An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: fluticasone furoate + vilanterol; inhaled corticosteroid with or without a long acting beta2-agonist
Intervention description: once daily via a Novel Dry Powder Inhaler; ICS alone or in combination with a long acting bronchodilator
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4233.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: respiratory; adult; asthma

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) 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.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects eligible for enrolment in the study must meet all of the following criteria:

          1. Informed consent: Subjects must be able to provide informed consent, have their
             consent signed and dated.

          2. Type of subject: Subjects with documented GP diagnosis of asthma as their primary
             respiratory disease.

          3. 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.

               -  Other background asthma medication such as anti-leukotrienes are permitted

          4. 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).

          5. 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

          6. 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:

               -  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 (<147 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).

        Exclusion Criteria:

        Subjects meeting any of the following criteria must not be enrolled in the study:

          1. Recent history of Life-threatening asthma: Defined for this protocol as an asthma
             episode that required intubation and/or was associated with hypercapnea, respiratory
             arrest or hypoxic seizures within the last 6 months.

          2. COPD Respiratory Disease: A subject must not have current evidence or GP diagnosis of
             chronic obstructive pulmonary disease.

          3. 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.

          4. Drug/food allergy: Subjects with a history of hypersensitivity to any of the study
             medications (e.g., beta2-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.

          5. Investigational Medications: A subject must not have used any investigational drug
             within 30 days prior to Visit 2 or within five half-lives (t½) of the prior
             investigational study (whichever is longer of the two), (if unsure discuss with the
             medical monitor prior to screening)

          6. Chronic user of systemic corticosteroids: A subject who, in the opinion of the
             GP/Investigator, is considered to be a chronic user of systemic corticosteroids for
             respiratory or other indications (if unsure discuss with the medical monitor prior to
             screening)

          7. Subjects who are using LABA without an ICS as asthma maintenance therapy.

          8. 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.