DISKUS vs. ELLIPTA Device Preference Study in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: ELLIPTA; DISKUS
Intervention description: Novel dry powder inhaler (placebo) with 30 doses (2 strips with 30 blisters per strip); Multidose dry powder inhaler (placebo) containing a foil strip worth 60 blisters (1 strip with 60 blisters per strip)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 287.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: fluticasone furoate; COPD; ELLIPTA; fluticasone propionate; DISKUS; Novel Dry Powder Inhaler (NDPI); device preference; salmeterol; vilanterol

Summary:

      Subjects who have not used the ELLIPTA™ inhaler nor the DISKUS™ inhaler in the past 6 months
      will be screened to participate in the study. Subjects will have an equal chance of being in
      any of the following two groups (1:1 allocation). One group will be dispensed the ELLIPTA
      inhaler at Visit 1 to use during the first period (once daily for 5 to9 days), and the DISKUS
      inhaler at Visit 2 to use during the second period (twice daily for 5 to 9 days). The other
      group will be dispensed the DISKUS inhaler at Visit 1 to use during the first period (twice
      daily for 5 to 9 days), and the ELLIPTA inhaler at Visit 2 to use during the second period
      (once daily for 5 to9 days). At the end of the second period, subjects will complete the
      study by answering 7 questions to assess their preference of device attributes and dosing
      regimens between the two inhalers.

      The null hypothesis for device preference for a specific attribute is that 50% subjects
      express a preference in that attribute for ELLIPTA and 50% do NOT express a preference in
      that attribute for ELLIPTA, i.e., the odds for preferring ELLIPTA to not preferring ELLIPTA
      is unity.

      The null hypothesis for dosing regimen preference is that 50% subjects express a preference
      of once daily dosing and 50% do not express a preference of once daily dosing (prefer twice
      daily dosing or have no preference).
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Informed consent

          -  Subject must give their signed and dated written informed consent to participate.

          -  Subject understands and is willing, able, and likely to comply with study procedures
             and restrictions.

          -  Subject must be able to read, comprehend, and record information in English.

          -  2. Age: >=40 years of age at Visit 1

          -  3. Gender: Male or female subjects

          -  4. COPD diagnosis subjects with a clinical history of COPD in accordance with the
             definition by the American Thoracic Society/European Respiratory Society

          -  5. Severity of disease:

          -  Subject with a measured post-albuterol Forced expiratory volume in 1 second (FEV1)/
             Forced vital capacity (FVC) ratio of <=0.70 at Visit 1

          -  Subjects with a measured post-albuterol FEV1 <=70% of predicted normal values
             calculated using Third National Health and Nutrition Examination Survey reference
             equations at Visit 1.

          -  Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the
             subject has self-administered 4 inhalations (i.e., total 400 micrograms) of albuterol
             via a metered dose inhaler (MDI) with a valved-holding chamber. The FEV1/FVC ratio and
             FEV1 percent predicted values will be calculated by the investigator site.

          -  Documented spirometry measurements that meet this criterion in the last 12 months
             preceding Visit 1 is acceptable.

          -  6. Tobacco use: current or former smokers

          -  Smokers are defined as those who smoke 10 pack-years of cigarette.

          -  Note: Pipe and/or cigar use cannot be used to calculate pack-year history.

          -  Number of pack years = (number of cigarettes per day/20) x number of years smoked

        Exclusion Criteria:

          -  1. Previous experience with the DISKUS inhaler

          -  Subjects who used any DISKUS inhaler (e.g., ADVAIR DISKUS, FLOVENT DISKUS®;
             participated in a clinical study of fluticasone propionate/salmeterol, or any
             component of them, or placebo) within 6 months (i.e., 180 days) prior to Visit 1.

          -  2. Previous experience with the ELLIPTA inhaler

          -  Subjects who used any ELLIPTA inhaler (e.g., participated in a clinical study of FF/VI
             or GSK573719/GW642444 [umeclidinium/vilanterol], or any component of them, or placebo)
             within 6 months (i.e., 180 days) prior to Visit 1.

          -  3. Asthma: Subjects with a current diagnosis of asthma.

          -  Subjects with a prior history of asthma are eligible if they have a current diagnosis
             of COPD.

          -  4. Poorly controlled COPD: Subjects with symptoms of poorly controlled COPD such as:

          -  Acute worsening of COPD that is managed by the subject with corticosteroids or
             antibiotics or that requires treatment prescribed by a physician, in the 4 weeks prior
             to Visit 1.

          -  Hospitalization due to acute worsening of COPD within 4 weeks of Visit 1.

          -  Use of a total of 8 puffs/day or more of short-acting symptom relief medications such
             as albuterol and ipratropium for 2 consecutive days or any 3 days within 7 days
             immediately preceding Visit 1.

          -  Changes in COPD symptoms and signs, suggesting worsening COPD health status at Visit
             1.

          -  5. Other diseases/abnormalities: Subjects with current evidence of uncontrolled or
             clinically significant disease.

          -  Significant is defined as any disease that, in the opinion of the 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 suspected or evidence of oropharyngeal candidiasis will be excluded from
             the study.

          -  Note: subjects who develop oropharyngeal candidiasis during the study will be treated
             at the discretion of the investigator.

          -  6. Drug/food allergy: Subjects with a history of hypersensitivity to any of the
             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
             investigator, contraindicates the subject's participation will also be excluded.

          -  7. Drug/alcohol abuse: Subjects with a known or suspected alcohol or drug abuse at
             Visit 1 which in the opinion of the investigator could interfere with the subject's
             proper completion of the protocol requirement

          -  8. Medication prior to spirometry: Subjects who are medically unable or unwilling to
             withhold their COPD medications prior to spirometry testing at Visit 1. Subjects, who
             have documented spirometry measurements that meet the specified Inclusion Criterion in
             the last 12 months preceding Visit 1, do not have to undergo repeat spirometry at
             Visit 1.

          -  9. Investigational drug or device: Subjects who participated in an interventional
             study or used any investigational drug or device within 30 days or 5 half lives,
             whichever is longer, prior to Visit 1

          -  10. Affiliation with investigator site: Study investigators, sub-investigators, study
             coordinators, employees of a participating investigator or immediate family members of
             the aforementioned are excluded from participating in this study.