AsthmaPhase 3NCT00482248
Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma
A Phase 3 study testing Omalizumab in people with Asthma, run by Novartis.
Trial summary
This study will assess further the safety and tolerability of long-term treatment with omalizumab by extending omalizumab treatment by 1 year for those patients with allergic asthma who successfully completed study CIGE25011E2. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Omalizumab
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Jun 2006
- 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 12 to 75 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patients with a history of severe allergic asthma who completed the treatment period of CIGE250011E3 protocol, without experiencing any significant drug-related adverse events
- Male or female patients 12-75 years of age who have given written informed consent approved by the ethical committee
Who cannot join
- Patients who had not received study medication for greater than 84 days since visit 38 of study CIGE240011E3
- Pregnant females or nursing mothers
- Patients with know hypersensitivity to any ingredients of Omalizumab or related drugs
- Other protocol-defined inclusion/exclusion criteria may apply
About this study
Official title: An Open-label Extension Study to Assess Long Term Safety and Tolerability of Omalizumab Treatment in Adults and Adolescents With Severe Allergic Asthma Who Participated in the 52 Week CIGE250011E2 Study
This study will assess further the safety and tolerability of long-term treatment with omalizumab by extending omalizumab treatment by 1 year for those patients with allergic asthma who successfully completed study CIGE25011E2.
- Conditions
- Asthma
- Being tested
- Omalizumab
- Keywords
- Asthma, anti-immunoglobulin E, omalizumab, allergic asthma
- Medical subject headings
- Asthma
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.
Safety assessed by adverse events, serious adverse events, hematology, blood chemistry and urinalysis value, vital signs data, the performance of physical examinations and body weight measurements.
Secondary outcomes (1)
Efficacy assessed by changes in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC), the investigator's assessment of asthma control, corticosteroid use, the incidence of hospitalization and outpatients visits, and absenteeism fr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startJun 2003
- Primary completionJun 2006
- Study completionJun 2006
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482248
- Sponsor's protocol ID
- CIGE0250011E3
- Status last verified
- Nov 2016
- First submitted
- 4 Jun 2007
- Last updated
- 18 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension Study to Assess Long Term Safety and Tolerability of Omalizumab Treatment in Adults and Adolescents With Severe Allergic Asthma Who Participated in the 52 Week CIGE250011E2 Study
- ClinicalTrials.gov ID
- NCT00482248
- Acronym / sponsor ID
- CIGE0250011E3
- Conditions
- Asthma
- Keywords
- Asthma, anti-immunoglobulin E, omalizumab, allergic asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Jun 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 5 Jun 2007 (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 assess further the safety and tolerability of long-term treatment with omalizumab by extending omalizumab treatment by 1 year for those patients with allergic asthma who successfully completed study CIGE25011E2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a history of severe allergic asthma who completed the treatment period of CIGE250011E3 protocol, without experiencing any significant drug-related adverse events
- Male or female patients 12-75 years of age who have given written informed consent approved by the ethical committee
Key exclusion criteria (4 listed)
- Patients who had not received study medication for greater than 84 days since visit 38 of study CIGE240011E3
- Pregnant females or nursing mothers
- Patients with know hypersensitivity to any ingredients of Omalizumab or related drugs
- Other protocol-defined inclusion/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
Safety assessed by adverse events, serious adverse events, hematology, blood chemistry and urinalysis value, vital signs data, the performance of physical examinations and body weight measurements.
1 secondary outcome
Efficacy assessed by changes in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC), the investigator's assessment of asthma control, corticosteroid use, the incidence of hospitalization and outpatients visits, and absenteeism fr
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 18 Nov 2016.
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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 study chair
Novartis Pharmaceuticals
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 18 Nov 2016. 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?
Safety assessed by adverse events, serious adverse events, hematology, blood chemistry and urinalysis value, vital signs data, the performance of physical examinations and body weight measurements.. 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 18 Nov 2016.