Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SYMBICORT TURBOHALER · 1 trial · 1 indication
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Baseline trough morning PEF was defined as the average value of recorded (nonmissing) morning assessments 5 out of the last 7 days prior to randomization. The first day before randomization consisted of the electronic patient diary entry at home on the morning of the randomization visit (Baseline \[Day 1\]) and the first day postrandomization consisted of the electronic patient diary entry at home on the morning of the day after the randomization visit (Baseline \[Day 1\]). For postdose weekly average of trough morning PEF measurements, the values were the averages based on the available data for that week. The averages were calculated as the sum of morning PEF values divided by the number of nonmissing assessments. The final value for change from baseline was calculated as the average of the weekly change from baseline averaged over 12 weeks.
| Arm | Type | Description |
|---|---|---|
| BF Spiromax | EXPERIMENTAL | 2 inhalations of BF Spiromax at a dosage of 160/4.5 mcg and 2 inhalations of SYMBICORT placebo administered twice daily (AM and PM) during the 12-week treatment period. |
| Symbicort Turbohaler | ACTIVE_COMPARATOR | 2 inhalations of SYMBICORT TURBOHALER at a dosage of 200/6 mcg and 2 inhalations of placebo SPIROMAX administered twice daily (AM and PM) during the 12-week treatment period. |
| Name | Type | Description |
|---|---|---|
| Budesonide/Formoterol SPIROMAX® | DRUG | BF Spiromax will be administered per dose and schedule specified in the arm. |
| SYMBICORT® TURBOHALER® | DRUG | Symbicort Turbohaler will be administered per dose and schedule specified in the arm. |
| SYMBICORT placebo | DRUG | SYMBICORT placebo multi-dose dry powder inhaler (DPI) identical in appearance to SYMBICORT TURBOHALER will be administered per dose and schedule specified in the arm. |
| SPIROMAX Placebo | DRUG | SPIROMAX Placebo multi-dose dry powder inhaler (DPI) identical in appearance to BF SPIROMAX will be administered per dose and schedule specified in the arm. |
Inclusion Criteria: * Male or female participants 12 years and older as of the screening visit. Male or female participants 18 years and older, as of the screening visit, in countries where local regulations or the regulatory status of study medication permit enrollment of adult participants only. ...
SYMBICORT TURBOHALER is used for the treatment of asthma. It is a small molecule respiratory therapy being developed by Teva Pharmaceutical Industries Limited. The drug is currently in Phase 3 clinical development for this indication.
SYMBICORT TURBOHALER is developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is being studied for the treatment of asthma.
SYMBICORT TURBOHALER is in Phase 3 clinical development. It is an investigational drug for asthma, meaning it has not yet been approved by regulatory authorities. One Phase 3 trial has been completed.
SYMBICORT TURBOHALER was studied in a completed Phase 3 trial with the identifier NCT01803555. This randomized, double-blind, active-controlled trial enrolled 605 participants aged 12 years and older with asthma across multiple European countries and Israel.
SYMBICORT TURBOHALER was compared against budesonide/formoterol SPIROMAX in a clinical trial. The trial evaluated the efficacy and safety of budesonide/formoterol SPIROMAX inhalation powder versus SYMBICORT TURBOHALER in patients with asthma.