drugset / Trial / NCT06245551

A Study to Investigate the Effects of PT027 (Budesonide/Albuterol Sulfate) Metered-dose Inhaler Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult Patients With Asthma

NCT06245551

Phase 3 Completed 64 enrolled AstraZeneca
RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of this Phase III, multicentre, randomized, double-blind, single-dose, 2-period, crossover study is to assess the efficacy and safety of PT027 (budesonide/albuterol sulfate) metered-dose inhaler compared with placebo on exercise-induced bronchoconstriction in adult patients with asthma. Subjects will receive each study treatment on separate visits and undergo a treadmill exercise challenge test so that the effect of study treatment on exercise-induced bronchoconstriction can be evaluated

Timeline

Start
2023-12-22
Primary completion
2024-06-29
Completion
2024-06-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 160 ug Inhaled
Subject Salbutamol Unknown 180 ug Inhaled