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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02777827 | A Single Dose PD & PK Study With Two Formulations of Abediterol in Patients With Asthma | PHASE1 | COMPLETED | 30 | — | — | Jun 21, 2016 | Nov 29, 2016 | Jan 24, 2019 | 4 | Germany |
Baseline for FEV1 was defined as the mean of the two measured values for the corresponding variable (2 measurements 30 min apart, at -45 min and -15 min), prior to the morning investigational product (IP) administration on Day 1 of each treatment period. If both were missing the screening value was used instead. Trough is defined as the mean of the FEV1 values obtained at 23 h and 24 h after the morning IP administration. If one of the values was missing, the other one was used as trough.
| Arm | Type | Description |
|---|---|---|
| Abediterol dry powder inhaler 0.156 μg | EXPERIMENTAL | Dry powder for inhalation administered via dry powder inhaler 0.156 μg/inhalation; (1 inhalation) |
| Abediterol dry powder inhaler 2.5 μg | EXPERIMENTAL | Dry powder for inhalation, administered via dry powder, inhaler 2.5 μg/inhalation; (1 inhalation). |
| Abediterol pressurised metered-dose inhaler 0.05μg | EXPERIMENTAL | Pressurised metered-dose, inhaler 0.025 μg/puff; (2 puffs). |
| Abediterol pressurised metered-dose inhaler 0.156 μg | EXPERIMENTAL | Pressurised metered-dose, inhaler 0.078 μg/puff; (2 puffs). |
| Abediterol pressurised metered-dose inhaler 2.5μg | EXPERIMENTAL | Pressurised metered-dose inhaler 1.25 μg/puff; (2 puffs). |
| Placebo | PLACEBO_COMPARATOR | Pressurised metered-dose inhaler (2 puffs) and Dry powder for inhalation administered via dry powder inhaler (1 inhalation). |
| Name | Type | Description |
|---|---|---|
| Abediterol 0.156 μg | DRUG | Dry powder for inhalation |
| Abediterol 2.5 μg | DRUG | Dry powder for inhalation |
| Abediterol 0.05 μg | DRUG | Pressurised metered-dose inhaler |
| Placebo | OTHER | Pressurised metered-dose inhaler and dry powder for inhalation. |
Inclusion Criteria: 1. Provision of informed consent before any study specific procedures. 2. Men or non-pregnant, non-lactating women 18 to 75 years of age, inclusive. 3. Non-smoker or ex-smoker (quit ≥6months prior to Visit 1) with a total smoking history of ≤10 pack years. 4. Documented clinical...