Efficacy and Safety of Glycopyrronium/Formoterol Fumarate Fixed-dose Combination Relative to Umeclidinium/Vilanterol Fixed-dose Combination Over 24 Weeks in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Glycopyrronium/Formoterol Fumarate; umeclidinium/vilanterol
Intervention description: Metered dose inhaler (MDI), contains glycopyrronium/formoterol fumarate fixed-dose combination 7.2/4.8 μg per actuation; Dry powder inhaler (DPI), Each metered dose contains umeclidinium/vilanterol 62.5/ 25μg fixed-dose combination per inhalation
Intervention MeSH terms: Glycopyrrolate; Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1119.0
Sex: All
Minimum age: 40 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      This is a phase IIIb randomised, double-blind, double-dummy, multicentre, parallel group, 24
      week study to assess the efficacy and safety of Glycopyrronium/Formoterol Fumarate (GFF)
      fixed-dose combination 7.2/4.8 μg 2 inhalations twice daily compared to
      Umeclidinium/Vilanterol (UV) 62.5/25 μg fixed-dose combination 1 inhalation once daily in
      Patients with moderate to very severe COPD.
    

Eligibility criteria:

        Inclusion criteria:

          -  Age 40-95 years at screening

          -  Current or former smoker with a history of at least 10 pack-years of cigarette smoking

          -  Current clinical diagnosis of COPD, with COPD symptoms > 1 year prior to screening, as
             defined by GOLD criteria or other current guidelines

          -  COPD Severity defined by FEV1/FVC ratio <0.70 and FEV1 <80% of predicted normal value
             at screening and at randomisation

          -  COPD treatment with rescue medication only, or stable dose of maintenance monotherapy
             (LAMA, LABA or ICS), or stable dose of double maintenance therapy (LAMA/LABA or
             ICS/LABA), for one month prior to screening

          -  COPD Assessment Test (CAT) score ≥10 at randomisation

          -  Documentation of a chest x-ray (as per local practice) or computed tomography (CT)
             within 6 months prior to screening, with no clinically significant pulmonary
             abnormalities other than related to COPD

        Exclusion criteria:

          -  Respiratory disease other than COPD, including:

          -  Current diagnosis of asthma

          -  Alpha-1 Antitrypsin Deficiency as the cause of COPD

          -  Other respiratory disorders and conditions as listed in the protocol

          -  Severe COPD exacerbation (resulting in hospitalisation) not resolved within 8 weeks
             prior to screening, or moderate exacerbation not resolved within 4 weeks, or during
             screening

          -  Pneumonia or lower respiratory tract infection that required antibiotics within 8
             weeks prior to screening, or during screening.

          -  Significant diseases or conditions other than COPD which may put the patient at risk,
             or influence the results of the study or the patient's ability to participate,
             including cardiac disease, advanced renal disease, and cancer that has not been in
             complete remission for at least 5 years.

          -  Patients who have needed additions or alterations to their usual maintenance therapy
             for COPD due to worsening symptoms within 1 month prior to and during screening

          -  Treatment with depot corticosteroids within 6 weeks, or other systemic corticosteroids
             within 4 weeks, prior to screening. (Patients maintained on an equivalent of 5 mg
             prednisone per day for at least 3 months prior to screening are allowed.)