Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomised, Double-blind, Active-controlled Parallel Group Study to Evaluate the Effect of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared With Tiotropium on Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Patients With Severe to Very Severe COPD. [DYNAGITO]
Brief Summary: The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.


Options:
A: Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo to tiotropium + olodaterol | Arm Label: tiotropium + olodaterol high dose with BM; Type: EXPERIMENTAL; Interventions: Drug: tiotropium +olodaterol | Arm Label: tiotropium; Type: ACTIVE_COMPARATOR; Interventions: Drug: tiotropium | Arm Label: tiotropium + olodaterol with exercise training and BM; Type: EXPERIMENTAL; Interventions: Drug: tiotropium+olodaterol | Intervention Type: DRUG; Name: placebo to tiotropium + olodaterol; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: tiotropium+olodaterol; Assigned to Arm(s): tiotropium + olodaterol with exercise training and BM | Intervention Type: DRUG; Name: tiotropium +olodaterol; Assigned to Arm(s): tiotropium + olodaterol high dose with BM | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium
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: GFF MDI (PT003); Type: EXPERIMENTAL; Interventions: Drug: GFF MDI (PT 003) | Arm Label: GP MDI (PT001); Type: EXPERIMENTAL; Interventions: Drug: GP MDI (PT001) | Arm Label: FF MDI (PT005); Type: EXPERIMENTAL; Interventions: Drug: FF MDI (PT005) | Arm Label: Open-label tiotropium bromide inhalation powder; Type: ACTIVE_COMPARATOR; Interventions: Drug: Open-label tiotropium bromide inhalation (Spiriva® Handihaler®) | Intervention Type: DRUG; Name: GFF MDI (PT 003); Assigned to Arm(s): GFF MDI (PT003) | Intervention Type: DRUG; Name: GP MDI (PT001); Assigned to Arm(s): GP MDI (PT001) | Intervention Type: DRUG; Name: FF MDI (PT005); Assigned to Arm(s): FF MDI (PT005) | Intervention Type: DRUG; Name: Open-label tiotropium bromide inhalation (Spiriva® Handihaler®); Assigned to Arm(s): Open-label tiotropium bromide inhalation powder
D: Arm Label: tiotropium + olodaterol high dose; Type: EXPERIMENTAL; Interventions: Drug: olodaterol, Drug: tiotropium | Arm Label: tiotropium; Type: ACTIVE_COMPARATOR; Interventions: Drug: tiotropium | Intervention Type: DRUG; Name: olodaterol; Assigned to Arm(s): tiotropium + olodaterol high dose | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium + olodaterol high dose | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium

Answer: D