A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 Years Old With Persistent Asthma
A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 Years Old With Persistent Asthma
This randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week
 study will evaluate the efficacy and safety of beclomethasone dipropionate (80 or 160
 mcg/day) administered via breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) in
 pediatric patients 4 through 11 years of age with persistent asthma, compared with placebo.

 Patients took 1 inhalation (with assistance from parents/guardians/caregivers, as needed)
 from each of 2 devices (BAI device followed by MDI device in that order) twice daily as per
 the double-dummy study design: 1 BAI treatment or placebo device and 1 MDI treatment or
 placebo device for a total of 2 inhalations each time.
Inclusion Criteria:

 -  Written informed consent

 -  Asthma diagnosis: The patient has a diagnosis of asthma as defined by the National
 Institute of Health (NIH). The asthma diagnosis has been present for a minimum of 3
 months and has been stable (defined as no exacerbations and no changes in medication)
 for at least 30 days before screening visit

 -  Severity of disease: The patient has persistent asthma, with a forced expiratory
 volume in 1 second (FEV1) 40% to 90% of the value predicted for age, height, and sex
 at screening visit (SV)

 -  Current asthma therapy: The patient is currently being treated with 1 of the
 following: 1) a stable daily dosage of an inhaled corticosteroid (ICS) in the range of
 88-176 mcg/day of fluticasone propionate (or equivalent) for a minimum of 4 weeks (28
 days) before screening visit 2) a stable daily dosage of non-corticosteroid therapy 3)
 a daily dose of ICS plus a long-acting beta2-agonist (LABA) (at a dose less than or
 equivalent to fluticasone propionate 100 mcg/salmeterol 50 mcg twice daily)

 -  Reversibility of disease: The patient has demonstrated at least 12% reversibility of
 FEV1 within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane
 (HFA) MDI (90 mcg ex-actuator) or equivalent at screening visit 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 hypercapnia,
 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). 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 has used tobacco products within the past year (eg, cigarettes, cigars,
 chewing tobacco, or pipe tobacco, as applicable).

 -  The patient has had an asthma exacerbation requiring oral corticosteroids within 30
 days before screening visit, or has had any hospitalization for asthma within 2 months
 before 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