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Effect of HSA or Saline Diluent on Immunotherapy Extract Stability as Determined by Graded ID Skin Tests

Primary Purpose

Allergic Rhinitis

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

saline with 1mg/ml Histamine base

diluent, saline with HSA--phenol

About this trial

This is an interventional other trial for Allergic Rhinitis focused on measuring diluent, rhinitis, allergic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

- 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

Sites / Locations

Martha Morehouse Medical Plaza, 2050 Kenny Rd,Suite 2200 and Suite 2600

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

diluents

Arm Description

Negative control = diluent, saline with HSA--phenol Positive control = saline with 1mg/ml Histamine base

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01989897

First Posted

June 11, 2013

Last Updated

October 20, 2021

Sponsor

Bryan Martin, DO

Collaborators

American College of Allergy, Asthma and Immunology

1. Study Identification

Unique Protocol Identification Number

NCT01989897

Brief Title

Effect of HSA or Saline Diluent on Immunotherapy Extract Stability as Determined by Graded ID Skin Tests

Official Title

Effect of HSA or Saline Diluent on Immunotherapy Extract Stability as Determined by Graded ID Skin Tests

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Funding for the trial was lost so study was ended. No participants were enrolled.

Study Start Date

March 2013 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Bryan Martin, DO

Collaborators

American College of Allergy, Asthma and Immunology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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). 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]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

Keywords

diluent, rhinitis, allergic

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

diluents

Arm Type

Experimental

Arm Description

Negative control = diluent, saline with HSA--phenol Positive control = saline with 1mg/ml Histamine base

Intervention Type

Drug

Intervention Name(s)

saline with 1mg/ml Histamine base

Intervention Type

Drug

Intervention Name(s)

diluent, saline with HSA--phenol

Other Intervention Name(s)

HSA 300mcg/ml (0.03%) and Saline

Primary Outcome Measure Information:

Title

to determine the stability of immunotherapy extract dilutions

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: - 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bryan Martin, DO

Organizational Affiliation

Ohio State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Martha Morehouse Medical Plaza, 2050 Kenny Rd,Suite 2200 and Suite 2600

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43221

Country

United States

12. IPD Sharing Statement

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Effect of HSA or Saline Diluent on Immunotherapy Extract Stability as Determined by Graded ID Skin Tests

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