AzTrials
AzTrials

AsthmaPhase 4NCT01922037

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

A Phase 4 study testing Omalizumab in people with Asthma, run by Hoffmann-La Roche at 145 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
Omalizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
806 participants
Where
145 sitesUnited States
Study dates
19 Jun 2013to 31 Mar 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

145 sites in 1 country.

145 sites in 1 country

United States145 sites

  • Pulmonary Research of Albingdon

    Abingdon, Virginia, 24210

  • Georgia Pollens

    Albany, Georgia, 31707

  • Central PA Asth & Allergy Care; Research Division

    Altoona, Pennsylvania, 16601

  • Allergy Partners of Western NC

    Asheville, North Carolina, 28801

  • Greater Austin Allergy Asthma and Immunology

    Austin, Texas, 78746

  • Chesapeake Clinical Research Inc - CRN

    Baltimore, Maryland, 21236

  • Dr. Paul Shapero

    Bangor, Maine, 04401

  • Bellingham Asthma, Allergy & Immunology

    Bellingham, Washington, 98225

  • Bend Memorial Clinic

    Bend, Oregon, 97701

  • Stuart Epstein MD - PP

    Beverly Hills, California, 90212

  • Alabama Allergy & Asthma

    Birmingham, Alabama, 35209

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • Brigham and Women's Hospital

    Boston, Massachusetts, 98410

  • Ocean Allergy & Resp Res Ctr

    Brick, New Jersey, 08724

  • Center for Clinical Research.

    Brockton, Massachusetts, 02301

  • SUNY Downstate Medical Center.

    Brooklyn, New York, 11203

  • Boris Sagalovich MD - PC

    Brooklyn, New York, 11229

  • IMMUNOe International Research Centers

    Centennial, Colorado, 80112

  • Allergy & Asthma Centre of Dayton

    Centerville, Ohio, 45458

  • Nat'l Aller Asth-Charleston

    Charleston, South Carolina, 29406

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Chest Medicine Consultants

    Chicago, Illinois, 60657

  • St. Francis Sleep; Allergy & Lung Institute

    Clearwater, Florida, 33765

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Asthma & Allergy Inst of MI

    Clinton Township, Michigan, 48038

  • Brookstone Clinical Res Ctr

    Columbus, Georgia, 31904

  • Island Medical Research Pc

    Commack, New York, 11725

  • AAADRS; Clinical Research Center

    Coral Gables, Florida, 33134

  • West Coast Clinical Trials Global, LLC

    Costa Mesa, California, 92626

  • Allergy Asthma Care

    Crown Point, Indiana, 46307

  • Elliot J. Ginchansky, MD, PA

    Dallas, Texas, 75230

  • Allergy Asthma Research Assoc

    Dallas, Texas, 75231

  • Peninsula Allergy Associates

    Daly City, California, 94015

  • Danbury Hospital

    Danbury, Connecticut, 06810

  • Adult Ped Aller Central Jersey

    Edison, New Jersey, 08820

  • Glenn M. Silber, M.D., P.A

    Ellicott City, Maryland, 21042

  • O & O Alpan, LLC

    Fairfax, Virginia, 22030

  • Abraham Research PLLC

    Florence, Kentucky, 41042

  • The Allergy and Asthma Center

    Fort Wayne, Indiana, 46804

  • Allianz Medical and Research Center

    Fountain Valley, California, 92708

  • William Ebbeling MD - PP

    Fresno, California, 93720

  • Gettysburg Medical Clinic

    Fresno, California, 93726

  • Allergy & Asthma Care Center

    Gainesville, Georgia, 30501

  • Family Allergy & Asthma

    Gaithersburg, Maryland, 20878

  • University of Texas Medical Branch;Division of APICS

    Galveston, Texas, 77555

  • Allergy Arth Fam Treatment Ctr

    Gardner, Massachusetts, 01440

  • Allergy Asthma & Immun Assoc

    Garland, Texas, 75044

  • San Tan Allergy & Asthma

    Gilbert, Arizona, 85234-2966

  • Allergy & Asthma Care LTD

    Glen Carbon, Illinois, 62034

  • Dedicated Clinical Research

    Goodyear, Arizona, 85395

  • Allergy & Asthma Inst Valley

    Granada Hills, California, 91344

  • North Shore Medical Arts, LLP

    Great Neck, New York, 11021

  • Allergy Asthma & Sinus Center

    Greenfield, Wisconsin, 53228

  • ADAC Research PA

    Greenville, South Carolina, 29607

  • Allergy and Asthmas; Specialists of Harrisburg

    Harrisburg, Pennsylvania, 17110

  • Clinical Research Partners, LLC

    Henrico, Virginia, 23233

  • Penn State Hershey Medical Group

    Hershey, Pennsylvania, 17033

  • Center for Asthma and Allergy

    Highland Park, New Jersey, 08904

  • Huntsville Lung Associates PC

    Huntsville, Alabama, 35801

  • Clinical Research Center of Indiana

    Indianapolis, Indiana, 46208

  • Jamaica Hospital Medical Center

    Jamaica, New York, 11418

  • University of Kansas Med Ctr; Int med/Allgy/Immun/Rheum

    Kansas City, Kansas, 66160-7350

  • East Tennessee Center for Clinical Research

    Knoxville, Tennessee, 37909

  • Inst for Resp & Sleep Med PC

    Langhorne, Pennsylvania, 19047

  • Impact Clinical Trials

    Las Vegas, Nevada, 89106

  • Allergy Asthma & Immun Center

    Leesburg, Florida, 34788

  • Allergy Asthma & Sinus Center

    Leesburg, Virginia, 20176

  • Allergy & Asth Phys of Cent KY

    Lexington, Kentucky, 40503

  • Little Rock Allergy & Asthma; Clinical Research Center

    Little Rock, Arkansas, 72205

  • VA Loma Linda Healthcare System

    Loma Linda, California, 92357

  • Allergy Asthma Care Ctr, Inc.

    Los Angeles, California, 90064

  • Dean Clinic

    Madison, Wisconsin, 53715

  • University of Wisconsin;Allergy & Asthma Clinical Research

    Madison, Wisconsin, 53792

  • LeBonheur Children's Hospital

    Memphis, Tennessee, 38103

  • Florida Ctr-Allergy & Asthma

    Miami, Florida, 33173

  • FL Ctr Allergy & Asthma Res

    Miami, Florida, 33176

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Winthrop Univ Hospital

    Mineola, New York, 11501

  • Clinical Research Inst

    Minneapolis, Minnesota, 55402

  • Southern California Research Center

    Mission Viejo, California, 92691

  • Allergy Associates of Utah

    Murray, Utah, 84107

  • North Bay Allergy & Asthma; Medical Assoc

    Napa, California, 94558

  • Vanderbilt Medical University

    Nashville, Tennessee, 37203

  • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

    New York, New York, 10016

  • Parikh Institute for Research LLC

    New York, New York

  • Albert P Hirdt DO - PP

    Newburgh, New York, 12550

  • Children's Hospital of the King's Daughter

    Norfolk, Virginia, 23510

  • Sneeze Wheeze and Itch Associates LLC

    Normal, Illinois, 61761

  • Infinity Medical Research Inc

    North Dartmouth, Massachusetts, 02747

  • Bridgerland Clinical Research

    North Logan, Utah, 84341

  • Allergy & Asthma Care of FL; Clinical Research

    Ocala, Florida, 34471

  • Atlantic Allergy Asthma Immunology Associates

    Ocean City, New Jersey, 07712

  • Santiago Reyes MD-Private Prac

    Oklahoma City, Oklahoma, 73112

  • Olean Medical Group

    Olean, New York, 14760

  • Choc Psf, Amc

    Orange, California, 92868

  • Clinical Trials of Orange County

    Orange, California, 92868

  • Central Florida Pulmonary Grou

    Orlando, Florida, 32803

  • Kansas City Allergy And Asthma Assoc.

    Overland Park, Kansas, 66210

  • Allergy Asthma & Sinus Center

    Palm Beach Gardens, Florida, 33410

  • California Allergy & Asthma Medical Group, Inc.

    Palmdale, California, 93551

  • Joann Blessing-Moore MD - PP

    Palo Alto, California, 94304

  • Allergy and Asthma Research of NJ, lnc

    Philadelphia, Pennsylvania, 19115

  • Allergy Treatment Center of New Jersey

    Piscataway, New Jersey, 08854

  • Allergy & Clinical Immun Assoc

    Pittsburgh, Pennsylvania, 15241

  • South Hills Pulmonary Assoc

    Pittsburgh, Pennsylvania, 15243

  • Gulf Coast Allergy Center, P.A.

    Port Charlotte, Florida, 33952

  • Asthma Allergy Ctr of SW MI

    Portage, Michigan, 49024

  • TPMG - Rancho Cordova

    Rancho Cordova, California, 95762

  • Respiratory Specialists

    Reading, Pennsylvania, 19610

  • Redding Allergy & Asthma Care

    Redding, California, 96003

  • Allergy & Asthma Consultants

    Redwood City, California, 94063

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14618

  • Advanced Allergy & Asthma PLLC

    Rockville Centre, New York, 11570

  • Capital Allergy Resp Dis Ctr

    Sacramento, California, 95819

  • Central Coast Allergy and Asthma

    Salinas, California, 93901

  • Live Oak Allergy & Asthma Clinic

    San Antonio, Texas, 78233

  • Allergy & Asthma Res Ctr PA

    San Antonio, Texas, 78251

  • Allergy Assoc Medical Group

    San Diego, California, 92108

  • Kaiser Permanente - San Diego

    San Diego, California, 92120

  • University of California at San Francisco

    San Francisco, California, 94115

  • Asthma & Allergy Clinic

    San Francisco, California, 94121

  • The Allergy and Asthma Clinic

    San Mateo, California, 94401

  • Aeroallergy Research Labs

    Savannah, Georgia, 31406

  • ASTHMA, Inc

    Seattle, Washington, 98105

  • Upstate Pharma Research

    Simpsonville, South Carolina, 29681

  • Pulmonary & Sleep Research

    Spokane, Washington, 99204

  • McGovern & Baja Allergy Assoc

    Springfield, Massachusetts, 01103

  • Washington Univ. School of Med

    St Louis, Missouri, 63141

  • Sugar Land Allerg Asthma Immun

    Sugar Land, Texas, 77479

  • Pulmonary and Allergy Associates

    Summit, New Jersey, 07901

  • USF Asthma Allergy & Immun; Clinical Research

    Tampa, Florida, 33613

  • Urban Health Plan, Inc.

    The Bronx, New York, 10459

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Alan Kaufman MD - PP

    The Bronx, New York, 10465

  • Allergy Associates of Tucson

    Tucson, Arizona, 85716

  • University of Arizona

    Tucson, Arizona, 85724-5030

  • Vital Prospects Clin Res Pc

    Tulsa, Oklahoma, 74136

  • Asthma & Allergy of Idaho

    Twin Falls, Idaho, 83301

  • University of Texas Health Center at Tyler

    Tyler, Texas, 75708

  • Northwest Asthma Allergy Center

    Vancouver, Washington, 98664

  • Allergy Consultants, PA

    Verona, New Jersey, 07044

  • Allergy & Asthma Medical Group; Clinical Research Division

    Walnut Creek, California, 94598

  • Christopher C Randolph MD - PP

    Waterbury, Connecticut, 06708

  • Waterbury Pulmonary Associates

    Waterbury, Connecticut, 06708

Other trials in United States

About this study

Official title: 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.

Conditions
Asthma
Being tested
Omalizumab
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OmalizumabDrug

    Also called Xolair

    Participants will receive omalizumab for up to 12 months per investigator standard of care and clinical practice.

Study groups in NCT01922037
Study groupRoleWhat they receive
Participants With Allergic AsthmaExperimentalParticipants 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.
Receives: Drug: Omalizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Months 1-12

Secondary outcomes (28)

  1. 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.

    Measured: Months 1-6

  2. 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.

    Measured: Months 7-12

  3. Total Number of Asthma-Related Hospital Admissions During Months 1-12

    Measured: Months 1-12

  4. Total Number of Asthma-Related Hospital Admissions During Months 1-6

    Measured: Months 1-6

  5. Total Number of Asthma-Related Hospital Admissions During Months 7-12

    Measured: Months 7-12

  6. Total Number of Asthma-Related ER Visits During Months 1-12

    Measured: Months 1-12

  7. Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6

    Measured: Months 1-6

  8. Total Number of Asthma-Related ER Visits During Months 7-12

    Measured: Months 7-12

  9. Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12

    Measured: Months 1-12

  10. Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6

    Measured: Months 1-6

  11. Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12

    Measured: Months 7-12

  12. Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12

    Measured: Months 1-12

  13. Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6

    Measured: Months 1-6

  14. Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12

    Measured: Months 7-12

  15. 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.

    Measured: Months 1-12

  16. 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.

    Measured: Months 1-12

  17. 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.

    Measured: Baseline, Month 6, end of study (EOS)/early termination (ET) (up to Month 12)

  18. 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.

    Measured: Baseline, Month 6, EOS/ET (up to Month 12)

  19. 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.

    Measured: Baseline, Month 6, EOS/ET (up to Month 12)

  20. 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.

    Measured: Baseline, Month 6, EOS/ET (up to Month 12)

  21. 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.

    Measured: Baseline

  22. 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.

    Measured: Baseline until EOS/ET (up to Month 12)

  23. 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.

    Measured: Baseline, Month 6, EOS/ET (up to Month 12)

  24. 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.

    Measured: Baseline, Months 3, 6, 9, 12

  25. 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.

    Measured: Baseline, Month 6, EOS/ET (up to Month 12)

  26. 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.

    Measured: EOS/ET (up to Month 12)

  27. 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.

    Measured: EOS/ET (up to Month 12)

  28. 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.

    Measured: Baseline, EOS/ET (up to Month 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2013 (estimated)
  2. Study start19 Jun 2013
  3. Primary completion31 Mar 2016
  4. Study completion31 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
806 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01922037
Sponsor's protocol ID
ML28528
Status last verified
Nov 2017
First submitted
12 Jul 2013
Last updated
11 Dec 2017

Publications

  • 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.

    PubMed 39309477

  • Chase 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.

    PubMed 38253245

  • 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.

    PubMed 35526776

  • 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.

    PubMed 33838339

  • 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.

    PubMed 33465457

  • 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.

    PubMed 33217063

  • 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.

    PubMed 31981731

  • 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.

    PubMed 30576755

  • 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.

    PubMed 29421314

  • 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.

    PubMed 29054589

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Omalizumab in people with Asthma, run by Hoffmann-La Roche at 145 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 145 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Number of Asthma Exacerbations During Months 1-12 (time frame: Months 1-12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01922037, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in