Clinical trial NCT01776177: The REALITY Study - a Real-life Long-term Analysis of Xolair Therapy
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergic Asthma
Keywords: Allergic asthma
Omalizumab therapy
IgE profile
Lead sponsor: Allergy & Asthma Research Center, San Antonio, TX
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2013-01-28
Enrollment: 240
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Single-center, retrospective study; total 240 patients. All 240 patients with moderate-to-severe allergic asthma who have received Omalizumab therapy at AAIAST/AARC \[from February 2004 to December 2011\].

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Moderate-to-severe persistent allergic asthmatic patients with inadequate asthma control
2. Received Omalizumab therapy per steps 5 \& 6 of the NHLBI guidelines
3. Positive skin test or in-vitro specific IgE to perennial allergens
4. Measured baseline total serum IgE level (within 1 year from first dose)
5. Patient followed at AAIAST/AARC (from February 2004 to December 2011)

Exclusion Criteria:

* N/A; retrospective study

Primary outcomes:
measure: Integrated Asthma control assessment(Change From Baseline)
timeFrame: February 2004 to December 2011. [ Time Frame: Baseline, 3-, 6-, 9-, 12-, 18-, 24-, 36-, 48-, 60-, 72- months of therapy]
measure: Integrated Asthma severity assessment (Change From Baseline): [ Time Frame: Baseline, 3-, 6-, 9-, 12-, 18-, 24-, 36-, 48-, 60-, 72- months of therapy]
timeFrame: February 2004 to December 2011. [ Time Frame: Baseline, 3-, 6-, 9-, 12-, 18-, 24-, 36-, 48-, 60-, 72- months of therapy]
Secondary outcomes:
measure: 'Clustering' of outcome variables
timeFrame: 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.
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Allergy & Asthma Research Center (AARC)
state: Texas
Study officials:
affiliation: Allergy & Asthma Research Center, San Antonio, TX
name: Joseph D Diaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.