Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Symbicort pMDI+ budesonide HFA pMDI · 3 trials · 1 indication
1h post-dose FEV1 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Number of participants experiencing an event in the composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization), using events adjudicated and confirmed by the Joint Adjudication Committee. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
Number of participants experiencing an event included in the definition of asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
| Arm | Type | Description |
|---|---|---|
| Symbicort pMDI 80/2.25 µg | ACTIVE_COMPARATOR | Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily |
| Symbicort pMDI 80/4.5µg | ACTIVE_COMPARATOR | Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily |
| Budesonide pMDI | ACTIVE_COMPARATOR | Budesonide pMDI 80µg, 2 acuations twice daily |
| 1 | EXPERIMENTAL | Symbicort |
| 2 | ACTIVE_COMPARATOR | budesonide |
| Name | Type | Description |
|---|---|---|
| Symbicort pMDI | DRUG | Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily |
| Budesonide pMDI | OTHER | Budesonide pMDI 80µg, 2 acuations twice daily |
| budesonide/formoterol | DRUG | - |
| Symbicort pMDI + budesonide HFA pMDI | DRUG | Symbicort 2 X 160/4.5mcg \& budesonide HFA pMDI 4 X 160mcg |
Inclusion Criteria: * Has a documented clinical diagnosis of asthma defined by the ATS for at least 6 months prior to Visit 2 * Have a morning pre-bronchodilator clinic FEV1 measured at least 6 hours after the last dose of inhaled SABA and at least 48 hours after last dose of inhaled LABA of 60% to...
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.