Not Signed In -
Allergy |
Allergies; Allergy/Allergies; Anaphylaxis |
Clinical Trial: A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma
This study is not yet open for patient recruitment.
Verified by Bernstein Clinical Research Center October 2005
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 consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Further study details as provided by Bernstein Clinical Research Center:
Expected Total Enrollment: 16
Study start: November 2005
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
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-
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00242359
Brian P Berendts, BSN, RN 513/931-0775 Ext. 1771 bernsteincrc@fuse.net
Jonathan A Bernstein, MD 513/931-0775 bernsteincrc@fuse.net
Jonathan A Bernstein, MD 513/931-0775 bernsteincrc@fuse.net
Ohio
Bernstein Clinical Research Center, Cincinnati, Ohio, 45231, United States
Brian P Berendts, BSN, RN 513-931-0775 Ext. 1771 bernsteincrc@fuse.net
Karen J Murphy, BS, RRT 513/931-0775 Ext. 1746 bernsteincrc@fuse.net
Jonathan A Bernstein, MD, Principal Investigator
Karen J Murphy, BS, RRT 513/931-0775 Ext. 1746 bernsteincrc@fuse.net
Jonathan A Bernstein, MD, Principal Investigator
More Information
Study ID Numbers: 2085
Last Updated: December 7, 2005
Record first received: October 17, 2005
ClinicalTrials.gov Identifier: NCT00242359
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 7, 2005
Record first received: October 17, 2005
ClinicalTrials.gov Identifier: NCT00242359
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
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