Asthma
Conditions
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.
Interventions
DRUGOmalizumab
Participants will receive omalizumab for up to 12 months per investigator standard of care and clinical practice.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | — |
| 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. |
| 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. |
| 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 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
Results are reported by age group (adult participants and adolescent participants) as well as for all participants.
Participants by arm
| Arm | Count |
|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first. | 69 |
| Participants With Allergic Asthma (Age >/=18 Years) Adult participants (age \>/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first. | 737 |
| Total | 806 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 7 |
| Overall Study | Death | 0 | 5 |
| Overall Study | Investigator/Sponsor decision | 1 | 4 |
| Overall Study | Other unspecified | 2 | 66 |
| Overall Study | Participant non-compliance | 4 | 46 |
| Overall Study | Pregnancy | 0 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 44 |
Baseline characteristics
| Characteristic | Participants With Allergic Asthma (Age 12-17 Years) | Participants With Allergic Asthma (Age >/=18 Years) | Total |
|---|---|---|---|
| Age, Continuous | 14.0 years STANDARD_DEVIATION 1.69 | 50.4 years STANDARD_DEVIATION 14.75 | 47.3 years STANDARD_DEVIATION 17.4 |
| Sex: Female, Male Female | 25 Participants | 487 Participants | 512 Participants |
| Sex: Female, Male Male | 44 Participants | 250 Participants | 294 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 69 | 58 / 732 | 67 / 801 |
| serious Total, serious adverse events | 5 / 69 | 85 / 732 | 90 / 801 |
Outcome results
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.
Time frame: Months 1-12
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Total Number of Asthma Exacerbations During Months 1-12 | 0.46 asthma exacerbations | Standard Deviation 0.815 |
| Participants With Allergic Asthma (Age >/=18 Years) | Total Number of Asthma Exacerbations During Months 1-12 | 0.81 asthma exacerbations | Standard Deviation 1.407 |
| Total Participants With Allergic Asthma | Total Number of Asthma Exacerbations During Months 1-12 | 0.78 asthma exacerbations | Standard Deviation 1.369 |
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.
Time frame: Baseline, Months 3, 6, 9, 12
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Asthma Control Test (ACT) Overall Score | Change at Month 6 | 3.57 units on a scale | Standard Deviation 4.339 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Asthma Control Test (ACT) Overall Score | Baseline | 16.40 units on a scale | Standard Deviation 5.117 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Asthma Control Test (ACT) Overall Score | Change at Month 12 | 3.90 units on a scale | Standard Deviation 4.997 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Asthma Control Test (ACT) Overall Score | Change at Month 3 | 3.11 units on a scale | Standard Deviation 4.141 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Asthma Control Test (ACT) Overall Score | Change at Month 9 | 3.90 units on a scale | Standard Deviation 4.844 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Asthma Control Test (ACT) Overall Score | Change at Month 6 | 4.16 units on a scale | Standard Deviation 4.677 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Asthma Control Test (ACT) Overall Score | Change at Month 9 | 4.39 units on a scale | Standard Deviation 4.91 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Asthma Control Test (ACT) Overall Score | Change at Month 3 | 3.58 units on a scale | Standard Deviation 4.263 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Asthma Control Test (ACT) Overall Score | Change at Month 12 | 4.48 units on a scale | Standard Deviation 4.926 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Asthma Control Test (ACT) Overall Score | Baseline | 13.71 units on a scale | Standard Deviation 4.91 |
| Total Participants With Allergic Asthma | Change From Baseline in Asthma Control Test (ACT) Overall Score | Change at Month 12 | 4.43 units on a scale | Standard Deviation 4.932 |
| Total Participants With Allergic Asthma | Change From Baseline in Asthma Control Test (ACT) Overall Score | Change at Month 3 | 3.54 units on a scale | Standard Deviation 4.252 |
| Total Participants With Allergic Asthma | Change From Baseline in Asthma Control Test (ACT) Overall Score | Change at Month 6 | 4.11 units on a scale | Standard Deviation 4.649 |
| Total Participants With Allergic Asthma | Change From Baseline in Asthma Control Test (ACT) Overall Score | Change at Month 9 | 4.35 units on a scale | Standard Deviation 4.903 |
| Total Participants With Allergic Asthma | Change From Baseline in Asthma Control Test (ACT) Overall Score | Baseline | 13.94 units on a scale | Standard Deviation 4.981 |
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.
