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Also known as Symbicort pMDI
Symbicort pMDI with spacer device · 2 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 |
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...
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 pMDI with spacer device is a pressurized metered-dose inhaler (pMDI) used with a spacer to deliver asthma therapy. It is a small-molecule combination product developed by AstraZeneca PLC (ticker: AZN). The device is designed to help patients inhale the medication effectively, particularly those who have difficulty coordinating inhalation with actuation.
Symbicort pMDI with spacer device is used for the treatment of asthma. It is indicated for patients with asthma, including children aged 6 to less than 12 years and adults and adolescents aged 12 years and older, as studied in Phase 3 clinical trials.
Symbicort pMDI with spacer device is developed by AstraZeneca PLC, which trades under the ticker symbol AZN. AstraZeneca is the company responsible for the clinical development of this asthma therapy.
Symbicort pMDI with spacer device is in Phase 3 clinical development. The development program includes two completed Phase 3 trials. It is an investigational product and has not been approved by the FDA for the studied indication.
Symbicort pMDI with spacer device has been evaluated in two completed Phase 3 trials: NCT02091986, a 12-week study in asthmatic children aged 6 to less than 12 years, and NCT01444430, a 6-month safety study in asthmatic adults and adolescents. Both trials are completed.