Trial Outcomes & Findings for Assess Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma. (NCT NCT03063086)
NCT ID: NCT03063086
Last Updated: 2021-10-04
Results Overview
The highest bronchodilator effect on FEV1 during a period of 5 min to 4 h after the last evening dose of each treatment period . To demonstrate superiority in peak bronchodilator effect of QVM149 at a dose of 150/50/160 μg o.d. and 150/50/80 μg o.d. compared to a FDC of salmeterol/fluticasone at a dose of 50/500 μg b.i.d. after 3 weeks of treatment in patients with asthma
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
116 participants
Primary outcome timeframe
3 weeks
Results posted on
2021-10-04
Participant Flow
Participant milestones
| Measure |
Sequence 1 (A-B-C)
QVM149 150/50/80 μg o.d; QVM149 150/50/160 μg o.d; salmeterol/fluticasone FDC 50/500 μg b.i.d.
|
Sequence 2(A-C-B)
QVM149 150/50/80 μg o.d; salmeterol/fluticasone FDC 50/500 μg b.i.d.; QVM149 150/50/160 μg o.d;
|
Sequence 3(B-C-A)
QVM149 150/50/160 μg o.d; salmeterol/fluticasone FDC 50/500 μg b.i.d.; QVM149 150/50/80 μg o.d
|
Sequence 4(B-A-C)
QVM149 150/50/160 μg o.d; QVM149 150/50/80 μg o.d; salmeterol/fluticasone FDC 50/500 μg b.i.d
|
Sequence 5(C-A-B)
salmeterol/fluticasone FDC 50/500 μg b.i.d; QVM149 150/50/80 μg o.d; QVM149 150/50/160 μg o.d
|
Sequence 6(C-B-A)
salmeterol/fluticasone FDC 50/500 μg b.i.d.; QVM149 150/50/160 μg o.d; QVM149 150/50/80 μg o.d
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
18
|
20
|
20
|
19
|
|
Overall Study
COMPLETED
|
16
|
19
|
17
|
17
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
1
|
3
|
0
|
1
|
Reasons for withdrawal
| Measure |
Sequence 1 (A-B-C)
QVM149 150/50/80 μg o.d; QVM149 150/50/160 μg o.d; salmeterol/fluticasone FDC 50/500 μg b.i.d.
|
Sequence 2(A-C-B)
QVM149 150/50/80 μg o.d; salmeterol/fluticasone FDC 50/500 μg b.i.d.; QVM149 150/50/160 μg o.d;
|
Sequence 3(B-C-A)
QVM149 150/50/160 μg o.d; salmeterol/fluticasone FDC 50/500 μg b.i.d.; QVM149 150/50/80 μg o.d
|
Sequence 4(B-A-C)
QVM149 150/50/160 μg o.d; QVM149 150/50/80 μg o.d; salmeterol/fluticasone FDC 50/500 μg b.i.d
|
Sequence 5(C-A-B)
salmeterol/fluticasone FDC 50/500 μg b.i.d; QVM149 150/50/80 μg o.d; QVM149 150/50/160 μg o.d
|
Sequence 6(C-B-A)
salmeterol/fluticasone FDC 50/500 μg b.i.d.; QVM149 150/50/160 μg o.d; QVM149 150/50/80 μg o.d
|
|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
technical problems
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
subject/guardian decision
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Non-compliance with study treatment
|
0
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Assess Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma.
Baseline characteristics by cohort
| Measure |
All Participants
n=116 Participants
All participants randomized to one of six treatment sequences
|
|---|---|
|
Age, Continuous
|
49.5 Years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
106 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: Pharmacodynamics set - The PD analysis set included all patients with any available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data.
