Drugs / budesonide/formoterol
budesonide/formoterol
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed intermittent asthma 1 milestone | |||||
| Filed | EU (EMA) | Symbicort Turbuhaler | intermittent asthma | 2019-05-20 | “A regulatory submission to expand the indication for Symbicort Turbuhaler as an anti-inflammatory reliever in mild asthma has been accepted in Europe.” astrazeneca.com ↗ |
| Rejected asthma 1 milestone | |||||
| Rejected (CRL) | US (FDA) | SYMBICORT | asthma | 2009-04-06 | “received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for SYMBICORT” astrazeneca.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT00463866 | Mar 2007 → Dec 2008 | asthma | AstraZeneca | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2020-09-07 | AstraZeneca | Results New analyses from Breztri Aerosphere Phase III ETHOS trial to be presented at the European Respiratory Society International Congress 2020 astrazeneca.com ↗
A post-hoc analysis of the Phase III ETHOS trial showed a consistent benefit of Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) in reducing the rate of moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations across all seasons compared with Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in patients with moderate to very severe disease. |
| 2018-01-26 | AstraZeneca | Results AstraZeneca reports top-line Phase III KRONOS trial results for PT010 triple combination therapy in chronic obstructive pulmonary disease astrazeneca.com ↗ |
| 2016-05-12 | AstraZeneca | Results AstraZeneca to highlight the breadth of its respiratory medicines at American Thoracic Society 2016 International Conference astrazeneca.com ↗
Pooled analyses from PINNACLE-1 and -2; the novel LAMA/LABA co-suspension technology glycopyrrolate/formoterol fixed-dose combination delivered by MDI shows significant improvement versus monocomponents in patients with COPD |
| 2013-03-19 | AstraZeneca | Results Real world study comparing commonly prescribed COPD medicines shows choice of treatment has impact on patient outcomes astrazeneca.com ↗
Overall, budesonide/formoterol reduced the annual rate of moderate to severe exacerbations by 26% compared to fluticasone/salmeterol (0.80 vs. 1.09 /patient-year; p<0.0001). |
All press releases naming this drug 6 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | budesonide/formoterol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00463866 ↗ |
| Known as | Symbicort SMART | “A randomised 6-month study compared two maintenance doses of budesonide/formoterol (Symbicort® Turbuhaler® (h) maintenance and reliever therapy (Symbicort SMART®), 160/4.5 μg 1...” PMID 21435854 ↗ Mar 2011 |
| Known as | Symbicort Turbuhaler | “A randomised 6-month study compared two maintenance doses of budesonide/formoterol (Symbicort® Turbuhaler® (h) maintenance and reliever therapy (Symbicort SMART®), 160/4.5 μg 1...” PMID 21435854 ↗ Mar 2011 |