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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This study has been withdrawn prior to enrollment.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)
Information provided by:
Bernstein Clinical Research Center Identifier:
First received: October 17, 2005
Last updated: January 27, 2009
Last verified: January 2009

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Anti-Allergic Agents
Anti-Asthmatic Agents
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses processed this record on February 27, 2015