At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2b Randomised, Double Blind, Placebo-Controlled, Parallel Arm, Multi-Centre Study to Assess Efficacy and Safety of Multiple Dose Levels of AZD7594 DPI Given Once Daily for Twelve Weeks, Compared to Placebo, in Asthmatics Symptomatic on Low Dose ICS
In Brief
A Phase 2 clinical trial evaluating AZD7594 DPI 55μg/50μg., AZD7594 DPI 99 µg/90 µg, and 5 other interventions for Asthma. Completed, enrolled 808 participants across 94 sites in 8 countries.
Detailed 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.
Study Details
Timeline
Interventions
A non-steroidal and selective modulator of the GR.
A non-steroidal and selective modulator of the GR.
A non-steroidal and selective modulator of the GR.
A non-steroidal and selective modulator of the GR.
A non-steroidal and selective modulator of the GR.
Placebo for AZD7594
Fluticasone furoate