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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06664619 | A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma | PHASE3 | RECRUITING | 724 | — | — | Dec 12, 2024 | May 31, 2026 | Mar 19, 2026 | 138 | United States, Argentina +9 |
Baseline values are averaged on day 1 to get a single value. Area under the effect curve will be calculated using measurements collected between zero and 6 hours after dosing. Baseline-adjusted post-dose FEV1 AUEC0-6h for visits on Day 1 and at Week 4 will be calculated using the trapezoidal rule.
| Arm | Type | Description |
|---|---|---|
| Fp/ABS eMDPI | EXPERIMENTAL | Fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module |
| Fp eMDPI | ACTIVE_COMPARATOR | Fluticasone propionate (Fp) dry powder inhaler with an integrated electronic module (eMDPI) |
| ABS eMDPI | ACTIVE_COMPARATOR | Albuterol sulfate (ABS) dry powder inhaler with an integrated electronic module (eMDPI) |
| Placebo eMDPI | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Fp/ABS | DRUG | Inhalation powder |
| FP | DRUG | Inhalation powder |
| ABS | DRUG | Inhalation powder |
| Placebo | DRUG | Inhalation powder |
Inclusion Criteria: * The participant has a diagnosis of asthma of at least 6 months duration. * Participants currently receive a beta-agonist (eg, salbutamol \[albuterol\] or ICS albuterol or ICS-formoterol) as rescue medication with or without asthma controller medication. * If female, a particip...