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: ADVAIR 100/50mcg; Type: EXPERIMENTAL; Interventions: Drug: ADVAIR 100/50mcg | Arm Label: ADVAIR 250/50mcg; Type: EXPERIMENTAL; Interventions: Drug: ADVAIR 250/50mcg | Arm Label: FLOVENT 100mcg; Type: ACTIVE_COMPARATOR; Interventions: Drug: FLOVENT 100mcg | Arm Label: FLOVENT 250mcg; Type: ACTIVE_COMPARATOR; Interventions: Drug: FLOVENT 250mcg | Intervention Type: DRUG; Name: ADVAIR 100/50mcg; Assigned to Arm(s): ADVAIR 100/50mcg | Intervention Type: DRUG; Name: ADVAIR 250/50mcg; Assigned to Arm(s): ADVAIR 250/50mcg | Intervention Type: DRUG; Name: FLOVENT 100mcg; Assigned to Arm(s): FLOVENT 100mcg | Intervention Type: DRUG; Name: FLOVENT 250mcg; Assigned to Arm(s): FLOVENT 250mcg
B: Arm Label: ADVAIR 100/50mcg; Type: EXPERIMENTAL; Interventions: Drug: ADVAIR 100/50mcg | Arm Label: ADVAIR 250/50mcg; Type: EXPERIMENTAL; Interventions: Drug: ADVAIR 250/50mcg | Arm Label: ADVAIR 500/50mcg; Type: EXPERIMENTAL; Interventions: Drug: ADVAIR 500/50mcg | Arm Label: FLOVENT 100mcg; Type: ACTIVE_COMPARATOR; Interventions: Drug: FLOVENT 100mcg | Arm Label: FLOVENT 250mcg; Type: ACTIVE_COMPARATOR; Interventions: Drug: FLOVENT 250mcg | Arm Label: FLOVENT 500mcg; Type: ACTIVE_COMPARATOR; Interventions: Drug: FLOVENT 500mcg | Intervention Type: DRUG; Name: ADVAIR 100/50mcg; Assigned to Arm(s): ADVAIR 100/50mcg | Intervention Type: DRUG; Name: ADVAIR 250/50mcg; Assigned to Arm(s): ADVAIR 250/50mcg | Intervention Type: DRUG; Name: ADVAIR 500/50mcg; Assigned to Arm(s): ADVAIR 500/50mcg | Intervention Type: DRUG; Name: FLOVENT 100mcg; Assigned to Arm(s): FLOVENT 100mcg | Intervention Type: DRUG; Name: FLOVENT 250mcg; Assigned to Arm(s): FLOVENT 250mcg | Intervention Type: DRUG; Name: FLOVENT 500mcg; Assigned to Arm(s): FLOVENT 500mcg
C: Arm Label: FLAMBOYANT 200/12; Type: EXPERIMENTAL; Interventions: Drug: Flamboyant 200/12, Other: Budesonide / Formoterol 400/12 Placebo | Arm Label: Budesonide/formoterol 400/12; Type: ACTIVE_COMPARATOR; Interventions: Drug: Budesonide / Formoterol 400/12, Other: Flamboyant 200/12 Placebo | Intervention Type: DRUG; Name: Flamboyant 200/12; Assigned to Arm(s): FLAMBOYANT 200/12 | Intervention Type: DRUG; Name: Budesonide / Formoterol 400/12; Assigned to Arm(s): Budesonide/formoterol 400/12 | Intervention Type: OTHER; Name: Flamboyant 200/12 Placebo; Assigned to Arm(s): Budesonide/formoterol 400/12 | Intervention Type: OTHER; Name: Budesonide / Formoterol 400/12 Placebo; Assigned to Arm(s): FLAMBOYANT 200/12
D: 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

Answer: D