Trial Outcomes & Findings for Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device in Adult and Adolescent Patients With Persistent Asthma (NCT NCT01555151)
NCT ID: NCT01555151
Last Updated: 2015-05-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
739 participants
Primary outcome timeframe
Day 29
Results posted on
2015-05-01
Participant Flow
Participant milestones
| Measure |
Mometasone Furoate 80 ug Daily Via the Concept1 Device
Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
|
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device
Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
|
Mometasone Furoate 320 ug Daily Via the Concept1 Device
Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
|
Mometasone Furoate 800 ug Via the Twisthaler® Device
Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
188
|
181
|
184
|
186
|
|
Overall Study
Safety Set (SAF)
|
186
|
180
|
183
|
186
|
|
Overall Study
COMPLETED
|
175
|
173
|
178
|
176
|
|
Overall Study
NOT COMPLETED
|
13
|
8
|
6
|
10
|
Reasons for withdrawal
| Measure |
Mometasone Furoate 80 ug Daily Via the Concept1 Device
Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
|
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device
Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
|
Mometasone Furoate 320 ug Daily Via the Concept1 Device
Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
|
Mometasone Furoate 800 ug Via the Twisthaler® Device
Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
0
|
2
|
|
Overall Study
Administrative
|
3
|
1
|
2
|
0
|
|
Overall Study
Protocol Violation
|
3
|
3
|
3
|
5
|
|
Overall Study
Adverse Event
|
1
|
2
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device in Adult and Adolescent Patients With Persistent Asthma
Baseline characteristics by cohort
| Measure |
Mometasone Furoate 80 ug Daily Via the Concept1 Device
n=188 Participants
Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
|
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device
n=181 Participants
Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
|
Mometasone Furoate 320 ug Daily Via the Concept1 Device
n=184 Participants
Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
|
Mometasone Furoate 800 ug Via the Twisthaler® Device
n=186 Participants
Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
|
Total
n=739 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 16.33 • n=93 Participants
|
45.9 years
STANDARD_DEVIATION 15.56 • n=4 Participants
|
46.0 years
STANDARD_DEVIATION 16.18 • n=27 Participants
|
45.5 years
STANDARD_DEVIATION 16.57 • n=483 Participants
|
45.4 years
STANDARD_DEVIATION 16.15 • n=36 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=93 Participants
|
94 Participants
n=4 Participants
|
113 Participants
n=27 Participants
|
97 Participants
n=483 Participants
|
402 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=93 Participants
|
87 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
89 Participants
n=483 Participants
|
337 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
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.
Outcome measures
| Measure |
Mometasone Furoate 80 ug Daily Via the Concept1 Device
n=171 Participants
Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
|
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device
n=165 Participants
Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
|
Mometasone Furoate 320 ug Daily Via the Concept1 Device
n=172 Participants
Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
|
Mometasone Furoate 800 ug Via the Twisthaler® Device
n=173 Participants
Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
|
|---|---|---|---|---|
|
Trough Forced Expiratory Volume in 1 Second (FEV1)
|
2.139 Liters
Standard Error 0.0281
|
2.071 Liters
Standard Error 0.0283
|
2.187 Liters
Standard Error 0.0281
|
2.162 Liters
Standard Error 0.0279
|
SECONDARY outcome
Timeframe: Days 8, 15 and 22Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
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.
Outcome measures
| Measure |
Mometasone Furoate 80 ug Daily Via the Concept1 Device
n=179 Participants
Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
|
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device
n=173 Participants
Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
|
Mometasone Furoate 320 ug Daily Via the Concept1 Device
n=181 Participants
Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
|
Mometasone Furoate 800 ug Via the Twisthaler® Device
n=181 Participants
Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
|
|---|---|---|---|---|
|
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
|
2.057 Liters
Standard Error 0.0253
|
2.113 Liters
Standard Error 0.0251
|
2.111 Liters
Standard Error 0.0250
|
|
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
|
2.048 Liters
Standard Error 0.0258
|
2.134 Liters
Standard Error 0.0257
|
2.135 Liters
Standard Error 0.0255
|
|
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
|
2.071 Liters
Standard Error 0.0286
|
2.175 Liters
Standard Error 0.0283
|
2.146 Liters
Standard Error 0.0282
|
SECONDARY outcome
Timeframe: Days 1, 8, 15, 22, 28 and 29 at all time pointsPopulation: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
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.
Outcome measures
| Measure |
Mometasone Furoate 80 ug Daily Via the Concept1 Device
n=178 Participants
Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
|
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device
n=172 Participants
Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
|
Mometasone Furoate 320 ug Daily Via the Concept1 Device
n=179 Participants
Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
|
Mometasone Furoate 800 ug Via the Twisthaler® Device
n=174 Participants
Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
|
|---|---|---|---|---|
|
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
|
3.115 Liters
Standard Error 0.0345
|
3.184 Liters
Standard Error 0.0340
|
3.180 Liters
Standard Error 0.0342
|
|
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
|
3.095 Liters
Standard Error 0.0348
|
3.153 Liters
Standard Error 0.0343
|
3.161 Liters
Standard Error 0.0344
|
|
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
|
3.092 Liters
Standard Error 0.0346
|
3.151 Liters
Standard Error 0.0343
|
3.184 Liters
Standard Error 0.0343
|
|
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
|
3.084 Liters
Standard Error 0.0353
|
3.158 Liters
Standard Error 0.0353
|
3.161 Liters
Standard Error 0.0350
|
|
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
|
3.113 Liters
Standard Error 0.0348
|
3.216 Liters
Standard Error 0.0343
|
3.194 Liters
Standard Error 0.0344
|
|
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
|
3.090 Liters
Standard Error 0.0363
|
3.192 Liters
Standard Error 0.0353
|
3.158 Liters
Standard Error 0.0355
|
|
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
|
2.893 Liters
Standard Error 0.0207
|
2.861 Liters
Standard Error 0.0209
|
2.897 Liters
Standard Error 0.0208
|
|
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
|
2.913 Liters
Standard Error 0.0238
|
2.943 Liters
Standard Error 0.0238
|
2.946 Liters
Standard Error 0.0235
|
|
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
|
3.096 Liters
Standard Error 0.0325
|
3.134 Liters
Standard Error 0.0321
|
3.139 Liters
Standard Error 0.0324
|
|
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
|
3.074 Liters
Standard Error 0.0324
|
3.121 Liters
Standard Error 0.0321
|
3.125 Liters
Standard Error 0.0323
|
|
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
|
3.090 Liters
Standard Error 0.0347
|
3.168 Liters
Standard Error 0.0348
|
3.155 Liters
Standard Error 0.0348
|
|
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
|
3.076 Liters
Standard Error 0.0348
|
3.137 Liters
Standard Error 0.0345
|
3.127 Liters
Standard Error 0.0348
|
|
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
|
3.091 Liters
Standard Error 0.0359
|
3.203 Liters
Standard Error 0.0355
|
3.152 Liters
Standard Error 0.0357
|
|
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
|
3.096 Liters
Standard Error 0.0363
|
3.198 Liters
Standard Error 0.0362
|
3.157 Liters
Standard Error 0.0361
|
SECONDARY outcome
Timeframe: Days 1, 8, 15, 22, 28 and 29 at all time pointsPopulation: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
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.
Outcome measures
| Measure |
Mometasone Furoate 80 ug Daily Via the Concept1 Device
n=178 Participants
Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
|
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device
n=172 Participants
Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
|
Mometasone Furoate 320 ug Daily Via the Concept1 Device
n=179 Participants
Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
|
Mometasone Furoate 800 ug Via the Twisthaler® Device
n=174 Participants
Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
|
|---|---|---|---|---|
|
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
|
1.300 Liters per second
Standard Error 0.0182
|
1.309 Liters per second
Standard Error 0.0182
|
1.308 Liters per second
Standard Error 0.0182
|
|
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
|
1.327 Liters per second
Standard Error 0.0201
|
1.316 Liters per second
Standard Error 0.0201
|
1.345 Liters per second
Standard Error 0.0199
|
|
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
|
1.449 Liters per second
Standard Error 0.0322
|
1.519 Liters per second
Standard Error 0.0317
|
1.525 Liters per second
Standard Error 0.0321
|
|
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
|
1.466 Liters per second
Standard Error 0.0328
|
1.542 Liters per second
Standard Error 0.0325
|
1.566 Liters per second
Standard Error 0.0328
|
|
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
|
1.430 Liters per second
Standard Error 0.0321
|
1.514 Liters per second
Standard Error 0.0320
|
1.544 Liters per second
Standard Error 0.0321
|
|
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
|
1.414 Liters per second
Standard Error 0.0326
|
1.520 Liters per second
Standard Error 0.0321
|
1.561 Liters per second
Standard Error 0.0327
|
|
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 0.0350
