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

A Prospective Observational Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Omalizumab

• Study Type: Interventional
• Enrollment (Actual): 806
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants With Allergic Asthma; 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.	Drug: Omalizumab; Participants will receive omalizumab for up to 12 months per investigator standard of care and clinical practice.; Other Names: Xolair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Months 1-12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Months 1-6
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.	Months 7-12
Total Number of Asthma-Related Hospital Admissions During Months 1-12		Months 1-12
Total Number of Asthma-Related Hospital Admissions During Months 1-6		Months 1-6
Total Number of Asthma-Related Hospital Admissions During Months 7-12		Months 7-12
Total Number of Asthma-Related ER Visits During Months 1-12		Months 1-12
Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6		Months 1-6
Total Number of Asthma-Related ER Visits During Months 7-12		Months 7-12
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12		Months 1-12
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6		Months 1-6
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12		Months 7-12
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12		Months 1-12
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6		Months 1-6
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12		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.	Months 1-12
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.	Months 1-12
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.	Baseline, Month 6, end of study (EOS)/early termination (ET) (up to Month 12)
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.	Baseline, Month 6, EOS/ET (up to Month 12)
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.	Baseline, Month 6, EOS/ET (up to Month 12)
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.	Baseline, Month 6, EOS/ET (up to Month 12)
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.	Baseline
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.	Baseline until EOS/ET (up to Month 12)
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.	Baseline, Month 6, EOS/ET (up to Month 12)
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.	Baseline, Months 3, 6, 9, 12
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.	Baseline, Month 6, EOS/ET (up to Month 12)
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.	EOS/ET (up to Month 12)
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.	EOS/ET (up to Month 12)
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.	Baseline, EOS/ET (up to Month 12)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2013
• Primary Completion (Actual): March 31, 2016
• Study Completion (Actual): March 31, 2016

Study Registration Dates

• First Submitted: July 12, 2013
• First Submitted That Met QC Criteria: August 13, 2013
• First Posted (Estimate): August 14, 2013

Study Record Updates

• Last Update Posted (Actual): December 11, 2017
• Last Update Submitted That Met QC Criteria: November 9, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Omalizumab
• Other Study ID Numbers: ML28528