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Efficacy and Safety of Mepolizumab as an Add-on Treatment in Chronic Obstructive Pulmonary Disease (COPD)

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: NCT02105961
Recruitment Status : Completed
First Posted : April 7, 2014
Results First Posted : April 6, 2018
Last Update Posted : August 16, 2018
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: Mepolizumab
Drug: Placebo
Enrollment 674
Recruitment Details Participants with chronic obstructive pulmonary disease (COPD) with frequent exacerbations, on high dose inhaled corticosteroid (ICS)-based triple inhaled maintenance therapy were included. Participants were randomized to receive mepolizumab (100 or 300 milligrams [mg]) or placebo by subcutaneous (SC) injection every 4 weeks for up to 52 weeks.
Pre-assignment Details A total of 674 participants were randomized and received at least one dose of study treatment and were included in the modified intent to treat (mITT) population. One participant randomized to the mepolizumab 300 mg group was withdrawn without receiving study treatment.
Arm/Group Title Placebo Mepolizumab 100 mg SC Mepolizumab 300 mg SC
Hide Arm/Group Description Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their standard of care (SoC) therapy. Salbutamol metered dose inhaler (MDI) was issued for use as rescue medication throughout the study. Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study. Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
Period Title: Overall Study
Started 226 223 225
Completed Investigational Product (IP) 170 196 183
Not Completed IP 56 27 42
Withdrew IP Due to: Adverse Event 27 9 25
Withdrew IP Due to: Stopping Criteria 1 1 0
Withdrew IP Due to: Lack of Efficacy 6 2 2
Withdrew IP Due to: Protocol Deviation 2 0 1
Withdrew IP Due to: Lost to Follow-up 1 1 1
Withdrew IP Due to: Physician Decision 2 3 1
Withdrew IP Due to: Withdrawal by Subj. 16 11 11
Withdrew IP Due to: Site Closed 1 0 1
Completed 185 206 195
Not Completed 41 17 30
Reason Not Completed
Adverse Event             18             7             13
Lack of Efficacy             3             0             3
Lost to Follow-up             2             0             1
Physician Decision             3             3             2
Withdrawal by Subject             15             7             11
Arm/Group Title Placebo Mepolizumab 100 mg SC Mepolizumab 300 mg SC Total
Hide Arm/Group Description Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study. Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study. Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study. Total of all reporting groups
Overall Number of Baseline Participants 226 223 225 674
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 226 participants 223 participants 225 participants 674 participants
65.8  (8.64) 64.8  (9.06) 64.8  (8.96) 65.1  (8.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 223 participants 225 participants 674 participants
Female
70
  31.0%
91
  40.8%
67
  29.8%
228
  33.8%
Male
156
  69.0%
132
  59.2%
158
  70.2%
446
  66.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race customized Number Analyzed 226 participants 223 participants 225 participants 674 participants
Asian-Central/South Asian Heritage
0
   0.0%
0
   0.0%
1
   0.4%
1
   0.1%
Asian-East Asian Heritage
25
  11.1%
26
  11.7%
26
  11.6%
77
  11.4%
Asian-Japanese Heritage
14
   6.2%
13
   5.8%
13
   5.8%
40
   5.9%
Asian-South East Asian Heritage
3
   1.3%
2
   0.9%
1
   0.4%
6
   0.9%
Black or African American
2
   0.9%
4
   1.8%
2
   0.9%
8
   1.2%
White-White/Caucasian/European Heritage
182
  80.5%
178
  79.8%
182
  80.9%
542
  80.4%
1.Primary Outcome
Title Rate of Moderate or Severe Exacerbations
Hide Description Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (>=24 hours) or result in death. Moderate and severe exacerbations occurring from the start of investigational product (IP) up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. The analysis was performed on the modified intent-to-treat (mITT) Population (all randomized participants who received at least one dose of study treatment).