The highest bronchodilator effect on FEV1 during a period of 5 min to 4 h after the last evening dose of each treatment period . To demonstrate superiority in peak bronchodilator effect of QVM149 at a dose of 150/50/160 μg o.d. and 150/50/80 μg o.d. compared to a FDC of salmeterol/fluticasone at a dose of 50/500 μg b.i.d. after 3 weeks of treatment in patients with asthma
Outcome measures
| Measure |
QVM149 150/50/160 μg o.d.
n=112 Participants
QVM149 150/50/160 μg o.d.
|
QVM149 150/50/80 μg o.d.
n=115 Participants
QVM149 150/50/80 μg o.d.
|
Salmeterol/Fluticasone 50/500 µg b.i.d
n=111 Participants
salmeterol/fluticasone 50/500 µg b.i.d
|
|---|---|---|---|
|
Peak FEV1 (L) Defined as the Highest Bronchodilatory Effect on FEV1 During a Period of 5 Min to 4 h After the Last Evening Dose of Each Treatment Period
|
2.792 Liters
Standard Error 0.0750
|
2.779 Liters
Standard Error 0.0750
|
2.620 Liters
Standard Error 0.0750
|
SECONDARY outcome
Timeframe: -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min at 3 weeksPopulation: Pharmacodynamics set - The PD analysis set included all patients with any available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data.
To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment at -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min.
Outcome measures
| Measure |
QVM149 150/50/160 μg o.d.
n=112 Participants
QVM149 150/50/160 μg o.d.
|
QVM149 150/50/80 μg o.d.
n=115 Participants
QVM149 150/50/80 μg o.d.
|
Salmeterol/Fluticasone 50/500 µg b.i.d
n=111 Participants
salmeterol/fluticasone 50/500 µg b.i.d
|
|---|---|---|---|
|
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
5 min
|
2.6412 Liters
Standard Error 0.07446
|
2.6179 Liters
Standard Error 0.07445
|
2.5035 Liters
Standard Error 0.07446
|
|
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
-45 min
|
2.6237 Liters
Standard Error 0.07505
|
2.5639 Liters
Standard Error 0.07503
|
2.4931 Liters
Standard Error 0.07505
|
|
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
-15 min
|
2.6023 Liters
Standard Error 0.07479
|
2.5630 Liters
Standard Error 0.07478
|
2.4835 Liters
Standard Error 0.07480
|
|
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
15 min
|
2.6696 Liters
Standard Error 0.07531
|
2.6137 Liters
Standard Error 0.07532
|
2.5172 Liters
Standard Error 0.07533
|
|
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
30 min
|
2.6873 Liters
Standard Error 0.07444
|
2.6504 Liters
Standard Error 0.07444
|
2.5286 Liters
Standard Error 0.07444
|
|
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
1 h
|
2.6922 Liters
Standard Error 0.07430
|
2.6825 Liters
Standard Error 0.07431
|
2.5398 Liters
Standard Error 0.07431
|
|
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
2 h
|
2.7033 Liters
Standard Error 0.07441
|
2.6996 Liters
Standard Error 0.07443
|
2.5244 Liters
Standard Error 0.07443
|
|
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
3 h
|
2.6995 Liters
Standard Error 0.07449
|
2.6719 Liters
Standard Error 0.07450
|
2.5296 Liters
Standard Error 0.07451
|
|
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
4 h
|
2.6815 Liters
Standard Error 0.07482
|
2.6565 Liters
Standard Error 0.07484
|
2.5164 Liters
Standard Error 0.07485
|
|
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
8 h
|
2.6801 Liters
Standard Error 0.07454
|
2.6550 Liters
Standard Error 0.07459
|
2.4918 Liters
Standard Error 0.07459
|
|
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
10 h
|
2.6999 Liters
Standard Error 0.07489
|
2.6796 Liters
Standard Error 0.07494
|
2.4908 Liters
Standard Error 0.07495
|
|
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
11h 55 min
|
2.7042 Liters
Standard Error 0.07486
|
2.6641 Liters
Standard Error 0.07490
|
2.4841 Liters
Standard Error 0.07491
|
|
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
14 h
|
2.6829 Liters
Standard Error 0.07456
|
2.6541 Liters
Standard Error 0.07459
|
2.5354 Liters
Standard Error 0.07461
|
|
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
18 h
|
2.6345 Liters
Standard Error 0.07451
|
2.6073 Liters
Standard Error 0.07455
|
2.5329 Liters
Standard Error 0.07457
|
|
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
21 h
|
2.6113 Liters
Standard Error 0.07466
|
2.5989 Liters
Standard Error 0.07472
|
2.5133 Liters
Standard Error 0.07475
|
|
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
23 h 15 min
|
2.6143 Liters
Standard Error 0.07433
|
2.5950 Liters
Standard Error 0.07438
|
2.4854 Liters
Standard Error 0.07439
|
|
FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose
23 h 45 min
|
2.5966 Liters
Standard Error 0.07433
|
2.5722 Liters
Standard Error 0.07438
|
2.4913 Liters
Standard Error 0.07439
|
SECONDARY outcome
Timeframe: -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min at 3 weeksPopulation: Pharmacodynamics set - The PD analysis set included all patients with any available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data.
To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment at -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min.
Outcome measures
| Measure |
QVM149 150/50/160 μg o.d.
n=112 Participants
QVM149 150/50/160 μg o.d.
|
QVM149 150/50/80 μg o.d.
n=115 Participants
QVM149 150/50/80 μg o.d.
|
Salmeterol/Fluticasone 50/500 µg b.i.d
n=111 Participants
salmeterol/fluticasone 50/500 µg b.i.d
|
|---|---|---|---|
|
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
-45min
|
3.9046 Liters
Standard Deviation 1.03169
|
3.8538 Liters
Standard Deviation 0.98086
|
3.7626 Liters
Standard Deviation 1.00067
|
|
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
-15min
|
3.8743 Liters
Standard Deviation 1.04318
|
3.8571 Liters
Standard Deviation 0.97420
|
3.7230 Liters
Standard Deviation 0.94180
|
|
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
5min
|
3.8656 Liters
Standard Deviation 0.99877
|
3.8976 Liters
Standard Deviation 1.00323
|
3.7536 Liters
Standard Deviation 0.93696
|
|
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
15min
|
3.8669 Liters
Standard Deviation 0.98489
|
3.8971 Liters
Standard Deviation 0.96840
|
3.7290 Liters
Standard Deviation 0.94033
|
|
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
30min
|
3.8700 Liters
Standard Deviation 0.99289
|
3.9002 Liters
Standard Deviation 0.99091
|
3.7695 Liters
Standard Deviation 0.96026
|
|
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
1h
|
3.8756 Liters
Standard Deviation 0.99978
|
3.8993 Liters
Standard Deviation 0.99141
|
3.7530 Liters
Standard Deviation 0.97083
|
|
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
2h
|
3.8698 Liters
Standard Deviation 0.99623
|
3.8985 Liters
Standard Deviation 0.99369
|
3.7629 Liters
Standard Deviation 0.97164
|
|
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
3h
|
3.8576 Liters
Standard Deviation 0.98598
|
3.8766 Liters
Standard Deviation 0.97806
|
3.7575 Liters
Standard Deviation 0.96899
|
|
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
4h
|
3.8744 Liters
Standard Deviation 0.99833
|
3.8627 Liters
Standard Deviation 0.95673
|
3.7629 Liters
Standard Deviation 0.98205
|
|
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
8h
|
3.9020 Liters
Standard Deviation 0.98241
|
3.9217 Liters
Standard Deviation 0.99184
|
3.7683 Liters
Standard Deviation 1.00410
|
|
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
10h
|
3.8976 Liters
Standard Deviation 0.98360
|
3.9504 Liters
Standard Deviation 0.99286
|
3.7809 Liters
Standard Deviation 0.98213
|
|
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
11h 55min
|
3.9271 Liters
Standard Deviation 0.98924
|
3.9405 Liters
Standard Deviation 1.00198
|
3.7911 Liters
Standard Deviation 0.99102
|
|
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
14h
|
3.9091 Liters
Standard Deviation 1.00241
|
3.9210 Liters
Standard Deviation 0.97942
|
3.8089 Liters
Standard Deviation 1.02918
|
|
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
18h
|
3.8675 Liters
Standard Deviation 0.95725
|
3.9151 Liters
Standard Deviation 1.02198
|
3.7824 Liters
Standard Deviation 0.98395
|
|
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
21h
|
3.8438 Liters
Standard Deviation 1.00672
|
3.8694 Liters
Standard Deviation 0.98786
|
3.7680 Liters
Standard Deviation 1.00768
|
|
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
23h 15min
|
3.7997 Liters
Standard Deviation 0.97550
|
3.8673 Liters
Standard Deviation 0.99915
|
3.7395 Liters
Standard Deviation 1.01764
|
|
FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose
23h 45min
|
3.8034 Liters
Standard Deviation 0.99036
|
3.8603 Liters
Standard Deviation 0.98502
|
3.7431 Liters
Standard Deviation 1.00668
|
SECONDARY outcome
Timeframe: -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min at 3 weeksPopulation: Pharmacodynamics set - The PD analysis set included all patients with any available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data.
To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment at -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min.
Outcome measures
| Measure |
QVM149 150/50/160 μg o.d.
n=112 Participants
QVM149 150/50/160 μg o.d.
|
QVM149 150/50/80 μg o.d.
n=115 Participants
QVM149 150/50/80 μg o.d.
|
Salmeterol/Fluticasone 50/500 µg b.i.d
n=111 Participants
salmeterol/fluticasone 50/500 µg b.i.d
|
|---|---|---|---|
|
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
15min
|
0.6873 Ratio
Standard Deviation 0.10126
|
0.6778 Ratio
Standard Deviation 0.10734
|
0.6560 Ratio
Standard Deviation 0.10823
|
|
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
-45min
|
0.6701 Ratio
Standard Deviation 0.10880
|
0.6612 Ratio
Standard Deviation 0.10358
|
0.6527 Ratio
Standard Deviation 0.10867
|
|
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
-15min
|
0.6707 Ratio
Standard Deviation 0.10646
|
0.6669 Ratio
Standard Deviation 0.10422
|
0.6539 Ratio
Standard Deviation 0.10526
|
|
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
5min
|
0.6788 Ratio
Standard Deviation 0.10300
|
0.6754 Ratio
Standard Deviation 0.10370
|
0.6563 Ratio
Standard Deviation 0.10639
|
|
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
30min
|
0.6878 Ratio
Standard Deviation 0.10137
|
0.6844 Ratio
Standard Deviation 0.10699
|
0.6573 Ratio
Standard Deviation 0.10552
|
|
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
1h
|
0.6900 Ratio
Standard Deviation 0.09764
|
0.6895 Ratio
Standard Deviation 0.09940
|
0.6632 Ratio
Standard Deviation 0.10403
|
|
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
2h
|
0.6939 Ratio
Standard Deviation 0.09629
|
0.6932 Ratio
Standard Deviation 0.10073
|
0.6647 Ratio
Standard Deviation 0.10413
|
|
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
3h
|
0.6968 Ratio
Standard Deviation 0.10159
|
0.6890 Ratio
Standard Deviation 0.10052
|
0.6634 Ratio
Standard Deviation 0.10436
|
|
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
4h
|
0.6897 Ratio
Standard Deviation 0.10060
|
0.6879 Ratio
Standard Deviation 0.09733
|
0.6605 Ratio
Standard Deviation 0.10419
|
|
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
8h
|
0.6842 Ratio
Standard Deviation 0.10782
|
0.6802 Ratio
Standard Deviation 0.11349
|
0.6492 Ratio
Standard Deviation 0.10814
|
|
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
10h
|
0.6916 Ratio
Standard Deviation 0.10550
|
0.6858 Ratio
Standard Deviation 0.10468
|
0.6489 Ratio
Standard Deviation 0.11155
|
|
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
11h 55min
|
0.6853 Ratio
Standard Deviation 0.10672
|
0.6791 Ratio
Standard Deviation 0.10656
|
0.6482 Ratio
Standard Deviation 0.10810
|
|
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
14h
|
0.6846 Ratio
Standard Deviation 0.10842
|
0.6848 Ratio
Standard Deviation 0.10450
|
0.6567 Ratio
Standard Deviation 0.11048
|
|
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
18h
|
0.6801 Ratio
Standard Deviation 0.09943
|
0.6741 Ratio
Standard Deviation 0.10240
|
0.6546 Ratio
Standard Deviation 0.10369
|
|
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
21h
|
0.6790 Ratio
Standard Deviation 0.10890
|
0.6785 Ratio
Standard Deviation 0.10387
|
0.6562 Ratio
Standard Deviation 0.10729
|
|
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
23h 15min
|
06821 Ratio
Standard Deviation 0.10386
|
0.6791 Ratio
Standard Deviation 0.09986
|
0.6548 Ratio
Standard Deviation 0.10423
|
|
FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose
23h 45min
|
0.6782 Ratio
Standard Deviation 0.10457
|
0.6776 Ratio
Standard Deviation 0.10111
|
0.6537 Ratio
Standard Deviation 0.10934
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Pharmacodynamics set - The PD analysis set included all patients with any available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data.
