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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Joseph D. Diaz, MD, Allergy & Asthma Research Center, San Antonio, TX
ClinicalTrials.gov Identifier:
NCT01776177
First received: September 18, 2012
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition
Allergic Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Allergy & Asthma Research Center, San Antonio, TX:

Primary Outcome Measures:
  • 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] ] [ Designated as safety issue: No ]
    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.

  • 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] ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • '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. ] [ Designated as safety issue: No ]

    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.


Estimated Enrollment: 240
Study Start Date: September 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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].

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776177

Locations
United States, Texas
Allergy & Asthma Research Center (AARC)
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Joseph D. Diaz, MD
Genentech, Inc.
Investigators
Principal Investigator: Joseph D Diaz, MD Allergy & Asthma Research Center, San Antonio, TX
  More Information

No publications provided

Responsible Party: Joseph D. Diaz, MD, Medical Director, Allergy & Asthma Research Center, San Antonio, TX
ClinicalTrials.gov Identifier: NCT01776177     History of Changes
Other Study ID Numbers: ML28357
Study First Received: September 18, 2012
Last Updated: January 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Allergy & Asthma Research Center, San Antonio, TX:
Allergic asthma
Omalizumab therapy
IgE profile

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014