MedTrace Logo

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

NCT03622112 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 808

Last updated 2020-11-27

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

AZD7594 DPI 55μg/50μg.

A non-steroidal and selective modulator of the GR.

DRUG

AZD7594 DPI 99 µg/90 µg

A non-steroidal and selective modulator of the GR.

DRUG

AZD7594 DPI 198 µg/180 µg

A non-steroidal and selective modulator of the GR.

DRUG

AZD7594 DPI 396 µg/360 µg once daily.

A non-steroidal and selective modulator of the GR.

DRUG

AZD7594 DPI 792 µg/720 µg

A non-steroidal and selective modulator of the GR.

DRUG

Placebo for AZD7594 once daily.

Placebo for AZD7594

DRUG

FF 100 µg once daily (open-label)

Fluticasone furoate

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Kai Michael Beeh, Dr med · Insaf - Institut für Atemwegsforschung GmbH, D65187, Germany.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-02
Primary Completion
2019-09-30
Completion
2019-09-30
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Germany
  • Hungary
  • Japan
  • Poland
  • South Africa
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03622112 on ClinicalTrials.gov