A Study to Evaluate Annual Rate of Exacerbations and Safety of 3 Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01017952
First received: November 19, 2009
Last updated: August 15, 2013
Last verified: August 2013
Results First Received: May 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: FF/GW642444 Inhalation Powder
Drug: GW642444 Inhalation Powder

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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. 2635 par. were screened, 2092 par. entered the RIP, and 1635 par. were randomized, out of which 1633 par. received >=1 study treatment dose.

Reporting Groups
  Description
FP/SAL 250/50 µg BID 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.
VI 25 µg QD 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.
FF/VI 50/25 µg QD Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the NDPI 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.
FF/VI 100/25 µg QD Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the NDPI 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.
FF/VI 200/25 µg QD Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the NDPI 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.

Participant Flow for 2 periods

Period 1:   4-week, Open-label Run-In Period
    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  
STARTED     2092     0     0     0     0  
COMPLETED     1633     0     0     0     0  
NOT COMPLETED     459     0     0     0     0  
Did Not Meet Continuation Criteria                 356                 0                 0                 0                 0  
Adverse Event                 23                 0                 0                 0                 0  
Study Closed/Tterminated                 1                 0                 0                 0                 0  
Lost to Follow-up                 6                 0                 0                 0                 0  
Physician Decision                 10                 0                 0                 0                 0  
Withdrawal by Subject                 63                 0                 0                 0                 0  

Period 2:   52-week, Double-blind Treatment Period
    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  
STARTED     0     409     412     403     409  
Completed the Treatment Period     0     285 [1]   305 [1]   293 [1]   307 [1]
COMPLETED     0     284 [2]   303 [2]   291 [2]   306 [2]
NOT COMPLETED     0     125     109     112     103  
Adverse Event                 0                 25                 32                 35                 30  
Withdrawal by Subject                 0                 30                 22                 25                 25  
Lack of Efficacy                 0                 35                 14                 16                 14  
Protocol Violation                 0                 7                 11                 9                 8  
Met Protocol-Defined Stopping Criteria                 0                 11                 13                 12                 9  
Study Closed/Terminated                 0                 1                 1                 0                 0  
Lost to Follow-up                 0                 6                 8                 6                 10  
Physician Decision                 0                 10                 8                 9                 7  
[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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
VI 25 µg QD 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.
FF/VI 50/25 µg QD Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the NDPI 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.
FF/VI 100/25 µg QD Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the NDPI 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.
FF/VI 200/25 µg QD Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the NDPI 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 Total of all reporting groups

Baseline Measures
    VI 25 µg QD     FF/VI 50/25 µg QD     FF/VI 100/25 µg QD     FF/VI 200/25 µg QD     Total  
Number of Participants  
[units: participants]
  409     412     403     409     1633  
Age  
[units: Years]
Mean ± Standard Deviation
  63.6  ± 9.29     63.7  ± 9.56     64.0  ± 9.28     63.5  ± 8.84     63.7  ± 9.24  
Gender  
[units: Participants]
         
Female     174     181     181     191     727  
Male     235     231     222     218     906  
Race/Ethnicity, Customized  
[units: participants]
         
White     360     359     353     359     1431  
African American/ African Heritage     9     14     7     9     39  
Asian     4     3     5     3     15  
African American/African Heritage & White     0     1     1     0     2  
American Indian or Alaska Native & White     20     19     21     20     80  
Asian & White     0     0     0     1     1  
Native Hawaiian or other Pacific Islander     0     0     0     1     1  
American Indian or Alaska Native     16     16     16     16     64  



  Outcome Measures
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1.  Primary:   Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean   [ Time Frame: From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal ]

2.  Secondary:   Time to First Occurrence of Moderate or Severe COPD Exacerbation   [ Time Frame: From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal ]

3.  Secondary:   Annual Rate of Exacerbations Requiring Systemic/Oral Corticosteroids Expressed as Least Square Mean   [ Time Frame: From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal ]

4.  Secondary:   Change From Baseline in Trough FEV1 at Week 52 (Visit 11)   [ Time Frame: Baseline to Visit 11 (Week 52)/Early Withdrawal ]


  Serious Adverse Events
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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).
Additional 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.

Reporting Groups
  Description
VI 25 µg QD 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.
FF/VI 50/25 µg QD 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.
FF/VI 100/25 µg QD 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.
FF/VI 200/25 µg QD 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.

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  
Total, serious adverse events          
# participants affected / at risk     66/409 (16.14%)     71/412 (17.23%)     67/403 (16.63%)     61/409 (14.91%)  
Blood and lymphatic system disorders          
Anaemia † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     2/403 (0.50%)     0/409 (0.00%)  
Cardiac disorders          
Atrial fibrillation † 1        
# participants affected / at risk     1/409 (0.24%)     1/412 (0.24%)     2/403 (0.50%)     0/409 (0.00%)  
Acute myocardial infarction † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     2/403 (0.50%)     0/409 (0.00%)  
Angina pectoris † 1        
# participants affected / at risk     1/409 (0.24%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Bradycardia † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     2/409 (0.49%)  
Cardiac arrest † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     1/403 (0.25%)     0/409 (0.00%)  
Cardiac failure † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Myocardial infarction † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     1/409 (0.24%)  
Supraventricular tachycardia † 1        
# participants affected / at risk     2/409 (0.49%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Tachycardia † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     2/403 (0.50%)     0/409 (0.00%)  
Angina unstable † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Atrial flutter † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Cardiac failure congestive † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Cardiomyopathy † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Coronary artery disease † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Coronary artery stenosis † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Myocardial ischaemia † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Tachyarrhythmia † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Ventricular tachycardia † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Ear and labyrinth disorders          
Vertigo † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Endocrine disorders          
Hyperthyroidism † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     1/409 (0.24%)  
Eye disorders          
Eye haemorrhage † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Gastrointestinal disorders          
Abdominal hernia † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     1/409 (0.24%)  
Abdominal pain † 1        
# participants affected / at risk     0/409 (0.00%)     2/412 (0.49%)     0/403 (0.00%)     0/409 (0.00%)  
Constipation † 1        
# participants affected / at risk     0/409 (0.00%)     2/412 (0.49%)     0/403 (0.00%)     0/409 (0.00%)  
Small intestinal obstruction † 1        
# participants affected / at risk     1/409 (0.24%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Abdominal adhesions † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Diverticulum intestinal † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Duodenal ulcer † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Gastric ulcer † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Gastrooesophageal reflux disease † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Ileus † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Inguinal hernia † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Intestinal obstruction † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Intestinal perforation † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Megacolon † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Oesophageal achalasia † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Oesophageal stenosis † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Pancreatitis acute † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
General disorders          
Non-cardiac chest pain † 1        
# participants affected / at risk     2/409 (0.49%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Chest pain † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     1/409 (0.24%)  
Fatigue † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Hepatobiliary disorders          
Cholelithiasis † 1        
# participants affected / at risk     1/409 (0.24%)     1/412 (0.24%)     2/403 (0.50%)     0/409 (0.00%)  
Cholecystitis † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Cholecystitis acute † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Immune system disorders          
Anaphylactic shock † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Infections and infestations          
Pneumonia † 1        
# participants affected / at risk     6/409 (1.47%)     10/412 (2.43%)     12/403 (2.98%)     9/409 (2.20%)  
Infective exacerbation of chronic obstructive airways diseas † 1        
# participants affected / at risk     0/409 (0.00%)     2/412 (0.49%)     2/403 (0.50%)     3/409 (0.73%)  
Bronchitis † 1        
# participants affected / at risk     2/409 (0.49%)     2/412 (0.49%)     1/403 (0.25%)     0/409 (0.00%)  
Cellulitis † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     2/403 (0.50%)     1/409 (0.24%)  
Lower respiratory tract infection † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     2/409 (0.49%)  
Diverticulitis † 1        
# participants affected / at risk     1/409 (0.24%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Lobar pneumonia † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     2/403 (0.50%)     0/409 (0.00%)  
Urinary tract infection † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     1/409 (0.24%)  
Abscess limb † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Bacteraemia † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Gastroenteritis † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Lung abscess † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Pelvic inflammatory disease † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Pneumonia primary atypical † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Postoperative wound infection † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Pyelonephritis † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Tracheobronchitis † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Injury, poisoning and procedural complications          
Hip fracture † 1        
# participants affected / at risk     1/409 (0.24%)     2/412 (0.49%)     0/403 (0.00%)     0/409 (0.00%)  
Acetabulum fracture † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Concussion † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Contusion † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Fall † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Femur fracture † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Humerus fracture † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Muscle strain † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Pelvic fracture † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Rib fracture † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Road traffic accident † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Spinal compression fracture † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Traumatic haematoma † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Investigations          
Blood pressure increased † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Electrocardiogram abnormal † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Metabolism and nutrition disorders          
Hyponatraemia † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Gout † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Musculoskeletal and connective tissue disorders          
Arthralgia † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Musculoskeletal chest pain † 1        
# participants affected / at risk     2/409 (0.49%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Arthropathy † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Osteoarthritis † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)          
Lung squamous cell carcinoma stage unspecified † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     1/403 (0.25%)     1/409 (0.24%)  
Prostate cancer † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     1/409 (0.24%)  
Small cell lung cancer stage unspecified † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     1/409 (0.24%)  
Thyroid cancer † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     2/409 (0.49%)  
B-cell lymphoma † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Basal cell carcinoma † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Bladder cancer † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Bladder neoplasm † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Bone neoplasm † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Breast cancer † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Bronchial neoplasm † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Laryngeal cancer † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Leukaemia † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Lung neoplasm † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Lung neoplasm malignant † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Malignant melanoma † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Metastases to bone † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Metastases to gastrointestinal tract † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Metastatic squamous cell carcinoma † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Neoplasm malignant † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Neoplasm recurrence † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Neuroendocrine tumour † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Pelvic neoplasm † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Pituitary tumour benign † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Renal cancer † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Renal cell carcinoma † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Skin cancer † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Squamous cell carcinoma † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Uterine leiomyoma † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Nervous system disorders          
Cerebrovascular accident † 1        
# participants affected / at risk     2/409 (0.49%)     1/412 (0.24%)     0/403 (0.00%)     1/409 (0.24%)  
Syncope † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     2/403 (0.50%)     0/409 (0.00%)  
Cerebral ischaemia † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Convulsion † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Ischaemic stroke † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Presyncope † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Subarachnoid haemorrhage † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Transient ischaemic attack † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Psychiatric disorders          
Major depression † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     1/409 (0.24%)  
Suicidal ideation † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Renal and urinary disorders          
Renal failure acute † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Calculus ureteric † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Haematuria † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Urinary bladder polyp † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Reproductive system and breast disorders          
Benign prostatic hyperplasia † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Cervical dysplasia † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Respiratory, thoracic and mediastinal disorders          
Chronic obstructive pulmonary disease † 1        
# participants affected / at risk     25/409 (6.11%)     26/412 (6.31%)     29/403 (7.20%)     23/409 (5.62%)  
Pneumothorax † 1        
# participants affected / at risk     0/409 (0.00%)     2/412 (0.49%)     1/403 (0.25%)     1/409 (0.24%)  
Respiratory failure † 1        
# participants affected / at risk     0/409 (0.00%)     2/412 (0.49%)     0/403 (0.00%)     2/409 (0.49%)  
Dyspnoea † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     1/403 (0.25%)     1/409 (0.24%)  
Pleural effusion † 1        
# participants affected / at risk     1/409 (0.24%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Acute respiratory failure † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Chronic respiratory failure † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Haemoptysis † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Hypoxia † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Pulmonary bulla † 1        
# participants affected / at risk     0/409 (0.00%)     1/412 (0.24%)     0/403 (0.00%)     0/409 (0.00%)  
Pulmonary hypertension † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Pulmonary oedema † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Respiratory distress † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Skin and subcutaneous tissue disorders          
Angioedema † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Urticaria † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Vascular disorders          
Aortic aneurysm † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Arteriosclerosis † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Circulatory collapse † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Deep vein thrombosis † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     0/403 (0.00%)     1/409 (0.24%)  
Haemorrhage † 1        
# participants affected / at risk     0/409 (0.00%)     0/412 (0.00%)     1/403 (0.25%)     0/409 (0.00%)  
Labile blood pressure † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Peripheral arterial occlusive disease † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Thrombophlebitis † 1        
# participants affected / at risk     1/409 (0.24%)     0/412 (0.00%)     0/403 (0.00%)     0/409 (0.00%)  
Events were collected by systematic assessment
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


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Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01017952     History of Changes
Other Study ID Numbers: 102970
Study First Received: November 19, 2009
Results First Received: May 30, 2013
Last Updated: August 15, 2013
Health Authority: United States: Food and Drug Administration