Trials Sponsors Conditions Drugs Pricing

Conditions

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.

Interventions

AZD7594 DPI 55μg/50μg.Drug

A non-steroidal and selective modulator of the GR.

AZD7594 Dose 1

AZD7594 DPI 99 µg/90 µgDrug

A non-steroidal and selective modulator of the GR.

AZD7594 Dose 2

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

Known or suspected hypersensitivity to any of the IPs, including budesonide, or excipients, including lactose
Systemic steroid use within the 6 weeks before Visit 1

Sponsors & Collaborators

Parexel
Industrycollaborator
AstraZeneca
Industrylead

Study Sites (94)

Research Site

Sheffield, Alabama, 35660, United States

Research Site

Phoenix, Arizona, 85018, United States

Research Site

Fullerton, California, 92835, United States

Research Site

Gold River, California, 95670, United States

Research Site

New Haven, Connecticut, 06520, United States

Research Site

Celebration, Florida, 34747, United States

Research Site

Miami, Florida, 33144, United States

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title: Global Clinical Lead
Organization: AstraZeneca AB

Study Officials

Kai Michael Beeh, Dr med
Insaf - Institut für Atemwegsforschung GmbH, D65187, Germany.
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

808 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, CARE PROVIDER
Masking Details: All double-blind medication kits will have similar appearance regardless of the IP (AZD7594 or placebo) contained in a DPI device and will be labelled using a unique medication identification number (Kit ID) that is linked to a treatment arm. IVRS/IWRS will assign the study medication to be dispensed to each subjects at Visit 3. Supplies of budesonide, FF and SABA (salbutamol/albuterol) will be open-label.
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 5, 2018

First Posted

August 9, 2018

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

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (24)

Study Arms (7)

AZD7594 Dose 1

AZD7594 Dose 2

AZD7594 Dose 3

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (94)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

AZD7594 Dose 4

AZD7594 Dose 5

Placebo

Fluticasone Furoate

Data Sharing

Source record

Documents

Locations