COPD Clinical Trial
Official title:
A Prospective, Multicenter, 12-week, Randomized Open-label Study to Evaluate the Efficacy and Safety of Glycopyrronium (50 Micrograms o.d.) or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination (110/50 Micrograms o.d.) Regarding Symptoms and Health Status in Patients With Moderate Chronic Obstructive Pulmonary Disease (COPD) Switching From Treatment With Any Standard COPD Regimen
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.
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
;
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