Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen
Condition: COPD
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The main goal of this study is to evaluate the efficacy and safety of glycopyrronium bromide
      and indacaterol maleate and glycopyrronium bromide fixed dose combination (FDC) in patients
      with moderate COPD who switch from their current COPD therapy. This study aims to provide
      data on how non-exacerbating, but still symptomatic patients with moderate COPD switching
      from their current COPD treatment to glycopyrronium bromide or indacaterol maleate and
      glycopyrronium bromide FDC maintain or improve their symptoms. Another purpose of this study
      is to increase awareness and usage of validated COPD symptoms tools and dyspnea
      questionnaires in order to facilitate clinical assessment and improve early diagnosis of
      symptomatic patients.
    

Detailed description: 
      The treatment epoch will last 12 weeks. The total duration of the study for each patient is
      12 weeks (from randomization) plus 30 days of safety follow-up.

      The study has three phases: screening phase (=wash-out period, if required), treatment phase
      and safety follow-up phase.

      Eligible patients will be randomized to either receive glycopyrronium or indacaterol maleate
      and glycopyrronium bromide fixed dose combination or to remain in their baseline therapy, in
      an allocation ratio of 3:1 for each cluster (Groups A, B, C, and D), based on their COPD
      symptoms and baseline treatment:

      Group A: Patients treated with any SABA ( Short-acting β2-adrenergic agonist) and/or SAMA
      (Short-acting muscarinic antagonist) as monotherapy or in free or fixed dose combination
      (FDC) will be assigned to glycopyrronium or will remain in their baseline therapy (3:1) Group
      B: Patients treated with any LABA (Long-acting β2-adrenergic agonist) or LAMA (Long-acting
      muscarinic antagonist) monotherapy and mMRC score =1 point will be assigned to glycopyrronium
      or will remain in their baseline therapy (3:1) Group C: Patients treated with any LABA and
      ICS (Inhaled corticosteroid) in free or FDC will be assigned to indacaterol maleate and
      glycopyrronium bromide fixed dose combination or will remain in their baseline therapy (3:1)
      Group D: Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point will be
      assigned to indacaterol maleate and glycopyrronium bromide fixed dose combination or will
      remain in their baseline therapy (3:1) Due to low recruitment in Groups A and B that would
      lead to a significant delay of trial completion, a protocol amendment was made in order to
      close the recruitment of Groups A and B at the time the randomization in Groups C and D would
      be completed. Recruitment of the Groups C and D continued as originally planned
    

Intervention name(s): Glycopyrronium; SABA; LABA; Indacaterol maleate and glycopyrronium bromide; LAMA; SAMA; ICS
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Glycopyrronium 50 µg capsule for inhalation via SDDPI once per day; Short-acting β2-adrenergic agonist (SABA) as per approved by each country and as prescribed for each patient, used as background therapy; Long Acting Beta Agonist (LABA) as per approved by each country and as prescribed for each patient, used as background therapy; Indacaterol maleate and glycopyrronium bromide fixed dose combination (110/50 µg) capsule for inhalation via SDDPI, once a day; Long Acting Muscarinic Antagonist (LAMA) as per approved by each country and as prescribed for each patient, used as background therapy; Short-acting muscarinic antagonist (SAMA) as per approved by each country and as prescribed for each patient, used as background therapy; Inhaled corticosteroid (ICS) as per approved by each country and as prescribed for each patient, used as background therapy
Other intervention name(s): glycopyrronium bromide
Intervention MeSH terms: Glycopyrrolate; Bromides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Moderate COPD, glycopyrronium bromide, indacaterol maleate and glycopyrronium bromide FDC, NVA237, QVA149