Please select the arm or intervention descriptions that belong to the clinical trial below.
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
Brief 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.


Options:
A: Intervention Type: DRUG; Name: Test: Tiotropium 18 µg per day (one inhalation capsule) plus 12 µg formoterol twice daily (two times one inhalation capsule); Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Reference: Salmeterol MDI 50 µg (2 puffs of 25 µg each) b.i.d., plus fluticasone propionate MDI 500 µg (2 puffs of 250 µg each) b.i.d.; Assigned to Arm(s): N/A
B: Arm Label: A1 (any SABA and/or SAMA); Type: EXPERIMENTAL; Interventions: Drug: Glycopyrronium, Drug: SABA, Drug: SAMA | Arm Label: A2 (glycopyrronium); Type: EXPERIMENTAL; Interventions: Drug: Glycopyrronium, Drug: SABA, Drug: LABA, Drug: SAMA | Arm Label: B1 (any LAMA or LABA and mMRC=1); Type: EXPERIMENTAL; Interventions: Drug: LABA, Drug: Indacaterol maleate and glycopyrronium bromide, Drug: LAMA, Drug: ICS | Arm Label: B2 (glycopyrronium and mMRC=1); Type: EXPERIMENTAL; Interventions: Drug: LABA, Drug: Indacaterol maleate and glycopyrronium bromide, Drug: LAMA | Arm Label: C1 (any LABA and ICS); Type: EXPERIMENTAL; Interventions: Drug: LABA, Drug: ICS | Arm Label: C2 (indacaterol/glycopyrronium); Type: EXPERIMENTAL; Interventions: Drug: LABA, Drug: ICS | Arm Label: D1 (any LAMA or LABA and mMRC>1); Type: EXPERIMENTAL; Interventions: Drug: LAMA | Arm Label: D2 (indacaterol/glycopyrronium and mMRC>1); Type: EXPERIMENTAL; Interventions: Drug: LAMA | Intervention Type: DRUG; Name: Glycopyrronium; Assigned to Arm(s): A1 (any SABA and/or SAMA), A2 (glycopyrronium) | Intervention Type: DRUG; Name: SABA; Assigned to Arm(s): A1 (any SABA and/or SAMA), A2 (glycopyrronium) | Intervention Type: DRUG; Name: LABA; Assigned to Arm(s): A2 (glycopyrronium), B1 (any LAMA or LABA and mMRC=1), B2 (glycopyrronium and mMRC=1), C1 (any LABA and ICS), C2 (indacaterol/glycopyrronium) | Intervention Type: DRUG; Name: Indacaterol maleate and glycopyrronium bromide; Assigned to Arm(s): B1 (any LAMA or LABA and mMRC=1), B2 (glycopyrronium and mMRC=1) | Intervention Type: DRUG; Name: LAMA; Assigned to Arm(s): B1 (any LAMA or LABA and mMRC=1), B2 (glycopyrronium and mMRC=1), D1 (any LAMA or LABA and mMRC>1), D2 (indacaterol/glycopyrronium and mMRC>1) | Intervention Type: DRUG; Name: SAMA; Assigned to Arm(s): A1 (any SABA and/or SAMA), A2 (glycopyrronium) | Intervention Type: DRUG; Name: ICS; Assigned to Arm(s): B1 (any LAMA or LABA and mMRC=1), C1 (any LABA and ICS), C2 (indacaterol/glycopyrronium)
C: Arm Label: Umeclidinium bromide/Vilanterol + placebo ACCUHALER/DISKUS; Type: EXPERIMENTAL; Interventions: Drug: Umeclidinium bromide/Vilanterol, Drug: Placebo ACCUHALER/DISKUS | Arm Label: Fluticasone propionate/Salmeterol + placebo NDPI; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone propionate/Salmeterol, Drug: Placebo NDPI | Intervention Type: DRUG; Name: Umeclidinium bromide/Vilanterol; Assigned to Arm(s): Umeclidinium bromide/Vilanterol + placebo ACCUHALER/DISKUS | Intervention Type: DRUG; Name: Placebo ACCUHALER/DISKUS; Assigned to Arm(s): Umeclidinium bromide/Vilanterol + placebo ACCUHALER/DISKUS | Intervention Type: DRUG; Name: Fluticasone propionate/Salmeterol; Assigned to Arm(s): Fluticasone propionate/Salmeterol + placebo NDPI | Intervention Type: DRUG; Name: Placebo NDPI; Assigned to Arm(s): Fluticasone propionate/Salmeterol + placebo NDPI
D: Intervention Type: DRUG; Name: Tiotropium plus Salmeterol; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Fluticasone/Salmeterol; Assigned to Arm(s): N/A

Answer: B