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

January 23, 2013 updated by: Joseph D. Diaz, MD

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Allergy & Asthma Research Center (AARC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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].

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Continue Therapy Group
Patients who continued to recieve Omalizumab therapy beyond 6 month period
Discontinued Therapy group
Patients who discontinued Omalizumab therapy prior to 6 month period from the start of therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Integrated Asthma control assessment(Change From Baseline)
Time Frame: February 2004 to December 2011. [ 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 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]
Time Frame: February 2004 to December 2011. [ 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]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
'Clustering' of outcome variables
Time Frame: 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.

Data from 240 omalizumab-treated patients will be collected for the 'secondary outcome measure' parameters (as stated above).

  1. Age
  2. Asthma duration and severity
  3. Therapy duration
  4. Drug dosage
  5. 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph D. Diaz, MD

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Joseph D Diaz, MD, Allergy & Asthma Research Center, San Antonio, TX

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

September 18, 2012

First Submitted That Met QC Criteria

January 23, 2013

First Posted (Estimate)

January 28, 2013

Study Record Updates

Last Update Posted (Estimate)

January 28, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28357

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Allergic Asthma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe