Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: AS MDI 90 μg; AS MDI 180 µg; Placebo MDI; Proventil 90 μg; Proventil 180 μg
Intervention description: AS MDI 90 μg (2 actuations of 45 μg/actuation); AS MDI 180 μg (2 actuations of 90 μg/actuation); Placebo MDI (2 actuations); Proventil 90 μg (1 actuation of 90 μg/actuation); Proventil 180 μg (2 actuations of 90 μg/actuation)
Intervention MeSH terms: Albuterol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 86.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, single-dose, placebo-controlled, 5-period, 5-treatment,
      crossover, multi-center study to assess the bronchodilatory effect and safety of 2 dose
      levels of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS
      MDI), 90 μg and 180 μg, compared with placebo for AS MDI (hereafter referred to as Placebo
      MDI) and open-label Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) 90
      μg and 180 μg in adult and adolescent subjects with mild to moderate asthma. This study
      design utilizes 10 treatment sequences.
    

Eligibility criteria:

        Inclusion Criteria

          -  Are at least 12 years of age and no older than 65 years

          -  Have stable (for 6 months) physician-diagnosed asthma with historical documentation of
             the diagnosis

          -  Must be receiving 1 of the following required inhaled asthma therapies listed below
             for at least the last 30 days; Only SABA, which is used as needed for rescue, or Low
             to medium doses of ICS (alone or in combination with LABA), used regularly as
             maintenance asthma therapy

          -  Demonstrate acceptable spirometry performance (ie, meet American Thoracic Society
             [ATS]/European Respiratory Society [ERS] acceptability/repeatability criteria

          -  Pre-bronchodilator FEV1 of ≥40 to <90% predicted normal value after withholding SABA
             for ≥6 hours

          -  Confirmed FEV1 reversibility to Ventolin, defined as a post-Ventolin increase in FEV1
             of ≥15%

          -  only 2 reversibility testing attempts are allowed

        Exclusion Criteria:

          -  Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic
             bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or
             bronchopulmonary dysplasia)

          -  Oral corticosteroid use (any dose) within 6 weeks

          -  Current smokers, former smokers with >10 pack-years history, or former smokers who
             stopped smoking <6 months (including all forms of tobacco, e-cigarettes [vaping], and
             marijuana)

          -  Life-threatening asthma as defined as any history of significant asthma episode(s)
             requiring intubation associated with hypercapnia, respiratory arrest, hypoxic
             seizures, or asthma-related syncopal episode(s)

          -  Historical or current evidence of a clinically significant disease

          -  Cancer not in complete remission for at least 5 years

          -  Hospitalized for psychiatric disorder or attempted suicide within 1 year

          -  Unable to abstain from protocol-defined prohibited medications during the study