Randomized, Placebo-controlled, Multi-dose, Study Comparing Budesonide/Formoterol to Symbicort® in Asthmatic Patients
Condition: Asthma
MeSH terms: Asthma
Intervention: Budesonide/Formoterol fumarate dihydrate; Symbicort; Placebo
Intervention description: Experimental: Treatment 1; Active Comparator: Treatment 2; Placebo Comparator: Treatment 3
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1762.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bioequivalence

Summary:

      A randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week
      run-in period followed by a 6-week treatment period of the placebo, Test product (Budesonide
      80 mcg / Formoterol fumarate dihydrate 4.5 mcg), or Reference product Symbicort® inhalation
      aerosol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male or female subjects of non-childbearing or of childbearing potential
             committed to consistent and correct use of an acceptable method of birth control

          -  Diagnosed with asthma, as defined by the National Asthma Education and Prevention
             Program (NAEPP),at least 6 months prior to screening

          -  Moderate-to-severe asthma with a pre-bronchodilator FEV1 of >45% and <85% of predicted
             normal, measured at least 6 hours after short-acting β agonist (SABA)and at least 24
             hours after the last dose of long-acting β agonist (LABA), at the screening visit and
             on the day of treatment

          -  >15% and >0.20 L reversibility of FEV1 within 30 minutes following 360 mcg of
             albuterol inhalation (pMDI)

          -  Patients should be stable on their chronic asthma treatment regimen for at least 4
             weeks prior to enrollment

          -  Currently non-smoking; having not used tobacco products (i.e., cigarettes, cigars,
             pipe tobacco) within the past year, and having < 10 pack-years of historical use

          -  Able to replace current regularly scheduled short-acting β agonists (SABAs) with
             salbutamol/albuterol inhaler for use only on an as-needed basis for the duration of
             the study (subjects should be able to withhold all inhaled SABAs for at least 6 hours
             prior to lung function assessments on study visits)

          -  Willing to discontinue their asthma medications (inhaled corticosteroids and
             long-acting β agonists) during the run-in period and for the remainder of the study

          -  Willingness to give their written informed consent to participate in the study

        Exclusion Criteria:

          -  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 episodes(s), or hospitalizations within the past
             year or during the run-in period

          -  Significant respiratory disease other than asthma (chronic obstructive pulmonary
             disease (COPD), interstitial lung disease, etc.)

          -  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
             exacerbated during the study

          -  Patients who required systemic corticosteroids (for any reason) within the past 4
             weeks

          -  Hypersensitivity to any sympathomimetic drug (e.g., formoterol or albuterol) or any
             inhaled, intranasal, or systemic corticosteroid therapy

          -  Patients currently receiving β-blockers