A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241)

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)

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.

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

Inclusion Criteria:

• Persistent asthma for at least 1-year
• Must use a daily asthma controller medication for at least 4 weeks prior to randomization, including an inhaled corticosteroid (ICS) with or without a long-acting beta agonist (LABA) or other adjunctive asthma therapy OR be using a leukotriene receptor antagonist (LTRA), xanthine or short acting beta agonist (SABA) as a monotherapy.
• Must be able to discontinue current asthma medication
• Must have a history of at least one asthma exacerbation in previous 4 to 52 weeks

Exclusion Criteria:

• Unstable asthma
• Taking high dose ICS with or without other adjunctive therapy who have an Asthma Control Questionnaire 6 (ACQ6) total score ≥ 1.5
• Taking LTRA, xanthine or SABA monotherapy with an ACQ-6 total score < 1.5 (controlled)
• Chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), or other significant, non-asthmatic, lung disease
• Clinically significant abnormality, illness or disorder of any body or organ system
• Significant underlying cardiovascular condition which may contraindicate use of a beta-agonist.
• History of smoking greater than 10-pack years
• Had an asthma exacerbation within 4 weeks of the Baseline Visit
• Had more than 4 asthma exacerbations or 2 hospitalizations within 52 weeks of the randomization visit
• Known or suspected hypersensitivity or intolerance to corticosteroids, beta-2 agonists, or any of the (inactive ingredients) excipients present in the medications used in this study
• Require the use of chronic systemic steroids, omalizumab, or other monoclonal or polyclonal antibodies
• Requires the use of beta-blockers
• History of life-threatening asthma, including an asthma episode that required intubation and/or was associated with hypercapnia requiring noninvasive ventilatory support
• Lactating, pregnant, or plans to become pregnant during the course of the trial