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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: November 23, 2016
Last verified: November 2016
Results First Received: May 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: FF/GW642444 Inhalation Powder
Drug: GW642444 Inhalation Powder

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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.
No text entered.

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 
Overall Participants Analyzed 
[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]
Count of Participants
         
Female      174  42.5%      181  43.9%      181  44.9%      191  46.7%      727  44.5% 
Male      235  57.5%      231  56.1%      222  55.1%      218  53.3%      906  55.5% 
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
  Show All Outcome Measures

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


  Other Adverse Events
  Hide Other Adverse Events

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.

Frequency Threshold
Threshold above which other adverse events are reported   3%  

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.

Other 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, Other (not including serious) Adverse Events         
# participants affected / at risk   211/409 (51.59%)   229/412 (55.58%)   239/403 (59.31%)   249/409 (60.88%) 
Gastrointestinal disorders         
Diarrhoea † 1         
# participants affected / at risk   4/409 (0.98%)   10/412 (2.43%)   14/403 (3.47%)   15/409 (3.67%) 
General disorders         
Oedema peripheral † 1         
# participants affected / at risk   16/409 (3.91%)   12/412 (2.91%)   12/403 (2.98%)   8/409 (1.96%) 
Infections and infestations         
Nasopharyngitis † 1         
# participants affected / at risk   58/409 (14.18%)   54/412 (13.11%)   68/403 (16.87%)   82/409 (20.05%) 
Oral candidiasis † 1         
# participants affected / at risk   29/409 (7.09%)   39/412 (9.47%)   39/403 (9.68%)   40/409 (9.78%) 
Upper respiratory tract infection † 1         
# participants affected / at risk   31/409 (7.58%)   37/412 (8.98%)   39/403 (9.68%)   36/409 (8.80%) 
Sinusitis † 1         
# participants affected / at risk   19/409 (4.65%)   26/412 (6.31%)   20/403 (4.96%)   27/409 (6.60%) 
Bronchitis † 1         
# participants affected / at risk   20/409 (4.89%)   25/412 (6.07%)   16/403 (3.97%)   23/409 (5.62%) 
Influenza † 1         
# participants affected / at risk   6/409 (1.47%)   18/412 (4.37%)   14/403 (3.47%)   18/409 (4.40%) 
Pharyngitis † 1         
# participants affected / at risk   12/409 (2.93%)   10/412 (2.43%)   10/403 (2.48%)   13/409 (3.18%) 
Rhinitis † 1         
# participants affected / at risk   12/409 (2.93%)   14/412 (3.40%)   5/403 (1.24%)   10/409 (2.44%) 
Pneumonia † 1         
# participants affected / at risk   6/409 (1.47%)   8/412 (1.94%)   14/403 (3.47%)   11/409 (2.69%) 
Lower respiratory tract infection † 1         
# participants affected / at risk   13/409 (3.18%)   7/412 (1.70%)   12/403 (2.98%)   5/409 (1.22%) 
Oropharyngeal candidiasis † 1         
# participants affected / at risk   3/409 (0.73%)   15/412 (3.64%)   11/403 (2.73%)   5/409 (1.22%) 
Musculoskeletal and connective tissue disorders         
Back pain † 1         
# participants affected / at risk   23/409 (5.62%)   19/412 (4.61%)   30/403 (7.44%)   17/409 (4.16%) 
Arthralgia † 1         
# participants affected / at risk   17/409 (4.16%)   6/412 (1.46%)   20/403 (4.96%)   13/409 (3.18%) 
Nervous system disorders         
Headache † 1         
# participants affected / at risk   30/409 (7.33%)   34/412 (8.25%)   32/403 (7.94%)   33/409 (8.07%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain † 1         
# participants affected / at risk   18/409 (4.40%)   23/412 (5.58%)   17/403 (4.22%)   26/409 (6.36%) 
Cough † 1         
# participants affected / at risk   20/409 (4.89%)   14/412 (3.40%)   15/403 (3.72%)   22/409 (5.38%) 
Dyspnoea † 1         
# participants affected / at risk   16/409 (3.91%)   12/412 (2.91%)   13/403 (3.23%)   10/409 (2.44%) 
Vascular disorders         
Hypertension † 1         
# participants affected / at risk   16/409 (3.91%)   12/412 (2.91%)   10/403 (2.48%)   15/409 (3.67%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA



  Limitations and Caveats
  Hide 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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