A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 Years Old With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Beclomethasone dipropionate; Placebo; Albuterol/salbutamol
Intervention description: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
Intervention MeSH terms: Beclomethasone; Albuterol; Bronchodilator Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1113.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: asthma; breath-actuated inhaler; metered-dose inhaler

Summary:

      This is a Phase 3, randomized, placebo-controlled, double-blind,double-dummy, parallel-group,
      12-week study in male and female patients, 12 years of age and older, with persistent asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severity of disease: The patient has persistent asthma, with a forced expiratory
             volume in 1 second (FEV1) 40%-85% of the value predicted for age, height, sex, and
             race as per the National Health and Nutrition Examination Survey (NHANES III)
             (Hankinson et al 1999) reference values at screening visit.

          -  Current asthma therapy: The patient must be on a stable dose of an inhaled
             corticosteroid (ICS) of at least 440 mcg/day of fluticasone propionate or equivalent
             for a minimum of 4 weeks before screening visit, or any inhaled
             corticosteroid/long-acting beta2-agonist (ICS/LABA) combination for a minimum of 4
             weeks before the prescreening visit.

          -  Reversibility of disease: The patient has demonstrated at least 12% reversibility of
             FEV1 and at least 200 mL increase from baseline FEV1 (patients age 18 and older)
             within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane
             (HFA) MDI (90 mcg ex-actuator) or equivalent at the screening visit

          -  If female, the patient is currently not pregnant, breast feeding, or attempting to
             become pregnant. If of childbearing potential, has a negative serum pregnancy test and
             is willing to commit to using a consistent and acceptable method of birth control.

          -  Other criteria apply, please contact the investigator for more information

        Exclusion Criteria:

          -  The patient has a history of life-threatening asthma, defined for this protocol as an
             asthma episode that required intubation and/or was associated with hypercapnea,
             respiratory arrest, or hypoxic seizures.

          -  The patient is pregnant or lactating, or plans to become pregnant during the study
             period or for 30 days after the patient's last study-related visit (for eligible
             patients only, if applicable). Eligible female patients unwilling to employ
             appropriate contraceptive measures to ensure that pregnancy will not occur during the
             study will be excluded. Any patient becoming pregnant during the study will be
             withdrawn from the study.

          -  The patient has a known hypersensitivity to any corticosteroid or any of the
             excipients in the study drug or rescue medication formulation.

          -  The patient currently smokes or has a smoking history of 10 pack-years or more (a
             pack-year is defined as smoking 1 pack of cigarettes/day for 1 year).

          -  The patient has had an asthma exacerbation requiring oral corticosteroids within 30
             days before the screening visit, or has had any hospitalization for asthma within 2
             months before the screening visit.

          -  The patient has historical or current evidence of a clinically significant disease.
             Significant disease is defined as any disease that in the medical judgment of the
             investigator would put the safety of the patient at risk through participation or that
             could affect the efficacy or safety analysis if the disease/condition worsened during
             the study.

          -  Other criteria apply, please contact the investigator for more information