Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1)
Condition: Asthma
MeSH terms: Asthma
Intervention: Mometasone furoate/formoterol (MF/F) MDI; Fluticasone propionate/salmeterol (F/SC) DPI
Intervention description: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks.; Fluticasone propionate 250 mcg and salmeterol 50 mcg fixed dose combination dry powder inhaler taken twice daily for 52 weeks.
Intervention MeSH terms: Fluticasone; Xhance; Mometasone Furoate; Formoterol Fumarate; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 722.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Glucocorticosteroids; Dry Powder Inhaler; Bronchodilator; Metered-Dose Inhaler

Summary:

      This study is being conducted to demonstrate the non-inferiority between two inhaled
      glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone
      furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone
      propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the
      onset of action, the overall safety, and how the drugs control asthma will also be assessed.
      The study is approximately 1 year in duration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have a diagnosis of asthma for at least 12 months' duration.

          -  A participant must have been using a medium daily dose of inhaled glucocorticosteroids
             (alone or in combination with long-acting beta 2-agonist [LABA]) for at least 12 weeks
             and must have been on a stable regimen for at least 2 weeks prior to Screening.

          -  If there is no inherent harm in changing the participant's current asthma therapy, the
             participant must be willing to discontinue his/her prescribed inhaled
             glucocorticosteroid (ICS) or ICS/LABA prior to initiating MF MDI run-in medication.

          -  The diagnosis of asthma must be documented by either demonstrating an increase in
             absolute forced expiratory volume in 1 second (FEV1) of at least 12% and a volume
             increase of at least 200 mL within approximately 15 to 20 minutes after administration
             of 4 inhalations of albuterol/salbutamol or of nebulized short-acting beta 2-agonist
             (SABA) OR peak expiratory flow (PEF) variability of more than 20% OR a diurnal
             variation PEF of more than 20% based on the difference between pre-bronchodilator
             (before taking albuterol/salbutamol) morning value and the post-bronchodilator value
             (after taking albuterol/salbutamol) from the evening before, expressed as a percentage
             of the mean daily PEF value on any day during the open-label Run-in Period.

          -  A participant must have a history of >= 2 asthma-related unscheduled visits to a
             physician or to an emergency room within the past year AND >= 3 asthma-related
             unscheduled visits within the past 2 years.

          -  Prior to randomization participants must have used a total of 12 or more inhalations
             of SABA rescue medication during the last 10 days of run-in.

          -  Clinical laboratory tests (complete blood counts [CBC], blood chemistries, including
             serum pregnancy for females of child-bearing potential, and urinalysis) conducted at
             the Screening Visit must be within normal limits or clinically acceptable to the
             investigator/sponsor before the participant is instructed to start using open-label MF
             MDI run-in medication.

          -  An electrocardiogram (ECG) performed at the Screening Visit, using a centralized
             trans-telephonic technology, must be clinically acceptable to the investigator.

          -  A chest x-ray performed at the Screening Visit, or within 12 months prior to the
             Screening Visit, must be clinically acceptable to the investigator.

          -  A non-pregnant female participant of childbearing potential must be using a medically
             acceptable, adequate form of birth control. A female participant of childbearing
             potential must have a negative serum pregnancy test at Screening in order to be
             considered eligible for enrollment.

        Exclusion Criteria:

          -  A participant who demonstrates a change in absolute FEV1 of > 20% at any time between
             the Screening and Baseline Visits on any 2 consecutive days between the Screening and
             Baseline visits.

          -  A participant who requires the use of greater than 8 inhalations per day of SABA MDI
             or 2 or more nebulized treatments per day of 2.5 mg SABA on any 2 consecutive days
             between the Screening and Baseline Visits.

          -  A participant who experiences a decrease in AM or PM PEF below the Run-in Period
             stability limit on any 2 consecutive days prior to randomization. The average AM and
             average PM PEF respective values from the preceding 7 days are added, divided by the
             number of non-missing values, and multiplied by 0.70 to determine the stability limit.

          -  A participant who experiences a clinical asthma exacerbation: defined as a clinical
             deterioration of asthma as judged by the clinical investigator between the Screening
             and Baseline Visits, that results in emergency treatment, hospitalization due to
             asthma, or treatment with additional, excluded asthma medication (including oral or
             other systemic corticosteroids, but allowing SABA).