AsthmaPhase 3NCT00232050
Study of Omalizumab in Moderate to Severe Bronchial Asthma
A Phase 3 study testing Omalizumab in people with Asthma, run by Novartis.
Trial summary
This study will evaluate the safety and efficacy of omalizumab up to 16 weeks in adult patients with moderate to severe bronchial asthma. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Omalizumab
- How many people
- 327 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to May 2005
- Phase
- Phase 3
- 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 20 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Allergic asthma patients
- Inadequately controlled patients
Who cannot join
- - History of severe anaphylactoid or anaphylactic reactions
- Previous treatment with omalizumab
- History of cancer or cancer
- Other protocol-defined exclusion criteria may apply
About this study
This study will evaluate the safety and efficacy of omalizumab up to 16 weeks in adult patients with moderate to severe bronchial asthma.
- Conditions
- Asthma
- Being tested
- Omalizumab
- Keywords
- Asthma, IgE, Omalizumab
- Medical subject headings
- Asthma, Epilepsy, Idiopathic Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Morning peak expiratory flow (PEF) at baseline and end of treatment.
Secondary outcomes (5)
Pulmonary function parameters measured by spirometer
Frequency of rescue medication use
Symptom score
Activities of daily living score
Nighttime sleep score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startOct 2002
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Co., Ltd.
- Investigators
- Novartis Pharmaceuticals Japan, Study chair, Novartis Pharmaceuticals Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232050
- Sponsor's protocol ID
- CIGE025A1304
- Status last verified
- Oct 2011
- First submitted
- 3 Oct 2005
- Last updated
- 25 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Omalizumab in Moderate to Severe Bronchial Asthma
- ClinicalTrials.gov ID
- NCT00232050
- Acronym / sponsor ID
- CIGE025A1304
- Conditions
- Asthma
- Keywords
- Asthma, IgE, Omalizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Co., Ltd.
- Study start
- Oct 2002
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 4 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.
This study will evaluate the safety and efficacy of omalizumab up to 16 weeks in adult patients with moderate to severe bronchial asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Allergic asthma patients
- Inadequately controlled patients
Key exclusion criteria (4 listed)
- - History of severe anaphylactoid or anaphylactic reactions
- Previous treatment with omalizumab
- History of cancer or cancer
- Other protocol-defined exclusion criteria may apply
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 | – |
Primary outcome
Morning peak expiratory flow (PEF) at baseline and end of treatment.
5 secondary outcomes
Pulmonary function parameters measured by spirometer
Frequency of rescue medication use
Symptom score
Activities of daily living score
Nighttime sleep score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2011.
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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.
Novartis Pharmaceuticals Japan study chair
Novartis Pharmaceuticals Japan
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omalizumab in people with Asthma, run by Novartis.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 25 Oct 2011. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Morning peak expiratory flow (PEF) at baseline and end of treatment.. It is what the study was designed to measure, not a finding.
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 25 Oct 2011.