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
1 other identifier
interventional
806
1 country
145
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Jun 2013
Typical duration for phase_4 asthma
145 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 2013
CompletedFirst Submitted
Initial submission to the registry
July 12, 2013
CompletedFirst Posted
Study publicly available on registry
August 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2016
CompletedResults Posted
Study results publicly available
December 11, 2017
CompletedDecember 11, 2017
November 1, 2017
2.8 years
July 12, 2013
November 9, 2017
November 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (28)
Total Number of Asthma Exacerbations During Months 1-6
Months 1-6
Total Number of Asthma Exacerbations During Months 7-12
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
- +23 more secondary outcomes
Study Arms (1)
Participants With Allergic Asthma
EXPERIMENTALParticipants 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.
Interventions
Participants will receive omalizumab for up to 12 months per investigator standard of care and clinical practice.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (145)
Alabama Allergy & Asthma
Birmingham, Alabama, 35209, United States
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, United States
Huntsville Lung Associates PC
Huntsville, Alabama, 35801, United States
San Tan Allergy & Asthma
Gilbert, Arizona, 85234-2966, United States
Dedicated Clinical Research
Goodyear, Arizona, 85395, United States
Allergy Associates of Tucson
Tucson, Arizona, 85716, United States
University of Arizona
Tucson, Arizona, 85724-5030, United States
Little Rock Allergy & Asthma; Clinical Research Center
Little Rock, Arkansas, 72205, United States
Stuart Epstein MD - PP
Beverly Hills, California, 90212, United States
West Coast Clinical Trials Global, LLC
Costa Mesa, California, 92626, United States
Peninsula Allergy Associates
Daly City, California, 94015, United States
Allianz Medical and Research Center
Fountain Valley, California, 92708, United States
William Ebbeling MD - PP
Fresno, California, 93720, United States
Gettysburg Medical Clinic
Fresno, California, 93726, United States
Allergy & Asthma Inst Valley
Granada Hills, California, 91344, United States
VA Loma Linda Healthcare System
Loma Linda, California, 92357, United States
Allergy Asthma Care Ctr, Inc.
Los Angeles, California, 90064, United States
Southern California Research Center
Mission Viejo, California, 92691, United States
North Bay Allergy & Asthma; Medical Assoc
Napa, California, 94558, United States
Choc Psf, Amc
Orange, California, 92868, United States
Clinical Trials of Orange County
Orange, California, 92868, United States
California Allergy & Asthma Medical Group, Inc.
Palmdale, California, 93551, United States
Joann Blessing-Moore MD - PP
Palo Alto, California, 94304, United States
TPMG - Rancho Cordova
Rancho Cordova, California, 95762, United States
Redding Allergy & Asthma Care
Redding, California, 96003, United States
Allergy & Asthma Consultants
Redwood City, California, 94063, United States
Capital Allergy Resp Dis Ctr
Sacramento, California, 95819, United States
Central Coast Allergy and Asthma
Salinas, California, 93901, United States
Allergy Assoc Medical Group
San Diego, California, 92108, United States
Kaiser Permanente - San Diego
San Diego, California, 92120, United States
University of California at San Francisco
San Francisco, California, 94115, United States
Asthma & Allergy Clinic
San Francisco, California, 94121, United States
The Allergy and Asthma Clinic
San Mateo, California, 94401, United States
Allergy & Asthma Medical Group; Clinical Research Division
Walnut Creek, California, 94598, United States
IMMUNOe International Research Centers
Centennial, Colorado, 80112, United States
Danbury Hospital
Danbury, Connecticut, 06810, United States
Christopher C Randolph MD - PP
Waterbury, Connecticut, 06708, United States
Waterbury Pulmonary Associates
Waterbury, Connecticut, 06708, United States
St. Francis Sleep; Allergy & Lung Institute
Clearwater, Florida, 33765, United States
AAADRS; Clinical Research Center
Coral Gables, Florida, 33134, United States
Allergy Asthma & Immun Center
Leesburg, Florida, 34788, United States
Florida Ctr-Allergy & Asthma
Miami, Florida, 33173, United States
FL Ctr Allergy & Asthma Res
Miami, Florida, 33176, United States
Allergy & Asthma Care of FL; Clinical Research
Ocala, Florida, 34471, United States
Central Florida Pulmonary Grou
Orlando, Florida, 32803, United States
Allergy Asthma & Sinus Center
Palm Beach Gardens, Florida, 33410, United States
Gulf Coast Allergy Center, P.A.
Port Charlotte, Florida, 33952, United States
USF Asthma Allergy & Immun; Clinical Research
Tampa, Florida, 33613, United States
Georgia Pollens
Albany, Georgia, 31707, United States
Brookstone Clinical Res Ctr
Columbus, Georgia, 31904, United States
Allergy & Asthma Care Center
Gainesville, Georgia, 30501, United States
Aeroallergy Research Labs
Savannah, Georgia, 31406, United States
Asthma & Allergy of Idaho
Twin Falls, Idaho, 83301, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Chest Medicine Consultants
Chicago, Illinois, 60657, United States
Allergy & Asthma Care LTD
Glen Carbon, Illinois, 62034, United States
Sneeze Wheeze and Itch Associates LLC
Normal, Illinois, 61761, United States
Allergy Asthma Care
Crown Point, Indiana, 46307, United States
The Allergy and Asthma Center
Fort Wayne, Indiana, 46804, United States
Clinical Research Center of Indiana
Indianapolis, Indiana, 46208, United States
University of Kansas Med Ctr; Int med/Allgy/Immun/Rheum
Kansas City, Kansas, 66160-7350, United States
Kansas City Allergy And Asthma Assoc.
Overland Park, Kansas, 66210, United States
Abraham Research PLLC
Florence, Kentucky, 41042, United States
Allergy & Asth Phys of Cent KY
Lexington, Kentucky, 40503, United States
Dr. Paul Shapero
Bangor, Maine, 04401, United States
Chesapeake Clinical Research Inc - CRN
Baltimore, Maryland, 21236, United States
Glenn M. Silber, M.D., P.A
Ellicott City, Maryland, 21042, United States
Family Allergy & Asthma
Gaithersburg, Maryland, 20878, United States
Brigham and Women's Hospital
Boston, Massachusetts, 98410, United States
Center for Clinical Research.
Brockton, Massachusetts, 02301, United States
Allergy Arth Fam Treatment Ctr
Gardner, Massachusetts, 01440, United States
Infinity Medical Research Inc
North Dartmouth, Massachusetts, 02747, United States
McGovern & Baja Allergy Assoc
Springfield, Massachusetts, 01103, United States
Asthma & Allergy Inst of MI
Clinton Township, Michigan, 48038, United States
Asthma Allergy Ctr of SW MI
Portage, Michigan, 49024, United States
Clinical Research Inst
Minneapolis, Minnesota, 55402, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington Univ. School of Med
St Louis, Missouri, 63141, United States
Impact Clinical Trials
Las Vegas, Nevada, 89106, United States
Ocean Allergy & Resp Res Ctr
Brick, New Jersey, 08724, United States
Adult Ped Aller Central Jersey
Edison, New Jersey, 08820, United States
Center for Asthma and Allergy
Highland Park, New Jersey, 08904, United States
Atlantic Allergy Asthma Immunology Associates
Ocean City, New Jersey, 07712, United States
Allergy Treatment Center of New Jersey
Piscataway, New Jersey, 08854, United States
Pulmonary and Allergy Associates
Summit, New Jersey, 07901, United States
Allergy Consultants, PA
Verona, New Jersey, 07044, United States
SUNY Downstate Medical Center.
Brooklyn, New York, 11203, United States
Boris Sagalovich MD - PC
Brooklyn, New York, 11229, United States
Island Medical Research Pc
Commack, New York, 11725, United States
North Shore Medical Arts, LLP
Great Neck, New York, 11021, United States
Jamaica Hospital Medical Center
Jamaica, New York, 11418, United States
Winthrop Univ Hospital
Mineola, New York, 11501, United States
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
New York, New York, 10016, United States
Parikh Institute for Research LLC
New York, New York, United States
Albert P Hirdt DO - PP
Newburgh, New York, 12550, United States
Olean Medical Group
Olean, New York, 14760, United States
University of Rochester
Rochester, New York, 14618, United States
Advanced Allergy & Asthma PLLC
Rockville Centre, New York, 11570, United States
Urban Health Plan, Inc.
