Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: GFF MDI (PT003); FF MDI (PT005); GP MDI (PT001); Placebo MDI
Intervention description: Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID); Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID); Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID); Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)
Intervention MeSH terms: Glycopyrrolate; Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1756.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI;
      PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-child bearing potential (ie, physiologically incapable of becoming pregnant,
             including any female who is 2 years post-menopausal); or Child bearing potential, has
             a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive
             methods used consistently and correctly for the duration of the study.

          -  Subjects with an established clinical history of COPD as defined by the American
             Thoracic Society (ATS)/European Respiratory Society (ERS).

          -  Current or former smokers with a history of at least 10 pack-years of cigarette
             smoking.

          -  Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio of <0.70.

          -  FEV1 must be <80% predicted normal value calculated using the Third National Health
             and Nutrition Examination Survey (NHANES III) reference equations. (Or reference norms
             applicable to other regions).

        Exclusion Criteria:

          -  Significant diseases other than COPD, ie, disease or condition which, in the opinion
             of the Investigator, may put the subject at risk because of participation in the study
             or may influence either the results of the study or the subject's ability to
             participate in the study.

          -  Women who are pregnant or lactating or women of childbearing potential who are not
             using an acceptable method of contraception.

          -  Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.

          -  Subjects who have been hospitalized due to poorly controlled COPD within 3 months
             prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).

          -  Subjects who have poorly controlled COPD, defined as acute worsening of COPD that
             requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to
             Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).

          -  Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of
             whether or not they have been treated. Subjects with a diagnosis of open angle
             glaucoma who have intraocular pressure controlled with medication(s) are eligible.

          -  Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or
             other muscarinic anticholinergics, or any component of the MDI.