Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen (NCT NCT01985334)
NCT ID: NCT01985334
Last Updated: 2019-03-19
Results Overview
Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
4389 participants
Primary outcome timeframe
Week 12 (Visit 4)
Results posted on
2019-03-19
Participant Flow
Participant milestones
| Measure |
A1 (Any SABA and/or SAMA)
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
130
|
387
|
420
|
1262
|
274
|
822
|
274
|
820
|
|
Overall Study
The Intention-to-treat (ITT) Population
|
122
|
369
|
420
|
1254
|
269
|
811
|
268
|
811
|
|
Overall Study
COMPLETED
|
107
|
303
|
367
|
1033
|
234
|
666
|
237
|
699
|
|
Overall Study
NOT COMPLETED
|
23
|
84
|
53
|
229
|
40
|
156
|
37
|
121
|
Reasons for withdrawal
| Measure |
A1 (Any SABA and/or SAMA)
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Administrative problems
|
1
|
1
|
0
|
2
|
0
|
1
|
1
|
3
|
|
Overall Study
Death
|
1
|
0
|
0
|
3
|
0
|
0
|
1
|
2
|
|
Overall Study
Worsening of disease
|
0
|
0
|
0
|
1
|
0
|
3
|
0
|
1
|
|
Overall Study
Other
|
4
|
2
|
3
|
10
|
1
|
6
|
2
|
2
|
|
Overall Study
Protocol deviation
|
6
|
31
|
25
|
84
|
17
|
47
|
15
|
42
|
|
Overall Study
Moderate / severe COPD exacerbation
|
5
|
14
|
12
|
40
|
6
|
40
|
8
|
19
|
|
Overall Study
Subject withdrawal of consent
|
3
|
6
|
2
|
28
|
4
|
19
|
0
|
20
|
|
Overall Study
Adverse Event
|
0
|
8
|
2
|
26
|
3
|
18
|
3
|
15
|
|
Overall Study
Medication non-compliance
|
0
|
4
|
1
|
6
|
2
|
3
|
1
|
3
|
|
Overall Study
Use of prohibited treatment
|
1
|
4
|
1
|
2
|
1
|
6
|
2
|
0
|
|
Overall Study
Investigator decision
|
0
|
3
|
0
|
7
|
1
|
1
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
3
|
1
|
4
|
0
|
3
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen
Baseline characteristics by cohort
| Measure |
A1 (Any SABA and/or SAMA)
n=130 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=387 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
n=420 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
n=1262 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
n=274 Participants
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
n=822 Participants
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
n=274 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
n=820 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
Total
n=4389 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.2 Years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
63.2 Years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
64.6 Years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
64.4 Years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
64.4 Years
STANDARD_DEVIATION 9.0 • n=21 Participants
|
64.7 Years
STANDARD_DEVIATION 8.7 • n=8 Participants
|
65.1 Years
STANDARD_DEVIATION 7.6 • n=8 Participants
|
65.4 Years
STANDARD_DEVIATION 8.3 • n=24 Participants
|
64.6 Years
STANDARD_DEVIATION 8.3 • n=42 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
376 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
286 Participants
n=8 Participants
|
95 Participants
n=8 Participants
|
276 Participants
n=24 Participants
|
1437 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
268 Participants
n=7 Participants
|
289 Participants
n=5 Participants
|
886 Participants
n=4 Participants
|
168 Participants
n=21 Participants
|
536 Participants
n=8 Participants
|
179 Participants
n=8 Participants
|
544 Participants
n=24 Participants
|
2952 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Week 12 (Visit 4)Population: The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval
Outcome measures
| Measure |
A1 (Any SABA and/or SAMA)
n=122 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=369 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)
|
1.8264 Liters
Interval 1.7797 to 1.8732
|
1.8916 Liters
Interval 1.8647 to 1.9185
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 12 (Visit 4)Population: The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval
Outcome measures
| Measure |
A1 (Any SABA and/or SAMA)
n=420 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=1254 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)
|
1.8004 Liters
Interval 1.7768 to 1.8239
|
1.8215 Liters
Interval 1.8078 to 1.8352
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 12 (Visit 4)Population: The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.
