A Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD7594 Administered Once Daily by Inhalation in Asthmatic Subjects
Public ClinicalTrials.gov record NCT03622112. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03622112
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 808 participants
Conditions and interventions
Conditions
Interventions
- AZD7594 DPI 55μg/50μg. Drug
- AZD7594 DPI 99 µg/90 µg Drug
- AZD7594 DPI 198 µg/180 µg Drug
- AZD7594 DPI 396 µg/360 µg once daily. Drug
- AZD7594 DPI 792 µg/720 µg Drug
- Placebo for AZD7594 once daily. Drug
- FF 100 µg once daily (open-label) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2, 2019 (Actual)
- Primary completion
- Sep 30, 2019 (Actual)
- Completion
- Sep 30, 2019 (Actual)
- Last update posted
- Nov 27, 2020
2019
United States locations
- U.S. sites
- 21
- U.S. states
- 12
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Sheffield | Alabama | 35660 | — |
| Research Site | Phoenix | Arizona | 85018 | — |
| Research Site | Fullerton | California | 92835 | — |
| Research Site | Gold River | California | 95670 | — |
| Research Site | New Haven | Connecticut | 06520 | — |
| Research Site | Celebration | Florida | 34747 | — |
| Research Site | Miami | Florida | 33144 | — |
| Research Site | Port Orange | Florida | 32127 | — |
| Research Site | Winter Park | Florida | 32789 | — |
| Research Site | North Dartmouth | Massachusetts | 02747 | — |
| Research Site | Farmington Hills | Michigan | 48336 | — |
| Research Site | Charlotte | North Carolina | 28207 | — |
| Research Site | Gastonia | North Carolina | 28054 | — |
| Research Site | Raleigh | North Carolina | 27607 | — |
| Research Site | Cincinnati | Ohio | 45242 | — |
| Research Site | Dublin | Ohio | 43016 | — |
| Research Site | Medford | Oregon | 97504-9741 | — |
| Research Site | Portland | Oregon | 97202 | — |
| Research Site | Spartanburg | South Carolina | 29303 | — |
| Research Site | Boerne | Texas | 78006 | — |
| Research Site | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 73 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03622112, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 27, 2020 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03622112 live on ClinicalTrials.gov.