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
1 other identifier
interventional
14
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 asthma
Started May 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 23, 2006
CompletedFirst Posted
Study publicly available on registry
May 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedJune 4, 2008
January 1, 2007
1 year
May 23, 2006
June 3, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2005-2007
Study Arms (2)
1
PLACEBO COMPARATORPlacebo will be compared to Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
2
EXPERIMENTALXolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
Interventions
Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- patients with severe asthma
- history of immunotherapy to any allergen within the past 3 years
- history of anaphylactic allergic reaction
- upper respiratory tract infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Mississippi Medical Centerlead
- Novartiscollaborator
Study Sites (1)
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gailen D. Marshall, MD/PhD
University of Mississippi Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 23, 2006
First Posted
May 24, 2006
Study Start
May 1, 2006
Primary Completion
May 1, 2007
Study Completion
October 1, 2007
Last Updated
June 4, 2008
Record last verified: 2007-01