Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Abediterol · 2 trials · 2 indications
To assess Cmax after single inhaled dose of abediterol 5 μg. Cmax will be taken directly from the individual concentration-time curve.
To assess tmax after single inhaled dose of abediterol 5 μg. tmax will be taken directly from the individual concentration-time curve.
To assess AUClast after single inhaled dose of abediterol 5 μg.
To assess AUC(0-24) after single inhaled dose of abediterol 5 μg.
To assess Cmax after multiple once daily inhaled doses of abediterol 5 μg. Cmax will be taken directly from the individual concentration-time curve.
To assess tmax after multiple once daily inhaled doses of abediterol 5 μg. tmax will be taken directly from the individual concentration-time curve.
To assess λz after multiple once daily inhaled doses of abediterol 5 μg.
To assess t½λz after multiple once daily inhaled doses of abediterol 5 μg.
To assess AUClast after multiple once daily inhaled doses of abediterol 5 μg.
To assess AUC(0-24) after multiple once daily inhaled doses of abediterol 5 μg.
To assess CL/F after multiple once daily inhaled doses of abediterol 5 μg.
To assess Cavg after multiple once daily inhaled doses of abediterol 5 μg.
To assess %Fluctuation after multiple once daily inhaled doses of abediterol 5 μg.
To assess Rac (Cmax) after multiple once daily inhaled doses of abediterol 5 μg.
To assess Rac (AUC0-24) after multiple once daily inhaled doses of abediterol 5 μg.
Systolic and diastolic BP (in mmHg) will be measured after the patient has rested in the supine position for at least 5 minutes and before taking any blood sample and conducting any spirometry.
Pulse (beats per minute \[bpm\]) will be measured after the patient has rested in the supine position for at least 5 minutes and before taking any blood sample and conducting any spirometry.
12-Lead ECG results performed for safety evaluation will be listed for each patient and will include the ECG parameters (where applicable \[Screening, pre-dose Day 1 and Follow-up\]) and changes from baseline, assessment by the Investigator (normal/abnormal not clinically significant/abnormal clinically significant) and details of any abnormalities (rhythm, ectopy, conduction, morphology, myocardial infarction, ST segment, T wave and U wave observations).
Hematology and clinical chemistry values (including serial potassium and glucose) will be listed by patient and time point including changes from baseline (pre-dose Day 1) and repeat/unscheduled measurements. Urinalysis will include glucose, protein, blood, leucocytes, flow cytometry, microscopy.
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be symptoms (e.g., nausea, chest pain), signs (e.g., tachycardia, enlarged liver) or the abnormal results of an investigation (e.g., laboratory findings, electrocardiogram). In clinical studies an AE can include an undesirable medical condition occurring at any time after the patient has signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
| Arm | Type | Description |
|---|---|---|
| Abediterol 5 μg | EXPERIMENTAL | Out of 12 randomized patients, 9 will receive abediterol 5 μg as dry inhalation powder orally once daily for 9 days. Patients will be provided salbutamol as rescue medication for use throughout the study. During the treatment period, all patients will be continued on their current ICSs. In addition, each patient will receive Abediterol 5.0 μg QD. |
| Placebo | PLACEBO_COMPARATOR | Out of 12 randomized patients, 3 will receive placebo as dry inhalation powder orally once daily for 9 days. Patients will be provided salbutamol as rescue medication for use throughout the study. During the treatment period, all patients will be continued on their current ICSs. In addition, each patient will receive placebo QD. |
| Treatment A (Abediterol ) | EXPERIMENTAL | Treatment A: The subjects will receive Abediterol 2.5 μg via DPI |
| Treatment B (AZD7594) | EXPERIMENTAL | Treatment B: The subjects will receive AZD7594 440 μg via DPI |
| Treatment C (AZD7594/abediterol ) | EXPERIMENTAL | Treatment C: The subjects will receive AZD7594/ abediterol 440 μg/2.5 μg FDC via DPI |
| Treatment D (AZD7594 and abediterol) | EXPERIMENTAL | Treatment D: The subjects will receive AZD7594 440 μg and abediterol 2.5 μg free combination administered via 2 separate DPIs |
| Name | Type | Description |
|---|---|---|
| Abediterol | DRUG | A β2-adrenoceptor agonists, produce smooth muscle relaxation in the airways and improves lung function. |
| Placebo | DRUG | Abediterol matching placebo without any pharmacological activity. |
| AZD7594 | DRUG | Treatment B: AZD7594 440 μg via DPI |
| AZD7594/abediterol | DRUG | Treatment C: AZD7594/abediterol 440 μg/2.5 μg FDC via DPI |
| AZD7594 and abediterol | DRUG | Treatment D: AZD7594 440 μg and abediterol 2.5 μg free combination administered via 2 separate DPIs |
Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures. * Male and non-pregnant, non-lactating female patients aged 18 - 55 years with asthma and with suitable veins for cannulation or repeated venipuncture. * Non-smoker or former smoker...
Abediterol is an investigational small molecule being developed for Chronic Obstructive Pulmonary Disease (COPD) and Asthma. It is administered via inhalation as a dry powder. As of the available data, it is in Phase 1 clinical development and has not been approved by regulatory authorities.
Abediterol 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 safety and pharmacokinetics in healthy volunteers and patients with respiratory conditions.
Abediterol is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. Clinical trials are ongoing to assess its safety, tolerability, and how the body processes the drug when administered via inhalation.
Abediterol has been studied in two completed Phase 1 clinical trials. NCT02967159 evaluated the disposition and safety of single inhaled doses in healthy male participants. NCT03273127 assessed pharmacokinetics, safety, and tolerability of once-daily dosing for 9 days in patients with asthma on inhaled corticosteroids.
No, Abediterol and AZD7594 are different drugs. In clinical trial NCT02967159, they were studied both alone and in combination to evaluate their disposition and safety. The trial used a dry powder inhaler to administer each drug separately, in a fixed dose combination, and in a free combination.