| May 23, 2006 |
| June 3, 2008 |
| May 2006 |
| May 2007 (final data collection date for primary outcome measure) |
| Evaluate the effect of omalizumab on systemic allergic reactions to specific immunotherapy (SIT) in patients with persistent allergic asthma who require treatment with inhaled steroids [ Time Frame: 2005-2007 ] [ Designated as safety issue: Yes ] |
| Evaluate the effect of omalizumab on systemic allergic reactions to specific immunotherapy (SIT) in patients with persistent allergic asthma who require treatment with inhaled steroids |
| Complete list of historical versions of study NCT00329381 on ClinicalTrials.gov Archive Site |
| |
- Evaluate the effect of omalizumab on the:
- severity of first systemic allergic reaction to SIT
- proportion of patients who were able to reach target maintenance SIT dose
- number of visits required to complete cluster SIT dosing regimen
- number of doses of rescue medications
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| |
| Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy |
| A26-wk,Randomized,Dble-Blinded,Parallel-Grp,Placebo-Controlled,Multi-Centered Study to Eval.the Effect of Xolair(Omalizumab)on Improving the Tolerability of Spec.Immunotherapy in Patients With at Least Mod. Persistent Allergic Asthma Inadequately Controlled w/Inhaled Corticosteroids |
In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab(administered per US product label), when compared to placebo, will provide the participants with significantly improved tolerability of specific allergen immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method). |
Omalizumab is an FDA approved anti-IgE drug used to treat allergic asthma. This study is designed to give omalizumab 13 weeks prior to administering rapid build up of specific allergy shot, with an overlap of omalizumab and cluster therapy for 3 weeks. The cluster therapy will take 4 week to complete with maintenance dosage lasting an additional 6 weeks. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Asthma |
| Drug: Xolair |
- Placebo Comparator: Placebo will be compared to Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
- Experimental: Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
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| |
| |
| Completed |
| 14 |
| October 2007 |
| May 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- clinical diagnosis and history of moderate persistent allergic asthma
- body weight >/= 20kg and </= 150kg
- Total serum IgE >/= 30 and </= 700IU/mL
- on a stable asthma treatment including corticosteroids for the preceding 4 weeks
- non smoker for at least 1 year prior to visit 1
Exclusion Criteria:
- patients with severe asthma
- history of immunotherapy to any allergen within the past 3 years
- history of anaphylactic allergic reaction
- upper respiratory tract infection
|
| Both |
| 18 Years to 55 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00329381 |
| Gailen D. Marshall, MD, PhD, University of Mississippi Medical Center |
| CiGE025AUS23 |
| University of Mississippi Medical Center |
| Novartis |
| Principal Investigator: |
Gailen D. Marshall, MD/PhD |
University of Mississippi Medical Center |
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| University of Mississippi Medical Center |
| January 2007 |
