The REALITY Study - a Real-life Long-term Analysis of Xolair Therapy
Status unconfirmed
Conditions studied: Allergic Asthma
In brief
The primary objective is to assess the clinical effectiveness of long-term omalizumab therapy in 240 patients treated over an 8 year period in a real-life clinical setting and to compare the pre- and post-treatment clinical characteristics to identify and better understand the markers of response to omalizumab. To date, there are no established criteria for identifying 'response' to omalizumab therapy. Currently, the commonly accepted clinical criterion for omalizumab treatment response is the physician's overall assessment, GETE (Global Evaluation of Treatment Effectiveness). Most clinical trials have evaluated the efficacy of omalizumab treatment after a 16 week treatment period and lack the impact of long-term omalizumab therapy. Investigators propose multiple approach modules to better assess and identify 'response' and to define 'responders' to omalizumab and evaluate the long-term impact in a real-world clinical practice. Besides evaluating individual outcome variables, it is important to attempt the 'clustering of variables' to further investigate if any baseline clinical phenotypes are predictive of better response enabling us to refine the patient population who will gain most benefit from therapy.
Key facts
- Study ID
- NCT01776177
- Run by
- Joseph D. Diaz, MD
- People needed
- 240
- Starts
- 2012-09-01
- Expected to finish
- 2013-08-01
- Last updated by the study team
- 2013-01-28
Who can join
Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Moderate-to-severe persistent allergic asthmatic patients with inadequate asthma control
- Received Omalizumab therapy per steps 5 \& 6 of the NHLBI guidelines
- Positive skin test or in-vitro specific IgE to perennial allergens
- Measured baseline total serum IgE level (within 1 year from first dose)
- Patient followed at AAIAST/AARC (from February 2004 to December 2011)
You may not qualify if…
- N/A; retrospective study
Where it is running
- Allergy & Asthma Research Center (AARC) — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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