Trial Outcomes & Findings for A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium Compared With Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease (NCT NCT02207829)
NCT ID: NCT02207829
Last Updated: 2018-01-24
Results Overview
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis performed using a repeated measures model with covariates of treatment, baseline FEV1, centre group, 24 hour subset flag, Day, Day by baseline and Day by treatment interactions. The least squares mean changes are presented here.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1017 participants
Primary outcome timeframe
Baseline (BL) and Day 85
Results posted on
2018-01-24
Participant Flow
Participants (Par.), with clinical history of chronic obstructive pulmonary disease, who met eligibility criteria at screening were enrolled in a 7 to 14 days run-in period. Eligible par. were randomized (1:1) to receive umeclidinium or tiotropium. A total of 1214 par. were screened; 1017 par. were randomized and entered into the study.
Participant milestones
| Measure |
Umeclidinium 62.5 mcg+Placebo QD
Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
|
Tiotropium 18 mcg+Placebo QD
Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
|
|---|---|---|
|
Overall Study
STARTED
|
509
|
508
|
|
Overall Study
COMPLETED
|
467
|
474
|
|
Overall Study
NOT COMPLETED
|
42
|
34
|
Reasons for withdrawal
| Measure |
Umeclidinium 62.5 mcg+Placebo QD
Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
|
Tiotropium 18 mcg+Placebo QD
Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
9
|
|
Overall Study
Lack of Efficacy
|
7
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Protocol deviation
|
5
|
4
|
|
Overall Study
Withdrew consent
|
18
|
14
|
Baseline Characteristics
A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium Compared With Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Umeclidinium 62.5 mcg+Placebo QD
n=509 Participants
Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
|
Tiotropium 18 mcg+Placebo QD
n=508 Participants
Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
|
Total
n=1017 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.4 Years
STANDARD_DEVIATION 8.12 • n=5 Participants
|
64.1 Years
STANDARD_DEVIATION 8.28 • n=7 Participants
|
64.2 Years
STANDARD_DEVIATION 8.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
364 Participants
n=5 Participants
|
371 Participants
n=7 Participants
|
735 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Central/South Asian Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese/East Asian/South East Asian Heritage
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
458 Participants
n=5 Participants
|
457 Participants
n=7 Participants
|
915 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage & White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (BL) and Day 85Population: Per Protocol(PP) Population(pop): Participants(par) in the Intent-To-Treat pop who did not have a full protocol deviation considered to impact efficacy. Par represent those with data available at time point presented; however, all par. in the PP pop. without missing covariate information and \>=1 post BL measurement are included in analysis
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis performed using a repeated measures model with covariates of treatment, baseline FEV1, centre group, 24 hour subset flag, Day, Day by baseline and Day by treatment interactions. The least squares mean changes are presented here.
Outcome measures
| Measure |
Umeclidinium 62.5 mcg+Placebo QD
n=392 Participants
Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
|
Tiotropium 18 mcg+Placebo QD
n=416 Participants
Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
|
|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85
|
0.154 Liter
Standard Error 0.0107
|
0.095 Liter
Standard Error 0.0106
|
Adverse Events
Umeclidinium 62.5 mcg+Placebo QD
Serious events: 17 serious events
Other events: 50 other events
Deaths: 0 deaths
Tiotropium 18 mcg+Placebo QD
Serious events: 16 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Umeclidinium 62.5 mcg+Placebo QD
n=509 participants at risk
Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
|
Tiotropium 18 mcg+Placebo QD
n=508 participants at risk
Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.39%
2/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
1.2%
6/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.20%
1/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Infections and infestations
Pneumonia
|
0.20%
1/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.20%
1/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Infections and infestations
Localised infection
|
0.00%
0/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.20%
1/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Infections and infestations
Lobar pneumonia
|
0.20%
1/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airway disease
|
0.00%
0/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.20%
1/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Infections and infestations
Appendicitis perforated
|
0.20%
1/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.20%
1/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.20%
1/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.20%
1/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.20%
1/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.20%
1/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.20%
1/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.20%
1/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.20%
1/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Vascular disorders
Hypertension
|
0.20%
1/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.20%
1/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Vascular disorders
Deep vein thrombosis
|
0.20%
1/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.20%
1/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.20%
1/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Cardiac disorders
Angina unstable
|
0.20%
1/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.20%
1/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Gastrointestinal disorders
Constipation
|
0.20%
1/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Nervous system disorders
Syncope
|
0.00%
0/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.20%
1/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Nervous system disorders
Seizure
|
0.00%
0/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.20%
1/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.20%
1/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.20%
1/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
Other adverse events
| Measure |
Umeclidinium 62.5 mcg+Placebo QD
n=509 participants at risk
Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
|
Tiotropium 18 mcg+Placebo QD
n=508 participants at risk
Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
|
|---|---|---|
|
Nervous system disorders
Headache
|
5.9%
30/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
6.3%
32/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
27/509 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
4.5%
23/508 • On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.
On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER