Asthma
Conditions
Keywords
Asthma
Brief summary
The purpose of this study is to compare the efficacy, safety and pharmacokinetics of Mometasone furoate delivered via Concept1 device or Twisthaler® device in adult and adolescent patients with persistent asthma.
Interventions
DRUGMometasone furoate
Mometasone furoate (MF) 80 µg once daily delivered via Concept1 device; MF 200 μg once daily delivered via Concept1 device; MF 320μg once daily delivered via Twisthaler® device or 800 μg once daily delivered via Twisthaler® device
DEVICEConcept 1
A single dose dry powder inhaler (SDDPI)
DEVICETwisthaler
A single dose dry powder inhaler (SDDPI)
Sponsors
Novartis Pharmaceuticals
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
* Males or females who were ≥ 12 years old at the time informed consent was obtained * Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally met the following criteria * Patients who were receiving ICS treatment up to the maximum dose per day as indicated in the corresponding package leaflet and also a stable ICS regimen for at least 4 weeks prior to screening (Visit 2). * Patients whose level of asthma control according to GINA 2010 guideline was Partly Controlled or Uncontrolled at screening (Visit 2). * Patients with a pre-bronchodilator FEV1 value of ≤ 80% of predicted normal value at screening (Visit 2). * Patients who demonstrated an increase of ≥ 12% and 200 mL in FEV1 over prebronchodilator value within 30 minutes after inhalation of 400 μg of salbutamol (360 μg of albuterol) at Visit 2 or between Visit 2 and Visit 5. * Patients who were confirmed as ICS sensitive by ACQ-5 and FEV1 at Visit 5. Key
Exclusion criteria
included: * Patients diagnosed with COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease, updated 2010. * Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active), or clinically significant bronchiectasis. * Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) or chronic lung diseases, which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study. * Patients with seasonal allergy which is likely to deteriorate his/her asthma condition during the study period judged by the investigator. * Patients who have had a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to Visit 1 or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure). * Patients who have had an emergency room visit for an asthma attack/exacerbation within 4 weeks prior to Visit 1 or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure). * Patients who have ever required intubation for a severe asthma attack/exacerbation. * Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1, or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure). Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) | Day 29 | Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced Vital Capacity (FVC) at All Time Points | Days 1, 8, 15, 22, 28 and 29 at all time points | Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data within 6 hr of rescue medication use is excluded from this analysis. Mixed model: FVC = treatment + gender+ baseline FVC + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. |
| Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Days 1, 8, 15, 22, 28 and 29 at all time points | The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. |
| Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Days 1, 8, 15, 22, 28 and 29 at all time points | Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. Data within 6 hr of rescue medication use is excluded from this analysis. |
| Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment | Baseline and week 4 | Peak expiratory flow rate (PEFR) was measured via electronice Peak flow meter by patient at home. Mixed model used: change from baseline in the mean evening PEFR = treatment + age + gender + baseline evening PEFR + level of asthma control + region + center (region)+ error. Center is included as a random effect nested within region. |
| Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment | Days 8, 15 and 22 | Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on days 8, 15 and 22 after treatment. Data within 6 hr of rescue medication use is excluded from this analysis. |
| Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment | Baseline and 4 weeks | Rescue medication data recorded during the 14 day run-in period is used to calculate the baseline. - Total number of puffs of rescue medication per day over the full 4 weeks is calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the subject. - MIXED model: Change = treatment + gender + baseline mean daily number of puffs + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. |
| Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment | 4 weeks | Mixed model used: percentage of days with no rescue medication use = treatment + age + gender + baseline percentage of days with no rescue use + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. A day with no rescue use is defined from diary data as any day where the subject does not use any puffs of rescue medication. The total number of days with no rescue use over the 4 week treatment period is divided by the total number of evaluable days in order to derive the percentage of days with no rescue use. |
| Fractional Exhaled Nitric Oxide (FeNO) | Days 15 and 29 | FeNO is widely accepted as a non-invasive marker for airway inflammation such as asthma and conducted according to published guideline. FeNO was measured on days 15 and 29 after treatment. |
| Plasma Cortisol Concentrations | Baseline, days 1 and 28 | Blood samples were taken from each subject participating in the study post dose at day 1 and week 4. Cortisol concentrations were evaluated. Results are presented as nmol/L |
| Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit | Baseline, days 8,15,22 and 29 | Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ-5 has five questions of the asthma symptoms to be answered by the patient. The overall score is the average of the 5 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. - Baseline ACQ-5 is defined as the questionnaire completed on Day 1 (randomization). |
Countries
Belgium, Canada, Estonia, Germany, Hungary, India, Japan, Latvia, Lithuania, Malaysia, Netherlands, Poland, Russia, Slovakia, Thailand, Turkey (Türkiye), Ukraine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening | 188 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening | 181 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening | 184 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening | 186 |
| Total | 739 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Administrative | 3 | 1 | 2 | 0 |
| Overall Study | Adverse Event | 1 | 2 | 1 | 2 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 3 | 3 | 3 | 5 |
| Overall Study | Withdrawal by Subject | 6 | 2 | 0 | 2 |
Baseline characteristics
| Characteristic | Mometasone Furoate 80 ug Daily Via the Concept1 Device | Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Mometasone Furoate 320 ug Daily Via the Concept1 Device | Mometasone Furoate 800 ug Via the Twisthaler® Device | Total |
|---|---|---|---|---|---|
| Age, Continuous | 44.4 years STANDARD_DEVIATION 16.33 | 45.9 years STANDARD_DEVIATION 15.56 | 46.0 years STANDARD_DEVIATION 16.18 | 45.5 years STANDARD_DEVIATION 16.57 | 45.4 years STANDARD_DEVIATION 16.15 |
| Sex: Female, Male Female | 98 Participants | 94 Participants | 113 Participants | 97 Participants | 402 Participants |
| Sex: Female, Male Male | 90 Participants | 87 Participants | 71 Participants | 89 Participants | 337 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 | 13 / 186 | 17 / 180 | 15 / 183 | 8 / 186 | 53 / 735 |
| serious Total, serious adverse events | 0 / 186 | 0 / 180 | 1 / 183 | 0 / 186 | 1 / 735 |
Outcome results
Primary
Trough Forced Expiratory Volume in 1 Second (FEV1)
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment.
Time frame: Day 29
Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Trough Forced Expiratory Volume in 1 Second (FEV1) | 2.139 Liters | Standard Error 0.0281 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Trough Forced Expiratory Volume in 1 Second (FEV1) | 2.071 Liters | Standard Error 0.0283 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Trough Forced Expiratory Volume in 1 Second (FEV1) | 2.187 Liters | Standard Error 0.0281 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Trough Forced Expiratory Volume in 1 Second (FEV1) | 2.162 Liters | Standard Error 0.0279 |
Secondary
Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit
Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ-5 has five questions of the asthma symptoms to be answered by the patient. The overall score is the average of the 5 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. - Baseline ACQ-5 is defined as the questionnaire completed on Day 1 (randomization).
Time frame: Baseline, days 8,15,22 and 29
Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit | Day 22-baseline (n=178,173,178,177) | -0.994 Units on a scale | Standard Error 0.062 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit | Day 15-baseline(n=180,174,179,178) | -0.899 Units on a scale | Standard Error 0.059 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit | Day 29-baseline (n=179,176,181,182) | -1.079 Units on a scale | Standard Error 0.063 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit | Day 8-baseline (n=179,176,182,182) | -0.662 Units on a scale | Standard Error 0.0543 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit | Day 8-baseline (n=179,176,182,182) | -0.730 Units on a scale | Standard Error 0.0546 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit | Day 22-baseline (n=178,173,178,177) | -0.982 Units on a scale | Standard Error 0.0628 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit | Day 29-baseline (n=179,176,181,182) | -1.109 Units on a scale | Standard Error 0.602 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit | Day 15-baseline(n=180,174,179,178) | -0.908 Units on a scale | Standard Error 0.0599 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit | Day 29-baseline (n=179,176,181,182) | -1.329 Units on a scale | Standard Error 0.0632 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit | Day 8-baseline (n=179,176,182,182) | -0.908 Units on a scale | Standard Error 0.054 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit | Day 22-baseline (n=178,173,178,177) | -1.262 Units on a scale | Standard Error 0.0622 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit | Day 15-baseline(n=180,174,179,178) | -1.117 Units on a scale | Standard Error 0.0595 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit | Day 15-baseline(n=180,174,179,178) | -0.973 Units on a scale | Standard Error 0.0593 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit | Day 22-baseline (n=178,173,178,177) | -1.097 Units on a scale | Standard Error 0.0622 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit | Day 8-baseline (n=179,176,182,182) | -0.890 Units on a scale | Standard Error 0.0538 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit | Day 29-baseline (n=179,176,181,182) | -1.162 Units on a scale | Standard Error 0.0625 |
Secondary
Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment
Rescue medication data recorded during the 14 day run-in period is used to calculate the baseline. - Total number of puffs of rescue medication per day over the full 4 weeks is calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the subject. - MIXED model: Change = treatment + gender + baseline mean daily number of puffs + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.
