Asthma
Conditions
Keywords
Asthma, LABA, Safety
Brief summary
Study CQMF149A2210 evaluated the safety of QMF149 Twisthaler® 500/400 μg, a fixed dose combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg, an inhaled corticosteroid (ICS) that is approved for use in the treatment of asthma. The objective of this safety trial was to assess the effect of treatment on the incidence of serious asthma exacerbations, defined as asthma related hospitalization and/or intubation and/or death. This was an event driven trial.
Interventions
DRUGQMF149 Twisthaler®
Once daily via multi-dose dry-powder inhaler
DRUGMometasone Twisthaler®
Once daily via multi-dose dry-powder inhaler
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a documented diagnosis of persistent asthma and who were currently treated with or qualified for treatment with both ICS and long-acting beta2-agonist (LABA) combination * Patients demonstrating an increase in forced expiration volume in 1 second (FEV1) of ≥ 12% or ≥ 200 mLs within 30 minutes after administration of short-acting beta2-agonist (SABA) * Patients with an FEV1 ≥ 50% of predicted normal
Exclusion criteria
* Patients with a previous diagnosis of chronic obstructive pulmonary disease (COPD) * Patients who had an asthma attack/exacerbation requiring hospitalization/emergency room visit or respiratory tract infection within 1 month prior to randomization * Patients who had ever required ventilator support for respiratory failure * Patients with diabetes Type I or uncontrolled diabetes Type II * Patients with concomitant pulmonary disease * Patients with certain cardiovascular co-morbid conditions * Patients with any significant medical condition that might compromise patient safety, interfere with evaluation or preclude completion of the study Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Serious Asthma Exacerbation | Up to 21 months | Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids | Up to 21 months | Number of patients requiring treatment with systemic corticosteroids (oral or parenteral) over the course of the study (up to 21 months). |
| Number of Patients With at Least One Asthma Worsening Post-baseline | Up to 21 months | The criterion for asthma worsening were: decrease in peak expiratory flow (PEF) \>= 20% from mean baseline on \>= 3 consecutive days, nighttime symptom score \>= 2 on \>= 2 consecutive nights, decrease in forced expiration volume in 1 second (FEV1) \>=20% from baseline at evening visits, daytime symptom score of 3 or 4 on \>= 2 consecutive days, requiring an urgent unscheduled visit for medical care, 24 hour rescue medication use \>= 8 puffs on \>= 2 consecutive days, and any other clinically important symptoms (pre-specified MedDRA preferred terms). |
| Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit | Baseline to the end of treatment (varying durations, up to 21 months) | Spirometry was conducted according to internationally accepted standards. Trough FEV1 was measured 15 minutes before dosing; measurements within 6 hours of rescue medication use were set to missing. Repeated measures of analysis of covariance model: change from baseline to trough FEV1 = treatment + visit + treatment\*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient. |
| Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit | Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose | Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FEV1 data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FEV1 = treatment + visit + treatment\*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient. |
| Change From Baseline in Forced Vital Capacity (FVC) at Final Visit | Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose | Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FVC data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FVC = treatment + visit + treatment\*visit interaction + baseline FVC + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient. |
| Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death. | up to 21 months | The number of patients with at least one serious asthma exacerbation over the course of the study. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death. |
| Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime | Baseline to the end of treatment (varying durations, up to 21 months) | Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient. |
| Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime | Baseline to the end of treatment (varying durations, up to 21 months) | Total asthma symptom score = morning symptoms (0, 1) + daytime score (0-4) + nighttime score (0-4). The range is from 0 to 9. A lower number indicates improvement. Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient. |
| Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime | Baseline to the end of treatment (varying durations, up to 21 months) | 24 hours consists of both 12 hour daytime and 12 hour nighttime. Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient. |
| Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit | Baseline to the end of treatment (varying durations, up to 21 months) | The Asthma Control Questionnaire score ranges from 0 (good control of asthma) to 6 (poor control of asthma). A negative change in score indicates improvement in asthma control. Repeated measures of analysis of covariance model: change from baseline in ACQ score = treatment + visit + treatment\*visit interaction + baseline ACQ score + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient. |
| Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period | Baseline to the end of treatment (varying durations, up to 21 months) | PEF was performed every morning and evening prior to study medication use except evenings on the day of clinic visits. Baseline is average over the last 14 days prior to start of treatment. Analysis of covariance model: change from baseline in PEF = treatment + baseline PEF + region + history of asthma related hospitalization in the past 12 months + history of asthma worsening in the past 12 months + African American patient. |
Countries
Brazil, Colombia, Czechia, Hungary, India, Peru, Slovakia, South Korea, United States
Participant flow
Pre-assignment details
2283 patients were screened. 1518 patients were randomized.
