A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: GSK573719/GW642444 125/25mcg; GSK573719 125mcg; GW642444 25mcg; Placebo only
Intervention description: 125/25mcg; 125mcg; 25mcg; Placebo
Intervention MeSH terms: Bromides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1493.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: anticholinergic; long-acting beta agonist

Summary:

      This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group
      study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719
      Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a
      Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who
      meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period
      followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a
      total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will
      be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal).
      The total duration of subject participation in the study will be approximately 27 weeks. A
      subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter
      monitoring during the study and provide serial blood samples for pharmacokinetic analysis.
      Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from
      non-subset subjects. The primary measure of efficacy is clinic visit trough
      (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by
      adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter
      monitoring (subset only).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of COPD

          -  10 pack-year or greater history of cigarette smoking

          -  Post-bronchodilator FEV1/FVC of <0.7

          -  Predicted FEV1 of 70% of normal or less

          -  Modified Medical Research Council (mMRC) dyspnea score of 2 or greater

        Exclusion Criteria:

          -  Women who are pregnant, lactating, or planning to become pregnant

          -  Respiratory disorders other than COPD, including a current diagnosis of asthma

          -  Clinically significant non-respiratory diseases or abnormalities that are not
             adequately controlled

          -  Significant allergy or hypersensitivity to anticholinergics, beta2-agonists, or the
             excipients of magnesium stereate or lactose used in the inhaler delivery device

          -  Hospitalization for COPD or pneumonia within 12 weeks prior to screening

          -  Lung volume reduction surgery within 12 weeks prior to screening

          -  Abnormal and clinically significant ECG findings at screening

          -  Clinically significant laboratory findings at screening

          -  Use of systemic corticosteroids, antibiotics for respiratory tract infections, strong
             cytochrome P450 3A4 inhibitors, high dose inhaled steroids (>1000mcg fluticasone
             propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short-
             and long-acting inhaled beta2-agonists, ipratropium, inhaled sodium cromoglycate or
             nedocromil sodium, or investigational medicines for defined time periods prior to the
             screening visit

          -  Use of long-term oxygen therapy (12 hours or greater per day)

          -  Regular use of nebulized treatment with short-acting bronchodilators

          -  Participation in the acute phase of a pulmonary rehabilitation program

          -  A know or suspected history of alcohol or drug abuse

          -  Affiliation with the investigational site

          -  Previous use of GSK573719 or GW642444 alone or in combination, including the
             combination of fluticasone furoate and GW642444