The Bronx, New York, 10459, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Alan Kaufman MD - PP
The Bronx, New York, 10465, United States
Allergy Partners of Western NC
Asheville, North Carolina, 28801, United States
Allergy & Asthma Centre of Dayton
Centerville, Ohio, 45458, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Santiago Reyes MD-Private Prac
Oklahoma City, Oklahoma, 73112, United States
Vital Prospects Clin Res Pc
Tulsa, Oklahoma, 74136, United States
Bend Memorial Clinic
Bend, Oregon, 97701, United States
Central PA Asth & Allergy Care; Research Division
Altoona, Pennsylvania, 16601, United States
Allergy and Asthmas; Specialists of Harrisburg
Harrisburg, Pennsylvania, 17110, United States
Penn State Hershey Medical Group
Hershey, Pennsylvania, 17033, United States
Inst for Resp & Sleep Med PC
Langhorne, Pennsylvania, 19047, United States
Allergy and Asthma Research of NJ, lnc
Philadelphia, Pennsylvania, 19115, United States
Allergy & Clinical Immun Assoc
Pittsburgh, Pennsylvania, 15241, United States
South Hills Pulmonary Assoc
Pittsburgh, Pennsylvania, 15243, United States
Respiratory Specialists
Reading, Pennsylvania, 19610, United States
Nat'l Aller Asth-Charleston
Charleston, South Carolina, 29406, United States
ADAC Research PA
Greenville, South Carolina, 29607, United States
Upstate Pharma Research
Simpsonville, South Carolina, 29681, United States
East Tennessee Center for Clinical Research
Knoxville, Tennessee, 37909, United States
LeBonheur Children's Hospital
Memphis, Tennessee, 38103, United States
Vanderbilt Medical University
Nashville, Tennessee, 37203, United States
Greater Austin Allergy Asthma and Immunology
Austin, Texas, 78746, United States
Elliot J. Ginchansky, MD, PA
Dallas, Texas, 75230, United States
Allergy Asthma Research Assoc
Dallas, Texas, 75231, United States
University of Texas Medical Branch;Division of APICS
Galveston, Texas, 77555, United States
Allergy Asthma & Immun Assoc
Garland, Texas, 75044, United States
Live Oak Allergy & Asthma Clinic
San Antonio, Texas, 78233, United States
Allergy & Asthma Res Ctr PA
San Antonio, Texas, 78251, United States
Sugar Land Allerg Asthma Immun
Sugar Land, Texas, 77479, United States
University of Texas Health Center at Tyler
Tyler, Texas, 75708, United States
Allergy Associates of Utah
Murray, Utah, 84107, United States
Bridgerland Clinical Research
North Logan, Utah, 84341, United States
Pulmonary Research of Albingdon
Abingdon, Virginia, 24210, United States
O & O Alpan, LLC
Fairfax, Virginia, 22030, United States
Clinical Research Partners, LLC
Henrico, Virginia, 23233, United States
Allergy Asthma & Sinus Center
Leesburg, Virginia, 20176, United States
Children's Hospital of the King's Daughter
Norfolk, Virginia, 23510, United States
Bellingham Asthma, Allergy & Immunology
Bellingham, Washington, 98225, United States
ASTHMA, Inc
Seattle, Washington, 98105, United States
Pulmonary & Sleep Research
Spokane, Washington, 99204, United States
Northwest Asthma Allergy Center
Vancouver, Washington, 98664, United States
Allergy Asthma & Sinus Center
Greenfield, Wisconsin, 53228, United States
Dean Clinic
Madison, Wisconsin, 53715, United States
University of Wisconsin;Allergy & Asthma Clinical Research
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (10)
Fiocchi A, Chinthrajah RS, Ansotegui IJ, Sriaroon P, Mustafa SS, Raut P, Cameron B, Gupta S, Fleischer DM. Does Comorbid Food Allergy Affect Response to Omalizumab in Patients with Asthma? J Asthma Allergy. 2024 Sep 17;17:889-900. doi: 10.2147/JAA.S475517. eCollection 2024.
PMID: 39309477DERIVEDChase NM, Littlejohn M, Holweg CTJ, Millette LA, Seetasith A, Steinke JW, Trzaskoma BL, Hanania NA, Casale TB. Effectiveness of omalizumab across different dosing regimens in patients with moderate-to-severe allergic asthma. Respir Med. 2024 Mar;223:107537. doi: 10.1016/j.rmed.2024.107537. Epub 2024 Jan 20.
PMID: 38253245DERIVEDDeLeon 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.
PMID: 35526776DERIVEDSoong 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.
PMID: 33838339DERIVEDChen 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.
PMID: 33465457DERIVEDChen 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.
PMID: 33217063DERIVEDHanania 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.
PMID: 31981731DERIVEDHanania 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.
PMID: 30576755DERIVEDLuskin 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.
PMID: 29421314DERIVEDChipps 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.
PMID: 29054589DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was designed as an observational registry of participants with allergic asthma; but, was later reclassified as an interventional trial because the protocol was amended to include blood draws that were not considered to be standard of care.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2013
First Posted
August 14, 2013
Study Start
June 19, 2013
Primary Completion
March 31, 2016
Study Completion
March 31, 2016
Last Updated
December 11, 2017
Results First Posted
December 11, 2017
Record last verified: 2017-11