Outcome measures
| Measure |
A1 (Any SABA and/or SAMA)
n=269 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=811 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC
|
1.6847 Liters
Interval 1.6542 to 1.7153
|
1.7558 Liters
Interval 1.7378 to 1.7737
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 12 (Visit 4)Population: The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.
Outcome measures
| Measure |
A1 (Any SABA and/or SAMA)
n=268 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=811 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)
|
1.6728 Liters
Interval 1.6461 to 1.6994
|
1.7742 Liters
Interval 1.7587 to 1.7896
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (baseline) and week 12Population: The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.
Outcome measures
| Measure |
A1 (Any SABA and/or SAMA)
n=122 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=369 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)
|
0.5117 Units on a scale
Interval -0.0073 to 1.0306
|
2.3005 Units on a scale
Interval 2.0015 to 2.5995
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (baseline) and week 12Population: The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.
Outcome measures
| Measure |
A1 (Any SABA and/or SAMA)
n=420 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=1254 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)
|
0.6969 Units on a scale
Interval 0.4169 to 0.9769
|
1.4351 Units on a scale
Interval 1.2718 to 1.5984
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (baseline) and week 12Population: The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.
Outcome measures
| Measure |
A1 (Any SABA and/or SAMA)
n=269 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=811 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC
|
0.8508 Units on a scale
Interval 0.4676 to 1.234
|
1.9491 Units on a scale
Interval 1.7207 to 2.1775
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (baseline) and week 12Population: The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.
Outcome measures
| Measure |
A1 (Any SABA and/or SAMA)
n=268 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=811 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)
|
0.8632 Units on a scale
Interval 0.5098 to 1.2166
|
2.1209 Units on a scale
Interval 1.913 to 2.3288
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval
Outcome measures
| Measure |
A1 (Any SABA and/or SAMA)
n=1623 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=542 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)
|
1.8373 Liters
Interval 1.825 to 1.8496
|
1.8065 Liters
Interval 1.7853 to 1.8276
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (baseline) and week 12Population: The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.
Outcome measures
| Measure |
A1 (Any SABA and/or SAMA)
n=1623 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=542 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline on on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or Long-acting Bronchodilators (LABA or LAMA Monotherapy)
|
1.6315 Score on a scale
Interval 1.4874 to 1.7756
|
0.6562 Score on a scale
Interval 0.4085 to 0.9039
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.
Outcome measures
| Measure |
A1 (Any SABA and/or SAMA)
n=1622 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=537 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC on Trough FEV1 at Week 12.
|
1.7650 Liters
Interval 1.7532 to 1.7768
|
1.6789 Liters
Interval 1.6587 to 1.6992
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (baseline) and week 12Population: The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.
Outcome measures
| Measure |
A1 (Any SABA and/or SAMA)
n=1622 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=537 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC
|
2.0354 Score on a scale
Interval 1.8811 to 2.1896
|
0.8588 Score on a scale
Interval 0.5983 to 1.1192
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (baseline) and Week 12Population: The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Total score of COPD Assessment Test (CAT) will be measured at baseline and at week 12. This questionnaire is completed by the patient. The score ranges from 0-40 where higher scores represent worse health status. CAT scores ≥ 10 are associated with significantly impaired health status.
Outcome measures
| Measure |
A1 (Any SABA and/or SAMA)
n=122 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=369 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
n=420 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
n=1254 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
n=269 Participants
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
n=811 Participants
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
n=268 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
n=811 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline on Total Score of COPD Assessment Test (CAT) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC
|
0.1 Score
Standard Deviation 4.6
|
-1.8 Score
Standard Deviation 5.3
|
0.1 Score
Standard Deviation 4.9
|
-0.5 Score
Standard Deviation 4.6
|
-0.4 Score
Standard Deviation 4.8
|
-1.4 Score
Standard Deviation 5.4
|
-0.9 Score
Standard Deviation 5.0
|
-1.9 Score
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Day 1 (baseline) and Week 12Population: The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
The Clinical COPD Questionnaire (CCQ) is a self-administered 10-item questionnaire developed to measure clinical control in patients with COPD. Patients will be instructed to recall their experiences during the previous week. They respond to each question using a 7-point scale from 0 = asymptomatic/no imitation to 6 = extremely symptomatic/totally limited. The questionnaire is divided into 3 domains (symptoms \[items 1, 2, 5, and 6\] functional \[items 7, 8, 9, and 10\] and mental state \[items 3 and 4\]). The overall clinical COPD control score and the scores of the domains are calculated by adding all the scores together and dividing this sum by the number of questions. Thus, the overall clinical COPD control score as well as the score on each of the three domains varies between 0 (very good control) to 6 (extremely poor control).
Outcome measures
| Measure |
A1 (Any SABA and/or SAMA)
n=122 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=369 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
n=420 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
n=1254 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
n=269 Participants
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
n=811 Participants
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
n=268 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
n=811 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline on Total Score of Clinical COPD Questionnaire (CCQ) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC
|
-0.0 Score
Standard Deviation 0.6
|
-0.3 Score
Standard Deviation 0.7
|
0.0 Score
Standard Deviation 0.7
|
-0.1 Score
Standard Deviation 0.7
|
-0.1 Score
Standard Deviation 0.7
|
-0.2 Score
Standard Deviation 0.8
|
-0.1 Score
Standard Deviation 0.8
|
-0.3 Score
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Mean number of puffs of rescue medication use will be measured using eDiary data over 12 weeks of treatment.
Outcome measures
| Measure |
A1 (Any SABA and/or SAMA)
n=122 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=369 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
n=420 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
n=1254 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
n=269 Participants
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
n=811 Participants
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
n=268 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
n=811 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Mean Number of Puffs of Rescue Medication Use for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC
|
1.8 Number of puffs
Standard Deviation 1.7
|
1.0 Number of puffs
Standard Deviation 1.3
|
0.8 Number of puffs
Standard Deviation 1.2
|
0.7 Number of puffs
Standard Deviation 1.1
|
1.6 Number of puffs
Standard Deviation 1.7
|
1.1 Number of puffs
Standard Deviation 1.4
|
1.4 Number of puffs
Standard Deviation 1.4
|
1.1 Number of puffs
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Patient-reported symptoms of COPD combined will be measured using eDiary data reported over the 12 week treatment period. The mean total symptom scores and mean individual symptom scores for the patient were calculated for the whole study period. The mean change from baseline in the total scores and in the individual scores were summarized by treatment and were analyzed for the percentage of nights with no nighttime awakenings and percentage of days with no symptoms.
Outcome measures
| Measure |
A1 (Any SABA and/or SAMA)
n=122 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=369 Participants
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or LABA and mMRC=1)
n=420 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium and mMRC=1)
n=1254 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
n=269 Participants
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/Glycopyrronium)
n=811 Participants
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or LABA and mMRC>1)
n=268 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/Glycopyrronium and mMRC>1)
n=811 Participants
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline Reported Symptoms of COPD for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC
|
-0.04 Percentage of days
Standard Deviation 0.15
|
-0.10 Percentage of days
Standard Deviation 0.22
|
-0.03 Percentage of days
Standard Deviation 0.19
|
-0.05 Percentage of days
Standard Deviation 0.20
|
-0.05 Percentage of days
Standard Deviation 0.19
|
-0.07 Percentage of days
Standard Deviation 0.22
|
-0.04 Percentage of days
Standard Deviation 0.19
|
-0.09 Percentage of days
Standard Deviation 0.21
|
Adverse Events
A1 (Any SABA and/or SAMA)
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
A2 (Glycopyrronium)
Serious events: 9 serious events
Other events: 67 other events
Deaths: 0 deaths
B1 (Any LAMA or@ LABA and mMRC eq 1)
Serious events: 11 serious events
Other events: 63 other events
Deaths: 0 deaths
B2 (Glycopyrronium@ and mMRC eq 1)
Serious events: 30 serious events
Other events: 163 other events
Deaths: 0 deaths
C1 (Any LABA and ICS)
Serious events: 6 serious events
Other events: 29 other events
Deaths: 0 deaths
C2 (Indacaterol/@Glycopyrronium)
Serious events: 22 serious events
Other events: 119 other events
Deaths: 0 deaths
D1 (Any LAMA or@ LABA and mMRC gt 1)
Serious events: 10 serious events
Other events: 20 other events
Deaths: 0 deaths
D2 (Indacaterol/@Glycopyrronium and@ mMRC gt 1)
Serious events: 34 serious events
Other events: 120 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A1 (Any SABA and/or SAMA)
n=125 participants at risk
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=385 participants at risk
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or@ LABA and mMRC eq 1)
n=417 participants at risk
