Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No. P06241 Also Known as P202)
Brief Summary: The purpose of this study is to test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which helps to relax the muscles of the airways in the lungs, making it easier to breathe. In combination, mometasone and formoterol are used for the treatment of asthma. This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events (hospitalization, intubation and death) compared to participants taking an ICS alone. The primary safety hypothesis is that the time-to-first serious asthma outcome (SAO) with mometasone furoate/formoterol (MF/F) MDI twice daily (BID) is non-inferior to that with mometasone furoate (MF) MDI BID in adolescents and adults with persistent asthma. If non-inferiority is achieved, the key secondary safety hypothesis of superiority of MF/F over MF will be assessed.


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: Fluticasone propionate/formoterol fumarate 100/10 | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone propionate 100 | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: Formoterol fumarate 10 | Arm Label: 4; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Fluticasone propionate/formoterol fumarate 100/10; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Fluticasone propionate 100; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Formoterol fumarate 10; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 4
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Fluticasone propionate/Formoterol fumarate 250/10 | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone propionate/Formoterol fumarate 100/10 | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone propionate 250 | Arm Label: 4; Type: ACTIVE_COMPARATOR; Interventions: Drug: Formoterol fumarate 10 | Arm Label: 5; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Fluticasone propionate/Formoterol fumarate 250/10; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 5 | Intervention Type: DRUG; Name: Fluticasone propionate/Formoterol fumarate 100/10; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Fluticasone propionate 250; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: Formoterol fumarate 10; Assigned to Arm(s): 4
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: budesonide/formoterol (Symbicort) | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: budesonide | Intervention Type: DRUG; Name: budesonide/formoterol (Symbicort); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: budesonide; Assigned to Arm(s): 2

Answer: A