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

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.

Study Overview

• Status: Withdrawn
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: saline with 1mg/ml Histamine base; Drug: diluent, saline with HSA--phenol

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 Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43221
      • Martha Morehouse Medical Plaza, 2050 Kenny Rd,Suite 2200 and Suite 2600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: diluents; Negative control = diluent, saline with HSA--phenol Positive control = saline with 1mg/ml Histamine base	Drug: saline with 1mg/ml Histamine base; Drug: diluent, saline with HSA--phenol; Other Names: HSA 300mcg/ml (0.03%) and Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.

Collaborators and Investigators

• Sponsor: Bryan Martin, DO
• Collaborators: American College of Allergy, Asthma and Immunology
• Investigators: Principal Investigator: Bryan Martin, DO, Ohio State University

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: June 11, 2013
• First Submitted That Met QC Criteria: November 15, 2013
• First Posted (ESTIMATE): November 21, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: rhinitis; allergic; diluent
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Histamine Agents; Pharmaceutical Solutions; Disinfectants; Sclerosing Solutions; Histamine Agonists; Phenol; Histamine
• Other Study ID Numbers: 2012H0217