Time frame: Baseline and 4 weeks
Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment | -0.456 number of puffs | Standard Error 0.0972 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment | -0.391 number of puffs | Standard Error 0.0985 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment | -0.600 number of puffs | Standard Error 0.0981 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment | -0.677 number of puffs | Standard Error 0.0963 |
Secondary
Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment
Peak expiratory flow rate (PEFR) was measured via electronice Peak flow meter by patient at home. Mixed model used: change from baseline in the mean evening PEFR = treatment + age + gender + baseline evening PEFR + level of asthma control + region + center (region)+ error. Center is included as a random effect nested within region.
Time frame: Baseline and week 4
Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment | Morning 4 wks-baseline (n=177,171, 175, 182) | -4.952 Liters per min | Standard Error 4.1929 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment | Evening 4 wks-baseline (n=176, 172, 174, 179) | 1.354 Liters per min | Standard Error 3.9003 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment | Morning 4 wks-baseline (n=177,171, 175, 182) | 3.955 Liters per min | Standard Error 4.2616 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment | Evening 4 wks-baseline (n=176, 172, 174, 179) | 0.293 Liters per min | Standard Error 3.9477 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment | Morning 4 wks-baseline (n=177,171, 175, 182) | 2.785 Liters per min | Standard Error 4.2349 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment | Evening 4 wks-baseline (n=176, 172, 174, 179) | -0.644 Liters per min | Standard Error 3.9427 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment | Morning 4 wks-baseline (n=177,171, 175, 182) | 1.606 Liters per min | Standard Error 4.1464 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment | Evening 4 wks-baseline (n=176, 172, 174, 179) | 6.287 Liters per min | Standard Error 3.8826 |
Secondary
Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points
The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.
Time frame: Days 1, 8, 15, 22, 28 and 29 at all time points
Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 29/23hr 45 min post-dose (n=171,161, 175,170) | 1.550 Liters per second | Standard Error 0.037 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 22/15 min pre-dose (n=168,170,174,172) | 1.540 Liters per second | Standard Error 0.0365 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 15/15 min pre-dose (n=175,168,176,167) | 1.494 Liters per second | Standard Error 0.0322 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 8/15 min pre-dose (n=175,172,179,173) | 1.458 Liters per second | Standard Error 0.0329 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 29/23hr 10 min post-dose (n=172,162,172,168) | 1.537 Liters per second | Standard Error 0.0369 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 15 /50 min pre-dose (n=175,169,170,169) | 1.509 Liters per second | Standard Error 0.0317 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 28/15 min pre-dose (n=169,165,174, 170) | 1.529 Liters per second | Standard Error 0.0357 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 28/30 min post-dose (n=172,167,172,172) | 1.566 Liters per second | Standard Error 0.0367 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 1/30 min post-dose (n=172,172,175,172) | 1.308 Liters per second | Standard Error 0.0181 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 1/1 hr post-dose (n=178,169,174,174) | 1.337 Liters per second | Standard Error 0.0197 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 22/50 min pre-dose (n=171,167,174,169) | 1.511 Liters per second | Standard Error 0.035 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 28/30 min post-dose (n=175,166,174,170) | 1.558 Liters per second | Standard Error 0.0362 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 28/50 min pre-dose (n=171,168,176,172) | 1.504 Liters per second | Standard Error 0.0353 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 8/50 min pre-dose (n=173,171,179,174) | 1.457 Liters per second | Standard Error 0.0323 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 28/30 min post-dose (n=175,166,174,170) | 1.457 Liters per second | Standard Error 0.0368 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 1/30 min post-dose (n=172,172,175,172) | 1.300 Liters per second | Standard Error 0.0182 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 22/15 min pre-dose (n=168,170,174,172) | 1.476 Liters per second | Standard Error 0.0362 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 1/1 hr post-dose (n=178,169,174,174) | 1.327 Liters per second | Standard Error 0.0201 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 8/50 min pre-dose (n=173,171,179,174) | 1.449 Liters per second | Standard Error 0.0322 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 8/15 min pre-dose (n=175,172,179,173) | 1.466 Liters per second | Standard Error 0.0328 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 15 /50 min pre-dose (n=175,169,170,169) | 1.430 Liters per