Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 11744
Healthy volunteers: no

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.

Detailed description:
Amendments 2 and 3 are specific to Brazil; all other countries will enroll patients under Amendment 1.

Arms:
arm 1: MF/F MDI BID (pooled MF/F MDI 200/10 mcg BID and MF/F MDI 400/10 mcg BID treatments) arm 2: MF MDI BID (pooled from MF MDI 200 mcg BID and MF MDI 400 mcg BID treatments)

Interventions: intervention 1: Mometasone Furoate/Formoterol MDI 100/5 mcg intervention 2: Mometasone Furoate/Formoterol MDI 200/5 mcg intervention 3: Mometasone Furoate MDI 100 mcg intervention 4: Mometasone Furoate MDI 200 mcg intervention 5: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI intervention 6: Prednisone/prednisolone
Intervention descriptions: intervention 1: two inhalations BID intervention 2: two inhalations BID intervention 3: two inhalations BID intervention 4: two inhalations BID intervention 5: use as needed for asthma symptoms intervention 6: Oral prednisone/prednisolone used only as an emergency rescue medication at the discretion of the investigator

Protocol document: