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NCT03622112 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD7594 Administered Once Daily by Inhalation in Asthmatic Subjects
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 808
- Enrollment target
NCT03622112: Completed Phase 2 study, sponsored by AstraZeneca.
NCT03622112 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 808 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (508% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03622112, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 808 participants
- Enrollment target
Study 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.
Primary Outcome
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 i
Interventions
- DRUG 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 808 participants |
| Start Date | 2019-01-02 |
| Est. Completion | 2019-09-30 |
| Phase | Phase 2 |
What the finished NCT03622112 record still lists
NCT03622112 is an interventional study that assigns participants to a tested intervention. The registered 808 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (508% higher).
The record links to 0 conditions, and to 5 interventions - of which AZD7594 DPI 55μg/50μg. is the first listed.
NCT03622112 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03622112 about?
NCT03622112 is a clinical study titled "A Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD7594 Administered Once Daily by Inhalation in Asthmatic Subjects". 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...
What is the current status of trial NCT03622112?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 808 participants. The study started on 2019-01-02. Estimated completion is 2019-09-30.
What interventions are being tested in trial NCT03622112?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT03622112?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03622112's enrollment target sits among peer trials
808 36th of 2000 higher than 1,965 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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