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)
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.
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
Inclusion Criteria:
Subjects eligible for enrolment in the study must meet all of the following criteria:
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.
Broadway, Davyhulme, Greater Manchester M41 7WJ, United Kingdom
Irlam, Manchester, Greater Manchester M44 5LH, United Kingdom
Pendlebury, Manchester, Greater Manchester M27 8HP, United Kingdom
Salford, Manchester, Greater Manchester M7 4TP, United Kingdom
Cadishead, Manchester, M44 5DD, United Kingdom
Eccles, Manchester, M30 0EA, United Kingdom
Eccles, Manchester, M30 0EJ, United Kingdom
Eccles, Manchester, M30 0LS, United Kingdom
Eccles, Manchester, M30 0NU, United Kingdom
Eccles, Manchester, M30 0PF, United Kingdom
Eccles, Manchester, M30 0TU, United Kingdom
Eccles, Manchester, M30 7JW, United Kingdom
Eccles, Manchester, M30 7NA, United Kingdom
Eccles, Manchester, M30 8AR, United Kingdom
Eccles, Manchester, M30 8JA, United Kingdom
Eccles, Manchester, M30 8QD, United Kingdom
Eccles, Manchester, M30 9PS, United Kingdom
Ellenbrook, Manchester, M28 1PB, United Kingdom
Irlam, Manchester, M44 5LH, United Kingdom
Irlam, Manchester, M44 6AJ, United Kingdom
Irlam, Manchester, M44 6BL, United Kingdom
Irlam, Manchester, M44 6FE, United Kingdom
Irlam, Manchester, M44 6FN, United Kingdom
Irlam, Salford, M44 6DP, United Kingdom
Irlam, Salford, M44 6ZS, United Kingdom
Little Hulton, Manchester, M28 0AY, United Kingdom
Little Hulton, Manchester, M28 0BA, United Kingdom
Little Hulton, Manchester, M38 9GH, United Kingdom
Little Hulton, Manchester, M38 9GR, United Kingdom
Little Hulton, Manchester, M38 9LQ, United Kingdom
Little Hulton, Manchester, M38 9RS, United Kingdom
Little Hulton, Manchester, M38 9WX, United Kingdom
Pendlebury, Manchester, M27 6EW, United Kingdom
Salford, Manchester, M3 6AF, United Kingdom
Salford, Manchester, M3 6BY, United Kingdom
Salford, Manchester, M5 3TP, United Kingdom
Salford, Manchester, M5 4QU, United Kingdom
Salford, Manchester, M5 5HJ, United Kingdom
Salford, Manchester, M5 5JR, United Kingdom
Salford, Manchester, M6 5FX, United Kingdom
Salford, Manchester, M6 5JA, United Kingdom
Salford, Manchester, M6 5JS, United Kingdom
Salford, Manchester, M6 5PH, United Kingdom
Salford, Manchester, M6 5WN, United Kingdom
Salford, Manchester, M6 5WW, United Kingdom
Salford, Manchester, M6 7GU, United Kingdom
Salford, Manchester, M6 7HL, United Kingdom
Salford, Manchester, M6 8HA, United Kingdom
Salford, Manchester, M6 8LE, United Kingdom
Salford, Manchester, M6 8NR, United Kingdom
Salford, Manchester, M7 1QE, United Kingdom
Salford, Manchester, M7 1RD, United Kingdom
Salford, Manchester, M7 1UD, United Kingdom
Salford, Manchester, M7 3SE, United Kingdom
Salford, Manchester, M7 4AE, United Kingdom
Salford, Manchester, M7 4AS, United Kingdom
Swinton, Manchester, M27 0EW, United Kingdom
Swinton, Manchester, M27 0NA, United Kingdom
Swinton, Manchester, M27 4AF, United Kingdom
Swinton, Manchester, M27 4BH, United Kingdom
Walkden, Manchester, M28 3AT, United Kingdom
Walkden, Manchester, M28 3BT, United Kingdom
Walkden, Manchester, M28 3DR, United Kingdom
Walkden, Manchester, M28 3EZ, United Kingdom
Walkden, Manchester, M28 3ZD, United Kingdom
Walkden, Manchester, United Kingdom
Worsley, Manchester, M28 1FB, United Kingdom
Worsley, Manchester, M28 1LZ, United Kingdom
Worsley, Manchester, M28 3AT, United Kingdom