Participants by arm
| Arm | Count |
|---|---|
| QMF149 Twisthaler® 500/400 QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD) | 749 |
| Mometasone Twisthaler® Mometasone Twisthaler®, 400 µg QD | 759 |
| Total | 1,508 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Abnormal laboratory values | 1 | 2 |
| Overall Study | Abnormal test procedure results | 3 | 1 |
| Overall Study | Administrative problems | 13 | 23 |
| Overall Study | Adverse Event | 43 | 23 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Lack of Efficacy | 10 | 17 |
| Overall Study | Lost to Follow-up | 29 | 23 |
| Overall Study | Patient's inability to use device | 6 | 1 |
| Overall Study | Protocol Violation | 17 | 20 |
| Overall Study | Withdrawal by Subject | 72 | 74 |
Baseline characteristics
| Characteristic | QMF149 Twisthaler® 500/400 | Mometasone Twisthaler® | Total |
|---|---|---|---|
| Age Continuous | 42.4 years STANDARD_DEVIATION 14.75 | 42.3 years STANDARD_DEVIATION 14.58 | 42.3 years STANDARD_DEVIATION 14.66 |
| Sex: Female, Male Female | 436 Participants | 449 Participants | 885 Participants |
| Sex: Female, Male Male | 313 Participants | 310 Participants | 623 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 510 / 749 | 477 / 759 |
| serious Total, serious adverse events | 30 / 749 | 44 / 759 |
Outcome results
Primary
Time to First Serious Asthma Exacerbation
Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.
Time frame: Up to 21 months
Population: Full analysis set: all randomized patients who received at least one dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| QMF149 Twisthaler® 500/400 | Time to First Serious Asthma Exacerbation | 13.3 months |
| Mometasone Twisthaler® | Time to First Serious Asthma Exacerbation | 13.4 months |
Secondary
Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit
The Asthma Control Questionnaire score ranges from 0 (good control of asthma) to 6 (poor control of asthma). A negative change in score indicates improvement in asthma control. Repeated measures of analysis of covariance model: change from baseline in ACQ score = treatment + visit + treatment\*visit interaction + baseline ACQ score + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.
Time frame: Baseline to the end of treatment (varying durations, up to 21 months)
Population: Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| QMF149 Twisthaler® 500/400 | Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit | -0.55 units on a scale | Standard Error 0.052 |
| Mometasone Twisthaler® | Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit | -0.32 units on a scale | Standard Error 0.052 |
Secondary
Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime
Total asthma symptom score = morning symptoms (0, 1) + daytime score (0-4) + nighttime score (0-4). The range is from 0 to 9. A lower number indicates improvement. Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.
Time frame: Baseline to the end of treatment (varying durations, up to 21 months)
Population: Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and endpoint were included in this analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| QMF149 Twisthaler® 500/400 | Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime | Total (n = 708, 733) | -1.22 units on a scale | Standard Error 0.088 |
| QMF149 Twisthaler® 500/400 | Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime | Daytime (n = 731, 749) | -0.50 units on a scale | Standard Error 0.043 |
| QMF149 Twisthaler® 500/400 | Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime | Nighttime (n = 730, 746) | -0.46 units on a scale | Standard Error 0.037 |
| Mometasone Twisthaler® | Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime | Total (n = 708, 733) | -0.94 units on a scale | Standard Error 0.088 |
| Mometasone Twisthaler® | Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime | Daytime (n = 731, 749) | -0.39 units on a scale | Standard Error 0.043 |
| Mometasone Twisthaler® | Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime | Nighttime (n = 730, 746) | -0.36 units on a scale | Standard Error 0.037 |
Secondary
Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit
Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FEV1 data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FEV1 = treatment + visit + treatment\*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.
