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
Condition: Asthma
MeSH terms: Asthma
Intervention: Beclomethasone dipropionate BAI; Placebo BAI; albuterol/salbutamol 90 mcg; Beclomethasone dipropionate MDI; Placebo MDI
Intervention description: Beclomethasone dipropionate (BDP), was delivered by a single inhalation using a breath-actuated inhaler (BAI) at levels of 40 mcg or 80 mcg per inhalation, twice each day.; Placebo was delivered by a single inhalation using a breath-actuated inhaler (BAI) twice each day.; 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.; Beclomethasone dipropionate (BDP), was delivered by a single inhalation using a metered-dose inhaler (MDI) at levels of 40 mcg or 80 mcg per inhalation, twice each day.; Placebo was delivered by a single inhalation using a metered-dose inhaler (MDI) twice each day.
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: 628.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: asthma; breath-actuated inhaler; metered dose inhaler

Summary:

      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.
    

Eligibility criteria:

        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