Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Symbicort Turbuhaler · 4 trials · 3 indications
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Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid \[GCS\] treatment, hospitalization, or emergency room \[ER\] treatment.
Total number of adverse events
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
The mean AUC of QTcF (ECG interval measured from the beginning of the Q wave to the end of the T wave, corrected for heart rate using Fridericia's formula)was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Change in the Morning PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| First Symbicort, then Terbutaline | EXPERIMENTAL | Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days |
| First Turbuhaler, then Symbicort | EXPERIMENTAL | Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days, |
| Symbicort pMDI | ACTIVE_COMPARATOR | Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Symbicort Turbuhaler | ACTIVE_COMPARATOR | Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily |
| Pulmicort Turbuhaler | ACTIVE_COMPARATOR | Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
| Name | Type | Description |
|---|---|---|
| Symbicort Turbuhaler (Budesonide/formoterol) | DRUG | 2 x 160/4.5 microgram, inhalation, bid, 52 weeks |
| Drug: any available COPD treatment; investigator to decide | DRUG | According to investigator decision, 52 weeks, Standard COPD treatment according to investigator decision |
| Symbicort Turbuhaler | DRUG | 160/4.5 µg |
| Terbutaline Turbuhaler | DRUG | 0.4 mg |
| Symbicort pMDI | DRUG | Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily |
| Pulmicort Turbuhaler | DRUG | Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily |
Inclusion Criteria: * A current clinical diagnosis of COPD according to the guidelines (GOLD, JPS) * Documented COPD symptoms for more than 2 years * Pre-bronchodilator FEV1≦50% of predicted normal value, and post-bronchodilator FEV1/FVC\<70% Exclusion Criteria: * History and/or current clinical ...
Symbicort Turbuhaler is used for asthma, bronchial asthma, and chronic obstructive pulmonary disease (COPD). It is a small molecule respiratory therapy developed by AstraZeneca PLC (AZN). The drug is delivered via the Turbuhaler device and is intended for patients with these chronic respiratory conditions.
Symbicort Turbuhaler contains a combination of an inhaled corticosteroid and a long-acting beta2-agonist. The corticosteroid reduces airway inflammation, while the beta2-agonist relaxes bronchial smooth muscle to improve airflow. This dual action addresses both the inflammatory and bronchoconstrictive components of asthma and COPD.
Symbicort Turbuhaler is developed and manufactured by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca has conducted multiple Phase 3 clinical trials to evaluate the safety and efficacy of Symbicort Turbuhaler in respiratory indications.
Symbicort Turbuhaler is in Phase 3 clinical development. All four completed trials listed are Phase 3 studies, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities based on the available data.
Symbicort Turbuhaler has been studied in four completed Phase 3 trials. NCT00536731 assessed therapeutic equivalence in bronchial asthma with 742 patients. NCT00837967 and NCT00839800 investigated safety and efficacy in asthma, enrolling 25 and 2091 patients respectively. NCT01070784 evaluated safety and efficacy in COPD with 328 patients.
Symbicort Turbuhaler is a specific formulation of Symbicort delivered via the Turbuhaler device. A clinical trial (NCT00536731) compared Symbicort Rapihaler to the Turbuhaler formulation for therapeutic equivalence in bronchial asthma, indicating they are distinct delivery forms of the same medication.