|
1.440 Liters per second
Standard Error 0.0353
|
1.565 Liters per second
Standard Error 0.0348
|
1.555 Liters per second
Standard Error 0.0351
|
|
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
|
1.476 Liters per second
Standard Error 0.0362
|
1.600 Liters per second
Standard Error 0.0361
|
1.591 Liters per second
Standard Error 0.0361
|
|
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
|
1.458 Liters per second
Standard Error 0.0354
|
1.581 Liters per second
Standard Error 0.0350
|
1.598 Liters per second
Standard Error 0.0351
|
|
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
|
1.481 Liters per second
Standard Error 0.0359
|
1.574 Liters per second
Standard Error 0.0354
|
1.584 Liters per second
Standard Error 0.0355
|
|
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
|
1.457 Liters per second
Standard Error 0.0368
|
1.557 Liters per second
Standard Error 0.0364
|
1.615 Liters per second
Standard Error 0.0364
|
|
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
|
1.460 Liters per second
Standard Error 0.0369
|
1.577 Liters per second
Standard Error 0.0368
|
1.593 Liters per second
Standard Error 0.0365
|
|
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
|
1.451 Liters per second
Standard Error 0.0376
|
1.604 Liters per second
Standard Error 0.0369
|
1.584 Liters per second
Standard Error 0.0371
|
|
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 0.0370
|
1.438 Liters per second
Standard Error 0.0378
|
1.576 Liters per second
Standard Error 0.0366
|
1.571 Liters per second
Standard Error 0.0369
|
SECONDARY outcome
Timeframe: Days 1, 8, 15, 22, 28 and 29 at all time pointsPopulation: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
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.
Outcome measures
| Measure |
Mometasone Furoate 80 ug Daily Via the Concept1 Device
n=178 Participants
Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
|
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device
n=172 Participants
Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
|
Mometasone Furoate 320 ug Daily Via the Concept1 Device
n=179 Participants
Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
|
Mometasone Furoate 800 ug Via the Twisthaler® Device
n=175 Participants
Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
|
|---|---|---|---|---|
|
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
|
66.541 Percent
Standard Error 0.4806
|
67.961 Percent
Standard Error 0.4667
|
67.831 Percent
Standard Error 0.4692
|
|
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
|
64.898 Percent
Standard Error 0.2556
|
65.184 Percent
Standard Error 0.2559
|
64.898 Percent
Standard Error 0.2554
|
|
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
|
64.833 Percent
Standard Error 0.2890
|
65.005 Percent
Standard Error 0.2885
|
65.072 Percent
Standard Error 0.2845
|
|
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
|
66.301 Percent
Standard Error 0.4286
|
67.344 Percent
Standard Error 0.4222
|
66.568 Percent
Standard Error 0.4264
|
|
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
|
66.790 Percent
Standard Error 0.4262
|
67.778 Percent
Standard Error 0.4224
|
67.156 Percent
Standard Error 0.4252
|
|
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
|
66.122 Percent
Standard Error 0.4398
|
67.487 Percent
Standard Error 0.4395
|
67.139 Percent
Standard Error 0.4407
|
|
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 0.4370
|
66.006 Percent
Standard Error 0.4443
|
67.607 Percent
Standard Error 0.4384
|
67.514 Percent
Standard Error 0.4456
|
|
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
|
66.567 Percent
Standard Error 0.4643
|
67.831 Percent
Standard Error 0.4584
|
67.742 Percent
Standard Error 0.4615
|
|
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
|
66.885 Percent
Standard Error 0.4629
|
68.143 Percent
Standard Error 0.4622
|
67.895 Percent
Standard Error 0.4612
|
|
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
|
66.835 Percent
Standard Error 0.4615
|
68.124 Percent
Standard Error 0.4567
|
67.810 Percent
Standard Error 0.4578
|
|
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
|
67.296 Percent
Standard Error 0.4854
|
68.255 Percent
Standard Error 0.4796
|
67.878 Percent
Standard Error 0.4804
|
|
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
|
67.013 Percent
Standard Error 0.4796
|
68.031 Percent
Standard Error 0.4755
|
68.126 Percent
Standard Error 0.4755
|
|
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
|
66.832 Percent
Standard Error 0.4741
|
68.243 Percent
Standard Error 0.4736
|
68.057 Percent
Standard Error 0.4698
|
|
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
|
66.711 Percent
Standard Error 0.4736
|
68.265 Percent
Standard Error 0.4654
|
67.592 Percent
Standard Error 0.4676
|
SECONDARY outcome
Timeframe: Baseline and week 4Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
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.
