Clinical Pharmacodynamic Bioequivalence Study of Beclomethasone Dipropionate 40 mcg INH
Condition: Bronchial Asthma
MeSH terms: Asthma
Intervention: Test Product; Reference Product; Placebo
Intervention description: Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg; Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg; Placebo Product
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1550.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To compare the therapeutic equivalence of Beclomethasone Dipropionate MDI (Inhalation
      Aerosol) 0.04 mg/ INH with the marketed QVAR® 40 mcg (Beclomethasone dipropionate
      hydrofluoroalkane (HFA)) and to demonstrate superiority of both active treatments over
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult male or female subjects of non-childbearing or of childbearing potential
             committing to consistent and correct use of an acceptable method of birth control.

          2. Diagnosis of asthma as defined by the National Asthma Education and Prevention Program
             at least 12 months prior to screening.

          3. Pre-bronchodilator FEV1 of >45% and <85% of predicted value during the screening visit
             and on the first day of treatment.

          4. >15% and >0.20 L reversibility of FEV1 within 30 minutes following 360 mcg of
             albuterol inhalation (pMDI).

          5. Patients should be stable on their chronic asthma treatment regimen for at least four
             weeks prior to enrollment.

          6. Currently non-smoking; had not used tobacco products (i.e., cigarettes, cigars, pipe
             tobacco) within the past year, and having had <10 pack-years of historical use.

          7. Ability to replace current short-acting β agonist (SABAs) with salbutamol/albuterol
             inhaler for use as needed for the duration of the study. Subjects should be able to
             withhold all inhaled SABAs for at least six hours prior to lung function assessments
             on study visits.

          8. Ability to discontinue their asthma medications (inhaled corticosteroids and
             long-acting β agonists) during the run-in period and for remainder of the study.

          9. Willingness to give their written informed consent to participate in the study.

        Exclusion Criteria:

          1. Life-threatening asthma, defined as a history of asthma episodes(s) requiring
             intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic
             seizures, asthma related syncopal episode(s), or hospitalizations within the past year
             prior to the screening or during the run-in period.

          2. Significant respiratory disease other than asthma (COPD, interstitial lung disease,
             etc.)

          3. Evidence or history of clinically significant disease or abnormality including
             congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery
             disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or
             current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal,
             or other diseases that, in the opinion of the investigator, would put the patient at
             risk through study participation, or would affect the study analyses if the disease
             exacerbates during the study.

          4. Viral or bacterial, upper or lower respiratory tract infection, or sinus, or middle
             ear infection within four weeks prior to the screening, during the run-in period, or
             on the day of treatment.

          5. Hypersensitivity to any sympathomimetic drug (e.g., albuterol) or any inhaled,
             intranasal, or systemic corticosteroid therapy.

          6. Patients receiving β2-blockers, anti-arrhythmics, anti-depressants, and monoamine
             oxidase inhibitors within 4 weeks prior to the screening.

          7. Patients who required systemic corticosteroids (for any reason) within the past 2
             months.