Time frame: Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose
Population: Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| QMF149 Twisthaler® 500/400 | Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit | 5 minutes post-dose (n = 578, 607) | 0.09 liters | Standard Error 0.018 |
| QMF149 Twisthaler® 500/400 | Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit | 30 minutes post-dose (n = 576, 605) | 0.12 liters | Standard Error 0.02 |
| QMF149 Twisthaler® 500/400 | Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit | 1 hour post-dose (n = 575, 602) | 0.13 liters | Standard Error 0.021 |
| QMF149 Twisthaler® 500/400 | Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit | 2 hours post-dose (n = 568, 601) | 0.14 liters | Standard Error 0.022 |
| Mometasone Twisthaler® | Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit | 2 hours post-dose (n = 568, 601) | -0.05 liters | Standard Error 0.022 |
| Mometasone Twisthaler® | Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit | 5 minutes post-dose (n = 578, 607) | -0.04 liters | Standard Error 0.018 |
| Mometasone Twisthaler® | Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit | 1 hour post-dose (n = 575, 602) | -0.06 liters | Standard Error 0.021 |
| Mometasone Twisthaler® | Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit | 30 minutes post-dose (n = 576, 605) | -0.05 liters | Standard Error 0.02 |
Secondary
Change From Baseline in Forced Vital Capacity (FVC) at Final Visit
Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FVC data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FVC = treatment + visit + treatment\*visit interaction + baseline FVC + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.
Time frame: Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose
Population: Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| QMF149 Twisthaler® 500/400 | Change From Baseline in Forced Vital Capacity (FVC) at Final Visit | 5 minutes post-dose (n = 578, 607) | -0.03 liter | Standard Error 0.023 |
| QMF149 Twisthaler® 500/400 | Change From Baseline in Forced Vital Capacity (FVC) at Final Visit | 30 minutes post-dose (n = 576, 605) | -0.03 liter | Standard Error 0.025 |
| QMF149 Twisthaler® 500/400 | Change From Baseline in Forced Vital Capacity (FVC) at Final Visit | 1 hour post-dose (n = 575, 602) | -0.01 liter | Standard Error 0.025 |
| QMF149 Twisthaler® 500/400 | Change From Baseline in Forced Vital Capacity (FVC) at Final Visit | 2 hours post-dose (n = 568, 601) | -0.02 liter | Standard Error 0.026 |
| Mometasone Twisthaler® | Change From Baseline in Forced Vital Capacity (FVC) at Final Visit | 2 hours post-dose (n = 568, 601) | -0.13 liter | Standard Error 0.026 |
| Mometasone Twisthaler® | Change From Baseline in Forced Vital Capacity (FVC) at Final Visit | 5 minutes post-dose (n = 578, 607) | -0.11 liter | Standard Error 0.023 |
| Mometasone Twisthaler® | Change From Baseline in Forced Vital Capacity (FVC) at Final Visit | 1 hour post-dose (n = 575, 602) | -0.13 liter | Standard Error 0.025 |
| Mometasone Twisthaler® | Change From Baseline in Forced Vital Capacity (FVC) at Final Visit | 30 minutes post-dose (n = 576, 605) | -0.13 liter | Standard Error 0.024 |
Secondary
Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime
Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.
Time frame: Baseline to the end of treatment (varying durations, up to 21 months)
Population: Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| QMF149 Twisthaler® 500/400 | Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime | Morning (n = 730, 746) | 22.3 percentage of days | Standard Error 2.17 |
| QMF149 Twisthaler® 500/400 | Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime | Daytime (n = 731, 749) | 27.1 percentage of days | Standard Error 2.96 |
| QMF149 Twisthaler® 500/400 | Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime | Nighttime (n = 730, 746) | 23.6 percentage of days | Standard Error 2.69 |
| Mometasone Twisthaler® | Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime | Morning (n = 730, 746) | 18.4 percentage of days | Standard Error 2.17 |
| Mometasone Twisthaler® | Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime | Daytime (n = 731, 749) | 19.5 percentage of days | Standard Error 2.95 |
| Mometasone Twisthaler® | Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime | Nighttime (n = 730, 746) | 17.3 percentage of days | Standard Error 2.68 |
Secondary
Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime
24 hours consists of both 12 hour daytime and 12 hour nighttime. Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.
Time frame: Baseline to the end of treatment (varying durations, up to 21 months)
Population: Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| QMF149 Twisthaler® 500/400 | Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime | 24 hours (n = 669, 696) | 29.1 percentage of days | Standard Error 2.88 |
| QMF149 Twisthaler® 500/400 | Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime | Daytime (n = 692, 711) | 23.6 percentage of days | Standard Error 2.74 |
| QMF149 Twisthaler® 500/400 | Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime | Nighttime (n = 691, 708) | 24.6 percentage of days | Standard Error 2.69 |
| Mometasone Twisthaler® | Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime | 24 hours (n = 669, 696) | 17.9 percentage of days | Standard Error 2.88 |
| Mometasone Twisthaler® | Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime | Daytime (n = 692, 711) | 13.8 percentage of days | Standard Error 2.74 |
| Mometasone Twisthaler® | Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime | Nighttime (n = 691, 708) | 14.5 percentage of days | Standard Error 2.68 |
Secondary
Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was measured 15 minutes before dosing; measurements within 6 hours of rescue medication use were set to missing. Repeated measures of analysis of covariance model: change from baseline to trough FEV1 = treatment + visit + treatment\*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.
Time frame: Baseline to the end of treatment (varying durations, up to 21 months)
Population: Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| QMF149 Twisthaler® 500/400 | Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit | 0.06 liters | Standard Error 0.025 |
| Mometasone Twisthaler® | Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit | -0.07 liters | Standard Error 0.024 |
Secondary
Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period
PEF was performed every morning and evening prior to study medication use except evenings on the day of clinic visits. Baseline is average over the last 14 days prior to start of treatment. Analysis of covariance model: change from baseline in PEF = treatment + baseline PEF + region + history of asthma related hospitalization in the past 12 months + history of asthma worsening in the past 12 months + African American patient.
Time frame: Baseline to the end of treatment (varying durations, up to 21 months)
Population: Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and at final visit were included in this analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| QMF149 Twisthaler® 500/400 | Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period | Morning PEF (n = 730, 746) | 0.43 liters per second | Standard Error 0.075 |
| QMF149 Twisthaler® 500/400 | Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period | Evening PEF (n = 731, 748) | 0.27 liters per second | Standard Error 0.076 |
| Mometasone Twisthaler® | Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period | Morning PEF (n = 730, 746) | 0.00 liters per second | Standard Error 0.075 |
| Mometasone Twisthaler® | Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period | Evening PEF (n = 731, 748) | -0.15 liters per second | Standard Error 0.075 |
Secondary
Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death.
The number of patients with at least one serious asthma exacerbation over the course of the study. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.
Time frame: up to 21 months
Population: Full analysis set: all randomized patients who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QMF149 Twisthaler® 500/400 | Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death. | 2 participants |
| Mometasone Twisthaler® | Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death. | 6 participants |
Secondary
Number of Patients With at Least One Asthma Worsening Post-baseline
The criterion for asthma worsening were: decrease in peak expiratory flow (PEF) \>= 20% from mean baseline on \>= 3 consecutive days, nighttime symptom score \>= 2 on \>= 2 consecutive nights, decrease in forced expiration volume in 1 second (FEV1) \>=20% from baseline at evening visits, daytime symptom score of 3 or 4 on \>= 2 consecutive days, requiring an urgent unscheduled visit for medical care, 24 hour rescue medication use \>= 8 puffs on \>= 2 consecutive days, and any other clinically important symptoms (pre-specified MedDRA preferred terms).
Time frame: Up to 21 months
Population: Full analysis set: all randomized patients who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QMF149 Twisthaler® 500/400 | Number of Patients With at Least One Asthma Worsening Post-baseline | 533 participants |
| Mometasone Twisthaler® | Number of Patients With at Least One Asthma Worsening Post-baseline | 637 participants |
Secondary
Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids
Number of patients requiring treatment with systemic corticosteroids (oral or parenteral) over the course of the study (up to 21 months).
Time frame: Up to 21 months
Population: Full analysis set: all randomized patients who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QMF149 Twisthaler® 500/400 | Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids | 124 participants |
| Mometasone Twisthaler® | Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids | 171 participants |