Allergic Asthma Clinical Trial
Official title:
A REAL-LIFE RETROSPECTIVE ANALYSIS OF CLINICAL CHARACTERISTICS AND IMPACT OF LONG-TERM TREATMENT WITH OMALIZUMAB WITH EMPHASIS ON MARKERS OF RESPONSE IN A CLINICAL PRACTICE IN APPROXIMATELY 240 PATIENTS WITH MODERATE-TO-SEVERE ALLERGIC ASTHMA
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.
Medical records from 240 omalizumab-treated patients will be evaluated. Comprehensive data
will be collected for any asthma-related event (see evaluation criteria below), omalizumab
dose, asthma-medications, spirometry, asthma control test (ACT) and any respiratory
infection and/or antibiotic use since last visit. Data will be analyzed to compare the
clinical phenotypes and outcome among patients to identify, characterize and define
'responders' and 'non-responders' to omalizumab. Periodic assessments for demonstrated level
of response and need for continued therapy will be evaluated quarterly. Also, real-life
patient adherence data to long-term omalizumab therapy will be analyzed and the factors for
withdrawal and non-adherence will be identified.
Reduction in annualized rate of asthma exacerbation, steroid bursts and oral steroid dosage,
ER/unscheduled doctor's visits, hospitalization and improvement in spirometry and ACT score
and review of asthma medications will be evaluated quarterly. 'Cluster analysis' will be
performed by grouping variables (such as age, asthma duration and severity, dosage, therapy
duration, sensitization profile, IgE levels etc.) in effort to identify groups of
responders.
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Observational Model: Cohort, Time Perspective: Retrospective
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