Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Symbicort pMDI with spacer device · 1 trial · 1 indication
To assess Cmax of Symbicort pMDI administered through a spacer device without charcoal under fasted condition (total systemic exposure). The analysis was done on pharmacokinetic analysis set.
To assess AUC0-t of Symbicort pMDI administered through a spacer device without charcoal under fasted condition (total systemic exposure). The analysis was done on pharmacokinetic analysis set.
To assess Cmax of Symbicort pMDI administered through a spacer device with charcoal under fasted condition (lung exposure). The analysis was done on pharmacokinetic analysis set.
To assess AUC0-t of Symbicort pMDI administered through a spacer device with charcoal under fasted condition (lung exposure). The analysis was done on pharmacokinetic analysis set.
To assess Cmax of Symbicort pMDI administered without a spacer device without charcoal under fasted condition (total systemic exposure). The analysis was done on pharmacokinetic analysis set.
To assess AUC0-t of Symbicort pMDI administered without a spacer device without charcoal under fasted condition (total systemic exposure). The analysis was done on pharmacokinetic analysis set.
To assess Cmax of Symbicort pMDI administered without a spacer device with charcoal under fasted condition (lung exposure). The analysis was done on pharmacokinetic analysis set.
To assess AUC0-t of Symbicort pMDI administered without a spacer device with charcoal under fasted condition (lung exposure). The analysis was done on pharmacokinetic analysis set.
| Arm | Type | Description |
|---|---|---|
| Treatment A | ACTIVE_COMPARATOR | 2 x 160/4.5 µg Symbicort pMDI administered with no spacer device; no activated charcoal (systemic exposure). |
| Treatment B | EXPERIMENTAL | 2 x 160/4.5 µg Symbicort pMDI administered through AeroChamber Plus Flow-Vu spacer device; no activated charcoal (systemic exposure). |
| Treatment C | ACTIVE_COMPARATOR | 160/4.5 µg Symbicort pMDI administered with no spacer device; with activated charcoal (lung exposure). |
| Treatment D | EXPERIMENTAL | 160/4.5 µg Symbicort pMDI administered through AeroChamber Plus Flow-Vu spacer device; with activated charcoal (lung exposure). |
| Name | Type | Description |
|---|---|---|
| Symbicort pMDI with spacer device | DRUG | Relative bioavailability of budesonide and formoterol delivered via Symbicort pressurized metered-dose inhaler (pMDI) with a spacer device (test) |
| Symbicort pMDI without spacer device | DRUG | Relative bioavailability of budesonide and formoterol delivered via Symbicort pMDI without a spacer device (reference) |
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male and/or female subjects aged 18 years (inclusive) and older, with suitable veins for cannulation or repeated venipuncture. 3. Females must have a negative pregnancy ...
Symbicort pMDI with spacer device is an investigational small molecule being studied for use in asthma. A Phase 1 study is being conducted in healthy volunteers to assess how much drug reaches the blood when given from Symbicort pMDI with spacer compared to without spacer. It is not approved and remains in clinical development.
Symbicort pMDI with spacer device is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate the drug's safety and efficacy in asthma patients and healthy volunteers.
Symbicort pMDI with spacer device is in Phase 1 clinical development. A Phase 1 study is being conducted in healthy volunteers to compare drug levels in the blood when administered with a spacer versus without a spacer. The drug is investigational and not yet approved.
Symbicort pMDI with spacer device has completed three clinical trials. These include NCT00651768, a Phase 3 titratable dosing study in moderate to severe asthmatics; NCT01444430, a 6-month safety study in asthmatic adults and adolescents; and NCT02091986, a 12-week study in asthmatic children. A Phase 1 study, NCT02934607, is being conducted in healthy volunteers.
Symbicort pMDI with spacer device is being studied in comparison to Symbicort pMDI without spacer. A Phase 1 clinical trial (NCT02934607) is assessing how much drug reaches the blood when given from Symbicort pMDI with spacer compared to that of Symbicort pMDI without spacer in healthy volunteers.