ClinicalTrials.gov
ClinicalTrials.gov Menu

24-week Trial Comparing GSK573719/GW642444 With GSK573719 and With Tiotropium in Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01316913
Recruitment Status : Completed
First Posted : March 16, 2011
Results First Posted : February 24, 2014
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: GSK573719/GW642444 125/25
Drug: GSK573719/GW642444 62.5/25
Drug: GSK573719
Drug: tiotropium bromide
Enrollment 872
Recruitment Details  
Pre-assignment Details Participants (par.) who met eligibility criteria at Screening (Visit 1) completed a 7- to10-day run-in period and were then randomized to a 24-week treatment period. A total of 1191 par. were screened; 872 par. were randomized and 869 par. entered the treatment period.
Arm/Group Title UMEC 125 µg QD UMEC/VI 62.5/25 µg QD UMEC/VI 125/25 µg QD TIO18 µg QD
Hide Arm/Group Description Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI) and placebo QD via a HandiHaler in the morning for 24 weeks. Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks. Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks. Participants received tiotropium bromide (TIO) 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
Period Title: Overall Study
Started 222 217 215 215
Completed 165 163 166 176
Not Completed 57 54 49 39
Reason Not Completed
Adverse Event             17             20             15             11
Lack of Efficacy             22             12             9             13
Protocol Violation             1             4             4             1
Protocol-defined Stopping Criteria             7             8             11             6
Lost to Follow-up             0             1             0             2
Withdrawal by Subject             10             9             10             6
Arm/Group Title UMEC 125 µg QD UMEC/VI 62.5/25 µg QD UMEC/VI 125/25 µg QD TIO18 µg QD Total
Hide Arm/Group Description Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks. Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks. Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks. Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 222 217 215 215 869
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 222 participants 217 participants 215 participants 215 participants 869 participants
64.5  (8.33) 65.0  (8.62) 63.8  (8.51) 65.2  (8.30) 64.6  (8.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 217 participants 215 participants 215 participants 869 participants
Female
74
  33.3%
77
  35.5%
67
  31.2%
62
  28.8%
280
  32.2%
Male
148
  66.7%
140
  64.5%
148
  68.8%
153
  71.2%
589
  67.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 222 participants 217 participants 215 participants 215 participants 869 participants
African American/African Heritage 6 8 9 8 31
Asian - East Asian Heritage 35 34 36 34 139
Asian - South East Asian Heritage 2 1 1 2 6
Native Hawaiian or other Pacific Islander 0 1 0 0 1
White - Arabic/North African Heritage 1 0 0 0 1
White - White/Caucasian/European Heritage 169 163 160 163 655
White - Mixed Race 0 1 0 0 1
Mixed Race 9 9 9 8 35
1.Primary Outcome
Title Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169
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. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (i.e., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline, smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat.
Time Frame Baseline and Day 169
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period. Participants analyzed are those with data available at the presented time point; but, all participants without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.
Arm/Group Title UMEC 125 µg QD UMEC/VI 62.5/25 µg QD UMEC/VI 125/25 QD TIO18 µg QD
Hide Arm/Group Description:
Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
Overall Number of Participants Analyzed 163 161 164 175
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.186  (0.0178) 0.208  (0.0180) 0.223  (0.0179) 0.149  (0.0176)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UMEC 125 µg QD, UMEC/VI 62.5/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.377
Comments [Not Specified]
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 0.022
Confidence Interval (2-Sided) 95%
-0.027 to 0.072
Estimation Comments Least squares mean difference=UMEC/VI 62.5/25 µg minus UMEC 125 µg.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection UMEC/VI 62.5/25 µg QD, TIO18 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
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 0.060
Confidence Interval (2-Sided) 95%
0.010 to 0.109
Estimation Comments Least squares mean difference=UMEC/VI 62.5/25 µg minus TIO 18 µg.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection UMEC 125 µg QD, UMEC/VI 125/25 QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.142
Comments [Not Specified]
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 0.037
Confidence Interval (2-Sided) 95%
-0.012 to 0.087
Estimation Comments Least squares mean difference=UMEC/VI 125/25 µg minus UMEC 125 µg.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection UMEC/VI 125/25 QD, TIO18 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
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 0.074
Confidence Interval (2-Sided) 95%
0.025 to 0.123
Estimation Comments Least squares mean difference=UMEC/VI 125/25 µg minus TIO 18 µg.
2.Secondary Outcome
Title Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168
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. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 84, and Day 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Change from BL at a particular visit was calculated as WM at that visit minus BL. Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, center group, day, and day by BL and day by treatment interactions.
Time Frame Baseline and Day 168
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.
Arm/Group Title UMEC 125 µg QD UMEC/VI 62.5/25 µg QD UMEC/VI 125/25 µg QD TIO18 µg QD
Hide Arm/Group Description:
Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
Overall Number of Participants Analyzed 161 161 164 172
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.206  (0.0167) 0.276  (0.0168) 0.282  (0.0167) 0.180  (0.0165)
3.Other Pre-specified Outcome
Title Change From Baseline (BL) in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24
Hide Description The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day’s activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Participants analyzed are those with data available at the presented time point; but, all participants without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.
Arm/Group Title UMEC 125 µg QD UMEC/VI 62.5/25 µg QD UMEC/VI 125/25 µg QD TIO18 µg QD
Hide Arm/Group Description:
Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
Overall Number of Participants Analyzed 104 114 117 121
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-0.19  (0.041) -0.29  (0.040) -0.33  (0.040) -0.21  (0.040)
Time Frame On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks).
Adverse Event Reporting Description On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.
 
Arm/Group Title UMEC 125 µg QD UMEC/VI 62.5/25 µg QD UMEC/VI 125/25 µg QD TIO18 µg QD
Hide Arm/Group Description Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks. Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks. Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks. Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
All-Cause Mortality
UMEC 125 µg QD UMEC/VI 62.5/25 µg QD UMEC/VI 125/25 µg QD TIO18 µg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
UMEC 125 µg QD UMEC/VI 62.5/25 µg QD UMEC/VI 125/25 µg QD TIO18 µg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/222 (6.76%)   22/217 (10.14%)   15/215 (6.98%)   9/215 (4.19%) 
Blood and lymphatic system disorders         
Anaemia  1  1/222 (0.45%)  0/217 (0.00%)  0/215 (0.00%)  0/215 (0.00%) 
Cardiac disorders         
Coronary artery disease  1  0/222 (0.00%)  0/217 (0.00%)  2/215 (0.93%)  0/215 (0.00%) 
Angina unstable  1  0/222 (0.00%)  1/217 (0.46%)  0/215 (0.00%)  0/215 (0.00%) 
Myocardial infarction  1  0/222 (0.00%)  1/217 (0.46%)  0/215 (0.00%)  0/215 (0.00%) 
Gastrointestinal disorders         
Gastritis  1  0/222 (0.00%)  0/217 (0.00%)  1/215 (0.47%)  0/215 (0.00%) 
Upper gastrointestinal haemorrhage  1  0/222 (0.00%)  0/217 (0.00%)  0/215 (0.00%)  1/215 (0.47%) 
General disorders         
Chest pain  1  1/222 (0.45%)  1/217 (0.46%)  0/215 (0.00%)  0/215 (0.00%) 
Hepatobiliary disorders         
Cholecystitis  1  0/222 (0.00%)  1/217 (0.46%)  0/215 (0.00%)  0/215 (0.00%) 
Cholelithiasis  1  0/222 (0.00%)  1/217 (0.46%)  0/215 (0.00%)  0/215 (0.00%) 
Immune system disorders         
Allergy to arthropod sting  1  1/222 (0.45%)  0/217 (0.00%)  0/215 (0.00%)  0/215 (0.00%) 
Infections and infestations         
Pneumonia  1  2/222 (0.90%)  2/217 (0.92%)  3/215 (1.40%)  2/215 (0.93%) 
Infective exacerbation of chronic obstructive airways diseas  1  0/222 (0.00%)  2/217 (0.92%)  0/215 (0.00%)  0/215 (0.00%) 
Appendicitis  1  0/222 (0.00%)  1/217 (0.46%)  0/215 (0.00%)  0/215 (0.00%) 
Bronchitis  1  0/222 (0.00%)  1/217 (0.46%)  0/215 (0.00%)  0/215 (0.00%) 
Erysipelas  1  0/222 (0.00%)  1/217 (0.46%)  0/215 (0.00%)  0/215 (0.00%) 
Herpes zoster  1  0/222 (0.00%)  0/217 (0.00%)  1/215 (0.47%)  0/215 (0.00%) 
Influenza  1  0/222 (0.00%)  0/217 (0.00%)  0/215 (0.00%)  1/215 (0.47%) 
Lower respiratory tract infection  1  0/222 (0.00%)  1/217 (0.46%)  0/215 (0.00%)  0/215 (0.00%) 
Pneumonia primary atypical  1  1/222 (0.45%)  0/217 (0.00%)  0/215 (0.00%)  0/215 (0.00%) 
Sinusitis  1  1/222 (0.45%)  0/217 (0.00%)  0/215 (0.00%)  0/215 (0.00%) 
Soft tissue infection  1  0/222 (0.00%)  0/217 (0.00%)  1/215 (0.47%)  0/215 (0.00%) 
Injury, poisoning and procedural complications         
Ankle fracture  1  1/222 (0.45%)  0/217 (0.00%)  0/215 (0.00%)  0/215 (0.00%) 
Facial bones fracture  1  0/222 (0.00%)  0/217 (0.00%)  1/215 (0.47%)  0/215 (0.00%) 
Foot fracture  1  0/222 (0.00%)  1/217 (0.46%)  0/215 (0.00%)  0/215 (0.00%) 
Hip fracture  1  1/222 (0.45%)  0/217 (0.00%)  0/215 (0.00%)  0/215 (0.00%) 
Meniscus lesion  1  0/222 (0.00%)  1/217 (0.46%)  0/215 (0.00%)  0/215 (0.00%) 
Wrist fracture  1  1/222 (0.45%)  0/217 (0.00%)  0/215 (0.00%)  0/215 (0.00%) 
Investigations         
Electrocardiogram T wave inversion  1  0/222 (0.00%)  1/217 (0.46%)  0/215 (0.00%)  0/215 (0.00%) 
Musculoskeletal and connective tissue disorders         
Patellofemoral pain syndrome  1  0/222 (0.00%)  1/217 (0.46%)  0/215 (0.00%)  0/215 (0.00%) 
Rotator cuff syndrome  1  0/222 (0.00%)  1/217 (0.46%)  0/215 (0.00%)  0/215 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Benign gastric neoplasm  1  1/222 (0.45%)  0/217 (0.00%)  0/215 (0.00%)  0/215 (0.00%) 
Lung adenocarcinoma  1  1/222 (0.45%)  0/217 (0.00%)  0/215 (0.00%)  0/215 (0.00%) 
Malignant neoplasm of ampulla of Vater  1  1/222 (0.45%)  0/217 (0.00%)  0/215 (0.00%)  0/215 (0.00%) 
Prostate cancer  1  0/222 (0.00%)  0/217 (0.00%)  1/215 (0.47%)  0/215 (0.00%) 
Tongue neoplasm malignant stage unspecified  1  0/222 (0.00%)  0/217 (0.00%)  0/215 (0.00%)  1/215 (0.47%) 
Nervous system disorders         
Cerebrovascular accident  1  1/222 (0.45%)  0/217 (0.00%)  0/215 (0.00%)  0/215 (0.00%) 
Haemorrhagic stroke  1  0/222 (0.00%)  1/217 (0.46%)  0/215 (0.00%)  0/215 (0.00%) 
Spinal epidural haemorrhage  1  0/222 (0.00%)  0/217 (0.00%)  1/215 (0.47%)  0/215 (0.00%) 
Syncope  1  0/222 (0.00%)  0/217 (0.00%)  0/215 (0.00%)  1/215 (0.47%) 
Transient ischaemic attack  1  0/222 (0.00%)  0/217 (0.00%)  0/215 (0.00%)  1/215 (0.47%) 
Psychiatric disorders         
Bipolar disorder  1  0/222 (0.00%)  0/217 (0.00%)  1/215 (0.47%)  0/215 (0.00%) 
Delirium  1  1/222 (0.45%)  0/217 (0.00%)  0/215 (0.00%)  0/215 (0.00%) 
Renal and urinary disorders         
Renal failure acute  1  0/222 (0.00%)  0/217 (0.00%)  1/215 (0.47%)  0/215 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  2/222 (0.90%)  7/217 (3.23%)  6/215 (2.79%)  1/215 (0.47%) 
Pleural effusion  1  1/222 (0.45%)  0/217 (0.00%)  0/215 (0.00%)  0/215 (0.00%) 
Pneumothorax  1  0/222 (0.00%)  0/217 (0.00%)  1/215 (0.47%)  0/215 (0.00%) 
Respiratory arrest  1  0/222 (0.00%)  0/217 (0.00%)  0/215 (0.00%)  1/215 (0.47%) 
Respiratory failure  1  0/222 (0.00%)  1/217 (0.46%)  0/215 (0.00%)  0/215 (0.00%) 
Vascular disorders         
Femoral artery occlusion  1  1/222 (0.45%)  0/217 (0.00%)  0/215 (0.00%)  0/215 (0.00%) 
Iliac artery occlusion  1  1/222 (0.45%)  0/217 (0.00%)  0/215 (0.00%)  0/215 (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%
UMEC 125 µg QD UMEC/VI 62.5/25 µg QD UMEC/VI 125/25 µg QD TIO18 µg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   75/222 (33.78%)   63/217 (29.03%)   66/215 (30.70%)   62/215 (28.84%) 
Gastrointestinal disorders         
Diarrhoea  1  8/222 (3.60%)  4/217 (1.84%)  1/215 (0.47%)  5/215 (2.33%) 
Infections and infestations         
Nasopharyngitis  1  6/222 (2.70%)  14/217 (6.45%)  16/215 (7.44%)  17/215 (7.91%) 
Upper respiratory tract infection  1  17/222 (7.66%)  6/217 (2.76%)  10/215 (4.65%)  14/215 (6.51%) 
Lower respiratory tract infection  1  1/222 (0.45%)  8/217 (3.69%)  3/215 (1.40%)  2/215 (0.93%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  10/222 (4.50%)  8/217 (3.69%)  6/215 (2.79%)  11/215 (5.12%) 
Pain in extremity  1  1/222 (0.45%)  7/217 (3.23%)  6/215 (2.79%)  4/215 (1.86%) 
Nervous system disorders         
Headache  1  25/222 (11.26%)  21/217 (9.68%)  20/215 (9.30%)  15/215 (6.98%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  14/222 (6.31%)  5/217 (2.30%)  8/215 (3.72%)  6/215 (2.79%) 
Oropharyngeal pain  1  8/222 (3.60%)  3/217 (1.38%)  6/215 (2.79%)  3/215 (1.40%) 
Vascular disorders         
Hypertension  1  9/222 (4.05%)  1/217 (0.46%)  4/215 (1.86%)  7/215 (3.26%) 
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: NCT01316913     History of Changes
Other Study ID Numbers: 113374
First Submitted: March 15, 2011
First Posted: March 16, 2011
Results First Submitted: January 9, 2014
Results First Posted: February 24, 2014
Last Update Posted: April 4, 2017