second | Standard Error 0.0321 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 15/15 min pre-dose (n=175,168,176,167) | 1.414 Liters per second | Standard Error 0.0326 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 22/50 min pre-dose (n=171,167,174,169) | 1.440 Liters per second | Standard Error 0.0353 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 28/50 min pre-dose (n=171,168,176,172) | 1.458 Liters per second | Standard Error 0.0354 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 28/15 min pre-dose (n=169,165,174, 170) | 1.481 Liters per second | Standard Error 0.0359 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 28/30 min post-dose (n=172,167,172,172) | 1.460 Liters per second | Standard Error 0.0369 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 29/23hr 10 min post-dose (n=172,162,172,168) | 1.451 Liters per second | Standard Error 0.0376 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 29/23hr 45 min post-dose (n=171,161, 175,170) | 1.438 Liters per second | Standard Error 0.0378 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 15/15 min pre-dose (n=175,168,176,167) | 1.520 Liters per second | Standard Error 0.0321 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 22/50 min pre-dose (n=171,167,174,169) | 1.565 Liters per second | Standard Error 0.0348 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 8/50 min pre-dose (n=173,171,179,174) | 1.519 Liters per second | Standard Error 0.0317 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 22/15 min pre-dose (n=168,170,174,172) | 1.600 Liters per second | Standard Error 0.0361 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 28/50 min pre-dose (n=171,168,176,172) | 1.581 Liters per second | Standard Error 0.035 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 28/15 min pre-dose (n=169,165,174, 170) | 1.574 Liters per second | Standard Error 0.0354 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 1/1 hr post-dose (n=178,169,174,174) | 1.316 Liters per second | Standard Error 0.0201 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 28/30 min post-dose (n=175,166,174,170) | 1.557 Liters per second | Standard Error 0.0364 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 1/30 min post-dose (n=172,172,175,172) | 1.309 Liters per second | Standard Error 0.0182 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 28/30 min post-dose (n=172,167,172,172) | 1.577 Liters per second | Standard Error 0.0368 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 8/15 min pre-dose (n=175,172,179,173) | 1.542 Liters per second | Standard Error 0.0325 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 15 /50 min pre-dose (n=175,169,170,169) | 1.514 Liters per second | Standard Error 0.032 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 29/23hr 45 min post-dose (n=171,161, 175,170) | 1.576 Liters per second | Standard Error 0.0366 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 29/23hr 10 min post-dose (n=172,162,172,168) | 1.604 Liters per second | Standard Error 0.0369 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 15 /50 min pre-dose (n=175,169,170,169) | 1.544 Liters per second | Standard Error 0.0321 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 28/30 min post-dose (n=175,166,174,170) | 1.615 Liters per second | Standard Error 0.0364 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 22/50 min pre-dose (n=171,167,174,169) | 1.555 Liters per second | Standard Error 0.0351 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 28/50 min pre-dose (n=171,168,176,172) | 1.598 Liters per second | Standard Error 0.0351 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 29/23hr 45 min post-dose (n=171,161, 175,170) | 1.571 Liters per second | Standard Error 0.0369 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 22/15 min pre-dose (n=168,170,174,172) | 1.591 Liters per second | Standard Error 0.0361 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 1/1 hr post-dose (n=178,169,174,174) | 1.345 Liters per second | Standard Error 0.0199 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 29/23hr 10 min post-dose (n=172,162,172,168) | 1.584 Liters per second | Standard Error 0.0371 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 8/50 min pre-dose (n=173,171,179,174) | 1.525 Liters per second | Standard Error 0.0321 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 15/15 min pre-dose (n=175,168,176,167) | 1.561 Liters per second | Standard Error 0.0327 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 28/30 min post-dose (n=172,167,172,172) | 1.593 Liters per second | Standard Error 0.0365 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 28/15 min pre-dose (n=169,165,174, 170) | 1.584 Liters per second | Standard Error 0.0355 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 8/15 min pre-dose (n=175,172,179,173) | 1.566 Liters per second | Standard Error 0.0328 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points | Day 1/30 min post-dose (n=172,172,175,172) | 1.308 Liters per second | Standard Error 0.0182 |
Secondary
Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points
Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. Data within 6 hr of rescue medication use is excluded from this analysis.
Time frame: Days 1, 8, 15, 22, 28 and 29 at all time points
Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 15 /50 min pre-dose (n=176,169,170,169) | 67.007 Percent | Standard Error 0.4329 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 28/30 min post-dose (n=173,167,172,172) | 67.945 Percent | Standard Error 0.4703 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 22/50 min pre-dose (n=172,167,174,169) | 67.081 Percent | Standard Error 0.4594 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 1/30 min post-dose (n=172,172,175,173) | 65.043 Percent | Standard Error 0.2548 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 22/15 min pre-dose (n=169,170,174,172) | 67.403 Percent | Standard Error 0.4657 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 29/23hr 10 min post-dose (n=173,162,172,168) | 67.427 Percent | Standard Error 0.4639 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 29/23hr 45 min post-dose (n=172,161, 175,170) | 67.630 Percent | Standard Error 0.4694 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 28/30 min post-dose (n=175,166,174,170) | 67.700 Percent | Standard Error 0.4723 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 8/50 min pre-dose (n=174,171,179,175) | 66.566 Percent | Standard Error 0.4281 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 15/15 min pre-dose (n=176,168,176,167) | 66.878 Percent | Standard Error 0.437 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 28/15 min pre-dose (n=170,165,174, 170) | 67.503 Percent | Standard Error 0.4813 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 28/50 min pre-dose (n=172,168,176,172) | 67.128 Percent | Standard Error 0.4584 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 8/15 min pre-dose (n=176,172,179,174) | 66.595 Percent | Standard Error 0.4259 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 1/1 hr post-dose (n=178,169,174,175) | 65.177 Percent | Standard Error 0.2833 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 28/50 min pre-dose (n=172,168,176,172) | 66.835 Percent | Standard Error 0.4615 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 28/15 min pre-dose (n=170,165,174, 170) | 67.296 Percent | Standard Error 0.4854 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 28/30 min post-dose (n=175,166,174,170) | 67.013 Percent | Standard Error 0.4796 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 22/15 min pre-dose (n=169,170,174,172) | 66.885 Percent | Standard Error 0.4629 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 29/23hr 10 min post-dose (n=173,162,172,168) | 66.711 Percent | Standard Error 0.4736 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 28/30 min post-dose (n=173,167,172,172) | 66.832 Percent | Standard Error 0.4741 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 15 /50 min pre-dose (n=176,169,170,169) | 66.122 Percent | Standard Error 0.4398 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 29/23hr 45 min post-dose (n=172,161, 175,170) | 66.541 Percent | Standard Error 0.4806 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 1/30 min post-dose (n=172,172,175,173) | 64.898 Percent | Standard Error 0.2556 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 8/50 min pre-dose (n=174,171,179,175) | 66.301 Percent | Standard Error 0.4286 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 1/1 hr post-dose (n=178,169,174,175) | 64.833 Percent | Standard Error 0.289 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 22/50 min pre-dose (n=172,167,174,169) | 66.567 Percent | Standard Error 0.4643 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 8/15 min pre-dose (n=176,172,179,174) | 66.790 Percent | Standard Error 0.4262 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 15/15 min pre-dose (n=176,168,176,167) | 66.006 Percent | Standard Error 0.4443 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 22/15 min pre-dose (n=169,170,174,172) | 68.143 Percent | Standard Error 0.4622 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 15/15 min pre-dose (n=176,168,176,167) | 67.607 Percent | Standard Error 0.4384 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 1/1 hr post-dose (n=178,169,174,175) | 65.005 Percent | Standard Error 0.2885 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 8/50 min pre-dose (n=174,171,179,175) | 67.344 Percent | Standard Error 0.4222 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 22/50 min pre-dose (n=172,167,174,169) | 67.831 Percent | Standard Error 0.4584 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 29/23hr 45 min post-dose (n=172,161, 175,170) | 67.961 Percent | Standard Error 0.4667 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 28/15 min pre-dose (n=170,165,174, 170) | 68.255 Percent | Standard Error 0.4796 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 15 /50 min pre-dose (n=176,169,170,169) | 67.487 Percent | Standard Error 0.4395 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 29/23hr 10 min post-dose (n=173,162,172,168) | 68.265 Percent | Standard Error 0.4654 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 8/15 min pre-dose (n=176,172,179,174) | 67.778 Percent | Standard Error 0.4224 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 28/30 min post-dose (n=173,167,172,172) | 68.243 Percent | Standard Error 0.4736 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 28/30 min post-dose (n=175,166,174,170) | 68.031 Percent | Standard Error 0.4755 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 1/30 min post-dose (n=172,172,175,173) | 65.184 Percent | Standard Error 0.2559 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 28/50 min pre-dose (n=172,168,176,172) | 68.124 Percent | Standard Error 0.4567 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 29/23hr 45 min post-dose (n=172,161, 175,170) | 67.831 Percent | Standard Error 0.4692 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 8/15 min pre-dose (n=176,172,179,174) | 67.156 Percent | Standard Error 0.4252 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 15 /50 min pre-dose (n=176,169,170,169) | 67.139 Percent | Standard Error 0.4407 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 22/50 min pre-dose (n=172,167,174,169) | 67.742 Percent | Standard Error 0.4615 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 22/15 min pre-dose (n=169,170,174,172) | 67.895 Percent | Standard Error 0.4612 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 28/30 min post-dose (n=173,167,172,172) | 68.057 Percent | Standard Error 0.4698 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 29/23hr 10 min post-dose (n=173,162,172,168) | 67.592 Percent | Standard Error 0.4676 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 1/30 min post-dose (n=172,172,175,173) | 64.898 Percent | Standard Error 0.2554 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 8/50 min pre-dose (n=174,171,179,175) | 66.568 Percent | Standard Error 0.4264 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 15/15 min pre-dose (n=176,168,176,167) | 67.514 Percent | Standard Error 0.4456 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 28/50 min pre-dose (n=172,168,176,172) | 67.810 Percent | Standard Error 0.4578 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 28/15 min pre-dose (n=170,165,174, 170) | 67.878 Percent | Standard Error 0.4804 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 28/30 min post-dose (n=175,166,174,170) | 68.126 Percent | Standard Error 0.4755 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points | Day 1/1 hr post-dose (n=178,169,174,175) | 65.072 Percent | Standard Error 0.2845 |
Secondary
Forced Vital Capacity (FVC) at All Time Points
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data within 6 hr of rescue medication use is excluded from this analysis. Mixed model: FVC = treatment + gender+ baseline FVC + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.
