Study Evaluating the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
Intervention: Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg; Fluticasone Propionate 250mcg / salmeterol 50mcg; Double-dummy placebo; Salbutamol as needed
Intervention description: inhalation powder; inhalation powder; inhalation powder; inhalation powder
Intervention MeSH terms: Fluticasone; Xhance; Albuterol; Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 512.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI
      100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily
      over a 12-week treatment period in subjects with COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated written informed consent

          -  Male or females ≥ 40 years of age

          -  Established clinical history of COPD by ATS/ERS definition

          -  Females are eligible to enter and participate if of non-childbearing potential, or if
             of child bearing potential, has a negative serum pregnancy test at screening, and
             agrees to one of the acceptable contraceptive methods listed in protocol, used
             consistently and correctly

          -  Former or current smoker > 10 pack years

          -  Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≤ 70% of predicted
             normal (NHANES III)

        Exclusion Criteria:

          -  Current diagnosis of asthma

          -  Subjects with other respiratory disorders including active tuberculosis,
             α1-antitrypsin deficiency, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis,
             pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases

          -  Lung volume reduction surgery within previous 12 months

          -  Clinically significant abnormalities not due to COPD by chest x-ray

          -  Hospitalized for poorly controlled COPD within 12 weeks of Screening

          -  Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD
             that is managed by the subject with corticosteroids or antibiotics or that requires
             treatment prescribed by a physician

          -  Lower respiratory infection requiring antibiotics 6 weeks prior to Screening

          -  Uncontrolled or clinically significant (in opinion of PI) cardiovascular,
             hypertension, neurological, psychiatric, renal, hepatic, immunological, endocrine,
             peptic ulcer disease, or hematological abnormalities

          -  Carcinoma not in complete remission for at least 5 years

          -  Subjects with history of hypersensitivity to study medications (e.g., beta-agonists,
             corticosteroid) or components of inhalation powder (e.g., lactose, magnesium stearate)

          -  Subjects with history of severe milk protein allergy that, in opinion of study
             physician, contraindicates subject's participation

          -  Known/suspected history of alcohol or drug abuse in the last 2 years

          -  Women who are pregnant or lactating or plan to become pregnant

          -  Subjects medically unable to withhold albuterol and/or ipratropium 4 hours prior to
             spirometry testing at each study visit

          -  Use of certain medications such as bronchodilators and corticosteroids for the
             protocol-specific times prior to Visit 1 (the Investigator will discuss the specific
             medications)

          -  Long Term Oxygen Therapy (LTOT) or nocturnal oxygen therapy >12 hours a day

          -  Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks
             prior to Screening or during the study

          -  Non-compliance or inability to comply with study procedures or scheduled visits

          -  Affiliation with investigator site