NCT03622112|CompletedPhase 2ResultsFDA Drug

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

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

AstraZeneca ClinicalTrials.gov

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1 other identifier

D3741C00007

Study Type

interventional

Target

808

Locations

8 countries

Sites

Timeline

RegisteredAug 2018

StartedJan 2019

CompletionSep 2019

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

808

participants targeted

Target at P75+ for phase_2 asthma

Timeline

Completed

Started Jan 2019

Shorter than P25 for phase_2 asthma

Geographic Reach

8 countries

94 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9 months study duration

First Submitted

Initial submission to the registry

July 5, 2018

Completed

1 month until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed

5 months until next milestone

Study Start

First participant enrolled

January 2, 2019

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

November 27, 2020

Completed

Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

July 5, 2018

Results QC Date

September 24, 2020

Last Update Submit

November 4, 2020

Conditions

Asthma

Keywords

Inhaled non-steroidal glucocorticoid receptor modulatorAsthmaInhaled corticosteroids.Glucocorticoid receptor (GA) agonists.Chronic obstructive pulmonary disease.Short-acting B2 agonist.Fluticasone furoate.

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Trough FEV1 at Week 12
Trough value was defined as the mean of the 2 measurements 30 minutes apart (23 hours after last dose) pre-dose for every visit throughout the Treatment Period (Visit 4/Week 2 to Visit 7/Week 12). Baseline was defined as the mean of the 2 measured values before first IP administration (30 minutes apart, at -45 minutes and -15 minutes, before IP administration) on Day 1 (Visit 3). Analyses were based on a Mixed-effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction and region as fixed effects, and baseline value and baseline by visit interaction as covariates. To investigate the clinical efficacy of AZD7594 at different dose levels in asthmatics symptomatic on low dose Inhaled corticosteroid (ICS).
At week 12

Secondary Outcomes (24)

Change From Baseline in Trough FEV1 at Weeks 2, 4, 8 and Average Over the Treatment Period
At week 2, 4 and 8
Change From Baseline in Fractional Exhaled Nitic Oxide (FENO) at Weeks 2, 4, 8, 12 and Average Over the Treatment Period
At week 2, 4, 8, and 12
Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 12 and Average Over the Treatment Period
At week 12
Change From Baseline in Asthma Control Questionnaire -5 (ACQ-5) at Week 12 and Average Over the Treatment Period
At week 12
Change From Baseline in Average Morning Peak Expiratory Flow (PEF) Over the Treatment Period
Week 0 (7 days prior to randomisation) to Week 12
+19 more secondary outcomes

Study Arms (7)

AZD7594 Dose 1

EXPERIMENTAL

The randomized subjects will receive AZD7594 55 μg/50 μg (nominal/delivered dose), oral inhalation via dry powder inhaler (DPI) once daily.

Drug: AZD7594 DPI 55μg/50μg.

AZD7594 Dose 2

EXPERIMENTAL

The randomized subjects will receive AZD7594 99 µg/90 µg, oral inhalation via DPI once daily.

Drug: AZD7594 DPI 99 µg/90 µg

AZD7594 Dose 3

EXPERIMENTAL

The randomized subjects will receive treatment with AZD7594 198 µg/180 µg, oral inhalation via DPI once daily.

Drug: AZD7594 DPI 198 µg/180 µg

AZD7594 Dose 4

EXPERIMENTAL

The randomized subjects will receive treatment with AZD7594 396 µg/360 µg, oral inhalation via DPI once daily.

Drug: AZD7594 DPI 396 µg/360 µg once daily.

AZD7594 Dose 5

EXPERIMENTAL

The randomized subjects will receive treatment with AZD7594 792 µg/720 µg, oral inhalation via DPI once daily.

Drug: AZD7594 DPI 792 µg/720 µg

Placebo

PLACEBO COMPARATOR

The randomized subjects will receive AZD7594 matching placebo oral inhalation via DPI once daily.

Drug: Placebo for AZD7594 once daily.

Fluticasone Furoate

ACTIVE COMPARATOR

The randomized subjects will receive treatment with fluticasone furoate (FF) oral inhalation via DPI, 100 µg per nominal dose, once daily (open-label).

Drug: FF 100 µg once daily (open-label)