Immune Dysfunction in Allergic Asthma

NCT00189228 | Completed Results DMC

• 2 other identifiers: UNMSCORR01HL044253
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

We are using anti-IgE to investigate the role of pulmonary mast cells in asthma.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Anti-KLH Antibody. This is Measured by ELISA and Expressed as ELISA Units Which Are Derived by Dilution of Serum Samples Until the Result Falls on a Linear Portion of the Response Curve. Final Values Are Derived From ELISA Units and the Serum Dilution

  Asthma and control patients are immunized with KLH. Mean levels of anti-KLH antibody as described above. This is measured by ELISA and expressed as ELISA units which are derived by dilution of serum samples until the result falls on a linear portion of the response curve. Final values are derived from ELISA units and the serum dilution

  6 months

Study Arms (1)

xolair

EXPERIMENTAL

This is a single arm, parallel study examining differences of therapeutic outcomes of Xolair. Xolair is being examined as an intervention that might change the outcome of immunization.

Drug: Xolair

Interventions

Xolair DRUG

Patients are administered Xolair

xolair

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Mild asthma, adults -

You may not qualify if:

• children. on inhaled or systemic steroids

Sponsors & Collaborators

• University of New Mexico: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UNM HSC

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Mark Schuyler
• Organization: University of New Mexico Health Sciences Center

mschuyler@salud.unm.edu

5059254197

Study Officials

• Mark Schuyler, MD

  UNM HSC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 16, 2005
• Study Start: September 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: September 27, 2019
• Results First Posted: September 27, 2019

Record last verified: 2019-09

Locations

US (1)