Drugs / budesonide/formoterol
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | SYMBICORT | childhood onset 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 3 | NCT00839800 | Feb 2009 → Feb 2011 | asthma | AstraZeneca | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-05-19 | AstraZeneca | Results Statistically significant and clinically meaningful BATURA Phase III trial results provide new evidence for Airsupra as standard of care for as-needed rescue treatment in asthma astrazeneca.com ↗
Positive full results from the BATURA Phase IIIb trial showed AstraZeneca’s anti-inflammatory reliever rescue therapy, Airsupra (albuterol/budesonide), demonstrated statistically significant and clinically meaningful improvements in all primary and secondary endpoints compared to albuterol in patients with mild asthma. |
| 2019-08-28 | AstraZeneca | Results Breztri Aerosphere Phase III ETHOS trial met its primary endpoint in chronic obstructive pulmonary disease astrazeneca.com ↗
At half of the budesonide dose, Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate 160/14.4/9.6mcg) also demonstrated a statistically-significant reduction in the rate of moderate or severe exacerbations compared with Bevespi Aerosphere and PT009. |
All press releases naming this drug 2 releases
Evidence & citations 2 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 | “We analyzed daily peak expiratory flow and symptom scores recorded by participants in the SAKURA study (NCT00839800), an international multicentre randomized controlled trial...” PMID 32718193 ↗ Aug 2020 |
| Route | Inhaled | “Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed” NCT00839800 ↗ |