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 ...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
Symbicort Turbuhaler is used to treat asthma, bronchial asthma, and chronic obstructive pulmonary disease (COPD). It is a small molecule therapy delivered by inhalation. Clinical development has covered both asthma and COPD populations, including a Phase 3 COPD study in Japan and Phase 3 asthma studies across multiple countries.
Symbicort Turbuhaler is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical trials evaluating the product in asthma and chronic obstructive pulmonary disease.
Symbicort Turbuhaler has been studied in Phase 3 clinical development. The trials listed are completed, and no active trials are currently recorded. The program includes randomized, double-blind, active-controlled studies in asthma and chronic obstructive pulmonary disease.
Symbicort Turbuhaler has been evaluated in completed Phase 3 trials including NCT01070784, a COPD safety and efficacy study in Japan; NCT00839800, an asthma SMART study across multiple countries; NCT00837967, a high-dose SMART study in Japanese patients; and NCT00536731, a therapeutic equivalence study in bronchial asthma.