Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Abediterol 0.156 μg · 1 trial · 1 indication
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...
Abediterol 0.156 μg is an investigational small molecule being developed for the treatment of asthma. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients.
Abediterol 0.156 μg is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's potential as a treatment for asthma.
Abediterol 0.156 μg is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety, tolerability, and pharmacokinetics in patients with asthma.
Abediterol 0.156 μg has been studied in one completed Phase 1 clinical trial, identified as NCT02777827. This was a randomized, double-blind, placebo-controlled study conducted in Germany with 30 adult asthma patients, evaluating the pharmacodynamics and pharmacokinetics of two formulations of the drug.
Abediterol 0.156 μg is a specific dose formulation of the investigational drug abediterol. The clinical trial NCT02777827 evaluated two formulations of abediterol at this dose in patients with asthma, and the drug is being developed by AstraZeneca PLC.