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A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT01009463
Recruitment Status : Completed
First Posted : November 6, 2009
Results First Posted : August 19, 2013
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: FF/GW642444 Inhalation Powder
Drug: GW642444 Inhalation Powder
Enrollment 1626
Recruitment Details  
Pre-assignment Details At Visit (V) 1, eligible participants (par.) entered a 4-week, open-label Run-In Period (RIP) to establish a stable Baseline. At V 2, eligible par. were randomized to a 52 week, double-blind Treatment Period. 2631 par. were screened, 2071 par. entered the RIP, and 1626 par. were randomized, out of which 1622 received at >= 1 study treatment dose.
Arm/Group Title FP/SAL 250/50 µg BID VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD
Hide Arm/Group Description Participants (Par.) were instructed to take open label Fluticasone Propionate and Salmeterol (FP/SAL) 250/50 microgram (µg) twice daily (BID) from the ACCUHALER/DISKUS, one inhalation each morning and evening with approximately 12 hours between doses. In addition, all par. were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] and/or nebules) to be used as needed throughout the study. Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Period Title: 4-week, Open-label Run-In Period
Started 2071 0 0 0 0
Completed 1622 0 0 0 0
Not Completed 449 0 0 0 0
Reason Not Completed
Did Not Meet Continuation Criteria             373             0             0             0             0
Adverse Event             10             0             0             0             0
Lost to Follow-up             6             0             0             0             0
Physician Decision             10             0             0             0             0
Withdrawal by Subject             50             0             0             0             0
Period Title: 52-week, Double-blind Treatment Period
Started 0 409 408 403 402
Completed the Treatment Period 0 295 [1] 318 [1] 314 [1] 303 [1]
Completed 0 294 [2] 315 [2] 312 [2] 301 [2]
Not Completed 0 115 93 91 101
Reason Not Completed
Adverse Event             0             22             25             29             31
Withdrawal by Subject             0             34             18             17             22
Lack of Efficacy             0             24             16             11             18
Protocol Violation             0             8             7             8             7
Met Protocol-Defined Stopping Criteria             0             10             14             13             10
Study Closed/Terminated             0             2             0             1             0
Lost to Follow-up             0             11             7             6             5
Physician Decision             0             4             6             6             8
[1]
Par. completed the treatment period if they attended the last treatment visit (Visit 11).
[2]
Par. completed the study if they completed the treatment period and safety follow-up phone contact.
Arm/Group Title VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD Total
Hide Arm/Group Description Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Total of all reporting groups
Overall Number of Baseline Participants 409 408 403 402 1622
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 409 participants 408 participants 403 participants 402 participants 1622 participants
63.6  (9.43) 63.6  (9.06) 63.6  (9.06) 63.8  (9.30) 63.6  (9.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 409 participants 408 participants 403 participants 402 participants 1622 participants
Female
170
  41.6%
163
  40.0%
172
  42.7%
153
  38.1%
658
  40.6%
Male
239
  58.4%
245
  60.0%
231
  57.3%
249
  61.9%
964
  59.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 409 participants 408 participants 403 participants 402 participants 1622 participants
White 331 334 332 324 1321
African American/ African Heritage 9 8 6 9 32
Asian 39 37 37 41 154
American Indian or Alaska Native & White 19 16 19 15 69
Asian & White 0 1 0 0 1
American Indian or Alaska Native 10 12 9 12 43
Unknown 1 0 0 1 2
1.Primary Outcome
Title Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean
Hide Description The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the treatment (trt) period (per participant [par.] per year) was assessed. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the par. without the use of oral corticosteroids or antibiotics; Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics; Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.
Time Frame From the start of the double blinded study medication until Visit 11 (Week 52)/Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.
Arm/Group Title VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD
Hide Arm/Group Description:
Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Overall Number of Participants Analyzed 409 408 403 402
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Exacerbations per participant per year
1.05
(0.92 to 1.21)
0.92
(0.80 to 1.06)
0.70
(0.60 to 0.81)
0.90
(0.78 to 1.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 50/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.181
Comments [Not Specified]
Method Generalized Linear Model
Comments Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.72 to 1.06
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 100/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Nominal p-value
Method Generalized Linear Model
Comments Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.54 to 0.81
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 200/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.109
Comments [Not Specified]
Method Generalized Linear Model
Comments Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.70 to 1.04
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to First Occurrence of Moderate or Severe COPD Exacerbation
Hide Description Time to first occurrence analyzed by using a Cox proportional hazards model with covariates of treatment, smoking status at screening (stratum), baseline disease severity (pre-dose Day 1 % predicted FEV1) and centre grouping. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. A moderate exacerbation is defined as worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. A severe exacerbation is defined as worsening symptoms of COPD that required treatment with in-patient hospitalization. The number of participants with a moderate or severe COPD exacerbation while on treatment are presented.
Time Frame From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD
Hide Arm/Group Description:
Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. )
Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Overall Number of Participants Analyzed 409 408 403 402
Measure Type: Number
Unit of Measure: Participants
202 190 160 178
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 50/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.430
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.76 to 1.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 100/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Nominal p-value
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.59 to 0.89
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 200/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.114
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.69 to 1.04
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Annual Rate of Exacerbations Requiring Systemic/Oral Corticosteroids Expressed as Least Square Mean
Hide Description The annual rate of COPD exacerbations during the treatment period (per participant per year) that required systemic/oral corticosteroids was assessed. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptom (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate, and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the participant. Mild exacerbations were not associated with the use of oral corticosteroids or antibiotics. Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.
Time Frame From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.
Arm/Group Title VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD
Hide Arm/Group Description:
Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Overall Number of Participants Analyzed 409 408 403 402
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Exacerbations per participant per year
0.84
(0.72 to 0.98)
0.71
(0.60 to 0.83)
0.52
(0.44 to 0.62)
0.68
(0.57 to 0.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 50/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.125
Comments [Not Specified]
Method Generalized Linear Model
Comments Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.67 to 1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 100/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Nominal p-value
Method Generalized Linear Model
Comments Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.49 to 0.78
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 200/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.064
Comments [Not Specified]
Method Generalized Linear Model
Comments Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.64 to 1.01
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Trough FEV1 at Week 52 (Visit 11)
Hide Description Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour post-dose FEV1 assessment, which was obtained at each visit. Analysis performed using a repeated measures model with covariates of treatment, smoking status at Screening (stratum), baseline (pre-dose Day 1), centre grouping, Week, Week by Baseline, and Week by treatment interactions.
Time Frame Baseline to Visit 11 (Week 52)/Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Number of participants presented represent those with data available at the time point being presented, however all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.
Arm/Group Title VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD
Hide Arm/Group Description:
Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Overall Number of Participants Analyzed 291 308 310 289
Least Squares Mean (Standard Error)
Unit of Measure: Liters
-0.040  (0.0114) 0.000  (0.0112) 0.018  (0.0112) 0.024  (0.0114)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 50/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments Nominal p-value
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.041
Confidence Interval (2-Sided) 95%
0.009 to 0.072
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 100/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Nominal p-value
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.058
Confidence Interval (2-Sided) 95%
0.027 to 0.090
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 200/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Nominal p-value
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.064
Confidence Interval (2-Sided) 95%
0.033 to 0.096
Estimation Comments [Not Specified]
Time Frame Serious adverse events (SAEs) and non-serious AEs will be collected from Baseline to the end of the treatment period (up to 52 weeks).
Adverse Event Reporting Description SAEs and non-serious adverse events are reported for members of the Intent-to-Treat Population, comprised of all randomized participants who received at least one dose of study medication during the treatment period.
 
Arm/Group Title VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD
Hide Arm/Group Description Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
All-Cause Mortality
VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   60/409 (14.67%)   65/408 (15.93%)   56/403 (13.90%)   63/402 (15.67%) 
Blood and lymphatic system disorders         
Anaemia  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  1/402 (0.25%) 
Cardiac disorders         
Myocardial infarction  1  1/409 (0.24%)  2/408 (0.49%)  2/403 (0.50%)  2/402 (0.50%) 
Acute coronary syndrome  1  1/409 (0.24%)  1/408 (0.25%)  1/403 (0.25%)  0/402 (0.00%) 
Angina pectoris  1  1/409 (0.24%)  2/408 (0.49%)  0/403 (0.00%)  0/402 (0.00%) 
Angina unstable  1  2/409 (0.49%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Acute myocardial infarction  1  1/409 (0.24%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Atrial fibrillation  1  1/409 (0.24%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Cardiac failure congestive  1  1/409 (0.24%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Cardio-respiratory arrest  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Coronary artery stenosis  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Coronary artery thrombosis  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Palpitations  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Supraventricular tachycardia  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Arrhythmia  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Cardiac arrest  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Cardiac failure  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Eye disorders         
Diplopia  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Gastrointestinal disorders         
Rectal haemorrhage  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Upper gastrointestinal haemorrhage  1  1/409 (0.24%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Abdominal pain  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Abdominal pain lower  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Abdominal strangulated hernia  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Constipation  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Diverticulum intestinal  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Gastric ulcer haemorrhage  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Gastritis  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Gastritis erosive  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Gastrointestinal haemorrhage  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Gastrooesophageal reflux disease  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Haemorrhoids  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Hiatus hernia  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Ileus  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Melaena  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
AE Term: Salivary gland enlargement  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Small intestinal obstruction  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
General disorders         
Chest pain  1  1/409 (0.24%)  2/408 (0.49%)  0/403 (0.00%)  0/402 (0.00%) 
Death  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Non-cardiac chest pain  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Hepatobiliary disorders         
Bile duct stone  1  1/409 (0.24%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Bile duct obstruction  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Cholecystitis  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Immune system disorders         
Anaphylactic shock  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Infections and infestations         
Pneumonia  1  2/409 (0.49%)  12/408 (2.94%)  9/403 (2.23%)  12/402 (2.99%) 
Cellulitis  1  2/409 (0.49%)  0/408 (0.00%)  4/403 (0.99%)  0/402 (0.00%) 
Infective exacerbation of chronic obstructive airway disease  1  2/409 (0.49%)  0/408 (0.00%)  2/403 (0.50%)  0/402 (0.00%) 
Bronchitis  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  2/402 (0.50%) 
Upper respiratory tract infection  1  2/409 (0.49%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Bronchopneumonia  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  1/402 (0.25%) 
Lobar pneumonia  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  1/402 (0.25%) 
Lung abscess  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  1/402 (0.25%) 
Arthritis bacterial  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Bone tuberculosis  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Clostridium difficile colitis  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Escherichia sepsis  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Gastroenteritis viral  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
H1N1 influenza  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Lower respiratory tract infection  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Mycobacterium avium complex infection  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Pulmonary tuberculosis  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Pyelonephritis acute  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Respiratory tract infection  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Septic shock  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Tuberculosis  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Urinary tract infection  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Urinary tract infection bacterial  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Injury, poisoning and procedural complications         
Fall  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Foot fracture  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Head injury  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Hip fracture  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Laceration  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Operative haemorrhage  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Pneumothorax traumatic  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Spinal compression fracture  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Toxicity to various agents  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Wrist fracture  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Metabolism and nutrition disorders         
Hypokalaemia  1  2/409 (0.49%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Hyperglycaemia  1  0/409 (0.00%)  0/408 (0.00%)  2/403 (0.50%)  0/402 (0.00%) 
Diabetes mellitus inadequate control  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Hyponatraemia  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Hypovolaemia  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Ketoacidosis  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Musculoskeletal and connective tissue disorders         
Musculoskeletal chest pain  1  2/409 (0.49%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Arthritis reactive  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Back pain  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Bursitis  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Costochondritis  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Intervertebral disc protrusion  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Joint stiffness  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Osteoarthritis  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Pancreatic carcinoma metastatic  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  1/402 (0.25%) 
Squamous cell carcinoma  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  2/402 (0.50%) 
Acute lymphocytic leukaemia  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Brain cancer metastatic  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Breast cancer  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Colon cancer  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Laryngeal cancer  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Lung cancer metastatic  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Lung neoplasm malignant  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Malignant hepatobiliary neoplasm  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Malignant melanoma  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Metastases to bone  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Metastases to liver  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Metastases to lung  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Metastatic carcinoma of the bladder  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Non-Hodgkin's lymphoma  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Small cell carcinoma  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Nervous system disorders         
Cerebrovascular accident  1  0/409 (0.00%)  0/408 (0.00%)  2/403 (0.50%)  3/402 (0.75%) 
Syncope  1  2/409 (0.49%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Carotid artery aneurysm  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Carotid artery stenosis  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Convulsion  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Dizziness  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Loss of consciousness  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Metabolic encephalopathy  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Psychiatric disorders         
Depression  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Depression suicidal  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Renal and urinary disorders         
Renal failure acute  1  0/409 (0.00%)  3/408 (0.74%)  0/403 (0.00%)  0/402 (0.00%) 
Calculus urinary  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Haematuria  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Urethral stenosis  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Reproductive system and breast disorders         
Benign prostatic hyperplasia  1  2/409 (0.49%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  28/409 (6.85%)  27/408 (6.62%)  26/403 (6.45%)  30/402 (7.46%) 
Acute respiratory failure  1  0/409 (0.00%)  3/408 (0.74%)  3/403 (0.74%)  2/402 (0.50%) 
Pleural effusion  1  0/409 (0.00%)  0/408 (0.00%)  2/403 (0.50%)  0/402 (0.00%) 
Pneumothorax  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  2/402 (0.50%) 
Respiratory failure  1  0/409 (0.00%)  2/408 (0.49%)  0/403 (0.00%)  0/402 (0.00%) 
Acute pulmonary oedema  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Asthma  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Bronchitis chronic  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Bronchopleural fistula  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Hypoxia  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Pulmonary embolism  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Pulmonary oedema  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Vocal cord disorder  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Vascular disorders         
Hypertension  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  1/402 (0.25%) 
Aortic aneurysm rupture  1  0/409 (0.00%)  0/408 (0.00%)  0/403 (0.00%)  1/402 (0.25%) 
Haematoma  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Hypertensive crisis  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Peripheral arterial occlusive disease  1  0/409 (0.00%)  0/408 (0.00%)  1/403 (0.25%)  0/402 (0.00%) 
Shock  1  1/409 (0.24%)  0/408 (0.00%)  0/403 (0.00%)  0/402 (0.00%) 
Shock haemorrhagic  1  0/409 (0.00%)  1/408 (0.25%)  0/403 (0.00%)  0/402 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   197/409 (48.17%)   227/408 (55.64%)   221/403 (54.84%)   225/402 (55.97%) 
Gastrointestinal disorders         
Diarrhoea  1  15/409 (3.67%)  12/408 (2.94%)  8/403 (1.99%)  15/402 (3.73%) 
Nausea  1  10/409 (2.44%)  24/408 (5.88%)  7/403 (1.74%)  10/402 (2.49%) 
General disorders         
Pyrexia  1  5/409 (1.22%)  17/408 (4.17%)  10/403 (2.48%)  8/402 (1.99%) 
Infections and infestations         
Nasopharyngitis  1  54/409 (13.20%)  58/408 (14.22%)  60/403 (14.89%)  76/402 (18.91%) 
Upper respiratory tract infection  1  45/409 (11.00%)  47/408 (11.52%)  51/403 (12.66%)  39/402 (9.70%) 
Oral candidiasis  1  21/409 (5.13%)  39/408 (9.56%)  34/403 (8.44%)  36/402 (8.96%) 
Bronchitis  1  20/409 (4.89%)  13/408 (3.19%)  21/403 (5.21%)  23/402 (5.72%) 
Sinusitis  1  17/409 (4.16%)  21/408 (5.15%)  22/403 (5.46%)  13/402 (3.23%) 
Pneumonia  1  10/409 (2.44%)  17/408 (4.17%)  16/403 (3.97%)  16/402 (3.98%) 
Influenza  1  21/409 (5.13%)  10/408 (2.45%)  13/403 (3.23%)  13/402 (3.23%) 
Pharyngitis  1  14/409 (3.42%)  8/408 (1.96%)  14/403 (3.47%)  16/402 (3.98%) 
Urinary tract infection  1  7/409 (1.71%)  16/408 (3.92%)  10/403 (2.48%)  17/402 (4.23%) 
Rhinitis  1  6/409 (1.47%)  9/408 (2.21%)  10/403 (2.48%)  15/402 (3.73%) 
Oropharyngeal candidiasis  1  2/409 (0.49%)  14/408 (3.43%)  7/403 (1.74%)  6/402 (1.49%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  30/409 (7.33%)  21/408 (5.15%)  24/403 (5.96%)  20/402 (4.98%) 
Arthralgia  1  13/409 (3.18%)  13/408 (3.19%)  16/403 (3.97%)  13/402 (3.23%) 
Nervous system disorders         
Headache  1  30/409 (7.33%)  27/408 (6.62%)  25/403 (6.20%)  34/402 (8.46%) 
Dizziness  1  8/409 (1.96%)  13/408 (3.19%)  5/403 (1.24%)  3/402 (0.75%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  14/409 (3.42%)  21/408 (5.15%)  16/403 (3.97%)  13/402 (3.23%) 
Oropharyngeal pain  1  13/409 (3.18%)  7/408 (1.72%)  14/403 (3.47%)  13/402 (3.23%) 
Dyspnoea  1  10/409 (2.44%)  13/408 (3.19%)  6/403 (1.49%)  4/402 (1.00%) 
Vascular disorders         
Hypertension  1  6/409 (1.47%)  15/408 (3.68%)  19/403 (4.71%)  12/402 (2.99%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01009463     History of Changes
Other Study ID Numbers: 102871
First Submitted: November 5, 2009
First Posted: November 6, 2009
Results First Submitted: May 30, 2013
Results First Posted: August 19, 2013
Last Update Posted: November 9, 2017