Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: BD MDI 320 µg; BD MDI 160 µg; BD MDI 80 µg; BD MDI 40 µg; Placebo MDI
Intervention description: Budesonide Inhalation Aerosol administered as 2 inhalations BID; Budesonide Inhalation Aerosol administered as 2 inhalations BID; Budesonide Inhalation Aerosol administered as 2 inhalations BID; Budesonide Inhalation Aerosol administered as 2 inhalations BID; Placebo MDI administered as 2 inhalations BID
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking description: Double Blind
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Mild; moderate persistent; Adult

Summary:

      Study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD
      MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent
      asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 - 65 years of age

          -  Diagnosis of mild to moderate persistent asthma, diagnosed at least 6 months prior to
             screening

          -  Currently receiving treatment with a low to medium dose of an inhaled corticosteroid
             (ICS) OR a combination of controller medications for at least 4 weeks preceding
             screening

          -  Pre-albuterol FEV1 of > 60% and < 85% of predicted normal value

          -  Reversibility: Increase in FEV1 of ≥ 12% and ≥ 200 mL over the pre-albuterol FEV1
             within 30 - 60 minutes after the inhalation of 4 puffs of Ventolin hydrofluoroalkane
             (HFA)

          -  Asthma Symptom Criteria: Have required albuterol use on at least two of the last seven
             days and have an Asthma Control Questionnaire (ACQ) total score ≥ 1.5 prior to
             Randomization

        Exclusion Criteria:

          -  Life-Threatening Asthma: A subject must not have life-threatening asthma defined as a
             history of significant asthma episode(s) requiring intubation associated with
             hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal
             episode(s) within the 12 months prior to screening

          -  Worsening of Asthma: A subject must not have experienced a worsening of asthma which
             involved an emergency department visit, hospitalization or use of oral/parenteral
             corticosteroids within 6 weeks of screening

          -  Intermittent, Seasonal, or Exercise-Induced Asthma Alone: Subjects with only
             intermittent, seasonal or exercise-induced asthma are excluded from participation in
             this study

          -  Concurrent Respiratory Disease

          -  Pregnant women or nursing mothers

          -  A current diagnosis of Chronic Obstructive Pulmonary Disease (COPD

          -  Current smokers or subjects with a > 10 pack year history of cigarettes, cigars, or
             pipe smoking

          -  Respiratory tract infection within 6 weeks prior to Visit 1

          -  Subjects with documented myocardial infarction within a year from screening visit

          -  Clinically significant abnormal ECG

          -  Abnormal liver function tests defined as aspartate aminotransferase (AST), alanine
             aminotransferace (ALT), alkaline phosphatase or total bilirubin ≥ 1.5 times upper
             limit of normal on repeat testing

          -  Subjects who have cancer that has not been in complete remission for at least 5 years

          -  Drug Allergy: Subjects who have a history of hypersensitivity to any component of the
             metered-dose inhaler (MDI)