Asthma
Conditions
Brief summary
This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate (MF) /formoterol fumarate (F)\[MF/F\] metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, subjects will receive open-label MF MDI 200 mcg twice daily (BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by The Area Under the Curve From 0 to 12 Hours \[AUC\](0-12 hours) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) \[Time Frame: Baseline to Week 12\] and Time-to-First Severe Asthma Exacerbation across the 26-week treatment period.
Interventions
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks
DRUGMometasone furoate MDI (MF MDI) 200 mcg
MF 200 mcg via metered dose inhaler twice daily for 26 weeks
F via metered dose inhaler 10 mcg twice a day for 26 weeks
DRUGPlacebo
Placebo metered dose inhaler twice a day for 26 weeks
Sponsors
Novartis
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult and adolescent subjects of either sex and any race, at least 12 years of age or older, with a diagnosis of asthma of at least 12 months' duration, will be eligible for enrollment. Subjects must meet all of the inclusion criteria and none of the
Exclusion criteria
to receive treatment assignment. Key Inclusion Criteria Include \- A subject must have been using a medium daily dose of inhaled glucocorticosteroid (ICS) (either alone or in combination with a long-acting beta agonist (LABA)) for at least 12 weeks and must have been on a stable regimen (daily dose unchanged) for at least 2 weeks prior to Screening. Medium daily doses of ICS are defined as follows: * \>500 to 1000 mcg beclomethasone chlorofluorocarbon (CFC) * \>250 to 500 mcg beclomethasone hydrofluoroalkane (HFA) * \>600 to 1000 mcg budesonide dry powder inhaler (DPI) * \>1000 to 2000 mcg flunisolide * \>250 to 500 mcg fluticasone * 400 mcg MF * \>1000 to 2000 mcg triamcinolone acetonide Note: Dose delivery by method or modality other than those noted above must be equivalent. * If, based upon the medical judgment of the investigator, there is no inherent harm in changing the subject's current asthma therapy, then the subject (and parent/guardian, if applicable) must be willing to discontinue his/her prescribed ICS or ICS/LABA combination at the Screening Visit, and be transferred to open-label treatment with MF MDI 200 mcg BID for 2 to 3 weeks prior to the Baseline/Randomization Visit. * To document the diagnosis of asthma and assure the subject's responsiveness to bronchodilators before randomization one of the following methods can be used at the Screening Visit, Day -14, or thereafter, but prior to the Baseline Visit: 1. The subject must demonstrate an increase in absolute FEV1 of at least 12% and at least 200 mL within 15 minutes after administration of four inhalations of albuterol/salbutamol (total dose of 360 to 400 mcg) or of nebulized SABA (2.5 mg) if confirmed as standard office practice, OR 2. The subject must demonstrate a peak expiratory flow (PEF) variability of more than 20% expressed as a percentage of the highest and lowest morning prebronchodilator PEF over at least 1 week, OR 3. The subject must demonstrate a diurnal variation in PEF of more than 20% based on the difference between the prebronchodilator morning value and the postbronchodilator value from the evening before, expressed as a percentage of the mean daily PEF value. * At the Screening Visit, the subject's FEV1 must be ≥60% and ≤90% predicted. * At the Baseline Visit, the subject's FEV1 must be ≥60% and ≤85% predicted when all restricted medications have been withheld for the appropriate intervals. * Clinical laboratory tests (complete blood counts \[CBC\], blood chemistries, and urinalysis) conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor. An electrocardiogram (ECG) using a centralized trans-telephonic technology at the Screening Visit must be clinically acceptable to the investigator. A chest x-ray performed at the Screening Visit, or within 12 months prior to the Screening Visit, must be clinically acceptable to the investigator. * A female subject of childbearing potential must have been using a medically acceptable, adequate form of birth control. This includes: 1) hormonal contraceptives as prescribed by a physician (oral combined, hormonal implant); 2) medically prescribed intra-uterine device (IUD); 3) condom in combination with a spermicide (double barrier method); 4) monogamous relationship with a male partner who has had a vasectomy. The subject must have started this birth control method at least 3 months prior to Screening (with the exception of condom in combination with spermicide), and must agree to continue its use for the duration of the study. A female subject of childbearing potential who is not currently sexually active must agree and consent to using a medically acceptable birth control method should she become sexually active during the course of this study. Women who have been surgically sterilized or are at least 1 year postmenopausal are not considered to be of childbearing potential. A female subject of childbearing potential must have a negative serum pregnancy test at Screening in order to be considered eligible for enrollment. Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF | Baseline to Endpoint (12 weeks) | — |
| Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F | 26-week Treatment Period | This endpoint was to measure the time it took for 50% of subjects in a treatment arm to experience a severe asthma exacerbation (also see the posted Other Pre-specified Outcome: Number of Participants With at Least One Severe Asthma Exacerbation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score | Baseline to Week 26 | AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). Standard deviations are pooled. |
| Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score | Baseline to week 26 | ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case). |
| Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA) | Baseline to Endpoint | Baseline is the proportion of nights of last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0=no awakenings to 1=awakenings every night. Standard deviation is pooled. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least One Severe Asthma Exacerbation | Baseline to Week 26 | A severe asthma exacerbation was defined as a clinically judged deterioration of asthma or a meaningful reduction in lung function based on any of the following criteria during the Treatment Period: * A decrease in FEV1 below the Treatment Period stability limit at any visit, * A decrease in AM or PM peak flow below the Treatment Period stability limits on any 2 consecutive days, * An occurrence of any clinical deterioration of asthma (ie, asthma attack) that resulted in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MF/F MDI 200/10 mcg BID mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks | 191 |
| MF MDI 200 mcg BID Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks | 192 |
| F MDI 10 mcg BID Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks | 202 |
| Placebo BID Placebo MDI BID for 26 weeks | 196 |
| Total | 781 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Administrative | 1 | 1 | 0 | 0 |
| Overall Study | Adverse Event | 4 | 6 | 9 | 7 |
| Overall Study | Did not meet protocol eligibility | 9 | 4 | 9 | 3 |
| Overall Study | Lost to Follow-up | 3 | 0 | 0 | 2 |
| Overall Study | Protocol Violation | 4 | 5 | 9 | 6 |
| Overall Study | Treatment Failure | 8 | 13 | 47 | 46 |
| Overall Study | Withdrawal by subject, reasons unrelated | 6 | 3 | 8 | 8 |
| Overall Study | Withdrawal by subjects, reasons related | 0 | 1 | 3 | 5 |
Baseline characteristics
| Characteristic | MF/F MDI 200/10 mcg BID | MF MDI 200 mcg BID | F MDI 10 mcg BID | Placebo BID | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 19 Participants | 10 Participants | 18 Participants | 16 Participants | 63 Participants |
| Age, Categorical >=65 years | 11 Participants | 9 Participants | 10 Participants | 11 Participants | 41 Participants |
| Age, Categorical Between 18 and 65 years | 161 Participants | 173 Participants | 174 Participants | 169 Participants | 677 Participants |
| Age, Continuous | 42.9 years STANDARD_DEVIATION 16.3 | 42.8 years STANDARD_DEVIATION 14.9 | 41.9 years STANDARD_DEVIATION 15.3 | 41.9 years STANDARD_DEVIATION 15.3 | 42.4 years STANDARD_DEVIATION 15.4 |
| Sex: Female, Male Female | 97 Participants | 112 Participants | 129 Participants | 122 Participants | 460 Participants |
| Sex: Female, Male Male | 94 Participants | 80 Participants | 73 Participants | 74 Participants | 321 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 25 / 984 | 31 / 191 | 35 / 192 | 29 / 202 | 30 / 196 |
| serious Total, serious adverse events | 4 / 984 | 5 / 191 | 3 / 192 | 3 / 202 | 3 / 196 |
Outcome results
Primary
Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF
Time frame: Baseline to Endpoint (12 weeks)
Population: Intent to Treat (ITT) population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| MF/F MDI 200/10 mcg BID | Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF | Endpoint (Change from Baseline) | 3.19 liters x hours | Standard Deviation 3.98 |
| MF/F MDI 200/10 mcg BID | Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF | Baseline (n=188/189/198/192, respectively) | 3.20 liters x hours | Standard Deviation 2.96 |
| MF MDI 200 mcg BID | Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF | Endpoint (Change from Baseline) | 1.31 liters x hours | Standard Deviation 3.98 |
| MF MDI 200 mcg BID | Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF | Baseline (n=188/189/198/192, respectively) | 1.29 liters x hours | Standard Deviation 2.96 |
| F MDI 10 mcg BID | Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF | Endpoint (Change from Baseline) | 1.60 liters x hours | Standard Deviation 3.98 |
| F MDI 10 mcg BID | Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF | Baseline (n=188/189/198/192, respectively) | 2.73 liters x hours | Standard Deviation 2.96 |
| Placebo BID | Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF | Endpoint (Change from Baseline) | 0.51 liters x hours | Standard Deviation 3.98 |
| Placebo BID | Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF | Baseline (n=188/189/198/192, respectively) | 1.42 liters x hours | Standard Deviation 2.96 |
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: 0.491ANCOVA
p-value: 0.055ANCOVA
p-value: 0.008ANCOVA
Primary
Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F
This endpoint was to measure the time it took for 50% of subjects in a treatment arm to experience a severe asthma exacerbation (also see the posted Other Pre-specified Outcome: Number of Participants With at Least One Severe Asthma Exacerbation)
Time frame: 26-week Treatment Period
Population: All Randomized Subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MF/F MDI 200/10 mcg BID | Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F | NA days |
| MF MDI 200 mcg BID | Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F | NA days |
| F MDI 10 mcg BID | Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F | 92 days |
| Placebo BID | Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F | 131 days |
Secondary
Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA)
Baseline is the proportion of nights of last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0=no awakenings to 1=awakenings every night. Standard deviation is pooled.
