A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® (Kronos)
Condition: COPD
Intervention: BGF MDI 320/14.4/9.6 μg; GFF MDI (PT003) 14.4/9.6 μg; BFF MDI (PT009) 320/9.6 μg; Symbicort® Turbuhaler® (TBH) Inhalation Powder
Intervention description: Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI]); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI); Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
Intervention MeSH terms: Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1902.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort®
      Turbuhaler® in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.
    

Eligibility criteria:

        Inclusion Criteria

          -  Given their signed written informed consent to participate.

          -  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), or other local applicable
             guidelines.

          -  Current or former smokers with a history of at least 10 pack-years of cigarette
             smoking.

          -  Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be
             <0.70 and FEV1 must be <80% predicted normal value calculated using NHANES III
             reference equations (or reference norms applicable to other regions).

          -  Required COPD maintenance therapy:

          -  All Subjects must have been on two or more inhaled maintenance therapies for the
             management of their COPD for at least 6 weeks prior to Screening. Scheduled SABA
             and/or scheduled SAMA are considered inhaled maintenance therapies

        Please refer to the study protocol for the complete inclusion criteria list.

        Exclusion Criteria

          -  Significant diseases or conditions other than COPD, 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 are planning to become pregnant during the
             course of the study, 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

          -  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

          -  Immune suppression or severe neurological disorders affecting control of the upper
             airway or other risk factors that in the opinion of the Investigator would put the
             subject at substantial risk of pneumonia.

          -  Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the
             Investigator, have not been adequately treated.

          -  Subjects who have a history of hypersensitivity to β2-agonists, budesonide or any
             other corticosteroid components, glycopyrronium or other muscarinic anticholinergics,
             or any other component of the IMPs.

        Please refer to the study protocol for the complete inclusion criteria list.