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium@ and mMRC eq 1)
n=1248 participants at risk
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
n=269 participants at risk
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/@Glycopyrronium)
n=816 participants at risk
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or@ LABA and mMRC gt 1)
n=269 participants at risk
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/@Glycopyrronium and@ mMRC gt 1)
n=814 participants at risk
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/125
|
0.52%
2/385
|
0.24%
1/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Cardiac disorders
Myocardial infarction
|
0.80%
1/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.37%
1/269
|
0.12%
1/814
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.37%
1/269
|
0.00%
0/814
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/125
|
0.26%
1/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Congenital, familial and genetic disorders
Congenital central nervous system anomaly
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/125
|
0.00%
0/385
|
0.24%
1/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/125
|
0.26%
1/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Infections and infestations
Bronchitis
|
0.00%
0/125
|
0.00%
0/385
|
0.24%
1/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Infections and infestations
Cystitis
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.37%
1/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/125
|
0.00%
0/385
|
0.24%
1/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Infections and infestations
Influenza
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Infections and infestations
Mediastinal abscess
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Infections and infestations
Pneumonia
|
0.00%
0/125
|
0.26%
1/385
|
0.00%
0/417
|
0.16%
2/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.37%
1/269
|
0.86%
7/814
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Injury, poisoning and procedural complications
Bursa injury
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.80%
1/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.25%
2/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.00%
0/125
|
0.26%
1/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/125
|
0.00%
0/385
|
0.24%
1/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Gastrointestinal disorders
Diverticulum oesophageal
|
0.00%
0/125
|
0.26%
1/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
General disorders
Chest pain
|
0.00%
0/125
|
0.26%
1/385
|
0.00%
0/417
|
0.16%
2/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.00%
0/269
|
0.00%
0/814
|
|
General disorders
Fatigue
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.00%
0/269
|
0.00%
0/814
|
|
General disorders
Hernia
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
General disorders
Sudden death
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
General disorders
Ulcer
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/125
|
0.26%
1/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.16%
2/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.37%
1/269
|
0.00%
0/814
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.37%
1/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/125
|
0.26%
1/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Cardiac disorders
Cardiac arrest
|
0.80%
1/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/125
|
0.00%
0/385
|
0.24%
1/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.37%
1/269
|
0.00%
0/814
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.37%
1/269
|
0.00%
0/814
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.37%
1/269
|
0.12%
1/814
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.37%
1/269
|
0.00%
0/814
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Investigations
Blood pressure increased
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Investigations
Heart rate decreased
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.37%
1/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.25%
2/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/125
|
0.26%
1/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.80%
1/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/125
|
0.00%
0/385
|
0.24%
1/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/125
|
0.00%
0/385
|
0.24%
1/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.37%
1/269
|
0.00%
0/814
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/125
|
0.00%
0/385
|
0.24%
1/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.37%
1/269
|
0.00%
0/814
|
|
Nervous system disorders
Syncope
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Nervous system disorders
Transient ischaemic attack
|
0.80%
1/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.37%
1/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Nervous system disorders
Vascular encephalopathy
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.37%