Time frame: Baseline, Month 6, EOS/ET (up to Month 12)
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score | Change at Month 6 | 0.94 units on a scale | Standard Deviation 1.134 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score | Change at EOS/ET | 1.11 units on a scale | Standard Deviation 1.174 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score | Baseline | 4.71 units on a scale | Standard Deviation 1.332 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score | Baseline | 3.93 units on a scale | Standard Deviation 1.348 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score | Change at Month 6 | 1.18 units on a scale | Standard Deviation 1.223 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score | Change at EOS/ET | 1.33 units on a scale | Standard Deviation 1.267 |
| Total Participants With Allergic Asthma | Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score | Change at Month 6 | 1.16 units on a scale | Standard Deviation 1.216 |
| Total Participants With Allergic Asthma | Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score | Baseline | 4.00 units on a scale | Standard Deviation 1.363 |
| Total Participants With Allergic Asthma | Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score | Change at EOS/ET | 1.31 units on a scale | Standard Deviation 1.259 |
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.
Time frame: Baseline, EOS/ET (up to Month 12)
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score | Baseline | 2.44 units on a scale | Standard Deviation 1.435 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score | Change at EOS/ET | -1.17 units on a scale | Standard Deviation 1.357 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score | Baseline | 2.76 units on a scale | Standard Deviation 1.375 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score | Change at EOS/ET | -0.99 units on a scale | Standard Deviation 1.307 |
| Total Participants With Allergic Asthma | Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score | Baseline | 2.73 units on a scale | Standard Deviation 1.382 |
| Total Participants With Allergic Asthma | Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score | Change at EOS/ET | -1.01 units on a scale | Standard Deviation 1.311 |
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.
Time frame: Baseline, Month 6, EOS/ET (up to Month 12)
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Percentage Predicted FEV1 (ppFEV1) | Change at Month 6: Post-bronchodilator ppFEV1 | 2.09 percentage of predicted FEV1 | Standard Deviation 16.398 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Percentage Predicted FEV1 (ppFEV1) | Change at EOS/ET: Pre-bronchodilator ppFEV1 | 6.00 percentage of predicted FEV1 | Standard Deviation 14.713 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Percentage Predicted FEV1 (ppFEV1) | Change at EOS/ET: Post-bronchodilator ppFEV1 | 7.39 percentage of predicted FEV1 | Standard Deviation 14.673 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Percentage Predicted FEV1 (ppFEV1) | Baseline: Pre-bronchodilator ppFEV1 | 87.89 percentage of predicted FEV1 | Standard Deviation 16.934 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Percentage Predicted FEV1 (ppFEV1) | Baseline: Post-bronchodilator ppFEV1 | 93.61 percentage of predicted FEV1 | Standard Deviation 16.416 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Percentage Predicted FEV1 (ppFEV1) | Change at Month 6: Pre-bronchodilator ppFEV1 | 2.72 percentage of predicted FEV1 | Standard Deviation 13.279 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Percentage Predicted FEV1 (ppFEV1) | Baseline: Post-bronchodilator ppFEV1 | 78.92 percentage of predicted FEV1 | Standard Deviation 19.514 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Percentage Predicted FEV1 (ppFEV1) | Change at Month 6: Pre-bronchodilator ppFEV1 | 1.77 percentage of predicted FEV1 | Standard Deviation 12.27 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Percentage Predicted FEV1 (ppFEV1) | Change at EOS/ET: Post-bronchodilator ppFEV1 | 0.82 percentage of predicted FEV1 | Standard Deviation 11.099 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Percentage Predicted FEV1 (ppFEV1) | Change at Month 6: Post-bronchodilator ppFEV1 | 1.47 percentage of predicted FEV1 | Standard Deviation 9.617 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Percentage Predicted FEV1 (ppFEV1) | Baseline: Pre-bronchodilator ppFEV1 | 74.23 percentage of predicted FEV1 | Standard Deviation 20.569 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Percentage Predicted FEV1 (ppFEV1) | Change at EOS/ET: Pre-bronchodilator ppFEV1 | 0.91 percentage of predicted FEV1 | Standard Deviation 12.922 |
| Total Participants With Allergic Asthma | Change From Baseline in Percentage Predicted FEV1 (ppFEV1) | Change at EOS/ET: Post-bronchodilator ppFEV1 | 1.40 percentage of predicted FEV1 | Standard Deviation 11.597 |
| Total Participants With Allergic Asthma | Change From Baseline in Percentage Predicted FEV1 (ppFEV1) | Baseline: Pre-bronchodilator ppFEV1 | 75.38 percentage of predicted FEV1 | Standard Deviation 20.631 |
| Total Participants With Allergic Asthma | Change From Baseline in Percentage Predicted FEV1 (ppFEV1) | Change at Month 6: Pre-bronchodilator ppFEV1 | 1.86 percentage of predicted FEV1 | Standard Deviation 12.359 |
| Total Participants With Allergic Asthma | Change From Baseline in Percentage Predicted FEV1 (ppFEV1) | Change at EOS/ET: Pre-bronchodilator ppFEV1 | 1.37 percentage of predicted FEV1 | Standard Deviation 13.163 |
| Total Participants With Allergic Asthma | Change From Baseline in Percentage Predicted FEV1 (ppFEV1) | Baseline: Post-bronchodilator ppFEV1 | 80.15 percentage of predicted FEV1 | Standard Deviation 19.69 |
| Total Participants With Allergic Asthma | Change From Baseline in Percentage Predicted FEV1 (ppFEV1) | Change at Month 6: Post-bronchodilator ppFEV1 | 1.52 percentage of predicted FEV1 | Standard Deviation 10.421 |
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.
Time frame: Baseline, Month 6, EOS/ET (up to Month 12)
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) | Change at Month 6:Pre-bronchodilator FEF25%-75% | -1.66 liters per second | Standard Deviation 13.518 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) | Baseline:Pre-bronchodilator FEF25%-75% | 3.96 liters per second | Standard Deviation 12.328 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) | Change at EOS/ET:Pre-bronchodilator FEF25%-75% | -1.69 liters per second | Standard Deviation 13.426 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) | Baseline:Post-bronchodilator FEF25%-75% | 3.76 liters per second | Standard Deviation 6.676 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) | Change at Month 6:Post-bronchodilator FEF25%-75% | -1.00 liters per second | Standard Deviation 7.513 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) | Change at EOS/ET:Post-bronchodilator FEF25%-75% | -0.76 liters per second | Standard Deviation 7.515 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) | Change at EOS/ET:Post-bronchodilator FEF25%-75% | -0.61 liters per second | Standard Deviation 10.926 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) | Change at Month 6:Pre-bronchodilator FEF25%-75% | -0.44 liters per second | Standard Deviation 10.868 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) | Change at Month 6:Post-bronchodilator FEF25%-75% | -0.59 liters per second | Standard Deviation 11.051 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) | Baseline:Pre-bronchodilator FEF25%-75% | 2.28 liters per second | Standard Deviation 9.646 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) | Baseline:Post-bronchodilator FEF25%-75% | 2.58 liters per second | Standard Deviation 9.503 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) | Change at EOS/ET:Pre-bronchodilator FEF25%-75% | -0.47 liters per second | Standard Deviation 10.825 |
| Total Participants With Allergic Asthma | Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) | Change at Month 6:Pre-bronchodilator FEF25%-75% | -0.55 liters per second | Standard Deviation 11.131 |
| Total Participants With Allergic Asthma | Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) | Change at EOS/ET:Pre-bronchodilator FEF25%-75% | -0.58 liters per second | Standard Deviation 11.08 |
| Total Participants With Allergic Asthma | Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) | Change at EOS/ET:Post-bronchodilator FEF25%-75% | -0.62 liters per second | Standard Deviation 10.661 |
| Total Participants With Allergic Asthma | Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) | Baseline:Post-bronchodilator FEF25%-75% | 2.68 liters per second | Standard Deviation 9.302 |
| Total Participants With Allergic Asthma | Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) | Baseline:Pre-bronchodilator FEF25%-75% | 2.42 liters per second | Standard Deviation 9.902 |
| Total Participants With Allergic Asthma | Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) | Change at Month 6:Post-bronchodilator FEF25%-75% | -0.63 liters per second | Standard Deviation 10.767 |
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.
Time frame: Baseline, Month 6, end of study (EOS)/early termination (ET) (up to Month 12)
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) | Baseline: Pre-bronchodilator FEV1 | 2.61 liters | Standard Deviation 0.736 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) | Change at Month 6: Pre-bronchodilator FEV1 | 0.09 liters | Standard Deviation 0.402 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) | Change at EOS/ET: Pre-bronchodilator FEV1 | 0.16 liters | Standard Deviation 0.463 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) | Baseline: Post-bronchodilator FEV1 | 2.79 liters | Standard Deviation 0.767 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) | Change at Month 6: Post-bronchodilator FEV1 | 0.05 liters | Standard Deviation 0.522 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) | Change at EOS/ET: Post-bronchodilator FEV1 | 0.18 liters | Standard Deviation 0.446 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) | Change at EOS/ET: Post-bronchodilator FEV1 | 0.02 liters | Standard Deviation 0.322 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) | Baseline: Pre-bronchodilator FEV1 | 2.24 liters | Standard Deviation 0.82 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) | Baseline: Post-bronchodilator FEV1 | 2.38 liters | Standard Deviation 0.81 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) | Change at Month 6: Post-bronchodilator FEV1 | 0.04 liters | Standard Deviation 0.286 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) | Change at Month 6: Pre-bronchodilator FEV1 | 0.06 liters | Standard Deviation 0.359 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) | Change at EOS/ET: Pre-bronchodilator FEV1 | 0.03 liters | Standard Deviation 0.378 |
| Total Participants With Allergic Asthma | Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) | Change at Month 6: Pre-bronchodilator FEV1 | 0.06 liters | Standard Deviation 0.363 |
| Total Participants With Allergic Asthma | Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) | Change at EOS/ET: Pre-bronchodilator FEV1 | 0.04 liters | Standard Deviation 0.388 |
| Total Participants With Allergic Asthma | Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) | Change at EOS/ET: Post-bronchodilator FEV1 | 0.03 liters | Standard Deviation 0.338 |
| Total Participants With Allergic Asthma | Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) | Baseline: Post-bronchodilator FEV1 | 2.41 liters | Standard Deviation 0.814 |
| Total Participants With Allergic Asthma | Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) | Baseline: Pre-bronchodilator FEV1 | 2.27 liters | Standard Deviation 0.819 |
| Total Participants With Allergic Asthma | Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) | Change at Month 6: Post-bronchodilator FEV1 | 0.05 liters | Standard Deviation 0.315 |
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.
Time frame: Baseline, Month 6, EOS/ET (up to Month 12)
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Raw Forced Vital Capacity (FVC) | Change at Month 6: Post-bronchodilator FVC | 0.06 liters | Standard Deviation 0.324 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Raw Forced Vital Capacity (FVC) | Change at EOS/ET: Pre-bronchodilator FVC | 0.22 liters | Standard Deviation 0.321 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Raw Forced Vital Capacity (FVC) | Baseline: Post-bronchodilator FVC | 3.43 liters | Standard Deviation 0.878 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Raw Forced Vital Capacity (FVC) | Change at EOS/ET: Post-bronchodilator FVC | 0.20 liters | Standard Deviation 0.301 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Raw Forced Vital Capacity (FVC) | Baseline: Pre-bronchodilator FVC | 3.36 liters | Standard Deviation 0.842 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Raw Forced Vital Capacity (FVC) | Change at Month 6: Pre-bronchodilator FVC | 0.09 liters | Standard Deviation 0.38 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Raw Forced Vital Capacity (FVC) | Baseline: Pre-bronchodilator FVC | 3.08 liters | Standard Deviation 0.987 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Raw Forced Vital Capacity (FVC) | Change at Month 6: Pre-bronchodilator FVC | 0.07 liters | Standard Deviation 0.562 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Raw Forced Vital Capacity (FVC) | Change at EOS/ET: Pre-bronchodilator FVC | 0.03 liters | Standard Deviation 0.417 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Raw Forced Vital Capacity (FVC) | Baseline: Post-bronchodilator FVC | 3.19 liters | Standard Deviation 0.959 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Raw Forced Vital Capacity (FVC) | Change at Month 6: Post-bronchodilator FVC | 0.07 liters | Standard Deviation 0.661 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Raw Forced Vital Capacity (FVC) | Change at EOS/ET: Post-bronchodilator FVC | 0.02 liters | Standard Deviation 0.349 |
| Total Participants With Allergic Asthma | Change From Baseline in Raw Forced Vital Capacity (FVC) | Change at EOS/ET: Post-bronchodilator FVC | 0.04 liters | Standard Deviation 0.348 |
| Total Participants With Allergic Asthma | Change From Baseline in Raw Forced Vital Capacity (FVC) | Baseline: Post-bronchodilator FVC | 3.21 liters | Standard Deviation 0.954 |
| Total Participants With Allergic Asthma | Change From Baseline in Raw Forced Vital Capacity (FVC) | Change at Month 6: Pre-bronchodilator FVC | 0.07 liters | Standard Deviation 0.548 |
| Total Participants With Allergic Asthma | Change From Baseline in Raw Forced Vital Capacity (FVC) | Baseline: Pre-bronchodilator FVC | 3.11 liters | Standard Deviation 0.978 |
| Total Participants With Allergic Asthma | Change From Baseline in Raw Forced Vital Capacity (FVC) | Change at EOS/ET: Pre-bronchodilator FVC | 0.04 liters | Standard Deviation 0.413 |
| Total Participants With Allergic Asthma | Change From Baseline in Raw Forced Vital Capacity (FVC) | Change at Month 6: Post-bronchodilator FVC | 0.07 liters | Standard Deviation 0.637 |
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.
