NCT06644924

A Study Evaluating the Effect of Inhaled PT007(AS MDI) Versus Placebo MDI and Ventolin Evohaler on Lung Function in Adult Participants With Asthma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Intervention: AS MDI	Drug Treatment: (Albuterol Sulfate metered dose inhaler \[AS MDI\] - PT007) Randomized participants will receive a single-dose (2 inhalations)
COMBINATION_PRODUCT	Intervention: Ventolin Evohaler	Drug: Treatment (Ventolin Evohaler) Randomized participants will receive a single-dose (2 inhalations)
COMBINATION_PRODUCT	Intervention: Placebo matching AS MDI	Drug: Treatment (Placebo MDI) Randomized participants will receive a single-dose (2 inhalations to match AS MDI)

Timeline

• Start date: 2025-02-10
• Primary completion: 2025-06-04
• Completion: 2025-06-04
• First posted: 2024-10-16
• Last updated: 2025-09-03

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study