Time Frame From randomization to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo Mepolizumab 100 mg SC Mepolizumab 300 mg SC
Hide Arm/Group Description:
Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
Overall Number of Participants Analyzed 226 223 225
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Moderate/severe exacerbations per year
1.49
(1.29 to 1.72)
1.19
(1.02 to 1.38)
1.27
(1.09 to 1.48)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 100 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.068
Comments Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure
Method Negative binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio (Mepolizumab 100/Placebo)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.65 to 0.98
Estimation Comments Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 100 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments Unadjusted p-value
Method Negative binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio (Mepolizumab 100/Placebo)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.65 to 0.98
Estimation Comments Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 300 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.140
Comments Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure
Method Negative binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio (Mepolizumab 300/Placebo)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.70 to 1.05
Estimation Comments Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 300 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.140
Comments Unadjusted p-value
Method Negative binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio (Mepolizumab 300/Placebo)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.70 to 1.05
Estimation Comments Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)
2.Secondary Outcome
Title Time to First Moderate/Severe Exacerbation
Hide Description Kaplan Meier estimates of the probability of a moderate or severe exacerbation are expressed as the percentage of participants with an exacerbation over time (by Week 8, 16, 24, 32, 40, 48, 52). Analysis of time to first moderate/severe exacerbation was performed on the mITT population and included exacerbations reported on-treatment and those reported after early discontinuation from IP by participants who remained in the study.
Time Frame From randomization to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo Mepolizumab 100 mg SC Mepolizumab 300 mg SC
Hide Arm/Group Description:
Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
Overall Number of Participants Analyzed 226 223 225
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 8
22.6
(17.7 to 28.6)
22.9
(17.9 to 29.0)
18.3
(13.8 to 24.0)
Week 16
40.7
(34.6 to 47.5)
36.0
(30.0 to 42.6)
29.0
(23.5 to 35.4)
Week 24
51.1
(44.6 to 57.8)
42.4
(36.2 to 49.2)
36.7
(30.8 to 43.4)
Week 32
58.3
(51.8 to 64.9)
46.1
(39.8 to 52.9)
44.9
(38.7 to 51.7)
Week 40
62.3
(55.8 to 68.7)
50.8
(44.4 to 57.6)
51.8
(45.4 to 58.6)
Week 48
64.2
(57.8 to 70.6)
55.5
(49.1 to 62.2)
58.3
(51.9 to 64.9)
Week 52
66.7
(60.2 to 73.1)
57.9
(51.5 to 64.5)
58.8
(52.4 to 65.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 100 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.140
Comments Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure
Method Cox Proportional Hazards Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio(Mepolizumab 100/Placebo)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.64 to 1.04
Estimation Comments Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 100 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments Unadjusted p-value
Method Cox Proportional Hazards Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (Mepolizumab/Placebo)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.64 to 1.04
Estimation Comments Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 300 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.140
Comments Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure
Method Cox Proportional Hazards Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (Mepolizumab 300/Placebo)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.60 to 0.97
Estimation Comments Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 300 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments Unadjusted p-value
Method Cox Proportional Hazards Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (Mepolizumab 300/Placebo)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.60 to 0.97
Estimation Comments Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status
3.Secondary Outcome
Title Rate of COPD Exacerbations Requiring Emergency Department (ED) Visits and/or Hospitalizations (Hosp)
Hide Description COPD exacerbations requiring an ED visit and/or hosp occurring from the start of IP up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. This analysis was performed on the mITT population.
Time Frame From randomization to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Placebo Mepolizumab 100 mg SC Mepolizumab 300 mg SC
Hide Arm/Group Description:
Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
Overall Number of Participants Analyzed 226 223 225
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Exacerbations requiring ED/hosp per year
0.28
(0.20 to 0.40)
0.17
(0.11 to 0.25)
0.23
(0.16 to 0.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 100 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.140
Comments Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure
Method Negative binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio (Mepolizumab 100/Placebo)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.35 to 0.98
Estimation Comments Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 100 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments Unadjusted p-value
Method Negative binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio (Mepolizumab 100/Placebo)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.35 to 0.98
Estimation Comments Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 300 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.447
Comments Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure
Method Negative binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio (Mepolizumab 300/Placebo)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.51 to 1.34
Estimation Comments Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 300 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.447
Comments Unadjusted p-value
Method Negative binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio (Mepolizumab 300/Placebo)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.51 to 1.34
Estimation Comments Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)
4.Secondary Outcome
Title Change From Baseline in Mean Total St. George's Respiratory Questionnaire (SGRQ) Score
Hide Description The SGRQ for COPD is a 40-item questionnaire derived from the original SGRQ , designed to measure health impairment by addressing the frequency of respiratory symptoms and current state of the participant. SGRQ Total Scores range from 0 to 100 with higher scores indicating worse health-related quality of life and reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product.Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Mean change from Baseline in SGRQ score at Week 52 has been presented.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Participants analyzed represents those with a Baseline and at least one post-Baseline assessment, and with no missing covariates.