Time frame: Baseline, Month 6, EOS/ET (up to Month 12)
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Work time missed: Change at Month 6 | 0.00 units on a scale | — |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Overall WI: Change at EOS/ET | -49.09 units on a scale | — |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Impairment while working: Change at Month 6 | 0.00 units on a scale | Standard Deviation 0 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Work time missed: Baseline | 10.37 units on a scale | Standard Deviation 14.759 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Overall WI: Change at Month 6 | 0.00 units on a scale | — |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Impairment while working: Change at EOS/ET | -30.00 units on a scale | — |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Overall WI: Baseline | 20.85 units on a scale | Standard Deviation 25.366 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Activity impairment: Change at Month 6 | -9.12 units on a scale | Standard Deviation 33.449 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Work time missed: Change at EOS/ET | -27.27 units on a scale | — |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Activity impairment: Change at EOS/ET | -14.83 units on a scale | Standard Deviation 31.967 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Activity impairment: Baseline | 36.12 units on a scale | Standard Deviation 27.577 |
| Participants With Allergic Asthma (Age 12-17 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Impairment while working: Baseline | 10.00 units on a scale | Standard Deviation 14.142 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Impairment while working: Change at EOS/ET | -15.93 units on a scale | Standard Deviation 27.677 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Activity impairment: Baseline | 48.79 units on a scale | Standard Deviation 28.749 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Work time missed: Baseline | 7.70 units on a scale | Standard Deviation 19.936 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Work time missed: Change at Month 6 | -3.31 units on a scale | Standard Deviation 19.796 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Work time missed: Change at EOS/ET | -4.06 units on a scale | Standard Deviation 21.977 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Impairment while working: Baseline | 31.36 units on a scale | Standard Deviation 27.111 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Impairment while working: Change at Month 6 | -16.24 units on a scale | Standard Deviation 26.775 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Overall WI: Baseline | 33.59 units on a scale | Standard Deviation 28.737 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Overall WI: Change at Month 6 | -15.55 units on a scale | Standard Deviation 27.476 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Overall WI: Change at EOS/ET | -16.24 units on a scale | Standard Deviation 29.578 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Activity impairment: Change at Month 6 | -19.30 units on a scale | Standard Deviation 30.445 |
| Participants With Allergic Asthma (Age >/=18 Years) | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Activity impairment: Change at EOS/ET | -21.40 units on a scale | Standard Deviation 32.424 |
| Total Participants With Allergic Asthma | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Overall WI: Change at Month 6 | -15.49 units on a scale | Standard Deviation 27.443 |
| Total Participants With Allergic Asthma | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Impairment while working: Baseline | 31.15 units on a scale | Standard Deviation 27.087 |
| Total Participants With Allergic Asthma | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Work time missed: Baseline | 7.72 units on a scale | Standard Deviation 19.89 |
| Total Participants With Allergic Asthma | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Overall WI: Change at EOS/ET | -16.35 units on a scale | Standard Deviation 29.59 |
| Total Participants With Allergic Asthma | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Work time missed: Change at EOS/ET | -4.14 units on a scale | Standard Deviation 21.982 |
| Total Participants With Allergic Asthma | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Activity impairment: Baseline | 47.70 units on a scale | Standard Deviation 28.893 |
| Total Participants With Allergic Asthma | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Work time missed: Change at Month 6 | -3.30 units on a scale | Standard Deviation 19.763 |
| Total Participants With Allergic Asthma | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Impairment while working: Change at EOS/ET | -15.98 units on a scale | Standard Deviation 27.643 |
| Total Participants With Allergic Asthma | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Activity impairment: Change at EOS/ET | -20.80 units on a scale | Standard Deviation 32.413 |
| Total Participants With Allergic Asthma | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Overall WI: Baseline | 33.49 units on a scale | Standard Deviation 28.705 |
| Total Participants With Allergic Asthma | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Impairment while working: Change at Month 6 | -16.13 units on a scale | Standard Deviation 26.719 |
| Total Participants With Allergic Asthma | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score | Activity impairment: Change at Month 6 | -18.38 units on a scale | Standard Deviation 30.84 |
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.
