Clinical trial NCT01922037: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-08-14
Enrollment: 806
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Total Number of Asthma Exacerbations During Months 1-12
timeFrame: Months 1-12
Secondary outcomes:
measure: Total Number of Asthma Exacerbations During Months 1-6
timeFrame: Months 1-6
measure: Total Number of Asthma Exacerbations During Months 7-12
timeFrame: Months 7-12
measure: Total Number of Asthma-Related Hospital Admissions During Months 1-12
timeFrame: Months 1-12
measure: Total Number of Asthma-Related Hospital Admissions During Months 1-6
timeFrame: Months 1-6
measure: Total Number of Asthma-Related Hospital Admissions During Months 7-12
timeFrame: Months 7-12
measure: Total Number of Asthma-Related ER Visits During Months 1-12
timeFrame: Months 1-12
measure: Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6
timeFrame: Months 1-6
measure: Total Number of Asthma-Related ER Visits During Months 7-12
timeFrame: Months 7-12
measure: Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12
timeFrame: Months 1-12
measure: Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6
timeFrame: Months 1-6
measure: Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12
timeFrame: Months 7-12
measure: Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12
timeFrame: Months 1-12
measure: Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6
timeFrame: Months 1-6
measure: Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12
timeFrame: Months 7-12
measure: Percentage of Participants by Number of Asthma Exacerbations
timeFrame: Months 1-12
measure: Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids
timeFrame: Months 1-12
measure: Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline, Month 6, end of study (EOS)/early termination (ET) (up to Month 12)
measure: Change From Baseline in Raw Forced Vital Capacity (FVC)
timeFrame: Baseline, Month 6, EOS/ET (up to Month 12)
measure: Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%)
timeFrame: Baseline, Month 6, EOS/ET (up to Month 12)
measure: Change From Baseline in Percentage Predicted FEV1 (ppFEV1)
timeFrame: Baseline, Month 6, EOS/ET (up to Month 12)
measure: Percentage of Participants With Prior Asthma Medications by Category or Class of Medications
timeFrame: Baseline
measure: Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications
timeFrame: Baseline until EOS/ET (up to Month 12)
measure: Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score
timeFrame: Baseline, Month 6, EOS/ET (up to Month 12)
measure: Change From Baseline in Asthma Control Test (ACT) Overall Score
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score
timeFrame: Baseline, Month 6, EOS/ET (up to Month 12)
measure: Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using Global Evaluation of Treatment Effectiveness (GETE) by Inversigator
timeFrame: EOS/ET (up to Month 12)
measure: Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using GETE by Participant
timeFrame: EOS/ET (up to Month 12)
measure: Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score
timeFrame: Baseline, EOS/ET (up to Month 12)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Allergy & Asthma
state: Alabama
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Huntsville
country: United States
facility: Huntsville Lung Associates PC
state: Alabama
city: Gilbert
country: United States
facility: San Tan Allergy & Asthma
state: Arizona
city: Goodyear
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Allergy Associates of Tucson
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Little Rock
country: United States
facility: Little Rock Allergy & Asthma; Clinical Research Center
state: Arkansas
city: Beverly Hills
country: United States
facility: Stuart Epstein MD - PP
state: California
city: Costa Mesa
country: United States
facility: West Coast Clinical Trials Global, LLC
state: California
city: Daly City
country: United States
facility: Peninsula Allergy Associates
state: California
city: Fountain Valley
country: United States
facility: Allianz Medical and Research Center
state: California
city: Fresno
country: United States
facility: William Ebbeling MD - PP
state: California
city: Fresno
country: United States
facility: Gettysburg Medical Clinic
state: California
city: Granada Hills
country: United States
facility: Allergy & Asthma Inst Valley
state: California
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System
state: California
city: Los Angeles
country: United States
facility: Allergy Asthma Care Ctr, Inc.
state: California
city: Mission Viejo
country: United States
facility: Southern California Research Center
state: California
city: Napa
country: United States
facility: North Bay Allergy & Asthma; Medical Assoc
state: California
city: Orange
country: United States
facility: Choc Psf, Amc
state: California
city: Orange
country: United States
facility: Clinical Trials of Orange County
state: California
city: Palmdale
country: United States
facility: California Allergy & Asthma Medical Group, Inc.
state: California
city: Palo Alto
country: United States
facility: Joann Blessing-Moore MD - PP
state: California
city: Rancho Cordova
country: United States
facility: TPMG - Rancho Cordova
state: California
city: Redding
country: United States
facility: Redding Allergy & Asthma Care
state: California
city: Redwood City
country: United States
facility: Allergy & Asthma Consultants
state: California
city: Sacramento
country: United States
facility: Capital Allergy Resp Dis Ctr
state: California
city: Salinas
country: United States
facility: Central Coast Allergy and Asthma
state: California
city: San Diego
country: United States
facility: Allergy Assoc Medical Group
state: California
city: San Diego
country: United States
facility: Kaiser Permanente - San Diego
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: San Francisco
country: United States
facility: Asthma & Allergy Clinic
state: California
city: San Mateo
country: United States
facility: The Allergy and Asthma Clinic
state: California
city: Walnut Creek
country: United States
facility: Allergy & Asthma Medical Group; Clinical Research Division
state: California
city: Centennial
country: United States
facility: IMMUNOe International Research Centers
state: Colorado
city: Danbury
country: United States
facility: Danbury Hospital
state: Connecticut
city: Waterbury
country: United States
facility: Christopher C Randolph MD - PP
state: Connecticut
city: Waterbury
country: United States
facility: Waterbury Pulmonary Associates
state: Connecticut
city: Clearwater
country: United States
facility: St. Francis Sleep; Allergy & Lung Institute
state: Florida
city: Coral Gables
country: United States
facility: AAADRS; Clinical Research Center
state: Florida
city: Leesburg
country: United States
facility: Allergy Asthma & Immun Center
state: Florida
city: Miami
country: United States
facility: Florida Ctr-Allergy & Asthma
state: Florida
city: Miami
country: United States
facility: FL Ctr Allergy & Asthma Res
state: Florida
city: Ocala
country: United States
facility: Allergy & Asthma Care of FL; Clinical Research
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Grou
state: Florida
city: Palm Beach Gardens
country: United States
facility: Allergy Asthma & Sinus Center
state: Florida
city: Port Charlotte
country: United States
facility: Gulf Coast Allergy Center, P.A.
state: Florida
city: Tampa
country: United States
facility: USF Asthma Allergy & Immun; Clinical Research
state: Florida
city: Albany
country: United States
facility: Georgia Pollens
state: Georgia
city: Columbus
country: United States
facility: Brookstone Clinical Res Ctr
state: Georgia
city: Gainesville
country: United States
facility: Allergy & Asthma Care Center
state: Georgia
city: Savannah
country: United States
facility: Aeroallergy Research Labs
state: Georgia
city: Twin Falls
country: United States
facility: Asthma & Allergy of Idaho
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: Chest Medicine Consultants
state: Illinois
city: Glen Carbon
country: United States
facility: Allergy & Asthma Care LTD
state: Illinois
city: Normal
country: United States
facility: Sneeze Wheeze and Itch Associates LLC
state: Illinois
city: Crown Point
country: United States
facility: Allergy Asthma Care
state: Indiana
city: Fort Wayne
country: United States
facility: The Allergy and Asthma Center
state: Indiana
city: Indianapolis
country: United States
facility: Clinical Research Center of Indiana
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Med Ctr; Int med/Allgy/Immun/Rheum
state: Kansas
city: Overland Park
country: United States
facility: Kansas City Allergy And Asthma Assoc.
state: Kansas
city: Florence
country: United States
facility: Abraham Research PLLC
state: Kentucky
city: Lexington
country: United States
facility: Allergy & Asth Phys of Cent KY
state: Kentucky
city: Bangor
country: United States
facility: Dr. Paul Shapero
state: Maine
city: Baltimore
country: United States
facility: Chesapeake Clinical Research Inc - CRN
state: Maryland
city: Ellicott City
country: United States
facility: Glenn M. Silber, M.D., P.A
state: Maryland
city: Gaithersburg
country: United States
facility: Family Allergy & Asthma
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Brockton
country: United States
facility: Center for Clinical Research.
state: Massachusetts
city: Gardner
country: United States
facility: Allergy Arth Fam Treatment Ctr
state: Massachusetts
city: North Dartmouth
country: United States
facility: Infinity Medical Research Inc
state: Massachusetts
city: Springfield
country: United States
facility: McGovern & Baja Allergy Assoc
state: Massachusetts
city: Clinton Township
country: United States
facility: Asthma & Allergy Inst of MI
state: Michigan
city: Portage
country: United States
facility: Asthma Allergy Ctr of SW MI
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Inst
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington Univ. School of Med
state: Missouri
city: Las Vegas
country: United States
facility: Impact Clinical Trials
state: Nevada
city: Brick Township
country: United States
facility: Ocean Allergy & Resp Res Ctr
state: New Jersey
city: Edison
country: United States
facility: Adult Ped Aller Central Jersey
state: New Jersey
city: Highland Park
country: United States
facility: Center for Asthma and Allergy
state: New Jersey
city: Ocean City
country: United States
facility: Atlantic Allergy Asthma Immunology Associates
state: New Jersey
city: Piscataway
country: United States
facility: Allergy Treatment Center of New Jersey
state: New Jersey
city: Summit
country: United States
facility: Pulmonary and Allergy Associates
state: New Jersey
city: Verona
country: United States
facility: Allergy Consultants, PA
state: New Jersey
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center.
state: New York
city: Brooklyn
country: United States
facility: Boris Sagalovich MD - PC
state: New York
city: Commack
country: United States
facility: Island Medical Research Pc
state: New York
city: Great Neck
country: United States
facility: North Shore Medical Arts, LLP
state: New York
city: Jamaica
country: United States
facility: Jamaica Hospital Medical Center
state: New York
city: Mineola
country: United States
facility: Winthrop Univ Hospital
state: New York
city: New York
country: United States
facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
state: New York
city: New York
country: United States
facility: Parikh Institute for Research LLC
state: New York
city: Newburgh
country: United States
facility: Albert P Hirdt DO - PP
state: New York
city: Olean
country: United States
facility: Olean Medical Group
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Rockville Center
country: United States
facility: Advanced Allergy & Asthma PLLC
state: New York
city: The Bronx
country: United States
facility: Urban Health Plan, Inc.
state: New York
city: The Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: The Bronx
country: United States
facility: Alan Kaufman MD - PP
state: New York
city: Asheville
country: United States
facility: Allergy Partners of Western NC
state: North Carolina
city: Centerville
country: United States
facility: Allergy & Asthma Centre of Dayton
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: Santiago Reyes MD-Private Prac
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clin Res Pc
state: Oklahoma
city: Bend
country: United States
facility: Bend Memorial Clinic
state: Oregon
city: Altoona
country: United States
facility: Central PA Asth & Allergy Care; Research Division
state: Pennsylvania
city: Harrisburg
country: United States
facility: Allergy and Asthmas; Specialists of Harrisburg
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Medical Group
state: Pennsylvania
city: Langhorne
country: United States
facility: Inst for Resp & Sleep Med PC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Allergy and Asthma Research of NJ, lnc
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allergy & Clinical Immun Assoc
state: Pennsylvania
city: Pittsburgh
country: United States
facility: South Hills Pulmonary Assoc
state: Pennsylvania
city: Reading
country: United States
facility: Respiratory Specialists
state: Pennsylvania
city: Charleston
country: United States
facility: Nat'l Aller Asth-Charleston
state: South Carolina
city: Greenville
country: United States
facility: ADAC Research PA
state: South Carolina
city: Simpsonville
country: United States
facility: Upstate Pharma Research
state: South Carolina
city: Knoxville
country: United States
facility: East Tennessee Center for Clinical Research
state: Tennessee
city: Memphis
country: United States
facility: LeBonheur Children's Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Medical University
state: Tennessee
city: Austin
country: United States
facility: Greater Austin Allergy Asthma and Immunology
state: Texas
city: Dallas
country: United States
facility: Elliot J. Ginchansky, MD, PA
state: Texas
city: Dallas
country: United States
facility: Allergy Asthma Research Assoc
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch;Division of APICS
state: Texas
city: Garland
country: United States
facility: Allergy Asthma & Immun Assoc
state: Texas
city: San Antonio
country: United States
facility: Live Oak Allergy & Asthma Clinic
state: Texas
city: San Antonio
country: United States
facility: Allergy & Asthma Res Ctr PA
state: Texas
city: Sugar Land
country: United States
facility: Sugar Land Allerg Asthma Immun
state: Texas
city: Tyler
country: United States
facility: University of Texas Health Center at Tyler
state: Texas
city: Murray
country: United States
facility: Allergy Associates of Utah
state: Utah
city: North Logan
country: United States
facility: Bridgerland Clinical Research
state: Utah
city: Abingdon
country: United States
facility: Pulmonary Research of Albingdon
state: Virginia
city: Fairfax
country: United States
facility: O & O Alpan, LLC
state: Virginia
city: Henrico
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Leesburg
country: United States
facility: Allergy Asthma & Sinus Center
state: Virginia
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughter
state: Virginia
city: Bellingham
country: United States
facility: Bellingham Asthma, Allergy & Immunology
state: Washington
city: Seattle
country: United States
facility: ASTHMA, Inc
state: Washington
city: Spokane
country: United States
facility: Pulmonary & Sleep Research
state: Washington
city: Vancouver
country: United States
facility: Northwest Asthma Allergy Center
state: Washington
city: Greenfield
country: United States
facility: Allergy Asthma & Sinus Center
state: Wisconsin
city: Madison
country: United States
facility: Dean Clinic
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin;Allergy & Asthma Clinical Research
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.