Time frame: Baseline to Endpoint
Population: ITT population from the entire 26-week treatment period
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| MF/F MDI 200/10 mcg BID | Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA) | Change from Baseline to Endpoint | -0.08 Ratio | Standard Deviation 0.17 |
| MF/F MDI 200/10 mcg BID | Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA) | Baseline (n=186/191/199/194, respectively) | 0.18 Ratio | Standard Deviation 0.31 |
| MF MDI 200 mcg BID | Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA) | Baseline (n=186/191/199/194, respectively) | 0.16 Ratio | Standard Deviation 0.27 |
| MF MDI 200 mcg BID | Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA) | Change from Baseline to Endpoint | -0.05 Ratio | Standard Deviation 0.17 |
| F MDI 10 mcg BID | Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA) | Baseline (n=186/191/199/194, respectively) | 0.16 Ratio | Standard Deviation 0.27 |
| F MDI 10 mcg BID | Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA) | Change from Baseline to Endpoint | 0.01 Ratio | Standard Deviation 0.17 |
| Placebo BID | Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA) | Change from Baseline to Endpoint | 0.00 Ratio | Standard Deviation 0.17 |
| Placebo BID | Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA) | Baseline (n=186/191/199/194, respectively) | 0.15 Ratio | Standard Deviation 0.27 |
p-value: 0.063ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: 0.003ANCOVA
p-value: 0.601ANCOVA
Secondary
Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score
AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). Standard deviations are pooled.
Time frame: Baseline to Week 26
Population: ITT population with non-missing post-baseline AQLQ result
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| MF/F MDI 200/10 mcg BID | Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score | Baseline (n=183/189/187/189, respectively) | 5.38 units on a scale | Standard Deviation 1.1 |
| MF/F MDI 200/10 mcg BID | Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score | Change from Baseline to Endpoint (26 weeks) | 0.49 units on a scale | Standard Deviation 0.85 |
| MF MDI 200 mcg BID | Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score | Change from Baseline to Endpoint (26 weeks) | 0.37 units on a scale | Standard Deviation 0.85 |
| MF MDI 200 mcg BID | Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score | Baseline (n=183/189/187/189, respectively) | 5.40 units on a scale | Standard Deviation 1.13 |
| F MDI 10 mcg BID | Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score | Baseline (n=183/189/187/189, respectively) | 5.51 units on a scale | Standard Deviation 1.11 |
| F MDI 10 mcg BID | Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score | Change from Baseline to Endpoint (26 weeks) | 0.05 units on a scale | Standard Deviation 0.85 |
| Placebo BID | Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score | Baseline (n=183/189/187/189, respectively) | 5.56 units on a scale | Standard Deviation 1.06 |
| Placebo BID | Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score | Change from Baseline to Endpoint (26 weeks) | -0.01 units on a scale | Standard Deviation 0.85 |
p-value: 0.174ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: 0.521ANCOVA
Secondary
Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score
ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case).
Time frame: Baseline to week 26
Population: ITT population with non-missing post-baseline ACQ result
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| MF/F MDI 200/10 mcg BID | Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score | Baseline (n=179/186/184/187, respectively) | 1.47 units on a scale | Standard Deviation 0.75 |
| MF/F MDI 200/10 mcg BID | Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score | Change from Baseline to Endpoint (week 26) | -0.40 units on a scale | Standard Deviation 0.74 |
| MF MDI 200 mcg BID | Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score | Change from Baseline to Endpoint (week 26) | -0.23 units on a scale | Standard Deviation 0.74 |
| MF MDI 200 mcg BID | Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score | Baseline (n=179/186/184/187, respectively) | 1.46 units on a scale | Standard Deviation 0.77 |
| F MDI 10 mcg BID | Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score | Baseline (n=179/186/184/187, respectively) | 1.43 units on a scale | Standard Deviation 0.79 |
| F MDI 10 mcg BID | Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score | Change from Baseline to Endpoint (week 26) | 0.11 units on a scale | Standard Deviation 0.74 |
| Placebo BID | Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score | Baseline (n=179/186/184/187, respectively) | 1.41 units on a scale | Standard Deviation 0.75 |
| Placebo BID | Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score | Change from Baseline to Endpoint (week 26) | 0.14 units on a scale | Standard Deviation 0.74 |
p-value: 0.026ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: 0.738ANCOVA
Other Pre-specified
Number of Participants With at Least One Severe Asthma Exacerbation
A severe asthma exacerbation was defined as a clinically judged deterioration of asthma or a meaningful reduction in lung function based on any of the following criteria during the Treatment Period: * A decrease in FEV1 below the Treatment Period stability limit at any visit, * A decrease in AM or PM peak flow below the Treatment Period stability limits on any 2 consecutive days, * An occurrence of any clinical deterioration of asthma (ie, asthma attack) that resulted in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication.
Time frame: Baseline to Week 26
Population: All Randomized Subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MF/F MDI 200/10 mcg BID | Number of Participants With at Least One Severe Asthma Exacerbation | 58 participants |
| MF MDI 200 mcg BID | Number of Participants With at Least One Severe Asthma Exacerbation | 65 participants |
| F MDI 10 mcg BID | Number of Participants With at Least One Severe Asthma Exacerbation | 109 participants |
| Placebo BID | Number of Participants With at Least One Severe Asthma Exacerbation | 109 participants |