Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomised, Double-blind, Active-controlled Study to Evaluate the Impact of Stepwise Withdrawal of Inhaled Corticosteroid Treatment in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) on Optimized Bronchodilator Therapy
Brief Summary: This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.


Options:
A: Arm Label: BGF MDI (PT010) 320/14.4/9.6 μg ex-actuator; Type: EXPERIMENTAL; Interventions: Drug: BGF MDI 320/14.4/9.6 μg | Arm Label: GFF MDI (PT003) 14.4/9.6 μg ex-actuator; Type: EXPERIMENTAL; Interventions: Drug: GFF MDI (PT003) 14.4/9.6 μg | Arm Label: BFF MDI (PT009) 320/9.6 μg ex-actuator; Type: EXPERIMENTAL; Interventions: Drug: BFF MDI (PT009) 320/9.6 μg | Arm Label: Symbicort; Type: ACTIVE_COMPARATOR; Interventions: Drug: Symbicort® Turbuhaler® (TBH) Inhalation Powder | Intervention Type: DRUG; Name: BGF MDI 320/14.4/9.6 μg; Assigned to Arm(s): BGF MDI (PT010) 320/14.4/9.6 μg ex-actuator | Intervention Type: DRUG; Name: GFF MDI (PT003) 14.4/9.6 μg; Assigned to Arm(s): GFF MDI (PT003) 14.4/9.6 μg ex-actuator | Intervention Type: DRUG; Name: BFF MDI (PT009) 320/9.6 μg; Assigned to Arm(s): BFF MDI (PT009) 320/9.6 μg ex-actuator | Intervention Type: DRUG; Name: Symbicort® Turbuhaler® (TBH) Inhalation Powder; Assigned to Arm(s): Symbicort
B: Arm Label: COPD subjects; Type: N/A; Interventions: Other: Novel endpoint determination | Arm Label: Smoker controls; Type: N/A; Interventions: Other: Novel endpoint determination | Arm Label: Non-smoker controls; Type: N/A; Interventions: Other: Novel endpoint determination | Intervention Type: OTHER; Name: Novel endpoint determination; Assigned to Arm(s): COPD subjects, Non-smoker controls, Smoker controls
C: Arm Label: fluticasone high dose; Type: EXPERIMENTAL; Interventions: Drug: tiotropium inhalation, Drug: salmeterol xinafoate, Drug: fluticasone propionate | Arm Label: fluticasone medium & low doses; Type: EXPERIMENTAL; Interventions: Drug: tiotropium inhalation, Drug: salmeterol xinafoate, Drug: fluticasone propionate, Drug: placebo matched for fluticasone propionate | Intervention Type: DRUG; Name: tiotropium inhalation; Assigned to Arm(s): fluticasone high dose, fluticasone medium & low doses | Intervention Type: DRUG; Name: salmeterol xinafoate; Assigned to Arm(s): fluticasone high dose, fluticasone medium & low doses | Intervention Type: DRUG; Name: fluticasone propionate; Assigned to Arm(s): fluticasone high dose, fluticasone medium & low doses | Intervention Type: DRUG; Name: placebo matched for fluticasone propionate; Assigned to Arm(s): fluticasone medium & low doses
D: Arm Label: Beclometasone/Formoterol/Glycopyrrolate; Type: EXPERIMENTAL; Interventions: Drug: Beclometasone/Formoterol/Glycopyrrolate | Arm Label: Beclometasone/Formoterol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Beclometasone/Formoterol | Intervention Type: DRUG; Name: Beclometasone/Formoterol/Glycopyrrolate; Assigned to Arm(s): Beclometasone/Formoterol/Glycopyrrolate | Intervention Type: DRUG; Name: Beclometasone/Formoterol; Assigned to Arm(s): Beclometasone/Formoterol

Answer: C