Allergy Induced AsthmaPhase 4NCT00242359
A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma
A Phase 4 study testing omalizumab in people with Allergy Induced Asthma, run by Bernstein Clinical Research Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergy Induced Asthma
- What is being tested?
- omalizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Jan 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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-
Who cannot join
- on allergen immunotherapy
- on prohibited medications
- unstable asthma
- recent URI
- known hypersensitivity to omalizumab-
About this study
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.
- Conditions
- Allergy Induced Asthma
- Being tested
- omalizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omalizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| omalizumab | Other | open-label Receives: Drug: omalizumab |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: could not find subject population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy Induced AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bernstein Clinical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan A. Bernstein, MD, Bernstein Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242359
- Sponsor's protocol ID
- 2085
- Status last verified
- Jul 2019
- First submitted
- 17 Oct 2005
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma
- ClinicalTrials.gov ID
- NCT00242359
- Acronym / sponsor ID
- 2085
- Conditions
- Allergy Induced Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: could not find subject population
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bernstein Clinical Research CenterUniversity, hospital or other
- Study start
- Nov 2005 (actual)
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 20 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| omalizumab | Other | Drug: omalizumabopen-label |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- on allergen immunotherapy
- on prohibited medications
- unstable asthma
- recent URI
- known hypersensitivity to omalizumab-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omalizumab | Drug | omalizumab |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing omalizumab in people with Allergy Induced Asthma, run by Bernstein Clinical Research Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.