Trials / Completed
CompletedNCT00264849
Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
A Randomized, Open Label, Parallel-group, International, Multicenter Study Evaluating Persistency of Response to Omalizumab During 32 Weeks Treatment Given as Add on to Optimized Asthma Therapy in Adult and Adolescent Patients With Severe Persistent Allergic Asthma, Who Remain Inadequately Controlled Despite GINA (2004) Step 4 Therapy
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 406 (actual)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 12 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma. THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Omalizumab | Omalizumab administered by subcutaneous injection. The dosage received was individualized based on body weight and serum IgE level. |
| OTHER | Optimized asthma therapy | Optimized asthma therapy (OAT) according to Global Initiative for Asthma (GINA) 2004 guidelines during the first 4 weeks of the run-in period of the study. |
Timeline
- Start date
- 2005-11-01
- Primary completion
- 2008-09-01
- Completion
- 2008-09-01
- First posted
- 2005-12-13
- Last updated
- 2018-06-29
- Results posted
- 2011-07-25
Locations
17 sites across 17 countries: Belgium, Canada, Denmark, Germany, Greece, Hungary, Ireland, Israel, Italy, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT00264849. Inclusion in this directory is not an endorsement.