Drugs / budesonide/formoterol
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT00915538 | Jul → Aug 2009 | asthma | Western Sky Medical Research | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2019-05-20 | AstraZeneca | Results New data show Symbicort reduces attacks in mild asthma when used as an anti-inflammatory reliever astrazeneca.com ↗
Symbicort Turbuhaler demonstrated a 51% reduction in the rate of annual asthma exacerbations compared to albuterol. |
| 2018-09-13 | AstraZeneca | Results AstraZeneca to present Fasenra long-term safety and efficacy data at European Respiratory Society International Congress 2018 astrazeneca.com ↗
Impact of eosinophil levels on lung function and exacerbation benefits with co-suspension delivery technology budesonide/glycopyrronium/formoterol metered dose inhaler (BGF MDI) in COPD (KRONOS study subgroup analysis) |
| 2017-01-26 | AstraZeneca | Regulatory Symbicort granted paediatric exclusivity in the US astrazeneca.com ↗
AstraZeneca today announced that on 25 January 2017 the US Food and Drug Administration (FDA) granted six months of paediatric exclusivity for Symbicort (budesonide/formoterol) Inhalation Aerosol. |
| 2009-04-06 | AstraZeneca | Regulatory AstraZeneca Receives FDA Complete Response Letter on Symbicort for the Treatment of Asthma in Children 6 to 11 Years Old astrazeneca.com ↗ |
| 2009-03-02 | AstraZeneca | Regulatory FDA Approves Symbicort for Chronic Obstructive Pulmonary Disease astrazeneca.com ↗
The FDA approval is based on results from two pivotal clinical trials, SHINE (6-month) and SUN (12-month), which found SYMBICORT significantly improved lung function within five minutes of the first dose and sustained that lung function improvement for the duration of the studies. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-05-20 | AstraZeneca | New data show Symbicort reduces attacks in mild asthma when used as an anti-inflammatory reliever astrazeneca.com ↗ |
| 2018-09-13 | AstraZeneca | AstraZeneca to present Fasenra long-term safety and efficacy data at European Respiratory Society International Congress 2018 astrazeneca.com ↗ |
| 2017-01-26 | AstraZeneca | Symbicort granted paediatric exclusivity in the US astrazeneca.com ↗ |
| 2009-04-06 | AstraZeneca | AstraZeneca Receives FDA Complete Response Letter on Symbicort for the Treatment of Asthma in Children 6 to 11 Years Old astrazeneca.com ↗ |
| 2009-03-02 | AstraZeneca | FDA Approves Symbicort for Chronic Obstructive Pulmonary Disease astrazeneca.com ↗ |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | budesonide/formoterol | “The asthmatic subjects will receive budesonide/formoterol pMDI 160/4.5 pMDI 2 inhalations used in conventional fashion” NCT00915538 ↗ |