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 | asthma | 2009-04-06 | “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 | NCT00252824 | Jul 2005 → Dec 2006 | asthma | AstraZeneca | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-02-13 | AstraZeneca | Results Positive and clinically meaningful results from the Phase III KALOS and LOGOS trials for Breztri in patients with uncontrolled asthma published in The Lancet Respiratory Medicine astrazeneca.com ↗
In the pooled analysis of KALOS and LOGOS, Breztri also demonstrated clinically meaningful reductions in the annualised rate of severe asthma exacerbations versus ICS/LABA medicines in patients with or without a recent asthma exacerbation. |
| 2021-01-26 | AstraZeneca | Regulatory Symbicort Turbuhaler approved in China as an anti-inflammatory reliever in mild asthma astrazeneca.com ↗
AstraZeneca’s Symbicort Turbuhaler (budesonide/formoterol 160/4.5mcg) has been approved in China as an anti-inflammatory reliever to be taken as-needed in response to symptoms to achieve asthma control in patients with mild asthma aged 12 years and older. |
| 2020-06-24 | AstraZeneca | Results Breztri Aerosphere significantly reduced rate of moderate or severe COPD exacerbations in Phase III ETHOS trial astrazeneca.com ↗
Breztri Aerosphere achieved a 13% reduction (p=0.003) compared with PT009 (budesonide/formoterol fumarate). |
| 2019-08-28 | AstraZeneca | Results Breztri Aerosphere Phase III ETHOS trial met its primary endpoint in chronic obstructive pulmonary disease astrazeneca.com ↗
At the standard budesonide dose, Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6mcg) demonstrated a statistically-significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate 14.4/9.6mcg) and PT009 (budesonide/formoterol fumarate 320/9.6mcg). |
| 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. |
| 2018-09-16 | AstraZeneca | Results The Lancet Respiratory Medicine publishes first Phase III trial for PT010 triple combination therapy in moderate to very severe chronic obstructive pulmonary disease astrazeneca.com ↗
PT010 also demonstrated reductions in the rate of moderate or severe COPD exacerbations versus PT009 and Symbicort (18% and 17% respectively), which were numerically but not statistically significant improvements. |
| 2018-09-13 | AstraZeneca | Results AstraZeneca to present Fasenra long-term safety and efficacy data at European Respiratory Society International Congress 2018 astrazeneca.com ↗
Adding budesonide to formoterol reduces risk of clinically important deteriorations (CID) in moderate to very severe COPD |
| 2018-05-17 | AstraZeneca | Results New England Journal of Medicine publishes two trials for Symbicort as an anti-inflammatory reliever therapy ‘as needed’ in mild asthma astrazeneca.com ↗
AstraZeneca today announced results from the Phase III SYGMA trials 1 , 2 of Symbicort Turbuhaler (budesonide/formoterol) given as an anti-inflammatory reliever ‘as needed’ versus two different treatment regimens in patients with mild asthma. |
| 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 ↗
In total, eight of the nine primary endpoints in the KRONOS trial were met, including two non-inferiority endpoints to qualify PT009, one of the comparators. |
| 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). |
| 2010-06-02 | AstraZeneca | Regulatory FDA updates US product labels for LABA-containing medications including AstraZeneca’s SYMBICORT astrazeneca.com ↗
The updated label for combination asthma medications, including SYMBICORT, provides guidance on how these products should be prescribed to treat asthma, including: |
All press releases naming this drug 11 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Budesonide/formoterol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00252824 ↗ |
| Route | Inhaled | “Symbicort Turbuhaler® 160/4.5 mg 1 Inhalation b.i.d. Plus As-needed” NCT00252824 ↗ |