A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma
Condition: Persistent Asthma
MeSH terms: Asthma
Intervention: Beclomethasone dipropionate breath-actuated inhaler; Placebo breath-actuated inhaler; albuterol/salbutamol
Intervention description: Beclomethasone dipropionate (BDP) breath-actuated inhaler (BAI) given in dosages of either 40 mcg/inhalation or 80 mcg/inhalation. Study drug was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.; Placebo was provided in matching breath-actuated inhaler (BAI) devices. The placebo devices were identical to the devices used to deliver active drug. Placebo was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.; 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: 273.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: asthma; breath-actuated inhaler; beclomethasone

Summary:

      This is a randomized, double-blind, placebo-controlled parallel-group study. Participants
      will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage
      of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI
      placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators
      will remain blinded to randomized treatment assignment during the study
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severity of Disease: The patient has persistent asthma, with an 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)
             reference values at screening visit (SV) (Hankinson et al 1999).

          -  Current asthma therapy: The patient is currently being treated with 1 of the
             following:

             1) inhaled corticosteroids (ICSs) at a stable daily dose of less than or equal to 220
             mcg/day fluticasone propionate via metered dose inhaler (MDI) or equivalent for a
             minimum of 4 weeks (28 days) before screening visit, or 2) a stable daily dosage of
             non-corticosteroid therapy, including leukotriene modifiers, theophylline, chromones,
             or short-acting beta-2 agonists (SABAs) alone or in combination for a minimum of 4
             weeks (28 days) before screening visit (SV).

          -  Reversibility of disease: The patient has demonstrated at least 15% 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 SV or on retesting. - 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 a pregnant or lactating female or plans to become pregnant.

          -  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 may
             not have used tobacco products within the past year.

          -  The patient has had an asthma exacerbation requiring oral corticosteroids within 1
             month before SV, or has had any hospitalization for asthma within 2 months before SV.

          -  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