Time frame: Days 1, 8, 15, 22, 28 and 29 at all time points
Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 15 /50 min pre-dose (n=175,169,170,169) | 3.134 Liters | Standard Error 0.0342 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 15/15 min pre-dose (n=176,168,176,167) | 3.109 Liters | Standard Error 0.0343 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 22/50 min pre-dose (n=172,167,174,169) | 3.136 Liters | Standard Error 0.0356 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 29/23hr 10 min post-dose (n=173,162,172,168) | 3.160 Liters | Standard Error 0.0342 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 28/50 min pre-dose (n=172,168,176,172) | 3.146 Liters | Standard Error 0.0342 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 22/15 min pre-dose (n=169,170,174,172) | 3.134 Liters | Standard Error 0.0365 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 29/23hr 45 min post-dose (n=172,161, 175,170) | 3.165 Liters | Standard Error 0.0355 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 28/30 min post-dose (n=173,167,172,172) | 3.140 Liters | Standard Error 0.0351 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 8/50 min pre-dose (n=174,171,179,174) | 3.111 Liters | Standard Error 0.0325 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 1/1 hr post-dose (n=178,169,174,175) | 2.930 Liters | Standard Error 0.0234 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 28/30 min post-dose (n=175,166,174,170) | 3.132 Liters | Standard Error 0.0341 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 8/15 min pre-dose (n=176,172,179,174) | 3.099 Liters | Standard Error 0.0324 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 1/30 min post-dose (n=172,172,175,173) | 2.892 Liters | Standard Error 0.0208 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 28/15 min pre-dose (n=170,165,174, 170) | 3.135 Liters | Standard Error 0.0345 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 28/15 min pre-dose (n=170,165,174, 170) | 3.095 Liters | Standard Error 0.0348 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 28/30 min post-dose (n=175,166,174,170) | 3.092 Liters | Standard Error 0.0346 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 28/50 min pre-dose (n=172,168,176,172) | 3.115 Liters | Standard Error 0.0345 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 22/50 min pre-dose (n=172,167,174,169) | 3.091 Liters | Standard Error 0.0359 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 1/1 hr post-dose (n=178,169,174,175) | 2.913 Liters | Standard Error 0.0238 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 15/15 min pre-dose (n=176,168,176,167) | 3.076 Liters | Standard Error 0.0348 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 8/15 min pre-dose (n=176,172,179,174) | 3.074 Liters | Standard Error 0.0324 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 22/15 min pre-dose (n=169,170,174,172) | 3.096 Liters | Standard Error 0.0363 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 29/23hr 10 min post-dose (n=173,162,172,168) | 3.113 Liters | Standard Error 0.0348 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 28/30 min post-dose (n=173,167,172,172) | 3.084 Liters | Standard Error 0.0353 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 8/50 min pre-dose (n=174,171,179,174) | 3.096 Liters | Standard Error 0.0325 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 29/23hr 45 min post-dose (n=172,161, 175,170) | 3.090 Liters | Standard Error 0.0363 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 15 /50 min pre-dose (n=175,169,170,169) | 3.090 Liters | Standard Error 0.0347 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 1/30 min post-dose (n=172,172,175,173) | 2.893 Liters | Standard Error 0.0207 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 29/23hr 45 min post-dose (n=172,161, 175,170) | 3.192 Liters | Standard Error 0.0353 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 15 /50 min pre-dose (n=175,169,170,169) | 3.168 Liters | Standard Error 0.0348 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 15/15 min pre-dose (n=176,168,176,167) | 3.137 Liters | Standard Error 0.0345 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 1/30 min post-dose (n=172,172,175,173) | 2.861 Liters | Standard Error 0.0209 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 1/1 hr post-dose (n=178,169,174,175) | 2.943 Liters | Standard Error 0.0238 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 8/50 min pre-dose (n=174,171,179,174) | 3.134 Liters | Standard Error 0.0321 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 8/15 min pre-dose (n=176,172,179,174) | 3.121 Liters | Standard Error 0.0321 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 22/50 min pre-dose (n=172,167,174,169) | 3.203 Liters | Standard Error 0.0355 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 22/15 min pre-dose (n=169,170,174,172) | 3.198 Liters | Standard Error 0.0362 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 28/50 min pre-dose (n=172,168,176,172) | 3.184 Liters | Standard Error 0.034 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 28/15 min pre-dose (n=170,165,174, 170) | 3.153 Liters | Standard Error 0.0343 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 28/30 min post-dose (n=175,166,174,170) | 3.151 Liters | Standard Error 0.0343 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 28/30 min post-dose (n=173,167,172,172) | 3.158 Liters | Standard Error 0.0353 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Forced Vital Capacity (FVC) at All Time Points | Day 29/23hr 10 min post-dose (n=173,162,172,168) | 3.216 Liters | Standard Error 0.0343 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 8/15 min pre-dose (n=176,172,179,174) | 3.125 Liters | Standard Error 0.0323 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 8/50 min pre-dose (n=174,171,179,174) | 3.139 Liters | Standard Error 0.0324 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 15/15 min pre-dose (n=176,168,176,167) | 3.127 Liters | Standard Error 0.0348 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 28/15 min pre-dose (n=170,165,174, 170) | 3.161 Liters | Standard Error 0.0344 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 1/1 hr post-dose (n=178,169,174,175) | 2.946 Liters | Standard Error 0.0235 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 1/30 min post-dose (n=172,172,175,173) | 2.897 Liters | Standard Error 0.0208 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 28/30 min post-dose (n=173,167,172,172) | 3.161 Liters | Standard Error 0.035 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 28/30 min post-dose (n=175,166,174,170) | 3.184 Liters | Standard Error 0.0343 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 29/23hr 45 min post-dose (n=172,161, 175,170) | 3.158 Liters | Standard Error 0.0355 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 22/15 min pre-dose (n=169,170,174,172) | 3.157 Liters | Standard Error 0.0361 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 22/50 min pre-dose (n=172,167,174,169) | 3.152 Liters | Standard Error 0.0357 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 15 /50 min pre-dose (n=175,169,170,169) | 3.155 Liters | Standard Error 0.0348 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 29/23hr 10 min post-dose (n=173,162,172,168) | 3.194 Liters | Standard Error 0.0344 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Forced Vital Capacity (FVC) at All Time Points | Day 28/50 min pre-dose (n=172,168,176,172) | 3.180 Liters | Standard Error 0.0342 |
Secondary
Fractional Exhaled Nitric Oxide (FeNO)
FeNO is widely accepted as a non-invasive marker for airway inflammation such as asthma and conducted according to published guideline. FeNO was measured on days 15 and 29 after treatment.
Time frame: Days 15 and 29
Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Fractional Exhaled Nitric Oxide (FeNO) | Day 15 (n= 142, 139, 139, 149) | 25.286 ppm | Standard Error 1.2983 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Fractional Exhaled Nitric Oxide (FeNO) | Day 29 (n=141, 143, 145, 150) | 23.777 ppm | Standard Error 1.3078 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Fractional Exhaled Nitric Oxide (FeNO) | Day 15 (n= 142, 139, 139, 149) | 26.762 ppm | Standard Error 1.3201 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Fractional Exhaled Nitric Oxide (FeNO) | Day 29 (n=141, 143, 145, 150) | 27.055 ppm | Standard Error 1.3035 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Fractional Exhaled Nitric Oxide (FeNO) | Day 29 (n=141, 143, 145, 150) | 18.468 ppm | Standard Error 1.2952 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Fractional Exhaled Nitric Oxide (FeNO) | Day 15 (n= 142, 139, 139, 149) | 19.098 ppm | Standard Error 1.3246 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Fractional Exhaled Nitric Oxide (FeNO) | Day 15 (n= 142, 139, 139, 149) | 21.017 ppm | Standard Error 1.2911 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Fractional Exhaled Nitric Oxide (FeNO) | Day 29 (n=141, 143, 145, 150) | 19.981 ppm | Standard Error 1.2803 |
Secondary
Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment
Mixed model used: percentage of days with no rescue medication use = treatment + age + gender + baseline percentage of days with no rescue use + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. A day with no rescue use is defined from diary data as any day where the subject does not use any puffs of rescue medication. The total number of days with no rescue use over the 4 week treatment period is divided by the total number of evaluable days in order to derive the percentage of days with no rescue use.