Outcome measures
| Measure |
Mometasone Furoate 80 ug Daily Via the Concept1 Device
n=177 Participants
Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
|
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device
n=172 Participants
Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
|
Mometasone Furoate 320 ug Daily Via the Concept1 Device
n=175 Participants
Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
|
Mometasone Furoate 800 ug Via the Twisthaler® Device
n=182 Participants
Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
|
|---|---|---|---|---|
|
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
|
3.955 Liters per min
Standard Error 4.2616
|
2.785 Liters per min
Standard Error 4.2349
|
1.606 Liters per min
Standard Error 4.1464
|
|
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
|
0.293 Liters per min
Standard Error 3.9477
|
-0.644 Liters per min
Standard Error 3.9427
|
6.287 Liters per min
Standard Error 3.8826
|
SECONDARY outcome
Timeframe: Baseline, days 8,15,22 and 29Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
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).
Outcome measures
| Measure |
Mometasone Furoate 80 ug Daily Via the Concept1 Device
n=180 Participants
Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
|
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device
n=176 Participants
Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
|
Mometasone Furoate 320 ug Daily Via the Concept1 Device
n=182 Participants
Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
|
Mometasone Furoate 800 ug Via the Twisthaler® Device
n=182 Participants
Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
|
|---|---|---|---|---|
|
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
|
-0.730 Units on a scale
Standard Error 0.0546
|
-0.908 Units on a scale
Standard Error 0.0540
|
-0.890 Units on a scale
Standard Error 0.0538
|
|
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 0.0590
|
-0.908 Units on a scale
Standard Error 0.0599
|
-1.117 Units on a scale
Standard Error 0.0595
|
-0.973 Units on a scale
Standard Error 0.0593
|
|
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 0.0620
|
-0.982 Units on a scale
Standard Error 0.0628
|
-1.262 Units on a scale
Standard Error 0.0622
|
-1.097 Units on a scale
Standard Error 0.0622
|
|
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 0.0630
|
-1.109 Units on a scale
Standard Error 0.602
|
-1.329 Units on a scale
Standard Error 0.0632
|
-1.162 Units on a scale
Standard Error 0.0625
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
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.
Outcome measures
| Measure |
Mometasone Furoate 80 ug Daily Via the Concept1 Device
n=177 Participants
Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
|
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device
n=172 Participants
Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
|
Mometasone Furoate 320 ug Daily Via the Concept1 Device
n=175 Participants
Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
|
Mometasone Furoate 800 ug Via the Twisthaler® Device
n=181 Participants
Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
|
|---|---|---|---|---|
|
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
|
-0.391 number of puffs
Standard Error 0.0985
|
-0.600 number of puffs
Standard Error 0.0981
|
-0.677 number of puffs
Standard Error 0.0963
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
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.
Outcome measures
| Measure |
Mometasone Furoate 80 ug Daily Via the Concept1 Device
n=124 Participants
Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
|
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device
n=116 Participants
Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
|
Mometasone Furoate 320 ug Daily Via the Concept1 Device
n=117 Participants
Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
|
Mometasone Furoate 800 ug Via the Twisthaler® Device
n=113 Participants
Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
|
|---|---|---|---|---|
|
Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment
|
74.148 percentage days
Standard Error 2.2576
|
75.236 percentage days
Standard Error 2.3291
|
75.157 percentage days
Standard Error 2.3044
|
80.578 percentage days
Standard Error 2.3476
|
SECONDARY outcome
Timeframe: Days 15 and 29Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.
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.
Outcome measures
| Measure |
Mometasone Furoate 80 ug Daily Via the Concept1 Device
n=142 Participants
Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
|
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device
n=143 Participants
Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
|
Mometasone Furoate 320 ug Daily Via the Concept1 Device
n=145 Participants
Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
|
Mometasone Furoate 800 ug Via the Twisthaler® Device
n=150 Participants
Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
|
|---|---|---|---|---|
|
Fractional Exhaled Nitric Oxide (FeNO)
Day 15 (n= 142, 139, 139, 149)
|
25.286 ppm
Standard Error 1.2983
|
26.762 ppm
Standard Error 1.3201
|
19.098 ppm
Standard Error 1.3246
|
21.017 ppm
Standard Error 1.2911
|
|
Fractional Exhaled Nitric Oxide (FeNO)
Day 29 (n=141, 143, 145, 150)
|
23.777 ppm
Standard Error 1.3078
|
27.055 ppm
Standard Error 1.3035
|
18.468 ppm
Standard Error 1.2952
|
19.981 ppm
Standard Error 1.2803
|
SECONDARY outcome
Timeframe: Baseline, days 1 and 28Population: The safety set includes all subjects who received at least one dose of study drug.