1/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Psychiatric disorders
Depression
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.37%
1/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/125
|
0.26%
1/385
|
0.24%
1/417
|
0.24%
3/1248
|
0.37%
1/269
|
0.37%
3/816
|
0.37%
1/269
|
0.37%
3/814
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/125
|
0.00%
0/385
|
0.24%
1/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.37%
1/269
|
0.12%
1/814
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.80%
1/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/125
|
0.26%
1/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/125
|
0.26%
1/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/125
|
0.00%
0/385
|
0.24%
1/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.25%
2/814
|
|
Vascular disorders
Femoral artery aneurysm
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Vascular disorders
Hypertension
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.37%
1/269
|
0.12%
1/814
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.37%
1/269
|
0.00%
0/814
|
|
Vascular disorders
Ischaemia
|
0.00%
0/125
|
0.26%
1/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.37%
3/814
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.37%
3/814
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.37%
1/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Vascular disorders
Shock
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.00%
0/814
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/125
|
0.00%
0/385
|
0.00%
0/417
|
0.00%
0/1248
|
0.00%
0/269
|
0.00%
0/816
|
0.00%
0/269
|
0.12%
1/814
|
Other adverse events
| Measure |
A1 (Any SABA and/or SAMA)
n=125 participants at risk
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
|
A2 (Glycopyrronium)
n=385 participants at risk
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
B1 (Any LAMA or@ LABA and mMRC eq 1)
n=417 participants at risk
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
|
B2 (Glycopyrronium@ and mMRC eq 1)
n=1248 participants at risk
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
|
C1 (Any LABA and ICS)
n=269 participants at risk
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
|
C2 (Indacaterol/@Glycopyrronium)
n=816 participants at risk
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
|
D1 (Any LAMA or@ LABA and mMRC gt 1)
n=269 participants at risk
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
|
D2 (Indacaterol/@Glycopyrronium and@ mMRC gt 1)
n=814 participants at risk
Patients treated with any LABA or LAMA monotherapy and mMRC score \>1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
2/125
|
0.00%
0/385
|
0.24%
1/417
|
0.24%
3/1248
|
0.00%
0/269
|
0.25%
2/816
|
0.00%
0/269
|
0.12%
1/814
|
|
Infections and infestations
Bronchitis
|
0.00%
0/125
|
1.0%
4/385
|
0.96%
4/417
|
0.32%
4/1248
|
0.37%
1/269
|
0.12%
1/816
|
0.37%
1/269
|
0.37%
3/814
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
8/125
|
9.9%
38/385
|
5.8%
24/417
|
5.7%
71/1248
|
4.1%
11/269
|
4.5%
37/816
|
3.7%
10/269
|
6.6%
54/814
|
|
Infections and infestations
Pharyngitis
|
2.4%
3/125
|
0.26%
1/385
|
0.00%
0/417
|
0.56%
7/1248
|
0.00%
0/269
|
0.37%
3/816
|
0.37%
1/269
|
0.61%
5/814
|
|
Infections and infestations
Rhinitis
|
0.00%
0/125
|
0.26%
1/385
|
1.7%
7/417
|
0.96%
12/1248
|
0.74%
2/269
|
0.61%
5/816
|
0.37%
1/269
|
1.2%
10/814
|
|
Infections and infestations
Tracheitis
|
1.6%
2/125
|
0.00%
0/385
|
0.48%
2/417
|
0.16%
2/1248
|
0.00%
0/269
|
0.25%
2/816
|
0.00%
0/269
|
0.25%
2/814
|
|
Infections and infestations
Urinary tract infection
|
1.6%
2/125
|
0.52%
2/385
|
0.24%
1/417
|
0.40%
5/1248
|
0.00%
0/269
|
0.12%
1/816
|
0.00%
0/269
|
0.37%
3/814
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
2/125
|
1.6%
6/385
|
0.72%
3/417
|
0.64%
8/1248
|
0.74%
2/269
|
1.2%
10/816
|
0.74%
2/269
|
1.4%
11/814
|
|
Nervous system disorders
Headache
|
0.00%
0/125
|
1.8%
7/385
|
0.72%
3/417
|
0.72%
9/1248
|
0.37%
1/269
|
1.5%
12/816
|
0.37%
1/269
|
0.98%
8/814
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
3/125
|
1.3%
5/385
|
3.1%
13/417
|
2.6%
33/1248
|
1.9%
5/269
|
5.4%
44/816
|
1.5%
4/269
|
3.3%
27/814
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.80%
1/125
|
1.3%
5/385
|
1.4%
6/417
|
1.0%
13/1248
|
2.2%
6/269
|
0.86%
7/816
|
0.74%
2/269
|
0.86%
7/814
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/125
|
1.0%
4/385
|
0.72%
3/417
|
0.80%
10/1248
|
1.5%
4/269
|
0.37%
3/816
|
0.37%
1/269
|
0.49%
4/814
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/125
|
1.0%
4/385
|
0.00%
0/417
|
0.08%
1/1248
|
0.00%
0/269
|
0.25%
2/816
|
0.74%
2/269
|
0.00%
0/814
|
|
Vascular disorders
Hypertension
|
0.80%
1/125
|
0.78%
3/385
|
1.7%
7/417
|
0.56%
7/1248
|
0.74%
2/269
|
0.61%
5/816
|
0.00%
0/269
|
0.86%
7/814
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 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 or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER