drugset / Trial / NCT03622112

A Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD7594 Administered Once Daily by Inhalation in Asthmatic Subjects

NCT03622112

Phase 2 Completed 808 enrolled AstraZeneca Parexel · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will assess the efficacy and safety of multiple dose levels of AZD7594 administered once daily (QD) by inhalation in a 12-week treatment period on asthma subjects. The activity will be assessed by comparing AZD7594 to placebo. The comparison between active comparator (FF) and placebo will be used for bench marking. The efficacy is assessed by the evaluation of change in trough forced expiratory volume in 1 second (FEV1). The aim is to develop AZD7594 as a once daily inhaled non-steroidal selective GR modulator (SGRM), which may ultimately lead to better disease control of both chronic obstructive pulmonary disease (COPD) and asthma through improved efficacy and compliance. The overall rationale for developing a once daily AZD7594 in a dry powder inhaler (DPI) is to provide a safe and effective future treatment option for both asthma and COPD subjects.

Timeline

Start
2019-01-02
Primary completion
2019-09-30
Completion
2019-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone Furoate Other / unclassified 100 ug Oral
Subject VELSECORAT Other / unclassified 55 ug Oral
Subject VELSECORAT Other / unclassified 99 ug Oral
Subject VELSECORAT Other / unclassified 198 ug Oral
Subject VELSECORAT Other / unclassified 396 ug Oral
Subject VELSECORAT Other / unclassified 792 ug Oral

Indications