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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922037
• Other study ID #: ML28528
• Status: Completed
• Phase: Phase 4
• First received: July 12, 2013
• Last updated: November 9, 2017
• Start date: June 19, 2013
• Est. completion date: March 31, 2016

Study information

• Verified date: November 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 806
• Est. completion date: March 31, 2016
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
United States	Pulmonary Research of Albingdon	Abingdon	Virginia
United States	Georgia Pollens	Albany	Georgia
United States	Central PA Asth & Allergy Care; Research Division	Altoona	Pennsylvania
United States	Allergy Partners of Western NC	Asheville	North Carolina
United States	Greater Austin Allergy Asthma and Immunology	Austin	Texas
United States	Chesapeake Clinical Research Inc - CRN	Baltimore	Maryland
United States	Dr. Paul Shapero	Bangor	Maine
United States	Bellingham Asthma, Allergy & Immunology	Bellingham	Washington
United States	Bend Memorial Clinic	Bend	Oregon
United States	Stuart Epstein MD - PP	Beverly Hills	California
United States	Achieve Clinical Research, LLC	Birmingham	Alabama
United States	Alabama Allergy & Asthma	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Ocean Allergy & Resp Res Ctr	Brick Township	New Jersey
United States	Center for Clinical Research.	Brockton	Massachusetts
United States	Boris Sagalovich MD - PC	Brooklyn	New York
United States	SUNY Downstate Medical Center.	Brooklyn	New York
United States	IMMUNOe International Research Centers	Centennial	Colorado
United States	Allergy & Asthma Centre of Dayton	Centerville	Ohio
United States	Nat'l Aller Asth-Charleston	Charleston	South Carolina
United States	Chest Medicine Consultants	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	St. Francis Sleep; Allergy & Lung Institute	Clearwater	Florida
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Asthma & Allergy Inst of MI	Clinton Township	Michigan
United States	Brookstone Clinical Res Ctr	Columbus	Georgia
United States	Island Medical Research Pc	Commack	New York
United States	AAADRS; Clinical Research Center	Coral Gables	Florida
United States	West Coast Clinical Trials Global, LLC	Costa Mesa	California
United States	Allergy Asthma Care	Crown Point	Indiana
United States	Allergy Asthma Research Assoc	Dallas	Texas
United States	Elliot J. Ginchansky, MD, PA	Dallas	Texas
United States	Peninsula Allergy Associates	Daly City	California
United States	Danbury Hospital	Danbury	Connecticut
United States	Adult Ped Aller Central Jersey	Edison	New Jersey
United States	Glenn M. Silber, M.D., P.A	Ellicott City	Maryland
United States	O & O Alpan, LLC	Fairfax	Virginia
United States	Abraham Research PLLC	Florence	Kentucky
United States	The Allergy and Asthma Center	Fort Wayne	Indiana
United States	Allianz Medical and Research Center	Fountain Valley	California
United States	Gettysburg Medical Clinic	Fresno	California
United States	William Ebbeling MD - PP	Fresno	California
United States	Allergy & Asthma Care Center	Gainesville	Georgia
United States	Family Allergy & Asthma	Gaithersburg	Maryland
United States	University of Texas Medical Branch;Division of APICS	Galveston	Texas
United States	Allergy Arth Fam Treatment Ctr	Gardner	Massachusetts
United States	Allergy Asthma & Immun Assoc	Garland	Texas
United States	San Tan Allergy & Asthma	Gilbert	Arizona
United States	Allergy & Asthma Care LTD	Glen Carbon	Illinois
United States	Dedicated Clinical Research	Goodyear	Arizona
United States	Allergy & Asthma Inst Valley	Granada Hills	California
United States	North Shore Medical Arts, LLP	Great Neck	New York
United States	Allergy Asthma & Sinus Center	Greenfield	Wisconsin
United States	ADAC Research PA	Greenville	South Carolina
United States	Allergy and Asthmas; Specialists of Harrisburg	Harrisburg	Pennsylvania
United States	Clinical Research Partners, LLC	Henrico	Virginia
United States	Penn State Hershey Medical Group	Hershey	Pennsylvania
United States	Center for Asthma and Allergy	Highland Park	New Jersey
United States	Huntsville Lung Associates PC	Huntsville	Alabama
United States	Clinical Research Center of Indiana	Indianapolis	Indiana
United States	Jamaica Hospital Medical Center	Jamaica	New York
United States	University of Kansas Med Ctr; Int med/Allgy/Immun/Rheum	Kansas City	Kansas
United States	East Tennessee Center for Clinical Research	Knoxville	Tennessee
United States	Inst for Resp & Sleep Med PC	Langhorne	Pennsylvania
United States	Impact Clinical Trials	Las Vegas	Nevada
United States	Allergy Asthma & Immun Center	Leesburg	Florida
United States	Allergy Asthma & Sinus Center	Leesburg	Virginia
United States	Allergy & Asth Phys of Cent KY	Lexington	Kentucky
United States	Little Rock Allergy & Asthma; Clinical Research Center	Little Rock	Arkansas
United States	VA Loma Linda Healthcare System	Loma Linda	California
United States	Allergy Asthma Care Ctr, Inc.	Los Angeles	California
United States	Dean Clinic	Madison	Wisconsin
United States	University of Wisconsin;Allergy & Asthma Clinical Research	Madison	Wisconsin
United States	LeBonheur Children's Hospital	Memphis	Tennessee
United States	FL Ctr Allergy & Asthma Res	Miami	Florida
United States	Florida Ctr-Allergy & Asthma	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Winthrop Univ Hospital	Mineola	New York
United States	Clinical Research Inst	Minneapolis	Minnesota
United States	Southern California Research Center	Mission Viejo	California
United States	Allergy Associates of Utah	Murray	Utah
United States	North Bay Allergy & Asthma; Medical Assoc	Napa	California
United States	Vanderbilt Medical University	Nashville	Tennessee
United States	Laura and ISAAC Perlmutter Cancer Center at NYU Langone.	New York	New York
United States	Parikh Institute for Research LLC	New York	New York
United States	Albert P Hirdt DO - PP	Newburgh	New York
United States	Children's Hospital of the King's Daughter	Norfolk	Virginia
United States	Sneeze Wheeze and Itch Associates LLC	Normal	Illinois
United States	Infinity Medical Research Inc	North Dartmouth	Massachusetts
United States	Bridgerland Clinical Research	North Logan	Utah
United States	Allergy & Asthma Care of FL; Clinical Research	Ocala	Florida
United States	Atlantic Allergy Asthma Immunology Associates	Ocean City	New Jersey
United States	Santiago Reyes MD-Private Prac	Oklahoma City	Oklahoma
United States	Olean Medical Group	Olean	New York
United States	Choc Psf, Amc	Orange	California
United States	Clinical Trials of Orange County	Orange	California
United States	Central Florida Pulmonary Grou	Orlando	Florida
United States	Kansas City Allergy And Asthma Assoc.	Overland Park	Kansas
United States	Allergy Asthma & Sinus Center	Palm Beach Gardens	Florida
United States	California Allergy & Asthma Medical Group, Inc.	Palmdale	California
United States	Joann Blessing-Moore MD - PP	Palo Alto	California
United States	Allergy and Asthma Research of NJ, lnc	Philadelphia	Pennsylvania
United States	Allergy Treatment Center of New Jersey	Piscataway	New Jersey
United States	Allergy & Clinical Immun Assoc	Pittsburgh	Pennsylvania
United States	South Hills Pulmonary Assoc	Pittsburgh	Pennsylvania
United States	Gulf Coast Allergy Center, P.A.	Port Charlotte	Florida
United States	Asthma Allergy Ctr of SW MI	Portage	Michigan
United States	TPMG - Rancho Cordova	Rancho Cordova	California
United States	Respiratory Specialists	Reading	Pennsylvania
United States	Redding Allergy & Asthma Care	Redding	California
United States	Allergy & Asthma Consultants	Redwood City	California
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Advanced Allergy & Asthma PLLC	Rockville Center	New York
United States	Capital Allergy Resp Dis Ctr	Sacramento	California
United States	Washington Univ. School of Med	Saint Louis	Missouri
United States	Central Coast Allergy and Asthma	Salinas	California
United States	Allergy & Asthma Res Ctr PA	San Antonio	Texas
United States	Live Oak Allergy & Asthma Clinic	San Antonio	Texas
United States	Allergy Assoc Medical Group	San Diego	California
United States	Kaiser Permanente - San Diego	San Diego	California
United States	Asthma & Allergy Clinic	San Francisco	California
United States	University of California at San Francisco	San Francisco	California
United States	The Allergy and Asthma Clinic	San Mateo	California
United States	Aeroallergy Research Labs	Savannah	Georgia
United States	ASTHMA, Inc	Seattle	Washington
United States	Upstate Pharma Research	Simpsonville	South Carolina
United States	Pulmonary & Sleep Research	Spokane	Washington
United States	McGovern & Baja Allergy Assoc	Springfield	Massachusetts
United States	Sugar Land Allerg Asthma Immun	Sugar Land	Texas
United States	Pulmonary and Allergy Associates	Summit	New Jersey
United States	USF Asthma Allergy & Immun; Clinical Research	Tampa	Florida
United States	Alan Kaufman MD - PP	The Bronx	New York
United States	Montefiore Medical Center	The Bronx	New York
United States	Urban Health Plan, Inc.	The Bronx	New York
United States	Allergy Associates of Tucson	Tucson	Arizona
United States	University of Arizona	Tucson	Arizona
United States	Vital Prospects Clin Res Pc	Tulsa	Oklahoma
United States	Asthma & Allergy of Idaho	Twin Falls	Idaho
United States	University of Texas Health Center at Tyler	Tyler	Texas
United States	Northwest Asthma Allergy Center	Vancouver	Washington
United States	Allergy Consultants, PA	Verona	New Jersey
United States	Allergy & Asthma Medical Group; Clinical Research Division	Walnut Creek	California
United States	Christopher C Randolph MD - PP	Waterbury	Connecticut
United States	Waterbury Pulmonary Associates	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total Number of Asthma Exacerbations During Months 1-6	An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/=3 days.	Months 1-6
Secondary	Total Number of Asthma Exacerbations During Months 7-12	An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.	Months 7-12
Secondary	Total Number of Asthma-Related Hospital Admissions During Months 1-12		Months 1-12
Secondary	Total Number of Asthma-Related Hospital Admissions During Months 1-6		Months 1-6
Secondary	Total Number of Asthma-Related Hospital Admissions During Months 7-12		Months 7-12
Secondary	Total Number of Asthma-Related ER Visits During Months 1-12		Months 1-12
Secondary	Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6		Months 1-6
Secondary	Total Number of Asthma-Related ER Visits During Months 7-12		Months 7-12
Secondary	Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12		Months 1-12
Secondary	Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6		Months 1-6
Secondary	Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12		Months 7-12
Secondary	Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12		Months 1-12
Secondary	Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6		Months 1-6
Secondary	Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12		Months 7-12
Secondary	Percentage of Participants by Number of Asthma Exacerbations	Percentage of participants by number of asthma exacerbations (0, 1, 2, 3, >/=4) was reported. An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.	Months 1-12
Secondary	Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids	Percentage of participants by number of asthma exacerbations (0, 1, 2, 3, >/=4) requiring treatment with systemic steroids was reported. An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.	Months 1-12
Secondary	Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1)	FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. Pre-bronchodilator FEV1 and post-bronchodilator FEV1 are reported for each timepoint. FEV1 was measured using spirometry.	Baseline, Month 6, end of study (EOS)/early termination (ET) (up to Month 12)
Secondary	Change From Baseline in Raw Forced Vital Capacity (FVC)	FVC was defined as the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pre-bronchodilator FVC and post-bronchodilator FVC are reported for each timepoint. FVC was measured using spirometry.	Baseline, Month 6, EOS/ET (up to Month 12)
Secondary	Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%)	FEF25%-75% was defined as the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Pre-bronchodilator FEF25%-75% and post-bronchodilator FEF25%-75% are reported for each timepoint. FEF25%-75% was measured using spirometry.	Baseline, Month 6, EOS/ET (up to Month 12)
Secondary	Change From Baseline in Percentage Predicted FEV1 (ppFEV1)	FEV1 is the volume of air that can be forced out in one second after taking a deep breath, as measured using spirometry. Hankinson and Wang standards were used to calculate ppFEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. ppFEV1= 100 multiplied by (*) FEV1 (in liters [L]) divided by (/) predicted FEV1 (in L). Pre-bronchodilator ppFEV1 and post-bronchodilator ppFEV1 are reported for each timepoint.	Baseline, Month 6, EOS/ET (up to Month 12)
Secondary	Percentage of Participants With Prior Asthma Medications by Category or Class of Medications	Prior asthma medications were defined as all medications used for asthma prior to the study (initiated within 90 days of baseline) and were assessed retrospectively at baseline. Participants received prior asthma medications of following categories or classes: short acting beta agonist (SABA), combination inhaled corticosteroids/long acting beta agonist (ICS/LABA), leukotriene receptor antagonist (LTRA), inhaled corticosteroids (ICS), oral/parenteral (systemic) corticosteroids, anticholinergic, long acting beta agonist (LABA), and other medication.	Baseline
Secondary	Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications	Concomitant and ongoing asthma medications were defined as all medications used for asthma which began on or after the participant's study start, as well as those ongoing at the beginning of the study. Participants received following categories or classes of concomitant and ongoing asthma medications: SABA, combination ICS/LABA, LTRA, oral/parenteral (systemic) corticosteroids, ICS, anticholinergic, LABA, and other medication.	Baseline until EOS/ET (up to Month 12)
Secondary	Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score	AQLQ +12 is a 32-item disease specific questionnaire designed to assess the participants' asthma-specific health-related quality of life (QOL). The questionnaire contains four domains: activity limitations (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). All items are scored on a 7-point likert scale. All item scores are averaged to produce one overall QOL score. Overall score ranges from 1 (total impairment) to 7 (no impairment), with higher scores indicating better QOL. A positive change from baseline indicated improved QOL.	Baseline, Month 6, EOS/ET (up to Month 12)
Secondary	Change From Baseline in Asthma Control Test (ACT) Overall Score	Multidimensional factors associated with asthma control from the participant's perspective were assessed using the ACT questionnaire. The ACT is a validated, five-item patient-reported outcome (PRO) questionnaire that measures the impact of asthma on home and work activities, shortness of breath, symptoms, rescue medication usage, and overall asthma control. All items are scored on a 5-point likert scale (1 to 5). All item scores are added together to calculate a total score. Total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. A positive change from baseline indicated improvement.	Baseline, Months 3, 6, 9, 12
Secondary	Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score	WPAI-asthma is a self-administered instrument to measure asthma-specific performance impairment of work and regular daily activity within the last 7 days and yields 4 types of scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (WI) (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Total score and each score ranged from 0 (not affected/no impairment) to 100 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. A negative change in score indicated improvement and a positive change indicated impairment.	Baseline, Month 6, EOS/ET (up to Month 12)
Secondary	Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using Global Evaluation of Treatment Effectiveness (GETE) by Inversigator	Response to treatment was assessed using the GETE. The GETE is a validated instrument that measures the overall impression of the effect of the study medication on typical asthma symptoms. The evaluation was performed using the 5-point scale. The GETE scale ranges were as follows: 1=excellent, 2=good, 3=moderate, 4=poor, 5= worsening. A good or excellent response on the 5 point scale indicated that a participant had responded to treatment. Percentage of participants who showed an improvement (GETE scale score of 1 or 2) in asthma symptoms, as assessed by investigator, is reported.	EOS/ET (up to Month 12)
Secondary	Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using GETE by Participant	Response to treatment was assessed using the GETE. The GETE is a validated instrument that measures the overall impression of the effect of the study medication on typical asthma symptoms. The evaluation was performed using the 5-point scale. The GETE scale ranges were as follows: 1=excellent, 2=good, 3=moderate, 4=poor, 5= worsening. A good or excellent response on the 5 point scale indicated that a participant had responded to treatment. Percentage of participants who showed an improvement (GETE scale score of 1 or 2) in asthma symptoms, as assessed by participant, is reported.	EOS/ET (up to Month 12)
Secondary	Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score	The MiniRQLQ is a shorter version of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) instrument. The MiniRQLQ is a validated quality of life questionnaire to measure the functional impairments that are most troublesome to adult participants with either seasonal or perennial rhinoconjunctivitis of either allergic or non-allergic origin. The miniRQLQ contains 14 items; each item scored on a 7-point scale ranging from 0 [not impaired at all] to 6 [severely impaired]). The overall quality of life score is the average of the all item scores and ranges from 0 (not impaired at all) to 6 (severely impaired), with higher scores indicating more impairment. A negative change in score indicated improvement and a positive change indicated impairment.	Baseline, EOS/ET (up to Month 12)