NCT00242359

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2005

Typical duration for phase_4

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2005

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

3.2 years

First QC Date

October 17, 2005

Last Update Submit

July 8, 2019

Conditions

Allergy Induced Asthma

Study Arms (1)

omalizumab

OTHER

open-label

Drug: omalizumab

Interventions

omalizumabDRUG
omalizumab

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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-

You may not qualify if:

  • on allergen immunotherapy
  • on prohibited medications
  • unstable asthma
  • recent URI
  • known hypersensitivity to omalizumab-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Omalizumab

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 17, 2005

First Posted

October 20, 2005

Study Start

November 1, 2005

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

July 10, 2019

Record last verified: 2019-07