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
Outcome measures
| Measure |
Mometasone Furoate 80 ug Daily Via the Concept1 Device
n=183 Participants
Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
|
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device
n=178 Participants
Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
|
Mometasone Furoate 320 ug Daily Via the Concept1 Device
n=179 Participants
Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
|
Mometasone Furoate 800 ug Via the Twisthaler® Device
n=181 Participants
Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
|
|---|---|---|---|---|
|
Plasma Cortisol Concentrations
Baseline (n= 183, 178, 179, 181)
|
150.040 nmol/L
Standard Deviation 80.3928
|
143.132 nmol/L
Standard Deviation 88.4206
|
143.791 nmol/L
Standard Deviation 85.8696
|
150.108 nmol/L
Standard Deviation 88.6815
|
|
Plasma Cortisol Concentrations
Day 1/1 Hr (n=179, 177,174, 176)
|
118.130 nmol/L
Standard Deviation 92.7539
|
106.965 nmol/L
Standard Deviation 81.5160
|
107.526 nmol/L
Standard Deviation 74.3770
|
115.489 nmol/L
Standard Deviation 79.3869
|
|
Plasma Cortisol Concentrations
Day 28/-25 Mins (n= 172, 169, 174, 172)
|
140.760 nmol/L
Standard Deviation 73.3567
|
140.604 nmol/L
Standard Deviation 72.8885
|
143.555 nmol/L
Standard Deviation 82.4961
|
145.484 nmol/L
Standard Deviation 92.2940
|
|
Plasma Cortisol Concentrations
Day 28/1 Hr (n= 172, 168, 174, 170)
|
105.399 nmol/L
Standard Deviation 68.9416
|
107.931 nmol/L
Standard Deviation 70.7374
|
105.468 nmol/L
Standard Deviation 57.9029
|
110.477 nmol/L
Standard Deviation 77.2220
|
Adverse Events
Mometasone Furoate 80 ug Daily Via the Concept1 Device
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Mometasone Furoate 320 ug Daily Via the Concept1 Device
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Mometasone Furoate 800 ug Via the Twisthaler® Device
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Total
Serious events: 1 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mometasone Furoate 80 ug Daily Via the Concept1 Device
n=186 participants at risk
Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
|
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device
n=180 participants at risk
Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
|
Mometasone Furoate 320 ug Daily Via the Concept1 Device
n=183 participants at risk
Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
|
Mometasone Furoate 800 ug Via the Twisthaler® Device
n=186 participants at risk
Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
|
Total
n=735 participants at risk
Total
|
|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/186
|
0.00%
0/180
|
0.55%
1/183
|
0.00%
0/186
|
0.14%
1/735
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/186
|
0.00%
0/180
|
0.55%
1/183
|
0.00%
0/186
|
0.14%
1/735
|
Other adverse events
| Measure |
Mometasone Furoate 80 ug Daily Via the Concept1 Device
n=186 participants at risk
Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
|
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device
n=180 participants at risk
Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
|
Mometasone Furoate 320 ug Daily Via the Concept1 Device
n=183 participants at risk
Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
|
Mometasone Furoate 800 ug Via the Twisthaler® Device
n=186 participants at risk
Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
|
Total
n=735 participants at risk
Total
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
1.6%
3/186
|
3.9%
7/180
|
3.3%
6/183
|
1.1%
2/186
|
2.4%
18/735
|
|
Investigations
Blood cortisol decreased
|
2.2%
4/186
|
1.7%
3/180
|
2.7%
5/183
|
3.2%
6/186
|
2.4%
18/735
|
|
Nervous system disorders
Headache
|
3.2%
6/186
|
2.8%
5/180
|
2.7%
5/183
|
0.00%
0/186
|
2.2%
16/735
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/186
|
2.2%
4/180
|
0.55%
1/183
|
0.00%
0/186
|
0.68%
5/735
|
Additional Information
Clinical Disclosure Office
Novartis Pharmaceuticals
Phone: +1(862)778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER