A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair)
- Registration Number
- NCT01922037
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 806
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Participants With Allergic Asthma Omalizumab 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.
- Primary Outcome Measures
Name Time Method Total Number of Asthma Exacerbations During Months 1-12 Months 1-12 An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for \>/= 3 days.
- Secondary Outcome Measures
Name Time Method 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 Exacerbations During Months 1-6 Months 1-6 An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for \>/=3 days.
Total Number of Asthma-Related ER Visits During Months 1-12 Months 1-12 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 Percentage of Participants by Number of Asthma Exacerbations Months 1-12 Percentage of participants by number of asthma exacerbations (0, 1, 2, 3, \>/=4) was reported. An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for \>/= 3 days.
Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids Months 1-12 Percentage of participants by number of asthma exacerbations (0, 1, 2, 3, \>/=4) requiring treatment with systemic steroids was reported. An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for \>/= 3 days.
Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) Baseline, Month 6, end of study (EOS)/early termination (ET) (up to Month 12) 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.
Total Number of Asthma Exacerbations During Months 7-12 Months 7-12 An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for \>/= 3 days.
Total Number of Asthma-Related Hospital Admissions During Months 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 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 Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score Baseline, Month 6, EOS/ET (up to Month 12) 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.
Change From Baseline in Raw Forced Vital Capacity (FVC) Baseline, Month 6, EOS/ET (up to Month 12) FVC was defined as the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pre-bronchodilator FVC and post-bronchodilator FVC are reported for each timepoint. FVC was measured using spirometry.
Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) Baseline, Month 6, EOS/ET (up to Month 12) FEF25%-75% was defined as the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Pre-bronchodilator FEF25%-75% and post-bronchodilator FEF25%-75% are reported for each timepoint. FEF25%-75% was measured using spirometry.
Change From Baseline in Percentage Predicted FEV1 (ppFEV1) Baseline, Month 6, EOS/ET (up to Month 12) FEV1 is the volume of air that can be forced out in one second after taking a deep breath, as measured using spirometry. Hankinson and Wang standards were used to calculate ppFEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. ppFEV1= 100 multiplied by (\*) FEV1 (in liters \[L\]) divided by (/) predicted FEV1 (in L). Pre-bronchodilator ppFEV1 and post-bronchodilator ppFEV1 are reported for each timepoint.
Percentage of Participants With Prior Asthma Medications by Category or Class of Medications Baseline Prior asthma medications were defined as all medications used for asthma prior to the study (initiated within 90 days of baseline) and were assessed retrospectively at baseline. Participants received prior asthma medications of following categories or classes: short acting beta agonist (SABA), combination inhaled corticosteroids/long acting beta agonist (ICS/LABA), leukotriene receptor antagonist (LTRA), inhaled corticosteroids (ICS), oral/parenteral (systemic) corticosteroids, anticholinergic, long acting beta agonist (LABA), and other medication.
Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications Baseline until EOS/ET (up to Month 12) Concomitant and ongoing asthma medications were defined as all medications used for asthma which began on or after the participant's study start, as well as those ongoing at the beginning of the study. Participants received following categories or classes of concomitant and ongoing asthma medications: SABA, combination ICS/LABA, LTRA, oral/parenteral (systemic) corticosteroids, ICS, anticholinergic, LABA, and other medication.
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score Baseline, Month 6, EOS/ET (up to Month 12) AQLQ +12 is a 32-item disease specific questionnaire designed to assess the participants' asthma-specific health-related quality of life (QOL). The questionnaire contains four domains: activity limitations (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). All items are scored on a 7-point likert scale. All item scores are averaged to produce one overall QOL score. Overall score ranges from 1 (total impairment) to 7 (no impairment), with higher scores indicating better QOL. A positive change from baseline indicated improved QOL.
Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score Baseline, EOS/ET (up to Month 12) 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.
Change From Baseline in Asthma Control Test (ACT) Overall Score Baseline, Months 3, 6, 9, 12 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.
Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using Global Evaluation of Treatment Effectiveness (GETE) by Inversigator EOS/ET (up to Month 12) Response to treatment was assessed using the GETE. The GETE is a validated instrument that measures the overall impression of the effect of the study medication on typical asthma symptoms. The evaluation was performed using the 5-point scale. The GETE scale ranges were as follows: 1=excellent, 2=good, 3=moderate, 4=poor, 5= worsening. A good or excellent response on the 5 point scale indicated that a participant had responded to treatment. Percentage of participants who showed an improvement (GETE scale score of 1 or 2) in asthma symptoms, as assessed by investigator, is reported.
Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using GETE by Participant EOS/ET (up to Month 12) 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.
Trial Locations
- Locations (143)
University of Rochester
🇺🇸Rochester, New York, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Chest Medicine Consultants
🇺🇸Chicago, Illinois, United States
Allergy & Clinical Immun Assoc
🇺🇸Pittsburgh, Pennsylvania, United States
ASTHMA, Inc
🇺🇸Seattle, Washington, United States
San Tan Allergy & Asthma
🇺🇸Gilbert, Arizona, United States
Dedicated Clinical Research
🇺🇸Goodyear, Arizona, United States
West Coast Clinical Trials Global, LLC
🇺🇸Costa Mesa, California, United States
Allergy & Asth Phys of Cent KY
🇺🇸Lexington, Kentucky, United States
Abraham Research PLLC
🇺🇸Florence, Kentucky, United States
Chesapeake Clinical Research Inc - CRN
🇺🇸Baltimore, Maryland, United States
North Bay Allergy & Asthma; Medical Assoc
🇺🇸Napa, California, United States
Waterbury Pulmonary Associates
🇺🇸Waterbury, Connecticut, United States
Dr. Paul Shapero
🇺🇸Bangor, Maine, United States
Family Allergy & Asthma
🇺🇸Gaithersburg, Maryland, United States
Gettysburg Medical Clinic
🇺🇸Fresno, California, United States
Allergy Asthma & Sinus Center
🇺🇸Greenfield, Wisconsin, United States
Georgia Pollens
🇺🇸Albany, Georgia, United States
Brookstone Clinical Res Ctr
🇺🇸Columbus, Georgia, United States
Asthma & Allergy of Idaho
🇺🇸Twin Falls, Idaho, United States
Allergy Asthma Care
🇺🇸Crown Point, Indiana, United States
VA Loma Linda Healthcare System
🇺🇸Loma Linda, California, United States
Allergy & Asthma Inst Valley
🇺🇸Granada Hills, California, United States
FL Ctr Allergy & Asthma Res
🇺🇸Miami, Florida, United States
Allergy & Asthma Care Center
🇺🇸Gainesville, Georgia, United States
Clinical Research Center of Indiana
🇺🇸Indianapolis, Indiana, United States
University of Kansas Med Ctr; Int med/Allgy/Immun/Rheum
🇺🇸Kansas City, Kansas, United States
William Ebbeling MD - PP
🇺🇸Fresno, California, United States
Allergy & Asthma Care LTD
🇺🇸Glen Carbon, Illinois, United States
Florida Ctr-Allergy & Asthma
🇺🇸Miami, Florida, United States
Aeroallergy Research Labs
🇺🇸Savannah, Georgia, United States
The Allergy and Asthma Center
🇺🇸Fort Wayne, Indiana, United States
Allergy Asthma & Immun Center
🇺🇸Leesburg, Florida, United States
Washington Univ. School of Med
🇺🇸Saint Louis, Missouri, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Asthma Allergy Ctr of SW MI
🇺🇸Portage, Michigan, United States
Bend Memorial Clinic
🇺🇸Bend, Oregon, United States
LeBonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
Allergy Asthma & Immun Assoc
🇺🇸Garland, Texas, United States
Clinical Research Partners, LLC
🇺🇸Henrico, Virginia, United States
Santiago Reyes MD-Private Prac
🇺🇸Oklahoma City, Oklahoma, United States
Live Oak Allergy & Asthma Clinic
🇺🇸San Antonio, Texas, United States
Allergy & Asthma Res Ctr PA
🇺🇸San Antonio, Texas, United States
Allergy Assoc Medical Group
🇺🇸San Diego, California, United States
Kaiser Permanente - San Diego
🇺🇸San Diego, California, United States
Clinical Research Inst
🇺🇸Minneapolis, Minnesota, United States
Impact Clinical Trials
🇺🇸Las Vegas, Nevada, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
Asthma & Allergy Clinic
🇺🇸San Francisco, California, United States
Huntsville Lung Associates PC
🇺🇸Huntsville, Alabama, United States
Achieve Clinical Research, LLC
🇺🇸Birmingham, Alabama, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Allergy Associates of Tucson
🇺🇸Tucson, Arizona, United States
Allergy & Asthma Care of FL; Clinical Research
🇺🇸Ocala, Florida, United States
Sneeze Wheeze and Itch Associates LLC
🇺🇸Normal, Illinois, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Alabama Allergy & Asthma
🇺🇸Birmingham, Alabama, United States
Stuart Epstein MD - PP
🇺🇸Beverly Hills, California, United States
Peninsula Allergy Associates
🇺🇸Daly City, California, United States
Allianz Medical and Research Center
🇺🇸Fountain Valley, California, United States
Allergy Asthma Care Ctr, Inc.
🇺🇸Los Angeles, California, United States
California Allergy & Asthma Medical Group, Inc.
🇺🇸Palmdale, California, United States
Clinical Trials of Orange County
🇺🇸Orange, California, United States
Choc Psf, Amc
🇺🇸Orange, California, United States
Joann Blessing-Moore MD - PP
🇺🇸Palo Alto, California, United States
Southern California Research Center
🇺🇸Mission Viejo, California, United States
TPMG - Rancho Cordova
🇺🇸Rancho Cordova, California, United States
Allergy & Asthma Consultants
🇺🇸Redwood City, California, United States
Redding Allergy & Asthma Care
🇺🇸Redding, California, United States
Central Coast Allergy and Asthma
🇺🇸Salinas, California, United States
The Allergy and Asthma Clinic
🇺🇸San Mateo, California, United States
Allergy & Asthma Medical Group; Clinical Research Division
🇺🇸Walnut Creek, California, United States
Danbury Hospital
🇺🇸Danbury, Connecticut, United States
IMMUNOe International Research Centers
🇺🇸Centennial, Colorado, United States
Christopher C Randolph MD - PP
🇺🇸Waterbury, Connecticut, United States
AAADRS; Clinical Research Center
🇺🇸Coral Gables, Florida, United States
St. Francis Sleep; Allergy & Lung Institute
🇺🇸Clearwater, Florida, United States
Gulf Coast Allergy Center, P.A.
🇺🇸Port Charlotte, Florida, United States
Kansas City Allergy And Asthma Assoc.
🇺🇸Overland Park, Kansas, United States
Glenn M. Silber, M.D., P.A
🇺🇸Ellicott City, Maryland, United States
Center for Clinical Research.
🇺🇸Brockton, Massachusetts, United States
Allergy Arth Fam Treatment Ctr
🇺🇸Gardner, Massachusetts, United States
Infinity Medical Research Inc
🇺🇸North Dartmouth, Massachusetts, United States
Asthma & Allergy Inst of MI
🇺🇸Clinton Township, Michigan, United States
McGovern & Baja Allergy Assoc
🇺🇸Springfield, Massachusetts, United States
Ocean Allergy & Resp Res Ctr
🇺🇸Brick Township, New Jersey, United States
Adult Ped Aller Central Jersey
🇺🇸Edison, New Jersey, United States
Center for Asthma and Allergy
🇺🇸Highland Park, New Jersey, United States
Atlantic Allergy Asthma Immunology Associates
🇺🇸Ocean City, New Jersey, United States
Allergy Treatment Center of New Jersey
🇺🇸Piscataway, New Jersey, United States
Pulmonary and Allergy Associates
🇺🇸Summit, New Jersey, United States
SUNY Downstate Medical Center.
🇺🇸Brooklyn, New York, United States
Boris Sagalovich MD - PC
🇺🇸Brooklyn, New York, United States
Allergy Consultants, PA
🇺🇸Verona, New Jersey, United States
Island Medical Research Pc
🇺🇸Commack, New York, United States
North Shore Medical Arts, LLP
🇺🇸Great Neck, New York, United States
Jamaica Hospital Medical Center
🇺🇸Jamaica, New York, United States
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
🇺🇸New York, New York, United States
Winthrop Univ Hospital
🇺🇸Mineola, New York, United States
Parikh Institute for Research LLC
🇺🇸New York, New York, United States
Olean Medical Group
🇺🇸Olean, New York, United States
Albert P Hirdt DO - PP
🇺🇸Newburgh, New York, United States
Urban Health Plan, Inc.
🇺🇸The Bronx, New York, United States
Advanced Allergy & Asthma PLLC
🇺🇸Rockville Center, New York, United States
Alan Kaufman MD - PP
🇺🇸The Bronx, New York, United States
Allergy & Asthma Centre of Dayton
🇺🇸Centerville, Ohio, United States
Allergy Partners of Western NC
🇺🇸Asheville, North Carolina, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Vital Prospects Clin Res Pc
🇺🇸Tulsa, Oklahoma, United States
Central PA Asth & Allergy Care; Research Division
🇺🇸Altoona, Pennsylvania, United States
Allergy and Asthmas; Specialists of Harrisburg
🇺🇸Harrisburg, Pennsylvania, United States
Allergy and Asthma Research of NJ, lnc
🇺🇸Philadelphia, Pennsylvania, United States
Penn State Hershey Medical Group
🇺🇸Hershey, Pennsylvania, United States
Inst for Resp & Sleep Med PC
🇺🇸Langhorne, Pennsylvania, United States
South Hills Pulmonary Assoc
🇺🇸Pittsburgh, Pennsylvania, United States
ADAC Research PA
🇺🇸Greenville, South Carolina, United States
Upstate Pharma Research
🇺🇸Simpsonville, South Carolina, United States
East Tennessee Center for Clinical Research
🇺🇸Knoxville, Tennessee, United States
Respiratory Specialists
🇺🇸Reading, Pennsylvania, United States
Vanderbilt Medical University
🇺🇸Nashville, Tennessee, United States
Elliot J. Ginchansky, MD, PA
🇺🇸Dallas, Texas, United States
Greater Austin Allergy Asthma and Immunology
🇺🇸Austin, Texas, United States
Allergy Asthma Research Assoc
🇺🇸Dallas, Texas, United States
University of Texas Medical Branch;Division of APICS
🇺🇸Galveston, Texas, United States
Sugar Land Allerg Asthma Immun
🇺🇸Sugar Land, Texas, United States
University of Texas Health Center at Tyler
🇺🇸Tyler, Texas, United States
Bridgerland Clinical Research
🇺🇸North Logan, Utah, United States
Allergy Associates of Utah
🇺🇸Murray, Utah, United States
Pulmonary Research of Albingdon
🇺🇸Abingdon, Virginia, United States
O & O Alpan, LLC
🇺🇸Fairfax, Virginia, United States
Children's Hospital of the King's Daughter
🇺🇸Norfolk, Virginia, United States
Bellingham Asthma, Allergy & Immunology
🇺🇸Bellingham, Washington, United States
Pulmonary & Sleep Research
🇺🇸Spokane, Washington, United States
Northwest Asthma Allergy Center
🇺🇸Vancouver, Washington, United States
Dean Clinic
🇺🇸Madison, Wisconsin, United States
University of Wisconsin;Allergy & Asthma Clinical Research
🇺🇸Madison, Wisconsin, United States
USF Asthma Allergy & Immun; Clinical Research
🇺🇸Tampa, Florida, United States
Central Florida Pulmonary Grou
🇺🇸Orlando, Florida, United States
Capital Allergy Resp Dis Ctr
🇺🇸Sacramento, California, United States
Nat'l Aller Asth-Charleston
🇺🇸Charleston, South Carolina, United States
Little Rock Allergy & Asthma; Clinical Research Center
🇺🇸Little Rock, Arkansas, United States
Montefiore Medical Center
🇺🇸The Bronx, New York, United States