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Trial record 1 of 6 for:    200812
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Comparative Study of Fluticasone Furoate(FF)/Umeclidinium Bromide (UMEC)/ Vilanterol (VI) Closed Therapy Versus FF/VI Plus UMEC Open Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT02729051
Recruitment Status : Completed
First Posted : April 6, 2016
Results First Posted : July 15, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: FF/UMEC/VI
Drug: FF/VI
Drug: UMEC
Drug: Placebo
Drug: Albuterol/salbutamol
Enrollment 1055
Recruitment Details This was a 24-week, randomized, double-blind, parallel group multicenter study to compare closed triple therapy Fluticasone Furoate/ Umeclidinium/ Vilanterol Trifenatate (FF/UMEC/VI) with open triple therapy (FF/VI + UMEC), in participants with chronic obstructive pulmonary disease (COPD). This study was conducted across 12 countries.
Pre-assignment Details A total of 1311 participants were pre-screened, of which 1278 participants were screened (33 pre-screen failures). There were 175 screen failures and 48 Run-in failures. A total of 1055 participants were randomized and received the study treatment.
Arm/Group Title FF/UMEC/VI 100/62.5/25 FF/VI 100/25 + UMEC 62.5
Hide Arm/Group Description Participants received FF/UMEC/VI, 100 micrograms (mcg)/62.5 mcg/25 mcg via ELLIPTA dry powder inhaler (DPI) once daily in morning and placebo inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period. Participants received FF/VI, 100 mcg/25 mcg via ELLIPTA DPI once daily in morning and UMEC 62.5 mcg inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
Period Title: Overall Study
Started 527 528
Completed 497 496
Not Completed 30 32
Reason Not Completed
Adverse Event             21             11
Lack of Efficacy             1             1
Lost to Follow-up             1             2
Physician Decision             1             1
Withdrawal by Subject             6             17
Arm/Group Title FF/UMEC/VI 100/62.5/25 FF/VI 100/25 + UMEC 62.5 Total
Hide Arm/Group Description Participants received FF/UMEC/VI, 100 mcg/62.5 mcg/25 mcg via ELLIPTA DPI once daily in morning and placebo inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period. Participants received FF/VI, 100 mcg/25 mcg via ELLIPTA DPI once daily in morning and UMEC 62.5 mcg inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period. Total of all reporting groups
Overall Number of Baseline Participants 527 528 1055
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 527 participants 528 participants 1055 participants
66.7  (8.46) 65.9  (8.77) 66.3  (8.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 527 participants 528 participants 1055 participants
Female
136
  25.8%
134
  25.4%
270
  25.6%
Male
391
  74.2%
394
  74.6%
785
  74.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 527 participants 528 participants 1055 participants
American Indian or Alaska Native
18
   3.4%
14
   2.7%
32
   3.0%
Asian - East Asian Heritage
29
   5.5%
30
   5.7%
59
   5.6%
Asian - Japanese Heritage
41
   7.8%
38
   7.2%
79
   7.5%
Asian - South East Asian Heritage
2
   0.4%
0
   0.0%
2
   0.2%
White - Arabic/North African Heritage
1
   0.2%
4
   0.8%
5
   0.5%
White - White/Caucasian/European Heritage
416
  78.9%
416
  78.8%
832
  78.9%
American Indian/Alaska Native and Asian and White
0
   0.0%
1
   0.2%
1
   0.1%
American Indian or Alaska Native and White
20
   3.8%
25
   4.7%
45
   4.3%
1.Primary Outcome
Title Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24
Hide Description FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. It was measured using centralized spirometry. FEV1 values at Week 0, pre-dose were considered as Baseline values. Change from Baseline was calculated by subtracting Baseline value from the value at indicated time point. Modified Per Protocol (mPP) Population was used which comprised of all participants in the Intent-to-Treat (ITT) Population, who do not have a full protocol deviation considered to impact efficacy. Data following a moderate/severe COPD exacerbation or pneumonia was excluded from analysis due to the potential impact of the exacerbation or the medications used to treat it. Participants with partial protocol deviations considered to impact efficacy were included in the mPP Population but had their data excluded from analysis from the time of deviation onwards. Analysis was performed using a mixed model repeated measures (MMRM) method.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mPP Population
Arm/Group Title FF/UMEC/VI 100/62.5/25 FF/VI 100/25 + UMEC 62.5
Hide Arm/Group Description:
Participants received FF/UMEC/VI, 100 mcg/62.5 mcg/25 mcg via ELLIPTA DPI once daily in morning and placebo inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
Participants received FF/VI, 100 mcg/25 mcg via ELLIPTA DPI once daily in morning and UMEC 62.5 mcg inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
Overall Number of Participants Analyzed 307 287
Least Squares Mean (Standard Error)
Unit of Measure: Liter
0.113  (0.0112) 0.095  (0.0116)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FF/UMEC/VI 100/62.5/25, FF/VI 100/25 + UMEC 62.5
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments If the lower bound of the two-sided 95% confidence interval around the (FF/UMEC/VI versus FF/VI+UMEC) treatment difference is above -50 milliliter (mL) then FF/UMEC/VI was to be considered non-inferior to FF/VI+UMEC.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.018
Confidence Interval (2-Sided) 95%
-0.013 to 0.050
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0161
Estimation Comments MMRM method included covariates of Baseline FEV1, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by Baseline interaction.
2.Secondary Outcome
Title Percentage of Responders Based on the Saint (St) George Respiratory Questionnaire (SGRQ) Total Score at Week 24
Hide Description SGRQ is a disease-specific questionnaire designed to measure impact of respiratory disease and its treatment on health related quality of life (HRQoL) of participants with COPD. It contains 14 questions with a total of 40 items grouped into domains (Symptoms, Activity and Impacts). SGRQ total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. It ranges from 0 to 100, higher score indicates poor HRQoL. Response was defined as an SGRQ total score of >=4 units below Baseline. Non response was defined as a SGRQ total score <4 units below Baseline or a missing SGRQ total score with no subsequent on treatment scores. ITT Population comprised of randomized participants, excluding those who were randomized in error. A participant screened or run-in failure and also randomized was considered to be randomized in error. Analysis was performed using a generalized linear mixed model with a logit link function.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title FF/UMEC/VI 100/62.5/25 FF/VI 100/25 + UMEC 62.5
Hide Arm/Group Description:
Participants received FF/UMEC/VI, 100 mcg/62.5 mcg/25 mcg via ELLIPTA DPI once daily in morning and placebo inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
Participants received FF/VI, 100 mcg/25 mcg via ELLIPTA DPI once daily in morning and UMEC 62.5 mcg inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
Overall Number of Participants Analyzed 489 483
Measure Type: Number
Unit of Measure: Percentage of Participants
50 51
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FF/UMEC/VI 100/62.5/25, FF/VI 100/25 + UMEC 62.5
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.71 to 1.20
Estimation Comments Analysis included covariates of treatment group, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), geographical region, visit, Baseline, Baseline by visit and treatment by visit interactions.
3.Secondary Outcome
Title Change From Baseline in SGRQ Total Score at Week 24
Hide Description SGRQ is a disease-specific questionnaire designed to measure impact of respiratory disease and its treatment on HRQoL of participants with COPD. It contains 14 questions with a total of 40 items grouped into domains (Symptoms, Activity and Impacts). SGRQ total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. It ranges from 0 to 100, higher score indicates poor HRQoL. Values at Week 0, pre-dose were considered as Baseline values. Change from Baseline was calculated by subtracting Baseline value from the value at indicated time point. Analysis was performed using a MMRM method including covariates of Baseline SGRQ Total score, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by Baseline interaction.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title FF/UMEC/VI 100/62.5/25 FF/VI 100/25 + UMEC 62.5
Hide Arm/Group Description:
Participants received FF/UMEC/VI, 100 mcg/62.5 mcg/25 mcg via ELLIPTA DPI once daily in morning and placebo inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
Participants received FF/VI, 100 mcg/25 mcg via ELLIPTA DPI once daily in morning and UMEC 62.5 mcg inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
Overall Number of Participants Analyzed 489 483
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-5.841  (0.5870) -4.935  (0.5904)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FF/UMEC/VI 100/62.5/25, FF/VI 100/25 + UMEC 62.5
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -0.906
Confidence Interval (2-Sided) 95%
-2.540 to 0.728
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.8327
Estimation Comments Analysis performed using a repeated measures model with covariates of Baseline SGRQ, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by Baseline.
4.Secondary Outcome
Title Percentage of Responders Based on Transitional Dyspnea Index (TDI) Focal Score at Week 24
Hide Description The TDI measures changes in the participant's dyspnea. TDI focal score was calculated as the sum of the ratings recorded for each of the 3 individual scales (Functional Impairment, Magnitude of Task, Magnitude of Effort). Each of these scales had a possible score ranging from -6 to +6. lower scores indicating more impairment. TDI focal score was calculated as the sum of the 3 individual scores and then divided by 2 (so the range of the TDI focal score is -9 to +9). The lower the score, the more deterioration in severity of dyspnea. If a score is missing for any of the three scales, then the TDI focal score was set to missing. A participant was considered as a responder if the on-treatment TDI focal score was at least 1 unit at that visit. Non-response was defined as a TDI focal score of less than 1 unit or a missing TDI focal score with no subsequent non-missing on-treatment scores. Analysis was performed using a generalized linear mixed model with a logit link function.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title FF/UMEC/VI 100/62.5/25 FF/VI 100/25 + UMEC 62.5
Hide Arm/Group Description:
Participants received FF/UMEC/VI, 100 mcg/62.5 mcg/25 mcg via ELLIPTA DPI once daily in morning and placebo inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
Participants received FF/VI, 100 mcg/25 mcg via ELLIPTA DPI once daily in morning and UMEC 62.5 mcg inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
Overall Number of Participants Analyzed 482 481
Measure Type: Number
Unit of Measure: Percentage of Participants
56 56
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FF/UMEC/VI 100/62.5/25, FF/VI 100/25 + UMEC 62.5
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.72 to 1.25
Estimation Comments Include covariates of treatment group, stratum (number of long-acting bronchodilators/ day during the run-in: 0/1 or 2), geographical region, visit, Baseline dyspnea index (BDI) focal score, BDI focal score/ visit and treatment/ visit interactions.
5.Secondary Outcome
Title TDI Focal Score at Week 24
Hide Description The TDI measures changes in the participant's dyspnoea. TDI focal score was calculated as the sum of the ratings recorded for each of the 3 individual scales (Functional Impairment, Magnitude of Task, Magnitude of Effort). Each of these scales had a possible score ranging from -6 to +6. lower scores indicating more impairment. TDI focal score was calculated as the sum of the 3 individual scores and then divided by 2 (so the range of the TDI focal score is -9 to +9). The lower the score, the more deterioration in severity of dyspnea. If a score is missing for any of the three scales, then the TDI focal score was set to missing. Analysis was performed using a repeated measures model.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title FF/UMEC/VI 100/62.5/25 FF/VI 100/25 + UMEC 62.5
Hide Arm/Group Description:
Participants received FF/UMEC/VI, 100 mcg/62.5 mcg/25 mcg via ELLIPTA DPI once daily in morning and placebo inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
Participants received FF/VI, 100 mcg/25 mcg via ELLIPTA DPI once daily in morning and UMEC 62.5 mcg inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
Overall Number of Participants Analyzed 482 481
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
2.029  (0.1252) 1.892  (0.1254)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FF/UMEC/VI 100/62.5/25, FF/VI 100/25 + UMEC 62.5
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.137
Confidence Interval (2-Sided) 95%
-0.211 to 0.485
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1773
Estimation Comments Analysis included covariates of BDI focal score, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by BDI Focal score interactions.
6.Secondary Outcome
Title Time to First Moderate or Severe Exacerbation
Hide Description COPD exacerbations were identified based on the investigator's clinical judgment. Worsening symptoms of COPD that required treatment with oral/systemic corticosteroids and/or antibiotics were considered as moderate exacerbation. Worsening symptoms of COPD that required treatment with in-subject hospitalization was considered as severe exacerbation. Hazard ratio and 95% confidence interval (CI) is from a Cox proportional hazards model with covariates of treatment group, sex, exacerbation history (0, 1, >=2 moderate/severe exacerbations, prior year), smoking status (screening), stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), geographical region and percent predicted FEV1 at Baseline. Median and inter-quartile range (first and third quartile) have been presented.
Time Frame Up to 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title FF/UMEC/VI 100/62.5/25 FF/VI 100/25 + UMEC 62.5
Hide Arm/Group Description:
Participants received FF/UMEC/VI, 100 mcg/62.5 mcg/25 mcg via ELLIPTA DPI once daily in morning and placebo inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
Participants received FF/VI, 100 mcg/25 mcg via ELLIPTA DPI once daily in morning and UMEC 62.5 mcg inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
Overall Number of Participants Analyzed 527 528
Median (Inter-Quartile Range)
Unit of Measure: Days
NA [1] 
(166 to NA)
NA [1] 
(150 to NA)
[1]
As <50% of participants experienced the event within a treatment, median and third-quartile of time to first moderate or severe exacerbation are displayed as NA (not applicable) for that treatment.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FF/UMEC/VI 100/62.5/25, FF/VI 100/25 + UMEC 62.5
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.68 to 1.12
Estimation Comments Analysis was performed using a Cox proportional hazards model.
Time Frame On-treatment serious adverse events (SAEs) and non-serious AEs (nSAEs) were collected from start of study treatment (Week 0) until Week 25 including 1 Week of follow-up.
Adverse Event Reporting Description On-treatment SAEs and nSAEs were reported for ITT Population.
 
Arm/Group Title FF/UMEC/VI 100/62.5/25 FF/VI 100/25 + UMEC 62.5
Hide Arm/Group Description Participants received FF/UMEC/VI, 100 mcg/62.5 mcg/25 mcg via ELLIPTA DPI once daily in morning and placebo inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period. Participants received FF/VI, 100 mcg/25 mcg via ELLIPTA DPI once daily in morning and UMEC 62.5 mcg inhalation powder via ELLIPTA DPI, once daily in the morning. Participants also received albuterol/salbutamol as a rescue medication when needed during the treatment period.
All-Cause Mortality
FF/UMEC/VI 100/62.5/25 FF/VI 100/25 + UMEC 62.5
Affected / at Risk (%) Affected / at Risk (%)
Total   7/527 (1.33%)   5/528 (0.95%) 
Hide Serious Adverse Events
FF/UMEC/VI 100/62.5/25 FF/VI 100/25 + UMEC 62.5
Affected / at Risk (%) Affected / at Risk (%)
Total   55/527 (10.44%)   60/528 (11.36%) 
Cardiac disorders     
Acute myocardial infarction  1  2/527 (0.38%)  1/528 (0.19%) 
Aortic valve incompetence  1  0/527 (0.00%)  1/528 (0.19%) 
Atrial fibrillation  1  2/527 (0.38%)  0/528 (0.00%) 
Cardiac failure  1  1/527 (0.19%)  1/528 (0.19%) 
Cardiac failure acute  1  1/527 (0.19%)  0/528 (0.00%) 
Cardio-respiratory arrest  1  0/527 (0.00%)  1/528 (0.19%) 
Cardiogenic shock  1  1/527 (0.19%)  1/528 (0.19%) 
Cardiomyopathy  1  1/527 (0.19%)  0/528 (0.00%) 
Cardiopulmonary failure  1  1/527 (0.19%)  0/528 (0.00%) 
Coronary artery disease  1  1/527 (0.19%)  0/528 (0.00%) 
Degenerative aortic valve disease  1  0/527 (0.00%)  1/528 (0.19%) 
Mitral valve incompetence  1  0/527 (0.00%)  1/528 (0.19%) 
Myocardial ischaemia  1  1/527 (0.19%)  0/528 (0.00%) 
Prinzmetal angina  1  1/527 (0.19%)  0/528 (0.00%) 
Sinus bradycardia  1  1/527 (0.19%)  0/528 (0.00%) 
Stress cardiomyopathy  1  0/527 (0.00%)  1/528 (0.19%) 
Ear and labyrinth disorders     
Sudden hearing loss  1  1/527 (0.19%)  0/528 (0.00%) 
Gastrointestinal disorders     
Gastritis hypertrophic  1  1/527 (0.19%)  0/528 (0.00%) 
Gastrointestinal polyp haemorrhage  1  0/527 (0.00%)  1/528 (0.19%) 
Gastrointestinal hypomotility  1  1/527 (0.19%)  0/528 (0.00%) 
General disorders     
Chest pain  1  1/527 (0.19%)  0/528 (0.00%) 
Death  1  1/527 (0.19%)  0/528 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  1/527 (0.19%)  0/528 (0.00%) 
Cholecystitis acute  1  2/527 (0.38%)  1/528 (0.19%) 
Cholelithiasis  1  0/527 (0.00%)  1/528 (0.19%) 
Infections and infestations     
Cholecystitis infective  1  1/527 (0.19%)  0/528 (0.00%) 
Enteritis infectious  1  0/527 (0.00%)  1/528 (0.19%) 
Gastroenteritis  1  0/527 (0.00%)  1/528 (0.19%) 
Infective exacerbation of chronic obstructive airways disease  1  3/527 (0.57%)  2/528 (0.38%) 
Influenza  1  1/527 (0.19%)  1/528 (0.19%) 
Pneumonia  1  9/527 (1.71%)  13/528 (2.46%) 
Pneumonia bacterial  1  0/527 (0.00%)  2/528 (0.38%) 
Pyelonephritis  1  0/527 (0.00%)  1/528 (0.19%) 
Respiratory tract infection bacterial  1  0/527 (0.00%)  1/528 (0.19%) 
Sepsis  1  0/527 (0.00%)  1/528 (0.19%) 
Septic shock  1  0/527 (0.00%)  1/528 (0.19%) 
Staphylococcal infection  1  0/527 (0.00%)  1/528 (0.19%) 
Superinfection  1  0/527 (0.00%)  1/528 (0.19%) 
Toxic shock syndrome  1  1/527 (0.19%)  0/528 (0.00%) 
Urinary tract infection  1  0/527 (0.00%)  1/528 (0.19%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  0/527 (0.00%)  1/528 (0.19%) 
Contusion  1  1/527 (0.19%)  0/528 (0.00%) 
Craniocerebral injury  1  1/527 (0.19%)  0/528 (0.00%) 
Femoral neck fracture  1  1/527 (0.19%)  0/528 (0.00%) 
Procedural complication  1  1/527 (0.19%)  0/528 (0.00%) 
Rib fracture  1  1/527 (0.19%)  0/528 (0.00%) 
Spinal compression fracture  1  0/527 (0.00%)  1/528 (0.19%) 
Spinal fracture  1  0/527 (0.00%)  1/528 (0.19%) 
Tibia fracture  1  0/527 (0.00%)  1/528 (0.19%) 
Investigations     
X-ray abnormal  1  1/527 (0.19%)  0/528 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/527 (0.19%)  0/528 (0.00%) 
Diabetes mellitus  1  0/527 (0.00%)  1/528 (0.19%) 
Hyponatraemia  1  1/527 (0.19%)  0/528 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/527 (0.00%)  1/528 (0.19%) 
Pseudarthrosis  1  1/527 (0.19%)  0/528 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Angiosarcoma  1  0/527 (0.00%)  1/528 (0.19%) 
Benign hepatic neoplasm  1  0/527 (0.00%)  1/528 (0.19%) 
Bladder cancer  1  1/527 (0.19%)  0/528 (0.00%) 
Colon cancer  1  0/527 (0.00%)  1/528 (0.19%) 
Glioblastoma  1  1/527 (0.19%)  0/528 (0.00%) 
Oesophageal adenocarcinoma  1  1/527 (0.19%)  0/528 (0.00%) 
Prostate cancer  1  0/527 (0.00%)  1/528 (0.19%) 
Nervous system disorders     
Brain injury  1  1/527 (0.19%)  0/528 (0.00%) 
Cerebrovascular accident  1  1/527 (0.19%)  0/528 (0.00%) 
Intensive care unit acquired weakness  1  1/527 (0.19%)  0/528 (0.00%) 
Ischaemic stroke  1  0/527 (0.00%)  1/528 (0.19%) 
Syncope  1  1/527 (0.19%)  0/528 (0.00%) 
Psychiatric disorders     
Organic brain syndrome  1  1/527 (0.19%)  0/528 (0.00%) 
Reproductive system and breast disorders     
Vaginal prolapse  1  1/527 (0.19%)  0/528 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  1/527 (0.19%)  0/528 (0.00%) 
Atelectasis  1  0/527 (0.00%)  1/528 (0.19%) 
Chronic obstructive pulmonary disease  1  24/527 (4.55%)  32/528 (6.06%) 
Haemoptysis  1  1/527 (0.19%)  0/528 (0.00%) 
Pneumothorax spontaneous  1  0/527 (0.00%)  1/528 (0.19%) 
Pulmonary fibrosis  1  0/527 (0.00%)  1/528 (0.19%) 
Respiratory acidosis  1  0/527 (0.00%)  1/528 (0.19%) 
Respiratory failure  1  0/527 (0.00%)  2/528 (0.38%) 
Vascular disorders     
Aortic aneurysm  1  0/527 (0.00%)  1/528 (0.19%) 
Hypertension  1  0/527 (0.00%)  1/528 (0.19%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
FF/UMEC/VI 100/62.5/25 FF/VI 100/25 + UMEC 62.5
Affected / at Risk (%) Affected / at Risk (%)
Total   122/527 (23.15%)   125/528 (23.67%) 
Infections and infestations     
Viral upper respiratory tract infection  1  56/527 (10.63%)  52/528 (9.85%) 
Upper respiratory tract infection  1  18/527 (3.42%)  24/528 (4.55%) 
Influenza  1  16/527 (3.04%)  17/528 (3.22%) 
Pharyngitis  1  12/527 (2.28%)  16/528 (3.03%) 
Nervous system disorders     
Headache  1  32/527 (6.07%)  33/528 (6.25%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02729051    
Other Study ID Numbers: 200812
2015-005212-14 ( EudraCT Number )
First Submitted: March 31, 2016
First Posted: April 6, 2016
Results First Submitted: April 25, 2018
Results First Posted: July 15, 2019
Last Update Posted: July 15, 2019