Time frame: Months 1-12
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants by Number of Asthma Exacerbations | 3 Asthma Exacerbations | 4.3 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants by Number of Asthma Exacerbations | 2 Asthma Exacerbations | 7.2 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants by Number of Asthma Exacerbations | No (0) Asthma Exacerbation | 69.6 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants by Number of Asthma Exacerbations | 1 Asthma Exacerbation | 18.8 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants by Number of Asthma Exacerbations | >/=4 Asthma Exacerbations | 0 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants by Number of Asthma Exacerbations | 2 Asthma Exacerbations | 9.2 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants by Number of Asthma Exacerbations | No (0) Asthma Exacerbation | 61.8 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants by Number of Asthma Exacerbations | 1 Asthma Exacerbation | 18.3 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants by Number of Asthma Exacerbations | 3 Asthma Exacerbations | 4.3 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants by Number of Asthma Exacerbations | >/=4 Asthma Exacerbations | 6.5 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants by Number of Asthma Exacerbations | >/=4 Asthma Exacerbations | 5.9 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants by Number of Asthma Exacerbations | 3 Asthma Exacerbations | 4.3 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants by Number of Asthma Exacerbations | No (0) Asthma Exacerbation | 62.4 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants by Number of Asthma Exacerbations | 2 Asthma Exacerbations | 9.0 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants by Number of Asthma Exacerbations | 1 Asthma Exacerbation | 18.3 percentage of participants |
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.
Time frame: Months 1-12
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids | 3 Asthma Exacerbations Requiring Treatment | 4.3 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids | 2 Asthma Exacerbations Requiring Treatment | 4.3 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids | No (0) Asthma Exacerbation Requiring Treatment | 71.0 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids | 1 Asthma Exacerbation Requiring Treatment | 20.3 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids | >/=4 Asthma Exacerbations Requiring Treatment | 0 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids | 2 Asthma Exacerbations Requiring Treatment | 9.4 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids | No (0) Asthma Exacerbation Requiring Treatment | 62.3 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids | 1 Asthma Exacerbation Requiring Treatment | 18.2 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids | 3 Asthma Exacerbations Requiring Treatment | 4.5 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids | >/=4 Asthma Exacerbations Requiring Treatment | 5.6 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids | >/=4 Asthma Exacerbations Requiring Treatment | 5.2 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids | 3 Asthma Exacerbations Requiring Treatment | 4.5 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids | No (0) Asthma Exacerbation Requiring Treatment | 63.1 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids | 2 Asthma Exacerbations Requiring Treatment | 8.9 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids | 1 Asthma Exacerbation Requiring Treatment | 18.3 percentage of participants |
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.
Time frame: EOS/ET (up to Month 12)
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using GETE by Participant | 87.3 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using GETE by Participant | 75.0 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using GETE by Participant | 76.1 percentage of participants |
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.
Time frame: EOS/ET (up to Month 12)
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using Global Evaluation of Treatment Effectiveness (GETE) by Inversigator | 81.0 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using Global Evaluation of Treatment Effectiveness (GETE) by Inversigator | 75.8 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using Global Evaluation of Treatment Effectiveness (GETE) by Inversigator | 76.3 percentage of participants |
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.
Time frame: Baseline until EOS/ET (up to Month 12)
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | Other medication | 7.2 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | All types | 100.0 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | LTRA | 69.6 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | LABA | 1.4 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | SABA | 91.3 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | Oral/Parenteral (systemic) corticosteroids | 37.7 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | ICS | 33.3 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | Combination ICS/LABA | 82.6 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | Anticholinergic | 11.6 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | SABA | 89.4 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | Anticholinergic | 32.6 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | All types | 99.2 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | LABA | 4.5 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | Other medication | 9.9 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | Oral/Parenteral (systemic) corticosteroids | 47.2 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | Combination ICS/LABA | 82.4 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | LTRA | 63.9 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | ICS | 34.3 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | Other medication | 9.7 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | Oral/Parenteral (systemic) corticosteroids | 46.4 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | All types | 99.3 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | SABA | 89.6 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | Combination ICS/LABA | 82.4 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | LTRA | 64.4 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | ICS | 34.2 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | Anticholinergic | 30.8 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications | LABA | 4.2 percentage of participants |
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.
Time frame: Baseline
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | All types | 98.6 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | LTRA | 73.9 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | Anticholinergic | 10.1 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | SABA | 91.3 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | ICS | 36.2 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | Other medication | 5.8 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | Combination ICS/LABA | 79.7 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | Oral/Parenteral (systemic) corticisteroids | 27.5 percentage of participants |
| Participants With Allergic Asthma (Age 12-17 Years) | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | LABA | 1.4 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | Oral/Parenteral (systemic) corticisteroids | 31.6 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | Anticholinergic | 28.4 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | LABA | 4.1 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | Other medication | 5.3 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | Combination ICS/LABA | 84.1 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | LTRA | 66.6 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | ICS | 33.8 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | SABA | 88.6 percentage of participants |
| Participants With Allergic Asthma (Age >/=18 Years) | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | All types | 99.3 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | Other medication | 5.3 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | All types | 99.3 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | SABA | 88.8 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | Combination ICS/LABA | 83.7 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | LTRA | 67.2 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | ICS | 34.0 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | Oral/Parenteral (systemic) corticisteroids | 31.3 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | Anticholinergic | 26.8 percentage of participants |
| Total Participants With Allergic Asthma | Percentage of Participants With Prior Asthma Medications by Category or Class of Medications | LABA | 3.8 percentage of participants |
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.
Time frame: Months 1-6
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Total Number of Asthma Exacerbations During Months 1-6 | 0.20 asthma exacerbations | Standard Deviation 0.44 |
| Participants With Allergic Asthma (Age >/=18 Years) | Total Number of Asthma Exacerbations During Months 1-6 | 0.51 asthma exacerbations | Standard Deviation 0.988 |
| Total Participants With Allergic Asthma | Total Number of Asthma Exacerbations During Months 1-6 | 0.48 asthma exacerbations | Standard Deviation 0.957 |
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.
Time frame: Months 7-12
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Total Number of Asthma Exacerbations During Months 7-12 | 0.29 asthma exacerbations | Standard Deviation 0.521 |
| Participants With Allergic Asthma (Age >/=18 Years) | Total Number of Asthma Exacerbations During Months 7-12 | 0.35 asthma exacerbations | Standard Deviation 0.756 |
| Total Participants With Allergic Asthma | Total Number of Asthma Exacerbations During Months 7-12 | 0.35 asthma exacerbations | Standard Deviation 0.738 |
Secondary
Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6
Time frame: Months 1-6
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6 | 0.04 asthma-related ER visits | Standard Deviation 0.205 |
| Participants With Allergic Asthma (Age >/=18 Years) | Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6 | 0.09 asthma-related ER visits | Standard Deviation 0.41 |
| Total Participants With Allergic Asthma | Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6 | 0.09 asthma-related ER visits | Standard Deviation 0.397 |
Secondary
Total Number of Asthma-Related ER Visits During Months 1-12
Time frame: Months 1-12
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Total Number of Asthma-Related ER Visits During Months 1-12 | 0.13 asthma-related ER visits | Standard Deviation 0.38 |
| Participants With Allergic Asthma (Age >/=18 Years) | Total Number of Asthma-Related ER Visits During Months 1-12 | 0.14 asthma-related ER visits | Standard Deviation 0.575 |
| Total Participants With Allergic Asthma | Total Number of Asthma-Related ER Visits During Months 1-12 | 0.14 asthma-related ER visits | Standard Deviation 0.56 |
Secondary
Total Number of Asthma-Related ER Visits During Months 7-12
Time frame: Months 7-12
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Total Number of Asthma-Related ER Visits During Months 7-12 | 0.10 asthma-related ER visits | Standard Deviation 0.296 |
| Participants With Allergic Asthma (Age >/=18 Years) | Total Number of Asthma-Related ER Visits During Months 7-12 | 0.06 asthma-related ER visits | Standard Deviation 0.293 |
| Total Participants With Allergic Asthma | Total Number of Asthma-Related ER Visits During Months 7-12 | 0.06 asthma-related ER visits | Standard Deviation 0.294 |
Secondary
Total Number of Asthma-Related Hospital Admissions During Months 1-12
Time frame: Months 1-12
