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 Compared With Usual Maintenance Therapy in Subjects With Asthma
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 Compared With Usual Maintenance Therapy in Subjects With Asthma
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) or 200mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) ) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing asthma maintenance therapy over twelve months in subjects diagnosed with asthma. 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 asthma in a localised geographical region of the UK
Inclusion Criteria:
Subjects eligible for enrolment in the study must meet all of the following criteria:
Informed consent: Subjects must be able to provide informed consent, have their consent signed and dated.
Type of subject: Subjects with documented GP diagnosis of asthma as their primary respiratory disease.
Current Anti-Asthma Therapy: All subjects must be prescribed maintenance therapy and receiving ICS with or without LABA (either a fixed combination or via separate inhalers), and for at least 4 weeks prior to Visit 2.
All subjects on ICS monotherapy or ICS/LABA combination (this can be a fixed dose combination or an ICS alone or LABA alone in separate inhalers) must have had symptoms in the past week prior to Visit 2. Symptoms are defined by daytime symptoms more than twice per week, use of short-acting beta2-agonist bronchodilator more than twice per week, any limitation of activities, or any nocturnal symptoms/awakening. (The symptoms are based on subject's recall and are consistent with the GINA and in principal with the BTS/SIGN guidelines).
Subject questionnaires: Subjects must be able to complete the electronic subject questionnaires as well as those questionnaires that are completed by phone or provide a proxy e.g. a partner/relative/a friend who can do so on their behalf
Gender and Age: Male or female subjects aged ≥18 years of age at Visit 1. A female is eligible to enter and participate in the study if she is of:
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).
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
Broadway, Davyhulme, Greater Manchester M41 7WJ, United Kingdom
Irlam, Manchester, Greater Manchester M44 5LH, United Kingdom
Salford, Manchester, Greater Manchester M6 6ES, 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 6ZS, United Kingdom
Little Hulton, Manchester, M28 0AY, United Kingdom
Little Hulton, Manchester, M28 0BA, 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 5PW, 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 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