To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/ fluticasone FDC by measuring standardized FEV1 AUCs after 3 weeks of treatment respective period.
Outcome measures
| Measure |
QVM149 150/50/160 μg o.d.
n=112 Participants
QVM149 150/50/160 μg o.d.
|
QVM149 150/50/80 μg o.d.
n=115 Participants
QVM149 150/50/80 μg o.d.
|
Salmeterol/Fluticasone 50/500 µg b.i.d
n=111 Participants
salmeterol/fluticasone 50/500 µg b.i.d
|
|---|---|---|---|
|
FEV1 AUC 5 Min - 1 h (Day 21) FEV1 AUC 5 Min - 4 h (Day 21) and FEV1 AUC 5 Min - 23 h 45 Min (Day 21)
FEV1 AUC 5 min - 1 h
|
2.673 Liters
Standard Error 0.0735
|
2.644 Liters
Standard Error 0.0736
|
2.513 Liters
Standard Error 0.0737
|
|
FEV1 AUC 5 Min - 1 h (Day 21) FEV1 AUC 5 Min - 4 h (Day 21) and FEV1 AUC 5 Min - 23 h 45 Min (Day 21)
FEV1 AUC 5 min - 4 h
|
2.687 Liters
Standard Error 0.0741
|
2.669 Liters
Standard Error 0.0741
|
2.510 Liters
Standard Error 0.0742
|
|
FEV1 AUC 5 Min - 1 h (Day 21) FEV1 AUC 5 Min - 4 h (Day 21) and FEV1 AUC 5 Min - 23 h 45 Min (Day 21)
FEV1 AUC 5 min - 23 h 45 min
|
2.677 Liters
Standard Error 0.0766
|
2.652 Liters
Standard Error 0.0768
|
2.515 Liters
Standard Error 0.0768
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Pharmacodynamics set - The PD analysis set included all patients with any available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data
To evaluate post-dose trough bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment in the respective treatment period. The trough FEV1 is the mean value of FEV1 at 23 h 15 min and 23 h 45 min post-dose
Outcome measures
| Measure |
QVM149 150/50/160 μg o.d.
n=112 Participants
QVM149 150/50/160 μg o.d.
|
QVM149 150/50/80 μg o.d.
n=115 Participants
QVM149 150/50/80 μg o.d.
|
Salmeterol/Fluticasone 50/500 µg b.i.d
n=111 Participants
salmeterol/fluticasone 50/500 µg b.i.d
|
|---|---|---|---|
|
Trough FEV1 After 21 Days of Treatment
|
2.623 Liters
Standard Error 0.0756
|
2.6046 Liters
Standard Error 0.0757
|
2.4998 Liters
Standard Error 0.0757
|
Adverse Events
QVM149 150/50/160 µg o.d.
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
QVM149 150/50/80 µg o.d.
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Salmeterol/Fluticasone 50/500 µg b.i.d.
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
QVM149 150/50/160 µg o.d.
n=112 participants at risk
QVM149 150/50/160 µg o.d.
|
QVM149 150/50/80 µg o.d.
n=115 participants at risk
QVM149 150/50/80 µg o.d.
|
Salmeterol/Fluticasone 50/500 µg b.i.d.
n=111 participants at risk
Salmeterol/fluticasone 50/500 µg b.i.d.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.7%
3/112 • Up to 22 days
|
6.1%
7/115 • Up to 22 days
|
3.6%
4/111 • Up to 22 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/112 • Up to 22 days
|
0.00%
0/115 • Up to 22 days
|
0.90%
1/111 • Up to 22 days
|
|
Nervous system disorders
Headache
|
8.9%
10/112 • Up to 22 days
|
8.7%
10/115 • Up to 22 days
|
11.7%
13/111 • Up to 22 days
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.4%
6/112 • Up to 22 days
|
0.87%
1/115 • Up to 22 days
|
5.4%
6/111 • Up to 22 days
|
Additional Information
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 or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER