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

Study Overview
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Brief Summary
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Omalizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants With Allergic Asthma<br>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. | Drug: Omalizumab<br>* Participants will receive omalizumab for up to 12 months per investigator standard of care and clinical practice.<br>* Other names: Xolair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Total Number of Asthma-Related Hospital Admissions During Months 1-12 |  | Months 1-12 | 
| Total Number of Asthma-Related Hospital Admissions During Months 1-6 |  | Months 1-6 | 
| Total Number of Asthma-Related Hospital Admissions During Months 7-12 |  | Months 7-12 | 
| Total Number of Asthma-Related ER Visits During Months 1-12 |  | Months 1-12 | 
| 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-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 | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 | 
| 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) | 
| 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) | 
| 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 | 
| 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) | 
| 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) | 
| 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) | 
| 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) |