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

This study has been withdrawn prior to enrollment.
(could not find subject population)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00242359
First Posted: October 20, 2005
Last Update Posted: January 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bernstein Clinical Research Center
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma

Resource links provided by NLM:


Further study details as provided by Bernstein Clinical Research Center:

Estimated Enrollment: 16
Study Start Date: November 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. on allergen immunotherapy
  2. on prohibited medications
  3. unstable asthma
  4. recent URI
  5. known hypersensitivity to omalizumab-
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Jonathan A. Bernstein, MD, Bernstein Clinical Research Cente
ClinicalTrials.gov Identifier: NCT00242359     History of Changes
Other Study ID Numbers: 2085
First Submitted: October 17, 2005
First Posted: October 20, 2005
Last Update Posted: January 28, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents