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A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Omalizumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants identified by the investigator as a candidate for treatment for asthma with omalizumab
  • Confirmation of access to omalizumab through insurance or other source of funding

Exclusion Criteria:

  • Enrollment in any other concurrent clinical trial or observational study
  • Participants for whom omalizumab treatment is contraindicated
  • Participants who had a prior allergic reaction to omalizumab or its excipients
  • Participants treated with omalizumab within the previous year
  • Participants who received an experimental drug as part of another study within 3 months of enrollment

Sites / Locations

  • Alabama Allergy & Asthma
  • Achieve Clinical Research, LLC
  • Huntsville Lung Associates PC
  • San Tan Allergy & Asthma
  • Dedicated Clinical Research
  • Allergy Associates of Tucson
  • University of Arizona
  • Little Rock Allergy & Asthma; Clinical Research Center
  • Stuart Epstein MD - PP
  • West Coast Clinical Trials Global, LLC
  • Peninsula Allergy Associates
  • Allianz Medical and Research Center
  • William Ebbeling MD - PP
  • Gettysburg Medical Clinic
  • Allergy & Asthma Inst Valley
  • VA Loma Linda Healthcare System
  • Allergy Asthma Care Ctr, Inc.
  • Southern California Research Center
  • North Bay Allergy & Asthma; Medical Assoc
  • Choc Psf, Amc
  • Clinical Trials of Orange County
  • California Allergy & Asthma Medical Group, Inc.
  • Joann Blessing-Moore MD - PP
  • TPMG - Rancho Cordova
  • Redding Allergy & Asthma Care
  • Allergy & Asthma Consultants
  • Capital Allergy Resp Dis Ctr
  • Central Coast Allergy and Asthma
  • Allergy Assoc Medical Group
  • Kaiser Permanente - San Diego
  • University of California at San Francisco
  • Asthma & Allergy Clinic
  • The Allergy and Asthma Clinic
  • Allergy & Asthma Medical Group; Clinical Research Division
  • IMMUNOe International Research Centers
  • Danbury Hospital
  • Christopher C Randolph MD - PP
  • Waterbury Pulmonary Associates
  • St. Francis Sleep; Allergy & Lung Institute
  • AAADRS; Clinical Research Center
  • Allergy Asthma & Immun Center
  • Florida Ctr-Allergy & Asthma
  • FL Ctr Allergy & Asthma Res
  • Allergy & Asthma Care of FL; Clinical Research
  • Central Florida Pulmonary Grou
  • Allergy Asthma & Sinus Center
  • Gulf Coast Allergy Center, P.A.
  • USF Asthma Allergy & Immun; Clinical Research
  • Georgia Pollens
  • Brookstone Clinical Res Ctr
  • Allergy & Asthma Care Center
  • Aeroallergy Research Labs
  • Asthma & Allergy of Idaho
  • Rush University Medical Center
  • Chest Medicine Consultants
  • Allergy & Asthma Care LTD
  • Sneeze Wheeze and Itch Associates LLC
  • Allergy Asthma Care
  • The Allergy and Asthma Center
  • Clinical Research Center of Indiana
  • University of Kansas Med Ctr; Int med/Allgy/Immun/Rheum
  • Kansas City Allergy And Asthma Assoc.
  • Abraham Research PLLC
  • Allergy & Asth Phys of Cent KY
  • Dr. Paul Shapero
  • Chesapeake Clinical Research Inc - CRN
  • Glenn M. Silber, M.D., P.A
  • Family Allergy & Asthma
  • Brigham and Women's Hospital
  • Center for Clinical Research.
  • Allergy Arth Fam Treatment Ctr
  • Infinity Medical Research Inc
  • McGovern & Baja Allergy Assoc
  • Asthma & Allergy Inst of MI
  • Asthma Allergy Ctr of SW MI
  • Clinical Research Inst
  • Mayo Clinic
  • Washington Univ. School of Med
  • Impact Clinical Trials
  • Ocean Allergy & Resp Res Ctr
  • Adult Ped Aller Central Jersey
  • Center for Asthma and Allergy
  • Atlantic Allergy Asthma Immunology Associates
  • Allergy Treatment Center of New Jersey
  • Pulmonary and Allergy Associates
  • Allergy Consultants, PA
  • SUNY Downstate Medical Center.
  • Boris Sagalovich MD - PC
  • Island Medical Research Pc
  • North Shore Medical Arts, LLP
  • Jamaica Hospital Medical Center
  • Winthrop Univ Hospital
  • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
  • Parikh Institute for Research LLC
  • Albert P Hirdt DO - PP
  • Olean Medical Group
  • University of Rochester
  • Advanced Allergy & Asthma PLLC
  • Urban Health Plan, Inc.
  • Montefiore Medical Center
  • Alan Kaufman MD - PP
  • Allergy Partners of Western NC
  • Allergy & Asthma Centre of Dayton
  • The Cleveland Clinic Foundation
  • Santiago Reyes MD-Private Prac
  • Vital Prospects Clin Res Pc
  • Bend Memorial Clinic
  • Central PA Asth & Allergy Care; Research Division
  • Allergy and Asthmas; Specialists of Harrisburg
  • Penn State Hershey Medical Group
  • Inst for Resp & Sleep Med PC
  • Allergy and Asthma Research of NJ, lnc
  • Allergy & Clinical Immun Assoc
  • South Hills Pulmonary Assoc
  • Respiratory Specialists
  • Nat'l Aller Asth-Charleston
  • ADAC Research PA
  • Upstate Pharma Research
  • East Tennessee Center for Clinical Research
  • LeBonheur Children's Hospital
  • Vanderbilt Medical University
  • Greater Austin Allergy Asthma and Immunology
  • Elliot J. Ginchansky, MD, PA
  • Allergy Asthma Research Assoc
  • University of Texas Medical Branch;Division of APICS
  • Allergy Asthma & Immun Assoc
  • Live Oak Allergy & Asthma Clinic
  • Allergy & Asthma Res Ctr PA
  • Sugar Land Allerg Asthma Immun
  • University of Texas Health Center at Tyler
  • Allergy Associates of Utah
  • Bridgerland Clinical Research
  • Pulmonary Research of Albingdon
  • O & O Alpan, LLC
  • Clinical Research Partners, LLC
  • Allergy Asthma & Sinus Center
  • Children's Hospital of the King's Daughter
  • Bellingham Asthma, Allergy & Immunology
  • ASTHMA, Inc
  • Pulmonary & Sleep Research
  • Northwest Asthma Allergy Center
  • Allergy Asthma & Sinus Center
  • Dean Clinic
  • University of Wisconsin;Allergy & Asthma Clinical Research
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants With Allergic Asthma

Arm Description

Participants with allergic asthma, who have decided to initiate treatment with omalizumab will be observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurs first.

Outcomes

Primary Outcome Measures

Total Number of Asthma Exacerbations During Months 1-12
An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.

Secondary Outcome Measures

Total Number of Asthma Exacerbations During Months 1-6
An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/=3 days.
Total Number of Asthma Exacerbations During Months 7-12
An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.
Total Number of Asthma-Related Hospital Admissions During Months 1-12
Total Number of Asthma-Related Hospital Admissions During Months 1-6
Total Number of Asthma-Related Hospital Admissions During Months 7-12
Total Number of Asthma-Related ER Visits During Months 1-12
Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6
Total Number of Asthma-Related ER Visits During Months 7-12
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12
Percentage of Participants by Number of Asthma Exacerbations
Percentage of participants by number of asthma exacerbations (0, 1, 2, 3, >/=4) was reported. An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.
Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids
Percentage of participants by number of asthma exacerbations (0, 1, 2, 3, >/=4) requiring treatment with systemic steroids was reported. An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.
Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1)
FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. Pre-bronchodilator FEV1 and post-bronchodilator FEV1 are reported for each timepoint. FEV1 was measured using spirometry.
Change From Baseline in Raw Forced Vital Capacity (FVC)
FVC was defined as the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pre-bronchodilator FVC and post-bronchodilator FVC are reported for each timepoint. FVC was measured using spirometry.
Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%)
FEF25%-75% was defined as the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Pre-bronchodilator FEF25%-75% and post-bronchodilator FEF25%-75% are reported for each timepoint. FEF25%-75% was measured using spirometry.
Change From Baseline in Percentage Predicted FEV1 (ppFEV1)
FEV1 is the volume of air that can be forced out in one second after taking a deep breath, as measured using spirometry. Hankinson and Wang standards were used to calculate ppFEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. ppFEV1= 100 multiplied by (*) FEV1 (in liters [L]) divided by (/) predicted FEV1 (in L). Pre-bronchodilator ppFEV1 and post-bronchodilator ppFEV1 are reported for each timepoint.
Percentage of Participants With Prior Asthma Medications by Category or Class of Medications
Prior asthma medications were defined as all medications used for asthma prior to the study (initiated within 90 days of baseline) and were assessed retrospectively at baseline. Participants received prior asthma medications of following categories or classes: short acting beta agonist (SABA), combination inhaled corticosteroids/long acting beta agonist (ICS/LABA), leukotriene receptor antagonist (LTRA), inhaled corticosteroids (ICS), oral/parenteral (systemic) corticosteroids, anticholinergic, long acting beta agonist (LABA), and other medication.
Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications
Concomitant and ongoing asthma medications were defined as all medications used for asthma which began on or after the participant's study start, as well as those ongoing at the beginning of the study. Participants received following categories or classes of concomitant and ongoing asthma medications: SABA, combination ICS/LABA, LTRA, oral/parenteral (systemic) corticosteroids, ICS, anticholinergic, LABA, and other medication.
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score
AQLQ +12 is a 32-item disease specific questionnaire designed to assess the participants' asthma-specific health-related quality of life (QOL). The questionnaire contains four domains: activity limitations (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). All items are scored on a 7-point likert scale. All item scores are averaged to produce one overall QOL score. Overall score ranges from 1 (total impairment) to 7 (no impairment), with higher scores indicating better QOL. A positive change from baseline indicated improved QOL.
Change From Baseline in Asthma Control Test (ACT) Overall Score
Multidimensional factors associated with asthma control from the participant's perspective were assessed using the ACT questionnaire. The ACT is a validated, five-item patient-reported outcome (PRO) questionnaire that measures the impact of asthma on home and work activities, shortness of breath, symptoms, rescue medication usage, and overall asthma control. All items are scored on a 5-point likert scale (1 to 5). All item scores are added together to calculate a total score. Total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. A positive change from baseline indicated improvement.
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score
WPAI-asthma is a self-administered instrument to measure asthma-specific performance impairment of work and regular daily activity within the last 7 days and yields 4 types of scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (WI) (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Total score and each score ranged from 0 (not affected/no impairment) to 100 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. A negative change in score indicated improvement and a positive change indicated impairment.
Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using Global Evaluation of Treatment Effectiveness (GETE) by Inversigator
Response to treatment was assessed using the GETE. The GETE is a validated instrument that measures the overall impression of the effect of the study medication on typical asthma symptoms. The evaluation was performed using the 5-point scale. The GETE scale ranges were as follows: 1=excellent, 2=good, 3=moderate, 4=poor, 5= worsening. A good or excellent response on the 5 point scale indicated that a participant had responded to treatment. Percentage of participants who showed an improvement (GETE scale score of 1 or 2) in asthma symptoms, as assessed by investigator, is reported.
Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using GETE by Participant
Response to treatment was assessed using the GETE. The GETE is a validated instrument that measures the overall impression of the effect of the study medication on typical asthma symptoms. The evaluation was performed using the 5-point scale. The GETE scale ranges were as follows: 1=excellent, 2=good, 3=moderate, 4=poor, 5= worsening. A good or excellent response on the 5 point scale indicated that a participant had responded to treatment. Percentage of participants who showed an improvement (GETE scale score of 1 or 2) in asthma symptoms, as assessed by participant, is reported.
Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score
The MiniRQLQ is a shorter version of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) instrument. The MiniRQLQ is a validated quality of life questionnaire to measure the functional impairments that are most troublesome to adult participants with either seasonal or perennial rhinoconjunctivitis of either allergic or non-allergic origin. The miniRQLQ contains 14 items; each item scored on a 7-point scale ranging from 0 [not impaired at all] to 6 [severely impaired]). The overall quality of life score is the average of the all item scores and ranges from 0 (not impaired at all) to 6 (severely impaired), with higher scores indicating more impairment. A negative change in score indicated improvement and a positive change indicated impairment.

Full Information

First Posted
July 12, 2013
Last Updated
November 9, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01922037
Brief Title
A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair)
Official Title
A Prospective Observational Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 19, 2013 (Actual)
Primary Completion Date
March 31, 2016 (Actual)
Study Completion Date
March 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This multicenter, prospective study will evaluate the baseline participant characteristics (including biomarkers) associated with a variety of individual and composite clinical outcomes in participants with moderate to severe asthma initiating treatment with omalizumab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
806 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants With Allergic Asthma
Arm Type
Experimental
Arm Description
Participants with allergic asthma, who have decided to initiate treatment with omalizumab will be observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurs first.
Intervention Type
Drug
Intervention Name(s)
Omalizumab
Other Intervention Name(s)
Xolair
Intervention Description
Participants will receive omalizumab for up to 12 months per investigator standard of care and clinical practice.
Primary Outcome Measure Information:
Title
Total Number of Asthma Exacerbations During Months 1-12
Description
An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.
Time Frame
Months 1-12
Secondary Outcome Measure Information:
Title
Total Number of Asthma Exacerbations During Months 1-6
Description
An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/=3 days.
Time Frame
Months 1-6
Title
Total Number of Asthma Exacerbations During Months 7-12
Description
An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.
Time Frame
Months 7-12
Title
Total Number of Asthma-Related Hospital Admissions During Months 1-12
Time Frame
Months 1-12
Title
Total Number of Asthma-Related Hospital Admissions During Months 1-6
Time Frame
Months 1-6
Title
Total Number of Asthma-Related Hospital Admissions During Months 7-12
Time Frame
Months 7-12
Title
Total Number of Asthma-Related ER Visits During Months 1-12
Time Frame
Months 1-12
Title
Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6
Time Frame
Months 1-6
Title
Total Number of Asthma-Related ER Visits During Months 7-12
Time Frame
Months 7-12
Title
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12
Time Frame
Months 1-12
Title
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6
Time Frame
Months 1-6
Title
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12
Time Frame
Months 7-12
Title
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12
Time Frame
Months 1-12
Title
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6
Time Frame
Months 1-6
Title
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12
Time Frame
Months 7-12
Title
Percentage of Participants by Number of Asthma Exacerbations
Description
Percentage of participants by number of asthma exacerbations (0, 1, 2, 3, >/=4) was reported. An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.
Time Frame
Months 1-12
Title
Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids
Description
Percentage of participants by number of asthma exacerbations (0, 1, 2, 3, >/=4) requiring treatment with systemic steroids was reported. An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.
Time Frame
Months 1-12
Title
Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1)
Description
FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. Pre-bronchodilator FEV1 and post-bronchodilator FEV1 are reported for each timepoint. FEV1 was measured using spirometry.
Time Frame
Baseline, Month 6, end of study (EOS)/early termination (ET) (up to Month 12)
Title
Change From Baseline in Raw Forced Vital Capacity (FVC)
Description
FVC was defined as the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pre-bronchodilator FVC and post-bronchodilator FVC are reported for each timepoint. FVC was measured using spirometry.
Time Frame
Baseline, Month 6, EOS/ET (up to Month 12)
Title
Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%)
Description
FEF25%-75% was defined as the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Pre-bronchodilator FEF25%-75% and post-bronchodilator FEF25%-75% are reported for each timepoint. FEF25%-75% was measured using spirometry.
Time Frame
Baseline, Month 6, EOS/ET (up to Month 12)
Title
Change From Baseline in Percentage Predicted FEV1 (ppFEV1)
Description
FEV1 is the volume of air that can be forced out in one second after taking a deep breath, as measured using spirometry. Hankinson and Wang standards were used to calculate ppFEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. ppFEV1= 100 multiplied by (*) FEV1 (in liters [L]) divided by (/) predicted FEV1 (in L). Pre-bronchodilator ppFEV1 and post-bronchodilator ppFEV1 are reported for each timepoint.
Time Frame
Baseline, Month 6, EOS/ET (up to Month 12)
Title
Percentage of Participants With Prior Asthma Medications by Category or Class of Medications
Description
Prior asthma medications were defined as all medications used for asthma prior to the study (initiated within 90 days of baseline) and were assessed retrospectively at baseline. Participants received prior asthma medications of following categories or classes: short acting beta agonist (SABA), combination inhaled corticosteroids/long acting beta agonist (ICS/LABA), leukotriene receptor antagonist (LTRA), inhaled corticosteroids (ICS), oral/parenteral (systemic) corticosteroids, anticholinergic, long acting beta agonist (LABA), and other medication.
Time Frame
Baseline
Title
Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications
Description
Concomitant and ongoing asthma medications were defined as all medications used for asthma which began on or after the participant's study start, as well as those ongoing at the beginning of the study. Participants received following categories or classes of concomitant and ongoing asthma medications: SABA, combination ICS/LABA, LTRA, oral/parenteral (systemic) corticosteroids, ICS, anticholinergic, LABA, and other medication.
Time Frame
Baseline until EOS/ET (up to Month 12)
Title
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score
Description
AQLQ +12 is a 32-item disease specific questionnaire designed to assess the participants' asthma-specific health-related quality of life (QOL). The questionnaire contains four domains: activity limitations (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). All items are scored on a 7-point likert scale. All item scores are averaged to produce one overall QOL score. Overall score ranges from 1 (total impairment) to 7 (no impairment), with higher scores indicating better QOL. A positive change from baseline indicated improved QOL.
Time Frame
Baseline, Month 6, EOS/ET (up to Month 12)
Title
Change From Baseline in Asthma Control Test (ACT) Overall Score
Description
Multidimensional factors associated with asthma control from the participant's perspective were assessed using the ACT questionnaire. The ACT is a validated, five-item patient-reported outcome (PRO) questionnaire that measures the impact of asthma on home and work activities, shortness of breath, symptoms, rescue medication usage, and overall asthma control. All items are scored on a 5-point likert scale (1 to 5). All item scores are added together to calculate a total score. Total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. A positive change from baseline indicated improvement.
Time Frame
Baseline, Months 3, 6, 9, 12
Title
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score
Description
WPAI-asthma is a self-administered instrument to measure asthma-specific performance impairment of work and regular daily activity within the last 7 days and yields 4 types of scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (WI) (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Total score and each score ranged from 0 (not affected/no impairment) to 100 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. A negative change in score indicated improvement and a positive change indicated impairment.
Time Frame
Baseline, Month 6, EOS/ET (up to Month 12)
Title
Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using Global Evaluation of Treatment Effectiveness (GETE) by Inversigator
Description
Response to treatment was assessed using the GETE. The GETE is a validated instrument that measures the overall impression of the effect of the study medication on typical asthma symptoms. The evaluation was performed using the 5-point scale. The GETE scale ranges were as follows: 1=excellent, 2=good, 3=moderate, 4=poor, 5= worsening. A good or excellent response on the 5 point scale indicated that a participant had responded to treatment. Percentage of participants who showed an improvement (GETE scale score of 1 or 2) in asthma symptoms, as assessed by investigator, is reported.
Time Frame
EOS/ET (up to Month 12)
Title
Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using GETE by Participant
Description
Response to treatment was assessed using the GETE. The GETE is a validated instrument that measures the overall impression of the effect of the study medication on typical asthma symptoms. The evaluation was performed using the 5-point scale. The GETE scale ranges were as follows: 1=excellent, 2=good, 3=moderate, 4=poor, 5= worsening. A good or excellent response on the 5 point scale indicated that a participant had responded to treatment. Percentage of participants who showed an improvement (GETE scale score of 1 or 2) in asthma symptoms, as assessed by participant, is reported.
Time Frame
EOS/ET (up to Month 12)
Title
Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score
Description
The MiniRQLQ is a shorter version of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) instrument. The MiniRQLQ is a validated quality of life questionnaire to measure the functional impairments that are most troublesome to adult participants with either seasonal or perennial rhinoconjunctivitis of either allergic or non-allergic origin. The miniRQLQ contains 14 items; each item scored on a 7-point scale ranging from 0 [not impaired at all] to 6 [severely impaired]). The overall quality of life score is the average of the all item scores and ranges from 0 (not impaired at all) to 6 (severely impaired), with higher scores indicating more impairment. A negative change in score indicated improvement and a positive change indicated impairment.
Time Frame
