Trial Outcomes & Findings for A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT02236611)
NCT ID: NCT02236611
Last Updated: 2018-05-02
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
PHASE4
Target enrollment
1036 participants
Primary outcome timeframe
Baseline (BL) and Day 85
Results posted on
2018-05-02
Participant Flow
A total of 1290 par. were screened; 1037 par. were randomized and 1034 were in the ITT population which comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Two par. were randomized in error and one par. was randomized, but did not take any study medication.
Participants, with clinical history of chronic obstructive pulmonary disease, who meet the eligibility criteria at screening were enrolled in a 7 to 14 day run-in period. Participant meeting continuation criteria, during run-in period, were randomized (1:1) to receive umeclidinium or glycopyrronium.
Participant milestones
| Measure |
UMEC 62.5 mcg QD
Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
|
GLYCO 44 mcg QD
Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
|
|---|---|---|
|
Overall Study
STARTED
|
516
|
518
|
|
Overall Study
COMPLETED
|
490
|
484
|
|
Overall Study
NOT COMPLETED
|
26
|
34
|
Reasons for withdrawal
| Measure |
UMEC 62.5 mcg QD
Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
|
GLYCO 44 mcg QD
Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
16
|
|
Overall Study
Lack of Efficacy
|
4
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Protocol deviation
|
3
|
5
|
|
Overall Study
Withdrew consent
|
9
|
4
|
Baseline Characteristics
A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
UMEC 62.5 mcg QD
n=516 Participants
Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
|
GLYCO 44 mcg QD
n=518 Participants
Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
|
Total
n=1034 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.1 Years
STANDARD_DEVIATION 8.35 • n=5 Participants
|
64.0 Years
STANDARD_DEVIATION 8.26 • n=7 Participants
|
64.1 Years
STANDARD_DEVIATION 8.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
161 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
329 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
355 Participants
n=5 Participants
|
350 Participants
n=7 Participants
|
705 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Central/South Asian Heritage (HRTG)
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese/East Asian Heritage/South East Asian HRTG
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
513 Participants
n=5 Participants
|
517 Participants
n=7 Participants
|
1030 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 |
UMEC 62.5 mcg QD
n=431 Participants
Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
|
GLYCO 44 mcg QD
n=425 Participants
Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
|
|---|---|---|
|
Change From Baseline in Trough FEV1 on Day 85
|
0.123 Liter
Standard Error 0.0105
|
0.099 Liter
Standard Error 0.0105
|
Adverse Events
UMEC 62.5 mcg QD
Serious events: 17 serious events
Other events: 77 other events
Deaths: 0 deaths
GLYCO 44 mcg QD
Serious events: 15 serious events
Other events: 80 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
UMEC 62.5 mcg QD
n=516 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) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
|
GLYCO 44 mcg QD
n=518 participants at risk
Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.4%
7/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.97%
5/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat 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
Dyspnoea
|
0.00%
0/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.19%
1/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat 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
|
0.19%
1/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.19%
1/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.19%
1/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.19%
1/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Cardiac disorders
Myocardial infarction
|
0.19%
1/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.19%
1/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.19%
1/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.19%
1/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat 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
|
0.39%
2/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.19%
1/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
General disorders
Sudden cardiac death
|
0.19%
1/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
General disorders
Sudden death
|
0.19%
1/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat 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
Ankle fracture
|
0.19%
1/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat 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
Femoral neck fracture
|
0.00%
0/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.19%
1/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat 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
|
0.00%
0/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.19%
1/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat 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)
Laryngeal cancer
|
0.00%
0/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.19%
1/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat 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)
Neoplasm malignant
|
0.19%
1/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.19%
1/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Nervous system disorders
Ischaemic stroke
|
0.19%
1/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.19%
1/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat 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
Hyponatraemia
|
0.00%
0/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.19%
1/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.19%
1/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat 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 |
UMEC 62.5 mcg QD
n=516 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) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
|
GLYCO 44 mcg QD
n=518 participants at risk
Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.1%
42/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
7.5%
39/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Nervous system disorders
Headache
|
8.1%
42/516 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
9.8%
51/518 • 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).
On-treatment SAEs and non-serious AEs were reported for the Intent-To Treat 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