Allergic AsthmaThe RealityNCT01776177
The REALITY Study - a Real-life Long-term Analysis of Xolair Therapy
An observational study of Allergic Asthma, run by Joseph D. Diaz, MD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Allergic Asthma
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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].
Who may be able to join
- Moderate-to-severe persistent allergic asthmatic patients with inadequate asthma control
- Received Omalizumab therapy per steps 5 \& 6 of the NHLBI guidelines
- Positive skin test or in-vitro specific IgE to perennial allergens
- Measured baseline total serum IgE level (within 1 year from first dose)
- Patient followed at AAIAST/AARC (from February 2004 to December 2011)
Who cannot join
- N/A; retrospective study
Trial locations and contacts
1 site in 1 country.
United States1 site
Allergy & Asthma Research Center (AARC)
San Antonio, Texas, 78229
About this study
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
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.
Read the 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.
- Conditions
- Allergic Asthma
- Keywords
- Allergic asthma, Omalizumab therapy, IgE profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: February 2004 to December 2011. [ Time Frame: Baseline, 3-, 6-, 9-, 12-, 18-, 24-, 36-, 48-, 60-, 72- months of therapy]
Secondary outcomes (1)
'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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionMar 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joseph D. Diaz, MD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor-investigator, Joseph D. Diaz, MD, Allergy & Asthma Research Center, San Antonio, TX
- Investigators
- Joseph D Diaz, MD, Principal investigator, Allergy & Asthma Research Center, San Antonio, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776177
- Sponsor's protocol ID
- ML28357
- Acronym
- The Reality
- Status last verified
- Jan 2013
- First submitted
- 18 Sep 2012
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31382020
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01776177
- Acronym / sponsor ID
- The Reality / ML28357
- Conditions
- Allergic Asthma
- Keywords
- Allergic asthma, Omalizumab therapy, IgE profile
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Joseph D. Diaz, MDIndustry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Sep 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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].
Key inclusion criteria (5 listed)
- Moderate-to-severe persistent allergic asthmatic patients with inadequate asthma control
- Received Omalizumab therapy per steps 5 \& 6 of the NHLBI guidelines
- Positive skin test or in-vitro specific IgE to perennial allergens
- Measured baseline total serum IgE level (within 1 year from first dose)
- Patient followed at AAIAST/AARC (from February 2004 to December 2011)
Key exclusion criteria (1 listed)
- N/A; retrospective study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
'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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
- Derived from this study: PubMed 31382020Singh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph D Diaz, MD principal investigator
Allergy & Asthma Research Center, San Antonio, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Asthma, run by Joseph D. Diaz, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01776177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2013.