Baseline, EOS/ET (up to Month 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants identified by the investigator as a candidate for treatment for asthma with omalizumab Confirmation of access to omalizumab through insurance or other source of funding Exclusion Criteria: Enrollment in any other concurrent clinical trial or observational study Participants for whom omalizumab treatment is contraindicated Participants who had a prior allergic reaction to omalizumab or its excipients Participants treated with omalizumab within the previous year Participants who received an experimental drug as part of another study within 3 months of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Allergy & Asthma
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Achieve Clinical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Huntsville Lung Associates PC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
San Tan Allergy & Asthma
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234-2966
Country
United States
Facility Name
Dedicated Clinical Research
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85395
Country
United States
Facility Name
Allergy Associates of Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85716
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5030
Country
United States
Facility Name
Little Rock Allergy & Asthma; Clinical Research Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Stuart Epstein MD - PP
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
West Coast Clinical Trials Global, LLC
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Peninsula Allergy Associates
City
Daly City
State/Province
California
ZIP/Postal Code
94015
Country
United States
Facility Name
Allianz Medical and Research Center
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
William Ebbeling MD - PP
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Gettysburg Medical Clinic
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
Facility Name
Allergy & Asthma Inst Valley
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
VA Loma Linda Healthcare System
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Facility Name
Allergy Asthma Care Ctr, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90064
Country
United States
Facility Name
Southern California Research Center
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
North Bay Allergy & Asthma; Medical Assoc
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
Facility Name
Choc Psf, Amc
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Clinical Trials of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
California Allergy & Asthma Medical Group, Inc.
City
Palmdale
State/Province
California
ZIP/Postal Code
93551
Country
United States
Facility Name
Joann Blessing-Moore MD - PP
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
TPMG - Rancho Cordova
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95762
Country
United States
Facility Name
Redding Allergy & Asthma Care
City
Redding
State/Province
California
ZIP/Postal Code
96003
Country
United States
Facility Name
Allergy & Asthma Consultants
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Capital Allergy Resp Dis Ctr
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Central Coast Allergy and Asthma
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Facility Name
Allergy Assoc Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Kaiser Permanente - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Asthma & Allergy Clinic
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
The Allergy and Asthma Clinic
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States
Facility Name
Allergy & Asthma Medical Group; Clinical Research Division
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
IMMUNOe International Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Danbury Hospital
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Christopher C Randolph MD - PP
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Waterbury Pulmonary Associates
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
St. Francis Sleep; Allergy & Lung Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
AAADRS; Clinical Research Center
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Allergy Asthma & Immun Center
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34788
Country
United States
Facility Name
Florida Ctr-Allergy & Asthma
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
FL Ctr Allergy & Asthma Res
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Allergy & Asthma Care of FL; Clinical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Central Florida Pulmonary Grou
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Allergy Asthma & Sinus Center
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Gulf Coast Allergy Center, P.A.
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
USF Asthma Allergy & Immun; Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Georgia Pollens
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707
Country
United States
Facility Name
Brookstone Clinical Res Ctr
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Allergy & Asthma Care Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Aeroallergy Research Labs
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Asthma & Allergy of Idaho
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Chest Medicine Consultants
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Allergy & Asthma Care LTD
City
Glen Carbon
State/Province
Illinois
ZIP/Postal Code
62034
Country
United States
Facility Name
Sneeze Wheeze and Itch Associates LLC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Allergy Asthma Care
City
Crown Point
State/Province
Indiana
ZIP/Postal Code
46307
Country
United States
Facility Name
The Allergy and Asthma Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Clinical Research Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46208
Country
United States
Facility Name
University of Kansas Med Ctr; Int med/Allgy/Immun/Rheum
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7350
Country
United States
Facility Name
Kansas City Allergy And Asthma Assoc.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Abraham Research PLLC
City
Florence
State/Province
Kentucky
ZIP/Postal Code
41042
Country
United States
Facility Name
Allergy & Asth Phys of Cent KY
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Dr. Paul Shapero
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Chesapeake Clinical Research Inc - CRN
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Glenn M. Silber, M.D., P.A
City
Ellicott City
State/Province
Maryland
ZIP/Postal Code
21042
Country
United States
Facility Name
Family Allergy & Asthma
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20878
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
98410
Country
United States
Facility Name
Center for Clinical Research.
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Allergy Arth Fam Treatment Ctr
City
Gardner
State/Province
Massachusetts
ZIP/Postal Code
01440
Country
United States
Facility Name
Infinity Medical Research Inc
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
McGovern & Baja Allergy Assoc
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Facility Name
Asthma & Allergy Inst of MI
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Asthma Allergy Ctr of SW MI
City
Portage
State/Province
Michigan
ZIP/Postal Code
49024
Country
United States
Facility Name
Clinical Research Inst
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington Univ. School of Med
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Impact Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Ocean Allergy & Resp Res Ctr
City
Brick Township
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
Adult Ped Aller Central Jersey
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Facility Name
Center for Asthma and Allergy
City
Highland Park
State/Province
New Jersey
ZIP/Postal Code
08904
Country
United States
Facility Name
Atlantic Allergy Asthma Immunology Associates
City
Ocean City
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Allergy Treatment Center of New Jersey
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Facility Name
Pulmonary and Allergy Associates
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Allergy Consultants, PA
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
SUNY Downstate Medical Center.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Boris Sagalovich MD - PC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
Island Medical Research Pc
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
North Shore Medical Arts, LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Jamaica Hospital Medical Center
City
Jamaica
State/Province
New York
ZIP/Postal Code
11418
Country
United States
Facility Name
Winthrop Univ Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Parikh Institute for Research LLC
City
New York
State/Province
New York
Country
United States
Facility Name
Albert P Hirdt DO - PP
City
Newburgh
State/Province
New York
ZIP/Postal Code
12550
Country
United States
Facility Name
Olean Medical Group
City
Olean
State/Province
New York
ZIP/Postal Code
14760
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Advanced Allergy & Asthma PLLC
City
Rockville Center
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Urban Health Plan, Inc.
City
The Bronx
State/Province
New York
ZIP/Postal Code
10459
Country
United States
Facility Name
Montefiore Medical Center
City
The Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Alan Kaufman MD - PP
City
The Bronx
State/Province
New York
ZIP/Postal Code
10465
Country
United States
Facility Name
Allergy Partners of Western NC
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Allergy & Asthma Centre of Dayton
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45458
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Santiago Reyes MD-Private Prac
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Vital Prospects Clin Res Pc
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Bend Memorial Clinic
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Central PA Asth & Allergy Care; Research Division
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16601
Country
United States
Facility Name
Allergy and Asthmas; Specialists of Harrisburg
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Penn State Hershey Medical Group
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Inst for Resp & Sleep Med PC
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Allergy and Asthma Research of NJ, lnc
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19115
Country
United States
Facility Name
Allergy & Clinical Immun Assoc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
South Hills Pulmonary Assoc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Respiratory Specialists
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Nat'l Aller Asth-Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
ADAC Research PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Upstate Pharma Research
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
East Tennessee Center for Clinical Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
LeBonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Vanderbilt Medical University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Greater Austin Allergy Asthma and Immunology
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Elliot J. Ginchansky, MD, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Allergy Asthma Research Assoc
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Texas Medical Branch;Division of APICS
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Allergy Asthma & Immun Assoc
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
Live Oak Allergy & Asthma Clinic
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
Allergy & Asthma Res Ctr PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78251
Country
United States
Facility Name
Sugar Land Allerg Asthma Immun
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
University of Texas Health Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Name
Allergy Associates of Utah
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Bridgerland Clinical Research
City
North Logan
State/Province
Utah
ZIP/Postal Code
84341
Country
United States
Facility Name
Pulmonary Research of Albingdon
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24210
Country
United States
Facility Name
O & O Alpan, LLC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Facility Name
Clinical Research Partners, LLC
City
Henrico
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Allergy Asthma & Sinus Center
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States
Facility Name
Children's Hospital of the King's Daughter
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
Bellingham Asthma, Allergy & Immunology
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
ASTHMA, Inc
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Pulmonary & Sleep Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Northwest Asthma Allergy Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Allergy Asthma & Sinus Center
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
Facility Name
Dean Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
University of Wisconsin;Allergy & Asthma Clinical Research
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35526776
Citation
DeLeon S, Barsanti F, Holweg CTJ, Yoo B, Creasy B, Wechsler ME. Omalizumab treatment reduces asthma exacerbations regardless of airway bronchodilator reversibility. J Allergy Clin Immunol Pract. 2022 Aug;10(8):2181-2183.e1. doi: 10.1016/j.jaip.2022.04.029. Epub 2022 May 6. No abstract available.
Results Reference
derived
PubMed Identifier
33838339
Citation
Soong W, Yoo B, Pazwash H, Holweg CTJ, Casale TB. Omalizumab response in patients with asthma by number and type of allergen. Ann Allergy Asthma Immunol. 2021 Aug;127(2):223-231. doi: 10.1016/j.anai.2021.04.002. Epub 2021 Apr 8.
Results Reference
derived
PubMed Identifier
33465457
Citation
Chen M, Choo E, Yoo B, Raut P, Haselkorn T, Pazwash H, Holweg CTJ, Hudes G. No difference in omalizumab efficacy in patients with asthma by number of asthma-related and allergic comorbidities. Ann Allergy Asthma Immunol. 2021 Jun;126(6):666-673. doi: 10.1016/j.anai.2021.01.015. Epub 2021 Jan 17.
Results Reference
derived
PubMed Identifier
33217063
Citation
Chen M, Shepard K 2nd, Yang M, Raut P, Pazwash H, Holweg CTJ, Choo E. Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma. Clin Exp Allergy. 2021 Apr;51(4):546-555. doi: 10.1111/cea.13790. Epub 2021 Jan 7.
Results Reference
derived
PubMed Identifier
31981731
Citation
Hanania NA, Djukanovic R, Heaney LG, Yang M, Yoo B, Iqbal A, Griffin NM, Chipps BE. Determinants of lung function improvement with omalizumab in adults with allergic asthma. J Allergy Clin Immunol Pract. 2020 Jun;8(6):2068-2070. doi: 10.1016/j.jaip.2020.01.019. Epub 2020 Jan 22. No abstract available.
Results Reference
derived
PubMed Identifier
30576755
Citation
Hanania NA, Chipps BE, Griffin NM, Yoo B, Iqbal A, Casale TB. Omalizumab effectiveness in asthma-COPD overlap: Post hoc analysis of PROSPERO. J Allergy Clin Immunol. 2019 Apr;143(4):1629-1633.e2. doi: 10.1016/j.jaci.2018.11.032. Epub 2018 Dec 18. No abstract available.
Results Reference
derived
PubMed Identifier
29421314
Citation
Luskin AT, Chipps BE, Casale TB, Griffin NM. Baseline asthma burden, comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO. Ann Allergy Asthma Immunol. 2018 May;120(5):549-550. doi: 10.1016/j.anai.2018.01.034. Epub 2018 Feb 5. No abstract available.
Results Reference
derived
PubMed Identifier
29054589
Citation
Chipps BE, Zeiger RS, Luskin AT, Busse WW, Trzaskoma BL, Antonova EN, Pazwash H, Limb SL, Solari PG, Griffin NM, Casale TB. Baseline asthma burden, comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO. Ann Allergy Asthma Immunol. 2017 Dec;119(6):524-532.e2. doi: 10.1016/j.anai.2017.09.056. Epub 2017 Oct 18.
Results Reference
derived

Learn more about this trial

A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair)

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