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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
11,744
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
Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms
The primary safety outcome was the time-to-first SAO (a composite endpoint of adjudicated asthma-related hospitalizations, adjudicated asthma-related intubations, and adjudicated asthma-related deaths). To accomplish this, the number of participants experiencing a first SAO was collected for 26 weeks following initiation of study treatment (or 7 days after the last treatment dose, whichever occurred later). Data generated by this methodology were used to compute a hazard ratio (HR) and 95% confidence interval (CI), modeling the likelihood of a first SAO occurring at any given time in the MF/F arm relative to the MF arm. Although data were sufficient to generate a HR and 95% CI, time-to-first SAO in the overall population could not be accurately reported due to insufficient SAO occurrence. Therefore, the number of first SAO in either arm is reported as a descriptive measure. For each participant, first SAO denotes first event per participant.
Time frame: 26 weeks, or 7 days after the last treatment dose, whichever occurred later
Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms
The key secondary efficacy outcome was time-to-first protocol-defined asthma exacerbation (SAEX). The SAEX were deteriorations of asthma requiring: use of systemic corticosteroids (tablets, suspension, or injection) for \>= 3 consecutive days, in-patient hospitalization \>= 24 hours, or an emergency department (ED) visit \< 24 hours that required systemic corticosteroids in the MF/F MDI BID arm versus the MF MDI BID arm. The number of first SAEX occurred from initiation of study treatment to 7 days after the last treatment (modified intention-to-treat). This outcome was measured as the HR and 95% CI for the number of first SAEX in the MF/F MDI BID arm versus the number of first SAEX in the MF MDI BID arm. Given insufficient data for SAEX events, it was not informative to report the time-to-first SAEX in the overall population. Therefore, the number of first SAEXs in either arm is reported as a descriptive measure. For each participant, first SAEX denotes first event per participant.
Time frame: 26 weeks, plus 7 days after the last treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.