A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241)
Condition: Asthma
MeSH terms: Asthma
Intervention: Mometasone Furoate/Formoterol MDI 100/5 mcg; Mometasone Furoate/Formoterol MDI 200/5 mcg; Mometasone Furoate MDI 100 mcg; Mometasone Furoate MDI 200 mcg; Albuterol 90 mcg /salbutamol 100 mcg HFA MDI; Prednisone/prednisolone
Intervention description: two inhalations BID; two inhalations BID; two inhalations BID; two inhalations BID; use as needed for asthma symptoms; Oral prednisone/prednisolone used only as an emergency rescue medication at the discretion of the investigator
Intervention MeSH terms: Mometasone Furoate; Prednisone; Prednisolone; Albuterol; Formoterol Fumarate; Mometasone Furoate, Formoterol Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11744.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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