Phase II study, to investigate the therapeutic efficacy and safety of inhaled PT007 (referred to as AS MDI) compared with placebo MDI and open-label Ventolin Evohaler in male and female participants aged 18 to 65 years (inclusive) with asthma. This study consists of a screening/run-in period, a treatment period, and a follow-up phone call.
This is a randomized, double-blind, single-dose, placebo-controlled, 3-period, 3-treatment, crossover, multicenter study to assess the bronchodilatory effect and safety of AS MDI (180 μg) compared with placebo MDI and open-label Ventolin Evohaler (200 μg) in adult participants (aged 18 to 65 years, inclusive) with asthma (pre-bronchodilator FEV1 of ≥ 40% of the predicted normal value) and demonstrated FEV1 reversibility to Ventolin hydrofluoroalkane (HFA) (improvement in FEV1 at 30 minutes post-Ventolin HFA dosing of ≥ 12% and ≥ 200 mL). The study duration will be a minimum of 15 days and up to a maximum of 52 days. Including: screening/run-in period: 3 to 28 days treatment period: 9 to 17 days follow-up phone call: 3 to 7 days after the final dose of study intervention Eligible participants will be randomized to 1 of 6 predefined treatment sequences in a 1:1:1:1:1:1 ratio. Each sequence will contain AS MDI, placebo MDI, and Ventolin Evohaler in a randomized order. Eligible participants will receive a single dose of randomized study intervention at each of 3 treatment visits (Visits 2, 3, and 4), with a 3- to 7-day washout period between treatment visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
118
Drug Treatment: (Albuterol Sulfate metered dose inhaler \[AS MDI\] - PT007) Randomized participants will receive a single-dose (2 inhalations)
Drug: Treatment (Ventolin Evohaler) Randomized participants will receive a single-dose (2 inhalations)
Drug: Treatment (Placebo MDI) Randomized participants will receive a single-dose (2 inhalations to match AS MDI)
Research Site
Encinitas, California, United States
Research Site
Lancaster, California, United States
Change From Baseline in FEV1 AUC 0-6 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis
Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. Area Under the Curve (AUC) 0-6 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 6 hours).
Time frame: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)
Change From Baseline in FEV1 AUC 0-6 Hours (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis
Change from baseline in FEV1 measured at each time point for Ventolin Evohaler and Placebo. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-6 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 6 hours).
Time frame: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)
Change From Baseline in FEV1 AUC 0-6 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis
Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-6 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 6 hours).
Time frame: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)
Change From Baseline in FEV1 AUC 0-4 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis
Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-4 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 4 hours).
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Research Site
Los Angeles, California, United States
Research Site
Newport Beach, California, United States
Research Site
San Diego, California, United States
Research Site
San Jose, California, United States
Research Site
Stockton, California, United States
Research Site
Clearwater, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Tallahassee, Florida, United States
...and 12 more locations
Time frame: 0 to 4 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose)
Change From Baseline in FEV1 AUC 0-4 Hours (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis
Change from baseline FEV1 measured at each time point for Ventolin Evohaler and Placebo. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-4 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 4 hours).
Time frame: 0 to 4 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose)
Change From Baseline in FEV1 AUC 0-4 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis
Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-4 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 4 hours).
Time frame: 0 to 4 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose)
Peak Change From Baseline in FEV1 (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis
Peak change from baseline in FEV1 is the difference between the maximum FEV1 value measured during the 6 hour post dose period and the baseline FEV1 for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values.
Time frame: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)
Peak Change From Baseline in FEV1 (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis
Peak change from baseline in FEV1 is the difference between the maximum FEV1 value measured during the 6 hour post dose period and the baseline FEV1 for Ventolin Evohaler and Placebo. Baseline FEV1 is the period specific mean of the available pre-dose values.
Time frame: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)
Peak Change From Baseline in FEV1 (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis
Peak change from baseline in FEV1 is the difference between the maximum FEV1 value measured during the 6 hour post dose period and the baseline FEV1 for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values.
Time frame: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)