Efficacy and Safety Study of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: FF Inhalation Powder; FF/GW642444 Inhalation Powder; GW642444 Inhalation Powder; Placebo
Intervention description: Inhaled Corticosteroid (ICS); Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD; Long Acting Beta Agonist(LABA); Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1226.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Chronic Obstructive Pulmonary Disease; Efficacy; FEV1; Safety

Summary:

      The Purpose of this study is to assess the efficacy and safety of two strengths of the
      FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type of subject: outpatient

          -  Informed consent: Subjects must give their signed and dated written informed consent
             to participate.

          -  Gender: Male or female subjects A female is eligible to enter and participate in the
             study if she is of:

          -  Non-child bearing potential OR

          -  Child bearing potential, has a negative pregnancy test at screening, and agrees to one
             of the acceptable contraceptive methods defined in the protocol

          -  Age: ≥40 years of age at Screening (Visit 1)

          -  COPD diagnosis: Subjects with a clinical history of COPD in accordance with the
             definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]

          -  Tobacco use: Subjects with a current or prior history of ≥10 pack-years of cigarette
             smoking at Screening (Visit 1).

          -  Severity of Disease: Subjects with a Screening (Visit 1) measured
             post-albuterol/salbutamol:

          -  FEV1/FVC ratio of ≤0.70 and

          -  FEV1 ≤70% of predicted normal values

          -  Dyspnea: Achieved a score of ≥2 on the Modified Medical Research Council Dyspnea Scale
             (mMRC) at Screening (Visit 1).

        Exclusion Criteria:

        Subjects meeting any of the following criteria must not be enrolled in the study:

          -  Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant
             during the study.

          -  Asthma: Subjects with a current diagnosis of asthma

          -  α1-antitrypsin deficiency: Subjects with α1-antitrypsin deficiency as the underlying
             cause of COPD

          -  Other respiratory disorders: Subjects with active tuberculosis, lung cancer,
             bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung
             diseases, or other active pulmonary diseases

          -  Lung resection: Subjects with lung volume reduction surgery within the 12 months prior
             to Screening (Visit 1)

          -  Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals
             evidence of clinically significant abnormalities not believed to be due to the
             presence of COPD.

          -  Hospitalization: Subjects who are hospitalized due to poorly controlled COPD within 12
             weeks of Visit 1.

          -  Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the
             occurrence of the following in the 6 weeks prior to Visit 1: Acute worsening of COPD
             that is managed by subject with corticosteroids or antibiotics or that requires
             treatment prescribed by a physician.

          -  Lower respiratory tract infection: Subjects with lower respiratory tract infection
             that required the use of antibiotics within 6 weeks prior to Visit 1.

          -  Other diseases/abnormalities: Subjects with historical or current evidence of
             clinically significant cardiovascular (i.e., pacemaker), neurological, psychiatric,
             renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid
             disease) or haematological abnormalities that are uncontrolled.

          -  Peptic Ulcer disease: Subjects with clinically significant peptic ulcer disease that
             is uncontrolled.

          -  Hypertension: Subjects with clinically significant hypertension that is uncontrolled.

          -  Cancer: Subjects with carcinoma that has not been in complete remission for at least 5
             years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell
             carcinoma of the skin would not be excluded if the subject has been considered cured
             within 5 years since diagnosis.

          -  Drug/food allergy: Subjects with a history of hypersensitivity to any of the study
             medication or components of the inhalation powder

          -  Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug
             abuse within the last 2 years

          -  Medication prior to spirometry: Subjects who are medically unable to withhold their
             albuterol/salbutamol and/or their ipratropium 4 hours prior to spirometry testing at
             each study visit

          -  Additional medication: Use of certain medications such as bronchodilators and
             corticosteroids for the protocol-specified times prior to Visit 1 (the Investigator
             will discuss the specific medications)

          -  Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or
             nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use
             (i.e., ≤12 hours per day) is not exclusionary.

          -  Sleep apnea: Subjects with clinically significant sleep apnea who require use of
             continuous positive airway pressure (CPAP) device or non-invasive positive pressure
             ventilation (NIPPV) device.

          -  Pulmonary rehabilitation: Subjects who have participated in the acute phase of a
             Pulmonary Rehabilitation Program within 4 weeks prior to Screening (Visit 1) or who
             will enter the acute phase of a Pulmonary Rehabilitation Program during the study.

          -  Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study
             procedures. Any infirmity, disability, or geographic location that would limit
             compliance for scheduled visits.

          -  Questionable validity of consent: Subjects with a history of psychiatric disease,
             intellectual deficiency, poor motivation or other conditions that will limit the
             validity of informed consent to participate in the study.

          -  Prior use of study medication/other investigational drugs

          -  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.