We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00242359
Recruitment Status : Withdrawn (could not find subject population)
First Posted : October 20, 2005
Last Update Posted : January 28, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Allergy Induced Asthma Drug: omalizumab Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
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
Study Start Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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-
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 Posted: October 20, 2005    Key Record Dates
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