Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma
Condition: Persistent Asthma
MeSH terms: Asthma
Intervention: Beclomethasone Dipropionate 640; Placebo; Beclomethasone dipropionate via 320 mcg BAI; albuterol/salbutamol; Beclomethasone dipropionate via 320 mcg MDI
Intervention description: Beclomethasone Dipropionate 640 mcg BAI; Placebo, taken in the morning and evening each day, was provided in matching BAI and MDI devices.
The placebo devices were identical to the devices used to deliver active drug.; Beclomethasone dipropionate treatment administered via breath-actuated inhaler (BAI) (320 mcg/day).; Each patient's current rescue medication was replaced with study-supplied albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent during the run-in and double-blind study periods.; Beclomethasone dipropionate treatment administered via metered-dose inhaler (MDI) (320 mcg/day).
Intervention MeSH terms: Beclomethasone; Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 713.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of beclomethasone
      dipropionate administered via BAI at a dose strength of 40 or 80 mcg per oral inhalation (320
      or 640 mcg/day, respectively) compared with placebo treatment in patients with persistent
      asthma as assessed by the standardized baseline-adjusted trough morning (pre-dose and
      pre-rescue bronchodilator) forced expiratory volume in 1 second (FEV1) area under the effect
      curve from time 0 to 6 weeks (AUEC[0-6wk]).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has a diagnosis of asthma as defined by the 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.

          -  The patient has been maintained on stable doses of :

               -  non-corticosteroid therapy

               -  inhaled corticosteroid therapy

          -  Written informed consent/assent is obtained. For adult patients (18 years of age and
             older, or as applicable per local regulations), the written informed consent form
             (ICF) must be signed and dated by the patient before conducting any study-related
             procedure. For minor patients (ages 12 to 17 years, or as applicable per local
             regulations), the written ICF must be signed and dated by the parent/legal guardian
             and the written informed assent form must be signed and dated by the patient before
             conducting any study-related procedure.

          -  The patient is a male or female 12 years of age or older as of the visit when informed
             consent/assent is signed (screening or prescreening visit, as applicable). (Note: Age
             requirements are as specified or allowed by local regulations.)

          -  The patient is able to perform acceptable and repeatable spirometry

          -  The patient is able to use an electronic diary after training.

          -  The patient is able to use devices properly

          -  If female, patient is currently not pregnant, not breast feeding, nor attempting to
             become pregnant (for 30 days before the screening visit (SV) and throughout the
             duration of the study and for 30 days after patient's last study visit) or, is of
             childbearing potential and not sexually active, has a negative urine pregnancy test,
             and is willing to commit to using a consistent and acceptable method of birth control

          -  If male, the patient is willing to commit to an acceptable method of birth control for
             the duration of the study, is surgically sterile or exclusively has same-sex
             partner(s).

          -  The patient does not have any concomitant conditions or treatments that could
             interfere with study conduct, influence the interpretation of study
             observations/results, or put the patient at increased risk during the study as judged
             by the investigator.

          -  The patient/parent/legal guardian is capable of understanding the requirements, risks,
             and benefits of study participation, and, as judged by the investigator, capable of
             giving informed consent/assent and being compliant with all study requirements (eg,
             dose schedules, visit schedules, procedures, and record keeping).

          -  The patient, as judged by the investigator, is able to discontinue all asthma
             medications at the SV.

               -  other criteria apply, please contact the investigator for more information

        Exclusion Criteria

          -  Life-threatening asthma, defined as a history of asthma episode(s) requiring
             intubation and/or associated with hypercapnea, respiratory arrest or hypoxic seizures,
             asthma-related syncopal episode(s), or hospitalizations within the past year.

          -  The patient received systemic corticosteroids within 30 days before the SV (for asthma
             exacerbation or for other indications).

          -  The patient has participated in any investigational drug study as a randomized patient
             within the 30 days (starting at the final visit of that study) preceding SV (or
             prescreening visit, as applicable), or plans to participate in another investigational
             drug study at any time during this study.

          -  The patient has previously participated in a beclomethasone dipropionate
             breath-actuated inhaler (device) (BAI) study as a randomized patient.

          -  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 been treated with any known strong cytochrome inhibitors during the
             study.

          -  The patient has been treated with any of the prohibited medications during the
             prescribed (per protocol) withdrawal periods before the SV.

          -  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 (eg, cigarettes, cigars, chewing
             tobacco, or pipe tobacco).

          -  The patient has a suspected bacterial or viral infection of the upper or lower
             respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before
             the SV.

          -  The patient has a history of alcohol or drug abuse within 2 years preceding SV.

          -  The patient has had an asthma exacerbation requiring oral corticosteroids within 1
             month before the SV, or has had any hospitalization for asthma within 3 months before
             SV.

          -  The patient has initiated immunotherapy (administered by any route) less than 90 days
             before the SV or had a dose escalation of immunotherapy less than 30 days before the
             SV.

          -  The patient is unable to tolerate or unwilling to comply with the required washout
             periods and withholding of all applicable medications.

          -  The patient has untreated oral candidiasis at SV. Patients with clinical visual
             evidence of oral candidiasis and who agree to receive treatment and comply with
             appropriate medical monitoring may enter the study.

          -  The patient is either an employee or an immediate relative of an employee of the
             clinical investigational center.

          -  A member of the patient's household is participating in the study at the same time.
             (However, after the enrolled patient completes or discontinues participation in the
             study, another patient from the same household may be screened).

          -  The patient has a disease/condition 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