A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)
May 3, 2017 updated by: GlaxoSmithKline
A 12-month, Open Label, Randomised, Effectiveness Study to Evaluate Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) Inhalation Powder Delivered Once Daily Via a Novel Dry Powder Inhaler (NDPI) Compared With the Existing COPD Maintenance Therapy Alone in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
This study is designed to compare the effectiveness and safety of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444)) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing COPD maintenance therapy over twelve months in subjects diagnosed with COPD.
This is a Phase III multi-centre, randomised open label study.
Subjects who meet the eligibility criteria are randomised and will enter a 12 month treatment period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a Phase III multi-centre, randomised open label study performed in subjects followed in primary care who have a diagnosis of and receive regular treatment for COPD in a localised geographical region of the UK
Study Type
Interventional
Enrollment (Actual)
2802
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cadishead, Manchester, United Kingdom, M44 5DD
- GSK Investigational Site
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Cheadle, United Kingdom, SK8 5BB
- GSK Investigational Site
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Eccles, United Kingdom, M30 0TU
- GSK Investigational Site
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Eccles, Manchester, United Kingdom, M30 0EA
- GSK Investigational Site
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Eccles, Manchester, United Kingdom, M30 0EJ
- GSK Investigational Site
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Eccles, Manchester, United Kingdom, M30 0LS
- GSK Investigational Site
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Eccles, Manchester, United Kingdom, M30 0NU
- GSK Investigational Site
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Eccles, Manchester, United Kingdom, M30 0PF
- GSK Investigational Site
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Eccles, Manchester, United Kingdom, M30 0TU
- GSK Investigational Site
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Eccles, Manchester, United Kingdom, M30 7JW
- GSK Investigational Site
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Eccles, Manchester, United Kingdom, M30 7NA
- GSK Investigational Site
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Eccles, Manchester, United Kingdom, M30 8AR
- GSK Investigational Site
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Eccles, Manchester, United Kingdom, M30 8JA
- GSK Investigational Site
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Eccles, Manchester, United Kingdom, M30 8QD
- GSK Investigational Site
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Eccles, Manchester, United Kingdom, M30 9PS
- GSK Investigational Site
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Ellenbrook, Manchester, United Kingdom, M28 1PB
- GSK Investigational Site
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Irlam, Manchester, United Kingdom, M44 5LH
- GSK Investigational Site
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Irlam, Manchester, United Kingdom, M44 6AJ
- GSK Investigational Site
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Irlam, Manchester, United Kingdom, M44 6BL
- GSK Investigational Site
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Irlam, Manchester, United Kingdom, M44 6FE
- GSK Investigational Site
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Irlam, Manchester, United Kingdom, M44 6FN
- GSK Investigational Site
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Irlam, Salford, United Kingdom, M44 6ZS
- GSK Investigational Site
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Irlam, Salford, United Kingdom, M44 6DP
- GSK Investigational Site
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Little Hulton, Manchester, United Kingdom, M28 0AY
- GSK Investigational Site
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Little Hulton, Manchester, United Kingdom, M28 0BA
- GSK Investigational Site
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Little Hulton, Manchester, United Kingdom, M38 9GR
- GSK Investigational Site
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Little Hulton, Manchester, United Kingdom, M38 9LQ
- GSK Investigational Site
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Little Hulton, Manchester, United Kingdom, M38 9RS
- GSK Investigational Site
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Little Hulton, Manchester, United Kingdom, M38 9WX
- GSK Investigational Site
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Little Hulton, Manchester, United Kingdom, M38 9GH
- GSK Investigational Site
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Manchester, United Kingdom, M28 1PB
- GSK Investigational Site
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Manchester, United Kingdom, M20 4SS
- GSK Investigational Site
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Manchester, United Kingdom, M22 4HD
- GSK Investigational Site
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Manchester, United Kingdom, M22 4QN
- GSK Investigational Site
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Manchester, United Kingdom, M23 1JX
- GSK Investigational Site
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Manchester, United Kingdom, M32 8AQ
- GSK Investigational Site
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Manchester, United Kingdom, M32 9PA
- GSK Investigational Site
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Manchester, United Kingdom, M33 3JS
- GSK Investigational Site
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Manchester, United Kingdom, M33 4DX
- GSK Investigational Site
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Manchester, United Kingdom, M33 7XZ
- GSK Investigational Site
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Manchester, United Kingdom, M41 5BG
- GSK Investigational Site
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Manchester, United Kingdom, M41 7AB
- GSK Investigational Site
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Manchester, United Kingdom, M41 8GY
- GSK Investigational Site
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Manchester, United Kingdom, M41 8TW
- GSK Investigational Site
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Manchester, United Kingdom, M41 9FD
- GSK Investigational Site
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Manchester, United Kingdom, M41 9NU
- GSK Investigational Site
