Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03622112 | A Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD7594 Administered Once Daily by Inhalation in Asthmatic Subjects | PHASE2 | COMPLETED | 808 | — | — | Jan 2, 2019 | Sep 30, 2019 | Nov 27, 2020 | 94 | United States, Bulgaria +6 |
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).
| Arm | Type | Description |
|---|---|---|
| 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. |
| AZD7594 Dose 2 | EXPERIMENTAL | The randomized subjects will receive AZD7594 99 µg/90 µg, oral inhalation via DPI once daily. |
| AZD7594 Dose 3 | EXPERIMENTAL | The randomized subjects will receive treatment with AZD7594 198 µg/180 µg, oral inhalation via DPI once daily. |
| AZD7594 Dose 4 | EXPERIMENTAL | The randomized subjects will receive treatment with AZD7594 396 µg/360 µg, oral inhalation via DPI once daily. |
| AZD7594 Dose 5 | EXPERIMENTAL | The randomized subjects will receive treatment with AZD7594 792 µg/720 µg, oral inhalation via DPI once daily. |
| Placebo | PLACEBO_COMPARATOR | The randomized subjects will receive AZD7594 matching placebo oral inhalation via DPI 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). |
| Name | Type | Description |
|---|---|---|
| AZD7594 DPI 55μg/50μg. | DRUG | A non-steroidal and selective modulator of the GR. |
| AZD7594 DPI 99 µg/90 µg | DRUG | A non-steroidal and selective modulator of the GR. |
| AZD7594 DPI 198 µg/180 µg | DRUG | A non-steroidal and selective modulator of the GR. |
| AZD7594 DPI 396 µg/360 µg once daily. | DRUG | A non-steroidal and selective modulator of the GR. |
| AZD7594 DPI 792 µg/720 µg | DRUG | A non-steroidal and selective modulator of the GR. |
| Placebo for AZD7594 once daily. | DRUG | Placebo for AZD7594 |
| FF 100 µg once daily (open-label) | DRUG | Fluticasone furoate |
Inclusion criteria 1\. Provision of informed consent prior to any study-specific procedures 2. Men and women 18 to 85 years of age, inclusive, with body mass index (BMI)≤35 3. Subjects need to be non-smokers or ex-smokers (have quit e cigarettes or other inhaled tobacco products ≥6 months before Vi...