Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: PT003 MDI; PT005 MDI; Placebo MDI; Tiotropium bromide 18 μg (Spiriva Handihaler®); Formoterol Fumarate 12 μg (Foradil® Aerolizer®); PT001 MDI
Intervention description: Inhaled PT003 MDI administered as two puffs BID for 7 days; Inhaled PT005 MDI administered as two puffs BID for 7 days; Inhaled placebo administered as two puffs BID for 7 days; Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days; Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days; Inhaled PT001 MDI administered as two puffs BID for 7 days
Intervention MeSH terms: Bromides; Formoterol Fumarate; Tiotropium Bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 118.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of
      PT003 compared with its individual components (PT001 and PT005), placebo and two active
      comparators to demonstrate superiority of the combination to its components, and to assess
      the relative contribution of the components compared with placebo, in patients with moderate
      to very severe COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed written informed consent

          -  40 - 80 years of age

          -  Clinical history of COPD with airflow limitation that is not fully reversible

          -  Females of non-child bearing potential or females of child bearing potential with
             negative pregnancy test; and acceptable contraceptive methods

          -  Current/former smokers with at least a 10 pack-year history of cigarette smoking

          -  A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70

          -  A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of
             predicted normal values

          -  Able to change COPD treatment as required by protocol

        Exclusion Criteria:

          -  Women who are pregnant or lactating

          -  Primary diagnosis of asthma

          -  Alpha-1 antitrypsin deficiency as the cause of COPD

          -  Active pulmonary diseases

          -  Prior lung volume reduction surgery

          -  Abnormal chest X-ray (or CT scan) not due to the presence of COPD

          -  Hospitalized due to poorly controlled COPD within 3 months of Screening

          -  Clinically significant medical conditions that preclude participation in the study
             (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma,
             symptomatic prostatic hypertrophy)

          -  Cancer that has not been in complete remission for at least 5 years

          -  Treatment with investigational study drug or participation in another clinical trial
             or study within the last 30 days or 5 half lives

        Other protocol defined inclusion/exclusion criteria may apply