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Total Number of Asthma-Related Hospital Admissions During Months 1-12 | 0.04 asthma-related hospital admissions | Standard Deviation 0.205 |
| Participants With Allergic Asthma (Age >/=18 Years) | Total Number of Asthma-Related Hospital Admissions During Months 1-12 | 0.06 asthma-related hospital admissions | Standard Deviation 0.356 |
| Total Participants With Allergic Asthma | Total Number of Asthma-Related Hospital Admissions During Months 1-12 | 0.06 asthma-related hospital admissions | Standard Deviation 0.346 |
Secondary
Total Number of Asthma-Related Hospital Admissions During Months 1-6
Time frame: Months 1-6
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Total Number of Asthma-Related Hospital Admissions During Months 1-6 | 0.03 asthma-related hospital admissions | Standard Deviation 0.169 |
| Participants With Allergic Asthma (Age >/=18 Years) | Total Number of Asthma-Related Hospital Admissions During Months 1-6 | 0.03 asthma-related hospital admissions | Standard Deviation 0.23 |
| Total Participants With Allergic Asthma | Total Number of Asthma-Related Hospital Admissions During Months 1-6 | 0.03 asthma-related hospital admissions | Standard Deviation 0.225 |
Secondary
Total Number of Asthma-Related Hospital Admissions During Months 7-12
Time frame: Months 7-12
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Total Number of Asthma-Related Hospital Admissions During Months 7-12 | 0.02 asthma-related hospital admissions | Standard Deviation 0.126 |
| Participants With Allergic Asthma (Age >/=18 Years) | Total Number of Asthma-Related Hospital Admissions During Months 7-12 | 0.03 asthma-related hospital admissions | Standard Deviation 0.215 |
| Total Participants With Allergic Asthma | Total Number of Asthma-Related Hospital Admissions During Months 7-12 | 0.03 asthma-related hospital admissions | Standard Deviation 0.208 |
Secondary
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12
Time frame: Months 1-12
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12 | 0.35 asthma-related telephone calls | Standard Deviation 0.783 |
| Participants With Allergic Asthma (Age >/=18 Years) | Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12 | 0.43 asthma-related telephone calls | Standard Deviation 1.181 |
| Total Participants With Allergic Asthma | Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12 | 0.43 asthma-related telephone calls | Standard Deviation 1.152 |
Secondary
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6
Time frame: Months 1-6
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6 | 0.16 asthma-related telephone calls | Standard Deviation 0.407 |
| Participants With Allergic Asthma (Age >/=18 Years) | Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6 | 0.24 asthma-related telephone calls | Standard Deviation 0.799 |
| Total Participants With Allergic Asthma | Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6 | 0.23 asthma-related telephone calls | Standard Deviation 0.773 |
Secondary
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12
Time frame: Months 7-12
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12 | 0.21 asthma-related telephone calls | Standard Deviation 0.544 |
| Participants With Allergic Asthma (Age >/=18 Years) | Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12 | 0.22 asthma-related telephone calls | Standard Deviation 0.692 |
| Total Participants With Allergic Asthma | Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12 | 0.22 asthma-related telephone calls | Standard Deviation 0.68 |
Secondary
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12
Time frame: Months 1-12
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12 | 0.39 asthma-related physician's office visits | Standard Deviation 0.771 |
| Participants With Allergic Asthma (Age >/=18 Years) | Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12 | 0.39 asthma-related physician's office visits | Standard Deviation 0.866 |
| Total Participants With Allergic Asthma | Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12 | 0.39 asthma-related physician's office visits | Standard Deviation 0.858 |
Secondary
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6
Time frame: Months 1-6
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6 | 0.23 asthma-related physician's office visits | Standard Deviation 0.598 |
| Participants With Allergic Asthma (Age >/=18 Years) | Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6 | 0.23 asthma-related physician's office visits | Standard Deviation 0.584 |
| Total Participants With Allergic Asthma | Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6 | 0.23 asthma-related physician's office visits | Standard Deviation 0.585 |
Secondary
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12
Time frame: Months 7-12
Population: All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Allergic Asthma (Age 12-17 Years) | Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12 | 0.17 asthma-related physician's office visits | Standard Deviation 0.423 |
| Participants With Allergic Asthma (Age >/=18 Years) | Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12 | 0.18 asthma-related physician's office visits | Standard Deviation 0.515 |
| Total Participants With Allergic Asthma | Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12 | 0.18 asthma-related physician's office visits | Standard Deviation 0.507 |