Arm/Group Title Placebo Mepolizumab 100 mg SC Mepolizumab 300 mg SC
Hide Arm/Group Description:
Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
Overall Number of Participants Analyzed 218 218 219
Least Squares Mean (Standard Error)
Unit of Measure: Score on SGRQ scale
-3.1  (0.98) -5.0  (0.95) -3.3  (0.96)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 100 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.447
Comments Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean difference(Mepolizumab 100-Placebo)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-4.5 to 0.8
Estimation Comments Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 100 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.180
Comments Unadjusted p-value
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean difference(Mepolizumab 100-Placebo)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-4.5 to 0.8
Estimation Comments Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 300 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.926
Comments Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean difference(Mepolizumab 300-Placebo)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-2.8 to 2.6
Estimation Comments Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 300 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.926
Comments Unadjusted p-value
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean difference(Mepolizumab 300-Placebo)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-2.8 to 2.6
Estimation Comments Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.
5.Secondary Outcome
Title Change From Baseline in Mean COPD Assessment Test (CAT) Score
Hide Description The CAT is an 8-item questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Each question is assessed on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment) with the CAT score ranging from 0-40. Higher scores indicate greater disease impact with reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Mean change from Baseline in CAT score at Week 52 has been presented.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Participants analyzed represents those with a Baseline and at least one post-Baseline assessment, and with no missing covariates.
Arm/Group Title Placebo Mepolizumab 100 mg SC Mepolizumab 300 mg SC
Hide Arm/Group Description:
Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
Overall Number of Participants Analyzed 222 216 219
Least Squares Mean (Standard Error)
Unit of Measure: Score on CAT scale
-0.4  (0.42) -1.6  (0.42) -0.8  (0.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 100 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.926
Comments Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean difference(Mepolizumab 100-Placebo)
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-2.3 to 0.0
Estimation Comments Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 100 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments Unadjusted p-value
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean difference(Mepolizumab 100-Placebo)
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-2.3 to 0.0
Estimation Comments Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 300 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.926
Comments Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean difference(Mepolizumab 300-Placebo)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.5 to 0.8
Estimation Comments Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Mepolizumab 300 mg SC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.547
Comments Unadjusted p-value
Method Mixed Model Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean difference(Mepolizumab 300-Placebo)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.5 to 0.8
Estimation Comments Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.
Time Frame Serious adverse events (SAEs) collected from the start of study participation until the end of follow up (up to Week 60). On-treatment non-serious adverse events (AEs) reported from start of study treatment until 4 weeks after last dose.
Adverse Event Reporting Description AEs and SAEs were collected in Safety Population which comprised of all randomized participants who received at least one dose of study treatment
 
Arm/Group Title Placebo Mepolizumab 100 mg SC Mepolizumab 300 mg SC
Hide Arm/Group Description Eligible participants were randomized to and received placebo by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study. Eligible participants were randomized to and received mepolizumab 100 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study. Eligible participants were randomized to and received mepolizumab 300 mg by SC injection every 4 weeks for up to 52 weeks in addition to their SoC therapy. Salbutamol MDI was issued for use as rescue medication throughout the study.
All-Cause Mortality
Placebo Mepolizumab 100 mg SC Mepolizumab 300 mg SC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/226 (3.98%)      4/223 (1.79%)      8/225 (3.56%)    
Hide Serious Adverse Events
Placebo Mepolizumab 100 mg SC Mepolizumab 300 mg SC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   68/226 (30.09%)      57/223 (25.56%)      60/225 (26.67%)    
Cardiac disorders       
Acute myocardial infarction †  3/226 (1.33%)  3 1/223 (0.45%)  1 2/225 (0.89%)  2
Atrial fibrillation †  3/226 (1.33%)  6 3/223 (1.35%)  3 0/225 (0.00%)  0
Cardio-respiratory arrest †  0/226 (0.00%)  0 1/223 (0.45%)  1 1/225 (0.44%)  1
Coronary artery disease †  1/226 (0.44%)  1 0/223 (0.00%)  0 1/225 (0.44%)  1
Stress cardiomyopathy †  1/226 (0.44%)  1 0/223 (0.00%)  0 1/225 (0.44%)  1
Supraventricular tachycardia †  0/226 (0.00%)  0 0/223 (0.00%)  0 2/225 (0.89%)  2
Acute coronary syndrome †  0/226 (0.00%)  0 0/223 (0.00%)  0 1/225 (0.44%)  1
Angina pectoris †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Angina unstable †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Arrhythmia †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Cardiac arrest †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Cardiac failure congestive †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Cor pulmonale †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Myocardial infarction †  0/226 (0.00%)  0 0/223 (0.00%)  0 1/225 (0.44%)  1
Endocrine disorders       
Inappropriate antidiuretic hormone secretion †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Eye disorders       
Cataract †  1/226 (0.44%)  1 0/223 (0.00%)  0 1/225 (0.44%)  1
Macular fibrosis †  0/226 (0.00%)  0 0/223 (0.00%)  0 1/225 (0.44%)  1
Gastrointestinal disorders       
Diarrhoea †  0/226 (0.00%)  0 3/223 (1.35%)  3 1/225 (0.44%)  1
Abdominal pain †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Diverticulum intestinal †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Duodenal ulcer †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Gastric haemorrhage †  0/226 (0.00%)  0 0/223 (0.00%)  0 1/225 (0.44%)  1
Gastritis †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Gastrointestinal haemorrhage †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Ileus †  0/226 (0.00%)  0 0/223 (0.00%)  0 1/225 (0.44%)  1
Inguinal hernia †  0/226 (0.00%)  0 0/223 (0.00%)  0 1/225 (0.44%)  1
Large intestine perforation †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Vomiting †  0/226 (0.00%)  0 0/223 (0.00%)  0 1/225 (0.44%)  1
General disorders       
Non-cardiac chest pain †  1/226 (0.44%)  1 1/223 (0.45%)  1 0/225 (0.00%)  0
Pyrexia †  1/226 (0.44%)  1 0/223 (0.00%)  0 1/225 (0.44%)  1
Death †  0/226 (0.00%)  0 0/223 (0.00%)  0 1/225 (0.44%)  1
General physical health deterioration †  0/226 (0.00%)  0 0/223 (0.00%)  0 1/225 (0.44%)  1
Vascular stent thrombosis †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Hepatobiliary disorders       
Hepatocellular injury †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Infections and infestations       
Pneumonia †  18/226 (7.96%)  19 16/223 (7.17%)  21 15/225 (6.67%)  16
Infective exacerbation of chronic obstructive airways disease †  5/226 (2.21%)  6 1/223 (0.45%)  1 3/225 (1.33%)  4
Sepsis †  1/226 (0.44%)  1 3/223 (1.35%)  3 0/225 (0.00%)  0
Urinary tract infection †  0/226 (0.00%)  0 3/223 (1.35%)  3 1/225 (0.44%)  1
Lower respiratory tract infection †  1/226 (0.44%)  1 1/223 (0.45%)  1 1/225 (0.44%)  1
Bronchitis †  1/226 (0.44%)  1 0/223 (0.00%)  0 1/225 (0.44%)  1
Influenza †  1/226 (0.44%)  1 0/223 (0.00%)  0 1/225 (0.44%)  1
Pneumonia pseudomonal †  0/226 (0.00%)  0 0/223 (0.00%)  0 2/225 (0.89%)  3
Upper respiratory tract infection †  1/226 (0.44%)  2 0/223 (0.00%)  0 1/225 (0.44%)  1
Abdominal wall abscess †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Appendicitis †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Atypical mycobacterial infection †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Clostridium difficile colitis †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Colonic abscess †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Cystitis †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Gastrointestinal infection †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Lung abscess †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Orchitis †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Osteomyelitis †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Pneumonia bacterial †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Pneumonia haemophilus †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Pneumonia necrotising †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Pneumonia pneumococcal †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Pulmonary tuberculosis †  0/226 (0.00%)  0 0/223 (0.00%)  0 1/225 (0.44%)  1
Respiratory tract infection †  0/226 (0.00%)  0 0/223 (0.00%)  0 1/225 (0.44%)  1
Viral infection †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Vulvovaginal mycotic infection †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Injury, poisoning and procedural complications       
Rib fracture †  0/226 (0.00%)  0 1/223 (0.45%)  1 1/225 (0.44%)  1
Clavicle fracture †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Femoral neck fracture †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Foot fracture †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Humerus fracture †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Injection related reaction †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Meniscus injury †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Post procedural haemorrhage †  1/226 (0.44%)  2 0/223 (0.00%)  0 0/225 (0.00%)  0
Spinal compression fracture †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Investigations       
Haematocrit increased †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Metabolism and nutrition disorders       
Diabetes mellitus inadequate control †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Rhabdomyolysis †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Spinal osteoarthritis †  0/226 (0.00%)  0 1/223 (0.45%)  2 0/225 (0.00%)  0
Spondyloarthropathy †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Prostate cancer †  1/226 (0.44%)  1 0/223 (0.00%)  0 2/225 (0.89%)  2
Breast cancer †  1/226 (0.44%)  1 1/223 (0.45%)  1 0/225 (0.00%)  0
Non-small cell lung cancer †  1/226 (0.44%)  1 0/223 (0.00%)  0 1/225 (0.44%)  1
Adenocarcinoma of colon †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Benign lung neoplasm †  0/226 (0.00%)  0 0/223 (0.00%)  0 1/225 (0.44%)  1
Bowen's disease †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Gastric cancer †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Lung adenocarcinoma †  0/226 (0.00%)  0 0/223 (0.00%)  0 1/225 (0.44%)  1
Lung neoplasm malignant †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Malignant melanoma †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Oropharyngeal cancer †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Rectal adenocarcinoma †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Nervous system disorders       
Cerebral ischaemia †  0/226 (0.00%)  0 0/223 (0.00%)  0 1/225 (0.44%)  1
Cerebrovascular accident †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Haemorrhagic stroke †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Peroneal nerve palsy †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Post herpetic neuralgia †  0/226 (0.00%)  0 0/223 (0.00%)  0 1/225 (0.44%)  1
Syncope †  0/226 (0.00%)  0 0/223 (0.00%)  0 1/225 (0.44%)  1
Transient ischaemic attack †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Psychiatric disorders       
Confusional state †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Delirium †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Calculus urinary †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Haematuria †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Renal colic †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Renal tubular necrosis †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Urinary retention †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Reproductive system and breast disorders       
Benign prostatic hyperplasia †  1/226 (0.44%)  1 1/223 (0.45%)  1 0/225 (0.00%)  0
Prostatic obstruction †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease †  37/226 (16.37%)  52 25/223 (11.21%)  34 32/225 (14.22%)  54
Acute respiratory failure †  2/226 (0.88%)  2 3/223 (1.35%)  4 0/225 (0.00%)  0
Respiratory failure †  1/226 (0.44%)  1 1/223 (0.45%)  1 2/225 (0.89%)  2
Pulmonary embolism †  1/226 (0.44%)  1 0/223 (0.00%)  0 2/225 (0.89%)  2
Pneumothorax †  0/226 (0.00%)  0 0/223 (0.00%)  0 2/225 (0.89%)  2
Atelectasis †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Chronic respiratory failure †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Hypercapnia †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Hypoxia †  0/226 (0.00%)  0 0/223 (0.00%)  0 1/225 (0.44%)  1
Interstitial lung disease †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Pleurisy †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Pneumonia aspiration †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Pneumothorax spontaneous †  1/226 (0.44%)  2 0/223 (0.00%)  0 0/225 (0.00%)  0
Vascular disorders       
Aortic aneurysm †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Aortic stenosis †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Essential hypertension †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Hypertension †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Hypertensive crisis †  1/226 (0.44%)  1 0/223 (0.00%)  0 0/225 (0.00%)  0
Hypotension †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
Orthostatic hypotension †  0/226 (0.00%)  0 1/223 (0.45%)  1 0/225 (0.00%)  0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo Mepolizumab 100 mg SC Mepolizumab 300 mg SC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   137/226 (60.62%)      147/223 (65.92%)      137/225 (60.89%)    
Gastrointestinal disorders       
Diarrhoea †  14/226 (6.19%)  14 13/223 (5.83%)  16 8/225 (3.56%)  12
Constipation †  10/226 (4.42%)  10 7/223 (3.14%)  8 5/225 (2.22%)  6
Nausea †  3/226 (1.33%)  3 9/223 (4.04%)  10 9/225 (4.00%)  13
Abdominal pain upper †  1/226 (0.44%)  1 9/223 (4.04%)  9 5/225 (2.22%)  5
General disorders       
Injection site reaction †  10/226 (4.42%)  17 6/223 (2.69%)  6 11/225 (4.89%)  27
Pyrexia †  9/226 (3.98%)  9 6/223 (2.69%)  7 12/225 (5.33%)  17
Non-cardiac chest pain †  7/226 (3.10%)  7 5/223 (2.24%)  8 7/225 (3.11%)  8
Fatigue †  4/226 (1.77%)  4 6/223 (2.69%)  6 8/225 (3.56%)  8
Oedema peripheral †  3/226 (1.33%)  3 7/223 (3.14%)  7 4/225 (1.78%)  6
Infections and infestations       
Nasopharyngitis †  48/226 (21.24%)  65 39/223 (17.49%)  57 40/225 (17.78%)  52
Upper respiratory tract infection †  20/226 (8.85%)  27 16/223 (7.17%)  19 12/225 (5.33%)  15
Pneumonia †  8/226 (3.54%)  9 10/223 (4.48%)  13 10/225 (4.44%)  11
Bronchitis †  8/226 (3.54%)  8 8/223 (3.59%)  12 11/225 (4.89%)  15
Sinusitis †  7/226 (3.10%)  11 8/223 (3.59%)  11 7/225 (3.11%)  9
Influenza †  11/226 (4.87%)  11 6/223 (2.69%)  7 3/225 (1.33%)  3
Oral candidiasis †  5/226 (2.21%)  7 3/223 (1.35%)  3 8/225 (3.56%)  9
Rhinitis †  5/226 (2.21%)  6 7/223 (3.14%)  9 4/225 (1.78%)  4
Urinary tract infection †  7/226 (3.10%)  8 7/223 (3.14%)  8 1/225 (0.44%)  1
Injury, poisoning and procedural complications       
Contusion †  2/226 (0.88%)  2 7/223 (3.14%)  7 3/225 (1.33%)  3
Musculoskeletal and connective tissue disorders       
Back pain †  11/226 (4.87%)  11 15/223 (6.73%)  18 17/225 (7.56%)  21
Arthralgia †  6/226 (2.65%)  7 10/223 (4.48%)  10 6/225 (2.67%)  6
Pain in extremity †  5/226 (2.21%)  6 7/223 (3.14%)  7 6/225 (2.67%)  10
Musculoskeletal pain †  2/226 (0.88%)  2 4/223 (1.79%)  4 7/225 (3.11%)  8
Nervous system disorders       
Headache †  20/226 (8.85%)  29 34/223 (15.25%)  62 22/225 (9.78%)  39
Respiratory, thoracic and mediastinal disorders       
Cough †  12/226 (5.31%)  16 14/223 (6.28%)  14 16/225 (7.11%)  22
Dyspnoea †  18/226 (7.96%)  19 12/223 (5.38%)  14 10/225 (4.44%)  17
Oropharyngeal pain †  4/226 (1.77%)  4 15/223 (6.73%)  15 11/225 (4.89%)  13
Chronic obstructive pulmonary disease †  5/226 (2.21%)  9 8/223 (3.59%)  12 10/225 (4.44%)  24
Vascular disorders       
Hypertension †  3/226 (1.33%)  3 8/223 (3.59%)  9 7/225 (3.11%)  7
†
Indicates events were collected by systematic assessment
[Not Specified]
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02105961    
Other Study ID Numbers: 117113
First Submitted: April 3, 2014
First Posted: April 7, 2014
Results First Submitted: January 12, 2018
Results First Posted: April 6, 2018
Last Update Posted: August 16, 2018