Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Generic Budesonide/Formoterol · 1 trial · 1 indication
FEV1 was measured using spirometry in accordance with the ATS/ERS consensus guidelines. Baseline-adjusted area under the serial FEV1-time curve was calculated from Time 0 to 12 hours on the first day of the Treatment Period (Day 1). FEV1 AUC0-12 was calculated from baseline-adjusted values using the linear trapezoidal method. The calculation assumed that at time of dosing (Time 0) the baseline adjusted FEV1 was also 0. The calculation proceeded over all available post-dose FEV1 assessments on Day 1 (including unscheduled time points, if any) using actual elapsed time from dosing. FEV1 baseline defined as the average of predose FEV1 values obtained on Day 1. If some of these values were missing, the average was calculated using the available values, however, a minimum of 2 predose FEV1 values were required; participants who had only 1 or no predose FEV1 measurements on Day 1 would have their FEV1 baseline missing, and the participant was to be excluded from analysis.
FEV1 was measured using spirometry in accordance with the ATS/ERS consensus guidelines. Baseline-adjusted area under the serial FEV1-time curve was calculated from Time 0 to 12 hours on the first day of the Treatment Period (Day 1). FEV1 AUC0-12 was calculated from baseline-adjusted values using the linear trapezoidal method. The calculation assumed that at time of dosing (Time 0) the baseline adjusted FEV1 was also 0. The calculation proceeded over all available post-dose FEV1 assessments on Day 1 (including unscheduled time points, if any) using actual elapsed time from dosing. FEV1 baseline defined as the average of predose FEV1 values obtained on Day 1. If some of these values were missing, the average was calculated using the available values, however, a minimum of 2 predose FEV1 values were required; participants who had only 1 or no predose FEV1 measurements on Day 1 would have their FEV1 baseline missing, and the participant was to be excluded from analysis.
FEV1 was measured using spirometry in accordance with the ATS/ERS consensus guidelines. Average predose FEV1 at End of Treatment defined as the average of all predose assessments on Day 42. If a participant had no predose assessment on Day 42, the average of all available predose assessments on the last day (for example, Early Termination visit \[up to Day 50\]) when at least 1 predose FEV1 assessments was available was imputed, if the participant discontinued due to lack of efficacy, otherwise there was no imputation. Baseline was defined as the average of at least 2 predose FEV1 values obtained on Day 1. The endpoint of baseline-adjusted predose FEV1 at end of treatment was calculated as follows: \[FEV1 at end of treatment\] - \[Baseline FEV1\].
FEV1 was measured using spirometry in accordance with the ATS/ERS consensus guidelines. Average predose FEV1 at End of Treatment defined as the average of all predose assessments on Day 42. If a participant had no predose assessment on Day 42, the average of all available predose assessments on the last day (for example, Early Termination visit \[up to Day 50\]) when at least 1 predose FEV1 assessments was available was imputed, if the participant discontinued due to lack of efficacy, otherwise there was no imputation. Baseline was defined as the average of at least 2 predose FEV1 values obtained on Day 1. The endpoint of baseline-adjusted predose FEV1 at end of treatment was calculated as follows: \[FEV1 at end of treatment\] - \[Baseline FEV1\].
| Arm | Type | Description |
|---|---|---|
| Generic Budesonide/Formoterol Fumarate Dihydrate | EXPERIMENTAL | After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants will administer 2 inhalations twice daily via a generic budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days. |
| Symbicort (Budesonide/Formoterol Fumarate Dihydrate) | ACTIVE_COMPARATOR | After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants will administer 2 inhalations twice daily via a Symbicort budesonide/formoterol fumarate dihydrate (80 μg/4.5 μg) pMDI for up to 50 days. |
| Placebo | PLACEBO_COMPARATOR | After a 2-week Run-in Period of administering 2 inhalations twice daily via a generic placebo pMDI device, participants will administer 2 inhalations twice daily via a generic placebo pMDI for up to 50 days. |
| Name | Type | Description |
|---|---|---|
| Generic Budesonide/Formoterol Fumarate Dihydrate | DRUG | Oral inhalation, generic formulation of the brand-name product. |
| Symbicort® (Budesonide/Formoterol Fumarate Dihydrate) | DRUG | Oral inhalation, brand-name product. |
| Placebo | DRUG | Oral inhalation, no active ingredient. |
Inclusion criteria: 1. Adolescent and adult male or female participants (≥12 and ≤75 years of age). 2. Female participants must not be lactating or pregnant at Screening, as documented by a negative serum pregnancy test with a minimum sensitivity of 25 international unit/liter (IU/L) or equivalent ...
Generic Budesonide/Formoterol is used for the treatment of asthma. It is a small molecule respiratory therapy being developed by Teva Pharmaceutical Industries Limited (TEVA). The drug is currently in Phase 3 clinical development and is being studied as a potential alternative to the branded product Symbicort.
Generic Budesonide/Formoterol combines budesonide, a corticosteroid, and formoterol, a long-acting beta-agonist. These components work together to reduce airway inflammation and relax bronchial muscles, helping to control asthma symptoms. The drug is being developed as a generic version of Symbicort.
Generic Budesonide/Formoterol is being developed by Teva Pharmaceutical Industries Limited, a company listed on the stock exchange under the ticker symbol TEVA. Teva is conducting the clinical development program for this asthma treatment, which is currently in Phase 3 trials.
Generic Budesonide/Formoterol is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will help determine whether the drug can be submitted for regulatory approval.
Generic Budesonide/Formoterol has one completed Phase 3 clinical trial, identified as NCT02495168. This randomized, double-blind, placebo-controlled study enrolled 1,714 participants with asthma in the United States. The trial compared the generic budesonide/formoterol combination to Symbicort in asthmatic participants aged 12 years and older.
Generic Budesonide/Formoterol is being developed as a generic version of Symbicort, which contains the same active ingredients: budesonide and formoterol fumarate dihydrate. The Phase 3 trial was designed to compare the generic product to Symbicort to demonstrate bioequivalence and similar efficacy in treating asthma.