The REALITY Study - a Real-life Long-term Analysis of Xolair Therapy

Allergic Asthma Clinical Trial

— The Reality  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01776177
• Other study ID #: ML28357
• Status: Active, not recruiting
• Phase: N/A
• First received: September 18, 2012
• Last updated: January 23, 2013
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: January 2013
• Source: Allergy & Asthma Research Center, San Antonio, TX
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: August 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Locations

Country	Name	City	State
United States	Allergy & Asthma Research Center (AARC)	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Joseph D. Diaz, MD	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]	No
Primary	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]	No
Secondary	'Clustering' of outcome variables	Data from 240 omalizumab-treated patients will be collected for the 'secondary outcome measure' parameters (as stated above).; Age; Asthma duration and severity; Therapy duration; Drug dosage; IgE levels Data will be analyzed to compare the clinical phenotypes and outcome among patients to identify, characterize and define 'responders' and 'non-responders' to omalizumab.	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.	No