Time frame: 4 weeks
Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment | 74.148 percentage days | Standard Error 2.2576 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment | 75.236 percentage days | Standard Error 2.3291 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment | 75.157 percentage days | Standard Error 2.3044 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment | 80.578 percentage days | Standard Error 2.3476 |
Secondary
Plasma Cortisol Concentrations
Blood samples were taken from each subject participating in the study post dose at day 1 and week 4. Cortisol concentrations were evaluated. Results are presented as nmol/L
Time frame: Baseline, days 1 and 28
Population: The safety set includes all subjects who received at least one dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Plasma Cortisol Concentrations | Baseline (n= 183, 178, 179, 181) | 150.040 nmol/L | Standard Deviation 80.3928 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Plasma Cortisol Concentrations | Day 28/-25 Mins (n= 172, 169, 174, 172) | 140.760 nmol/L | Standard Deviation 73.3567 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Plasma Cortisol Concentrations | Day 28/1 Hr (n= 172, 168, 174, 170) | 105.399 nmol/L | Standard Deviation 68.9416 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Plasma Cortisol Concentrations | Day 1/1 Hr (n=179, 177,174, 176) | 118.130 nmol/L | Standard Deviation 92.7539 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Plasma Cortisol Concentrations | Baseline (n= 183, 178, 179, 181) | 143.132 nmol/L | Standard Deviation 88.4206 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Plasma Cortisol Concentrations | Day 28/1 Hr (n= 172, 168, 174, 170) | 107.931 nmol/L | Standard Deviation 70.7374 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Plasma Cortisol Concentrations | Day 28/-25 Mins (n= 172, 169, 174, 172) | 140.604 nmol/L | Standard Deviation 72.8885 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Plasma Cortisol Concentrations | Day 1/1 Hr (n=179, 177,174, 176) | 106.965 nmol/L | Standard Deviation 81.516 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Plasma Cortisol Concentrations | Day 28/1 Hr (n= 172, 168, 174, 170) | 105.468 nmol/L | Standard Deviation 57.9029 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Plasma Cortisol Concentrations | Baseline (n= 183, 178, 179, 181) | 143.791 nmol/L | Standard Deviation 85.8696 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Plasma Cortisol Concentrations | Day 1/1 Hr (n=179, 177,174, 176) | 107.526 nmol/L | Standard Deviation 74.377 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Plasma Cortisol Concentrations | Day 28/-25 Mins (n= 172, 169, 174, 172) | 143.555 nmol/L | Standard Deviation 82.4961 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Plasma Cortisol Concentrations | Day 28/1 Hr (n= 172, 168, 174, 170) | 110.477 nmol/L | Standard Deviation 77.222 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Plasma Cortisol Concentrations | Baseline (n= 183, 178, 179, 181) | 150.108 nmol/L | Standard Deviation 88.6815 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Plasma Cortisol Concentrations | Day 1/1 Hr (n=179, 177,174, 176) | 115.489 nmol/L | Standard Deviation 79.3869 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Plasma Cortisol Concentrations | Day 28/-25 Mins (n= 172, 169, 174, 172) | 145.484 nmol/L | Standard Deviation 92.294 |
Secondary
Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on days 8, 15 and 22 after treatment. Data within 6 hr of rescue medication use is excluded from this analysis.
Time frame: Days 8, 15 and 22
Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment | Day 22 (n=174,170,177,177) | 2.126 Liters | Standard Error 0.0284 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment | Day 8 (n=178,173,181,181) | 2.069 Liters | Standard Error 0.0252 |
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment | Day 15 (n=179,171,177,178) | 2.095 Liters | Standard Error 0.0254 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment | Day 15 (n=179,171,177,178) | 2.048 Liters | Standard Error 0.0258 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment | Day 8 (n=178,173,181,181) | 2.057 Liters | Standard Error 0.0253 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment | Day 22 (n=174,170,177,177) | 2.071 Liters | Standard Error 0.0286 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment | Day 22 (n=174,170,177,177) | 2.175 Liters | Standard Error 0.0283 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment | Day 8 (n=178,173,181,181) | 2.113 Liters | Standard Error 0.0251 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment | Day 15 (n=179,171,177,178) | 2.134 Liters | Standard Error 0.0257 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment | Day 15 (n=179,171,177,178) | 2.135 Liters | Standard Error 0.0255 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment | Day 8 (n=178,173,181,181) | 2.111 Liters | Standard Error 0.025 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment | Day 22 (n=174,170,177,177) | 2.146 Liters | Standard Error 0.0282 |