A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma

This study has been withdrawn prior to recruitment.

( could not find subject population )

First Received: October 17, 2005 Last Updated: January 27, 2009 History of Changes

Sponsored by:	Bernstein Clinical Research Center
Information provided by:	Bernstein Clinical Research Center
ClinicalTrials.gov Identifier:	NCT00242359

Purpose

Management of animal induced occupational asthma is mainly avoidance, but this is not feasible for many occupations. Treatment with avoidance and conventional treatment is also not always successful. Omalizumab is FDA approved for the treatment of allergic asthma and may be effective at reducing symptoms and disease progression in the animal handlers population.

Condition	Intervention	Phase
Allergy Induced Asthma	Drug: omalizumab	Phase IV

MedlinePlus related topics: Allergy Asthma

Drug Information available for: Omalizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma

Further study details as provided by Bernstein Clinical Research Center:

Estimated Enrollment:	16
Study Start Date:	November 2005

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ages 18-65
occupation that involves close contact with animals
stable dose of ICS for 30 days
Skin test positive to one or more animals
evidence of asthma on spirometry
demonstrate PEFR variability-

Exclusion Criteria:

on allergen immunotherapy
on prohibited medications
unstable asthma
recent URI
known hypersensitivity to omalizumab-

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Bernstein Clinical Research Cente ( Jonathan A. Bernstein, MD )
Study ID Numbers:	2085
Study First Received:	October 17, 2005
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00242359 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases
Hypersensitivity, Immediate

Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Omalizumab
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity
Omalizumab

ClinicalTrials.gov processed this record on May 07, 2009