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Manchester, United Kingdom, M41 9SB
- GSK Investigational Site
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Manchester, United Kingdom, M7 4PF
- GSK Investigational Site
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Pendlebury, Manchester, United Kingdom, M27 6EW
- GSK Investigational Site
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Salford, United Kingdom, M5 3PH
- GSK Investigational Site
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Salford, United Kingdom, M5 4BS
- GSK Investigational Site
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Salford, United Kingdom, M6 3PH
- GSK Investigational Site
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Salford, United Kingdom, M6 5FX
- GSK Investigational Site
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Salford, United Kingdom, M6 5JG
- GSK Investigational Site
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Salford, United Kingdom, M6 5PP
- GSK Investigational Site
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Salford, United Kingdom, M6 5QQ
- GSK Investigational Site
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Salford, United Kingdom, M6 6ES
- GSK Investigational Site
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Salford, United Kingdom, M7 3SE
- GSK Investigational Site
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Salford, United Kingdom, M7 4UF
- GSK Investigational Site
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Salford, United Kingdom, M7 4LZ
- GSK Investigational Site
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Salford, United Kingdom, M7 4NX
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M3 6AF
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M3 6BY
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M5 3TP
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M5 4QU
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M5 5HJ
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M5 5JR
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M6 5FX
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M6 5JA
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M6 5JS
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M6 5PH
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M6 5WN
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M6 5WW
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M6 7GU
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M6 7HL
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M6 8HA
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M6 8LE
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M6 8NR
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M7 1QE
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M7 1RD
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M7 1UD
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M7 3SE
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M7 4AE
- GSK Investigational Site
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Salford, Manchester, United Kingdom, M7 4AS
- GSK Investigational Site
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Stockport, United Kingdom, SK2 7EY
- GSK Investigational Site
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Stockport, United Kingdom, SK3 9AD
- GSK Investigational Site
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Stockport, United Kingdom, SK8 3JD
- GSK Investigational Site
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Stockport, United Kingdom, SK8 3QA
- GSK Investigational Site
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Stockport, United Kingdom, SK8 5LL
- GSK Investigational Site
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Swinton, United Kingdom, M27 8HP
- GSK Investigational Site
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Swinton, United Kingdom, M27 4BJ
- GSK Investigational Site
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Swinton, Manchester, United Kingdom, M27 0EW
- GSK Investigational Site
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Swinton, Manchester, United Kingdom, M27 0NA
- GSK Investigational Site
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Swinton, Manchester, United Kingdom, M27 4AF
- GSK Investigational Site
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Swinton, Manchester, United Kingdom, M27 4BH
- GSK Investigational Site
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Walkden, Manchester, United Kingdom, M28 3AT
- GSK Investigational Site
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Walkden, Manchester, United Kingdom, M28 3BT
- GSK Investigational Site
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Walkden, Manchester, United Kingdom, M28 3DR
- GSK Investigational Site
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Walkden, Manchester, United Kingdom, M28 3ZD
- GSK Investigational Site
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Walkden, Manchester, United Kingdom
- GSK Investigational Site
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Walkden, Manchester, United Kingdom, M28 3EZ
- GSK Investigational Site
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Worsley, Manchester, United Kingdom, M28 1FB
- GSK Investigational Site
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Worsley, Manchester, United Kingdom, M28 1LZ
- GSK Investigational Site
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Worsley, Manchester, United Kingdom, M28 3AT
- GSK Investigational Site
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Wythenshawe, United Kingdom, M22 0LA
- GSK Investigational Site
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Cheshire
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Altrincham, Cheshire, United Kingdom, WA14 2NW
- GSK Investigational Site
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Altrincham, Cheshire, United Kingdom, WA14 5ET
- GSK Investigational Site
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Altrincham, Cheshire, United Kingdom, WA14 5GR
- GSK Investigational Site
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Altrincham, Cheshire, United Kingdom, WA14 5NH
- GSK Investigational Site
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Altrincham, Cheshire, United Kingdom, WA14 5PF
- GSK Investigational Site
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Bowdon, Cheshire, United Kingdom, WA14 3BD
- GSK Investigational Site
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Cheadle, Cheshire, United Kingdom, SK8 6LQ
- GSK Investigational Site
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Cheadle Hulme, Cheshire, United Kingdom, SK8 5EG
- GSK Investigational Site
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Edgeley, Cheshire, United Kingdom, SK3 9LQ
- GSK Investigational Site
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Gatley, Cheshire, United Kingdom, SK84NG
- GSK Investigational Site
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Heald Green, Cheshire, United Kingdom, SK8 3QA
- GSK Investigational Site
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Sale, Cheshire, United Kingdom, M33 2RH
- GSK Investigational Site
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Sale, Cheshire, United Kingdom, M33 2UP
- GSK Investigational Site
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Sale, Cheshire, United Kingdom, M33 4BR
- GSK Investigational Site
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Sale, Cheshire, United Kingdom, M33 7SS
- GSK Investigational Site
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Stockport, Cheshire, United Kingdom, SK3 9NX
- GSK Investigational Site
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Timperley, Cheshire, United Kingdom, WA15 7DD
- GSK Investigational Site
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Timperley, Cheshire, United Kingdom, WA15 7UN
- GSK Investigational Site
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Greater Manchester
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Altrincham, Greater Manchester, United Kingdom, WA14 2DW
- GSK Investigational Site
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Altrincham, Greater Manchester, United Kingdom, WA15 6PH
- GSK Investigational Site
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Broadway, Davyhulme, Greater Manchester, United Kingdom, M41 7WJ
- GSK Investigational Site
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Irlam, Greater Manchester, United Kingdom, M44 5LH
- GSK Investigational Site
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Irlam, Manchester, Greater Manchester, United Kingdom, M44 5LH
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M22 4DH
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M20 2RN
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M20 1EB
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M20 2DN
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M20 3BG
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M20 4SS
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M20 6WF
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M22 5DW
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M22 5RB
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M22 5RX
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M22 9UE
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M23 1JP
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M23 1JX
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M23 9AB
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M27 9LB
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M32 0DF
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M32 0PA
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M32 0RW
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M33 2TB
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M33 3HF
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M33 4WB
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M33 5JD
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M33 5PN
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M33 7SS
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M33 7XN
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M41 0NA
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M41 0SE
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M41 0TZ
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M41 5AA
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M41 7FN
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M41 7WJ
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, M41 8AA
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, WA15 6BP
- GSK Investigational Site
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Manchester, Greater Manchester, United Kingdom, WA15 7UN
- GSK Investigational Site
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Newall Green, Greater Manchester, United Kingdom, M23 2SY
- GSK Investigational Site
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Northenden, Greater Manchester, United Kingdom, M22 4DH
- GSK Investigational Site
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Northern Moor, Greater Manchester, United Kingdom, M23 0BX
- GSK Investigational Site
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Pendlebury, Greater Manchester, United Kingdom, M27 8HP
- GSK Investigational Site
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Pendlebury, Manchester, Greater Manchester, United Kingdom, M27 8HP
- GSK Investigational Site
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Salford, Greater Manchester, United Kingdom, M6 7HL
- GSK Investigational Site
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Salford, Greater Manchester, United Kingdom, M7 1RD
- GSK Investigational Site
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Salford, Greater Manchester, United Kingdom, M6 5PW
- GSK Investigational Site
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Salford, Greater Manchester, United Kingdom, M6 6ES
- GSK Investigational Site
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Salford, Manchester, Greater Manchester, United Kingdom, M7 4TP
- GSK Investigational Site
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Stretford, Greater Manchester, United Kingdom, M32 9BD
- GSK Investigational Site
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Timperley, Greater Manchester, United Kingdom, WA15 6PH
- GSK Investigational Site
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Withington, Greater Manchester, United Kingdom, M20 1EY
- GSK Investigational Site
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Wythenshawe, Greater Manchester, United Kingdom, M22 0EP
- GSK Investigational Site
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Wythenshawe, Greater Manchester, United Kingdom, M22 5RN
- GSK Investigational Site
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Wythenshawe, Greater Manchester, United Kingdom, M22 5RX
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Subjects eligible for enrolment in the study must meet all of the following criteria:
- Type of subject: Subjects with documented GP diagnosis of COPD, and currently receiving maintenance therapy
- Informed consent: Subjects must be able to provide informed consent, have their consent signed and dated. Subjects must be able to complete the electronic subject questionnaires or allow a proxy to do so on their behalf.
- Gender and Age: Male or female subjects aged ≥40 years of age at Visit 1 A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. However in questionable cases, a blood sample with FSH > 40MIU/ml and estradiol <40pg/ml (<140 pmol/L) is confirmatory. Or child bearing potential has a negative urine pregnancy test at Visit 2, and agrees to one of the highly effective and acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - Visit 2 to the end of the study).
- Subjects with Exacerbation History
- Current COPD Maintenance Therapy
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
- Subjects with any life threatening condition (e.g. low probability (in the opinion of the GP/Investigator) of 12 month survival due to severity of COPD or co-morbid condition) at the point of entry into the study.
- Other diseases/abnormalities: Subjects with historical or current evidence of uncontrolled or clinically significant disease. Significant is defined as any disease that, in the opinion of the GP/ Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
Subjects with unstable COPD, defined as the occurrence of the following in the 2 weeks prior to Visit 2:
- Acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician.
- Chronic user of oral corticosteroids: Subjects who, in the opinion of the GP/Investigator, are considered to be a chronic user of oral corticosteroids for respiratory or other indications (if unsure discuss with the medical monitor prior to screening)
- Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g., beta-agonists, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the GP/ Investigator, contraindicates the subject's participation will also be excluded.
- Investigational Medications: A subject must not have used any investigational drug treatment within 30 days prior to Visit 2 or within five half-lives (t½) of the prior investigational study (whichever is the longer of the two).
- Subjects who plan to move away from the geographical area where the study is being conducted during the study period and/or if subjects have not consented to their medical records being part of the electronic medical records database that is operational in the Salford area.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: FF/VI
once daily via a Novel Dry Powder Inhaler
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FF/VI
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Other: Existing Maintenance Therapy
Existing Maintenance Therapy:
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Existing Maintenance Therapy:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Mean Annual Rate of Moderate or Severe COPD Exacerbations
Time Frame: Up to 54 weeks
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Mean annual rate of moderate or severe COPD exacerbations during treatment were assessed.
Moderate exacerbation: participant received exacerbation-related prescription of oral corticosteroids and/ or antibiotic (with/without National Health Service [NHS] contact) not requiring hospitalisation.
Severe exacerbation: an exacerbation-related hospitalisation.
Analysis method was Generalised Linear Model (GLM) assuming the negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable, adjusted for randomized treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in previous year and smoking status at baseline.
Intent to treat (ITT) population: all randomised participants who received a prescription of study medication.
Primary Efficacy Analysis Population: all ITT participants who had at least one moderate/severe exacerbation in the year prior to randomization
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Up to 54 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Serious Adverse Events (SAEs) of Pneumonia During the Study
Time Frame: Up to 58 weeks
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Incidence of SAE of pneumonia was defined for each randomized treatment group as the proportion (number) of participants in that group who experienced at least one SAE of pneumonia in the Pneumonia Adverse Event of Special Interest subgroup during the treatment period (from start date of exposure to stop date of exposure + 28 days).
Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2. Serious Adverse Events of pneumonia are defined by the Pneumonia Special Interest Group, which for SAEs of pneumonia collected for these subjects includes the following preferred terms: Pneumonia, Pneumonia aspiration, Aspergillus infection, Empyema, Pneumonia streptococcal, Pneumonitis, Pulmonary tuberculosis.
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Up to 58 weeks
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Mean Number of Serious Adverse Events of Pneumonia During the Study
Time Frame: Up to 58 weeks
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The mean number of SAE of pneumonia over the treatment period (from first date of exposure to last date of exposure + 28 days was calculated.
Analysis was performed using a negative binomial regression model with covariates of randomised treatment and with logarithm of time on treatment as an offset variable.
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Up to 58 weeks
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Time to the First Serious Adverse Event of Pneumonia Occuring in a Year
Time Frame: Up to 52 weeks
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The analysis method was a Cox proportional hazards model adjusted for randomized treatment.
Analyses included those on-treatment SAEs of pneumonia that had an onset over the first 364 days of exposure, as defined.
Participants who did not have an SAE of pneumonia during the first 364 days of the treatment period (start date of exposure to end date of exposure + 28 days were considered censored.
Number of participants with event is presented.
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Up to 52 weeks
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Number of COPD-related Secondary Care Contacts Expressed as Least Square Mean
Time Frame: Up to 54 weeks
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A COPD-related secondary care contact was defined as an inpatient admission or a specialist outpatient visit or an accident & emergency (A&E) contact.
A participant with an A&E contact and subsequent inpatient admission was considered to have had two healthcare contacts.
Inpatient admissions recorded at two hospitals on the same day, this was counted as a single (inpatient admission) secondary care contact.
COPD-related contacts were identified using predefined lists of ICD-10 codes, specialty descriptions and diagnosis codes recorded in the patients electronic health record (EHR).
GLM assuming the negative binomial distribution with log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in the previous year to randomisation and smoking status at baseline.
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Up to 54 weeks
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Number of COPD-related Primary Care Contacts Expressed Using Least Square Mean
Time Frame: Up to 54 weeks
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A COPD-related primary care contact was defined as a primary care contact on a given calendar date with either a nurse, general physician (GP) or other healthcare professional that were considered as COPD-related, if the most prominent signs and symptoms the participant was presenting were as a direct result of the participant's COPD, as per Readcodes recorded in the patients electronic health record (EHR).
The analysis method was General Linear Model assuming an underlying negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in the previous year to randomisation and smoking status at baseline.
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Up to 54 weeks
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Number of All Secondary Care Contacts Expressed Using Least Square Mean
Time Frame: Up to 54 weeks
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A secondary care contact was defined as an inpatient admission or a specialist outpatient visit or an A&E contact.
A participant with an A&E contact and subsequent inpatient admission was considered to have had two healthcare contacts.
In the situation where inpatient admissions were recorded at two hospitals on the same day, this was counted as a single secondary care contact.
The analysis method was General Linear Model assuming an underlying negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomization stratification, number of moderate/severe COPD exacerbations in the previous year to randomization and smoking status at baseline.
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Up to 54 weeks
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Number of All Primary Care Contacts Expressed Using Least Square Mean
Time Frame: Up to 54 weeks
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A primary care contact was defined as contact with a either a nurse, general practitioner, or other healthcare professional.
The analysis method was General Linear Model assuming an underlying negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in the previous year to randomisation and smoking status at baseline.
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Up to 54 weeks
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Time to an Event of Discontinuation of Initial Therapy Occurring in a Year
Time Frame: Up to 364 days
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Initial therapy was defined as the treatment that the subject was randomised to at randomisation.
Discontinuation of initial therapy was defined as any modification of initial therapy.
These included stepping up, stepping down or switching to another class/class combination, or withdrawal from the study.
Switching within the same drug class did not count unless participant switched from FF/VI to a different ICS/LABA.
The analysis method was a Cox proportional hazards model adjusted for randomized treatment.
The probability of discontinuation of initial therapy was measured from the date of randomisation (i.e., exposure start date) to the date of discontinuation of initial therapy to which the participant was randomized, or date of treatment termination (Visit 6 or early withdrawal visit) for participants who completed the study without discontinuing the initial therapy (censored).
Number of participants with event is presented.
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Up to 364 days
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Time to the Addition of a Further COPD Controller Medication Occurring in a Year
Time Frame: Up to 364 days
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The date of an event for addition of a further COPD controller medication was defined as the exposure start date of the first modified treatment medication that included a new COPD maintenance therapy of a new class of drug (to the initial therapy) during the study treatment period, as collected on the investigational product page of the eCRF.
Participants who did not add any COPD controller medication during the study were censored at the end of the treatment period (Day 364).
This was equivalent to stepping up, defined as the addition of at least one new class of drug.
The probability of an event was measured from the date of randomisation (i.e., treatment initiation) to the date of a change event.
The analysis method was a Cox proportional hazards model adjusted for randomized treatment.
Number of participants with event is presented.
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Up to 364 days
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Time to First Moderate/Severe Exacerbations Occurring in a Year
Time Frame: Up to 364 days
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The date of an event for moderate / severe COPD exacerbation was defined as the exacerbation onset date.
The analysis method was a Cox proportional hazards model adjusted for randomized treatment.
The probability of a first moderate / severe exacerbation was measured from the date of randomisation (i.e., treatment initiation) to the onset date of first moderate or severe COPD exacerbation, as recorded on eCRF, or date of treatment termination (Visit 6 or early withdrawal visit) for participants who completed the study without any moderate or severe exacerbations (censored).
Participants who completed the study without a moderate or severe COPD exacerbation and analyses of time to first moderate/severe exacerbation were censored at Day 364.
Number of participants with event is presented.
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Up to 364 days
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Time to First Moderate/Severe Exacerbations on Initial Therapy Occurring in a Year
Time Frame: Up to 364 days
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The date of an event for moderate / severe COPD exacerbation was defined as the exacerbation onset date.
The analysis method was a Cox proportional hazards model adjusted for randomized treatment.
The probability of first moderate / severe exacerbation on initial therapy was measured from the date of randomisation (i.e., exposure start date) to the onset date of first moderate or severe COPD exacerbation, or to the date of discontinuation of initial therapy (analysis was censored at date of discontinuation of initial therapy) for participants who completed the study without any moderate or severe exacerbations on initial therapy.
Number of participants with event is presented.
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Up to 364 days
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Time to First Severe Exacerbations Occurring in a Year
Time Frame: Up to 364 days
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The date of an event for severe exacerbation was defined as the exacerbation onset date. Participants who completed the study without a severe exacerbation were censored. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. The probability of first severe exacerbation was measured from the date of randomisation (i.e., treatment initiation) to the onset date of first severe exacerbation, as recorded on eCRF, or date of treatment termination (Visit 6 or early withdrawal visit) for participants who completed the study without any severe exacerbations (censored). At Day 364, all participants who have not experienced a severe exacerbation are considered censored, regardless of whether their on-treatment phase continues beyond day 364, including those who withdrew early. Number of participants with event is presented. |
Up to 364 days
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Number of Participants With Fatal Serious Adverse Events of Pneumonia
Time Frame: Upto 58 weeks
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All SAEs included in the AE subgroup of special interest of "pneumonia" were considered as an SAE of pneumonias.
A fatal SAE was defined as a SAE with outcome of fatal for study participant.
The number of participants with fatal SAEs of pneumonia was assessed over 14 months.
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Upto 58 weeks
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Number of Participants With Non-serious Adverse Drug Reactions (ADR)
Time Frame: Up to 54 weeks
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The number of participants with non-serious ADRs was assessed for up to 54 weeks.
An ADR is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, for which there is a reasonable possibility that the untoward occurrence is causally related to the medicinal product.
A non-serious ADR included one of the following: exacerbation of chronic or intermittent pre-existing condition; signs, symptoms, or the clinical sequelae of a suspected interaction; signs, symptoms, or new conditions detected or diagnosed after study treatment administration.
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Up to 54 weeks
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Number of Participants With Serious Adverse Events
Time Frame: Up to 56 weeks
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SAEs assessed included medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a significant medical event in the investigator's judgment, or is an event of possible drug-induced liver injury with hyperbilirubinaemia.
SAEs were includes if the onset date was on or after the treatment start date and on or before the treatment stop date.
However, the window for an SAE of pneumonia was longer and included 28 days post study treatment stop date.
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Up to 56 weeks
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Number of Participants With Serious Adverse Drug Reactions
Time Frame: Upto 12 months
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A serious adverse drug reactions (SADR) is any untoward medical occurrence suspected to be medicinal product-related that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
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Upto 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- New JP, Bakerly ND, Leather D, Woodcock A. Obtaining real-world evidence: the Salford Lung Study. Thorax. 2014 Dec;69(12):1152-4. doi: 10.1136/thoraxjnl-2014-205259. Epub 2014 Mar 6. Erratum In: Thorax. 2015 Oct;70(10):1008.
- Vestbo J, Waterer G, Leather D, Crim C, Diar Bakerly N, Frith L, Jacques L, Harvey C, Satia I, Woodcock A; Salford Lung Study Investigators. Mortality after admission with pneumonia is higher than after admission with an exacerbation of COPD. Eur Respir J. 2022 May 19;59(5):2102899. doi: 10.1183/13993003.02899-2021. Print 2022 May.
- Bakerly ND, Browning D, Boucot I, Crawford J, McCorkindale S, Stein N, New JP. The impact of fluticasone furoate/vilanterol on healthcare resource utilisation in the Salford Lung Study in chronic obstructive pulmonary disease. Ther Adv Respir Dis. 2021 Jan-Dec;15:17534666211001013. doi: 10.1177/17534666211001013.
- Sperrin M, Webb DJ, Patel P, Davis KJ, Collier S, Pate A, Leather DA, Pimenta JM. Chronic obstructive pulmonary disease exacerbation episodes derived from electronic health record data validated using clinical trial data. Pharmacoepidemiol Drug Saf. 2019 Oct;28(10):1369-1376. doi: 10.1002/pds.4883. Epub 2019 Aug 5.
- Bakerly ND, Woodcock A, Collier S, Leather DA, New JP, Crawford J, Harvey C, Vestbo J, Boucot I. Benefit and safety of fluticasone furoate/vilanterol in the Salford Lung Study in chronic obstructive pulmonary disease (SLS COPD) according to baseline patient characteristics and treatment subgroups. Respir Med. 2019 Feb;147:58-65. doi: 10.1016/j.rmed.2018.12.016. Epub 2019 Jan 10.
- Woodcock A, Boucot I, Leather DA, Crawford J, Collier S, Bakerly ND, Hilton E, Vestbo J. Effectiveness versus efficacy trials in COPD: how study design influences outcomes and applicability. Eur Respir J. 2018 Feb 21;51(2):1701531. doi: 10.1183/13993003.01531-2017. Print 2018 Feb.
- Vestbo J, Leather D, Diar Bakerly N, New J, Gibson JM, McCorkindale S, Collier S, Crawford J, Frith L, Harvey C, Svedsater H, Woodcock A; Salford Lung Study Investigators. Effectiveness of Fluticasone Furoate-Vilanterol for COPD in Clinical Practice. N Engl J Med. 2016 Sep 29;375(13):1253-60. doi: 10.1056/NEJMoa1608033. Epub 2016 Sep 4.
- Bakerly ND, Woodcock A, New JP, Gibson JM, Wu W, Leather D, Vestbo J. The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in chronic obstructive pulmonary disease. Respir Res. 2015 Sep 4;16(1):101. doi: 10.1186/s12931-015-0267-6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 13, 2012
Primary Completion (Actual)
November 24, 2015
Study Completion (Actual)
November 24, 2015
Study Registration Dates
First Submitted
March 1, 2012
First Submitted That Met QC Criteria
March 12, 2012
First Posted (Estimate)
March 13, 2012
Study Record Updates
Last Update Posted (Actual)
May 31, 2017
Last Update Submitted That Met QC Criteria
May 3, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 115151
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Study Protocol
Information identifier: 115151Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 115151Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Informed Consent Form
Information identifier: 115151Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Individual Participant Data Set
Information identifier: 115151Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistical Analysis Plan
Information identifier: 115151Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Annotated Case Report Form
Information identifier: 115151Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Clinical Study Report
Information identifier: 115151Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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