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

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

Outcome

Missed primary endpoint

registry analysis (superiority test); AZD7594 50 μg vs Placebo to AZD7594; p = 0.437 NCT03622112 ↗

registry analysis (superiority test); AZD7594 90 μg vs Placebo to AZD7594; p = 0.236 NCT03622112 ↗

registry analysis (superiority test); AZD7594 180 μg vs Placebo to AZD7594; p = 0.389 NCT03622112 ↗

registry analysis (superiority test); AZD7594 360 μg vs Placebo to AZD7594; p = 0.094 NCT03622112 ↗

registry analysis (superiority test); AZD7594 720 μg vs Placebo to AZD7594; p = 0.060 NCT03622112 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
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