Allergy Induced Asthma Clinical Trial
Official title:
A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma
| NCT number | NCT00242359 |
| Other study ID # | 2085 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | November 2005 |
| Est. completion date | January 2009 |
| Verified date | July 2019 |
| Source | Bernstein Clinical Research Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | January 2009 |
| Est. primary completion date | January 2009 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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- |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Bernstein Clinical Research Center |