The Reality
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
Sponsor study identifier
observational
240
1 country
1
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
September 18, 2012
Actual (reported)January 28, 2013
Actual (reported)March 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Integrated Asthma control assessment(Change From Baseline)
Data from 240 omalizumab-treated patients will be collected for for the above stated time frame for pre- and post-treatment periods. The parameters assessed will be for Spirometry, Asthma Medications, ACT score.
February 2004 to December 2011. [ Time Frame: Baseline, 3-, 6-, 9-, 12-, 18-, 24-, 36-, 48-, 60-, 72- months of therapy]
Integrated Asthma severity assessment (Change From Baseline): [ Time Frame: Baseline, 3-, 6-, 9-, 12-, 18-, 24-, 36-, 48-, 60-, 72- months of therapy]
Data from 240 omalizumab-treated patients will be collected for for the above stated time frame for pre- and post-treatment periods. The parameters assessed will be for Asthma exacerbation, Steroid bursts, Oral steroid, Hospitalization/ ER visits.
February 2004 to December 2011. [ Time Frame: Baseline, 3-, 6-, 9-, 12-, 18-, 24-, 36-, 48-, 60-, 72- months of therapy]
'Clustering' of outcome variables
February 2004 to December 2011. The time frame of all subjects is variable ranging from 3 months to 8 years depending on the duration the patients were on omalizumab therapy.
Patients who continued to recieve Omalizumab therapy beyond 6 month period
Patients who discontinued Omalizumab therapy prior to 6 month period from the start of therapy
Single-center, retrospective study; total 240 patients. All 240 patients with moderate-to-severe allergic asthma who have received Omalizumab therapy at AAIAST/AARC \[from February 2004 to December 2011\].
Allergy & Asthma Research Center (AARC)
San Antonio, Texas, 78229, United States
Singh H, Peters JI, Kaur Y, Maselli DJ, Diaz JD. Long-term evaluation of response to omalizumab therapy in real life by a novel multimodular approach: The Real-life Effectiveness of Omalizumab Therapy (REALITY) study. Ann Allergy Asthma Immunol. 2019 Nov;123(5):476-482.e1. doi: 10.1016/j.anai.2019.07.026. Epub 2019 Aug 2.
Joseph D Diaz, MD
Allergy & Asthma Research Center, San Antonio, TX
First Submitted
September 18, 2012
First Posted
January 28, 2013
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2013
Study to Evaluate the Effect of Omalizumab on Improving the Tolerability of Specific Immunotherapy in Patients With Persistent Allergic Asthma
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 28, 2013
Record last verified: 2013-01
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