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

NCT01989897 | Withdrawn Phase 1 DMC

• 1 other identifier: 2012H0217
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Keywords

diluent; rhinitis; allergic

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

diluents

EXPERIMENTAL

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

Interventions

saline with 1mg/ml Histamine base DRUG

diluents

diluent, saline with HSA--phenol DRUG

Also known as: HSA 300mcg/ml (0.03%) and Saline

diluents

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
• \. Subjects of either gender, ages 18-60 years, with a history of allergic rhinitis related to exposure to the allergen of interest.
• \. 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.
• \. AND (in addition to #3) sum of erythema after SPT of at least 50mm or erythema in largest diameter of at least 30mm.
• \. 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.

You may not qualify if:

• \- 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.
• \. 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

Sponsors & Collaborators

• Bryan Martin, DO: lead
• American College of Allergy, Asthma and Immunology: collaborator

Study Sites (1)

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

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Bryan Martin, DO

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DO

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: November 21, 2013
• Study Start: March 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

US (1)