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

NCT ID: NCT00242359

Last Updated: 2019-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Allergy Induced Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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omalizumab

open-label

Group Type OTHER

omalizumab

Intervention Type DRUG

Interventions

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omalizumab

Intervention Type DRUG

Eligibility Criteria

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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-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bernstein Clinical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Jonathan A. Bernstein, MD

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2085

Identifier Type: -

Identifier Source: org_study_id

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