in people with Allergic Rhinitis, run by Bryan Martin, DO 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 2 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: withdrawn, as of the sponsor's last update on 28 Oct 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 stability of immunotherapy extract dilutions (time frame: The participants will be at the study site for one visit, the visit will last approximately three (3) hours. There will be one short follow-up phone call.). 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 28 Oct 2021.