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

NCT01989897 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2021-10-28

No results posted yet for this study

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

Interventions

DRUG

saline with 1mg/ml Histamine base

DRUG

diluent, saline with HSA--phenol

Sponsors & Collaborators

  • American College of Allergy, Asthma and Immunology

    collaborator OTHER

  • Bryan Martin, DO

    lead OTHER

Principal Investigators

  • Bryan Martin, DO · Ohio State University

Study Design

Allocation
NA
Purpose
OTHER
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01989897 on ClinicalTrials.gov