A Study Evaluating the Effect of Inhaled PT007(AS MDI) Versus Placebo MDI and Ventolin Evohaler on Lung Function in Adult Participants With Asthma
brief summary
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.
detailed description
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.
official title
A Phase II, Randomized, Double-blind, Single-dose, Placebo-controlled, 3-Period, 3-Treatment, Crossover, Multicenter Study to Compare the Bronchodilatory Effect and Safety of PT007 to Placebo MDI and Open-Label Ventolin® Evohaler in Adult Participants With Asthma