A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: FF/VI; Existing Maintenance Therapy
Intervention description: FF/VI; Existing Maintenance Therapy:
Long acting bronchodilator therapy alone
ICS alone or in combination with a long acting bronchodilator
Triple maintenance therapy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2802.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Exacerbation; Adult; COPD; Respiratory

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects eligible for enrolment in the study must meet all of the following criteria:

          1. Type of subject: Subjects with documented GP diagnosis of COPD, and currently
             receiving maintenance therapy

          2. 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.

          3. 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).

          4. Subjects with Exacerbation History

          5. Current COPD Maintenance Therapy

        Exclusion Criteria:

        Subjects meeting any of the following criteria must not be enrolled in the study:

          1. 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.

          2. 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.

          3. 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.

          4. 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)

          5. 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.

          6. 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).

          7. 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.