Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Prospective, Randomised, Open-label, Multicentre, Active Drug Controlled, Parallel Group Design Clinical Trial of the Efficacy and Safety of Beclomethasone Dipropionate 400 mcg + Formoterol 24 mcg pMDI Via HFA-134a (Foster™) vs. Fluticasone Propionate 500 mcg + Salmeterol Xinafoate 100 mcg DPI (Seretide Diskus®) in the 6 Months Stepdown Treatment of Adult Patients With Controlled Asthma
Brief Summary: Asthma is a serious global health problem. People of all ages in countries throughout the world are affected by this chronic airway disorder that can be severe and sometimes fatal. The prevalence of asthma is increasing everywhere, especially among children.According to international guidelines, once control of asthma is achieved and maintained for at least 3 months, a gradual reduction of the maintenance therapy should be tried in order to identify the minimum therapy required to maintain control. This will help reduce the risk of side effects and enhance patient adherence to the treatment plan.

Reduction of therapy in patients on combination therapy should begin with a reduction in the dose of inhaled glucocorticosteroid.1 The present study is designed to evaluate if patients with controlled asthma treated with FP 1000 mcg + salmeterol 100 mcg daily can be stepped down. Stepping-down will be attempted with two medications: a new combination of extrafine beclomethasone dipropionate 400 mcg + formoterol 24 mcg daily (test medication, Foster™) and, alternatively, fluticasone propionate 500 mcg + salmeterol 100 mcg daily(reference medication) without losing asthma control.If this hypothesis will be confirmed, the present study will demonstrate that asthma control can be maintained with less than half the dose of inhaled corticosteroid and with less medical costs.

Given the aims of this study, the population to be monitored includes adult patients with moderate persistent asthma, which can be defined controlled according to the current guidelines under standard stabilised treatment. The intended treatment duration is therefore designed to ensure that good control of asthma is firmly achieved before stepping down the treatment (8 weeks run-in period), but also that the condition of the patients are followed long enough (24 weeks comparative treatment period) to ensure that a new stable condition is also obtained and properly monitored.


Options:
A: Arm Label: Mometasone Furoate/Formoterol MDI BID; Type: EXPERIMENTAL; Interventions: Drug: Mometasone Furoate/Formoterol MDI 100/5 mcg, Drug: Mometasone Furoate/Formoterol MDI 200/5 mcg, Drug: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI, Drug: Prednisone/prednisolone | Arm Label: Mometasone Furoate MDI BID; Type: ACTIVE_COMPARATOR; Interventions: Drug: Mometasone Furoate MDI 100 mcg, Drug: Mometasone Furoate MDI 200 mcg, Drug: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI, Drug: Prednisone/prednisolone | Intervention Type: DRUG; Name: Mometasone Furoate/Formoterol MDI 100/5 mcg; Assigned to Arm(s): Mometasone Furoate/Formoterol MDI BID | Intervention Type: DRUG; Name: Mometasone Furoate/Formoterol MDI 200/5 mcg; Assigned to Arm(s): Mometasone Furoate/Formoterol MDI BID | Intervention Type: DRUG; Name: Mometasone Furoate MDI 100 mcg; Assigned to Arm(s): Mometasone Furoate MDI BID | Intervention Type: DRUG; Name: Mometasone Furoate MDI 200 mcg; Assigned to Arm(s): Mometasone Furoate MDI BID | Intervention Type: DRUG; Name: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI; Assigned to Arm(s): Mometasone Furoate MDI BID, Mometasone Furoate/Formoterol MDI BID | Intervention Type: DRUG; Name: Prednisone/prednisolone; Assigned to Arm(s): Mometasone Furoate MDI BID, Mometasone Furoate/Formoterol MDI BID
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Beclomethasone plus formoterol fixed combination | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone plus salmeterol fixed combination | Intervention Type: DRUG; Name: Beclomethasone plus formoterol fixed combination; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Fluticasone plus salmeterol fixed combination; Assigned to Arm(s): 2
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: budesonide/formoterol (Symbicort) | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: fluticasone/salmeterol (Advair) | Intervention Type: DRUG; Name: budesonide/formoterol (Symbicort); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: fluticasone/salmeterol (Advair); Assigned to Arm(s): 2
D: Intervention Type: DRUG; Name: FLUTIFORM® (Formoterol fumarate / Fluticasone propionate); Assigned to Arm(s): N/A

Answer: B