Drugs / Budesonide/Formoterol
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT00255255 | Nov 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. |
| 2020-10-19 | AstraZeneca | Regulatory Trixeo Aerosphere recommended for approval in the EU by CHMP for the maintenance treatment of COPD astrazeneca.com ↗
AstraZeneca’s Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) has been recommended for marketing authorisation in the European Union (EU) for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA), or a combination of a LABA and a long-acting muscarinic antagonist. |
| 2020-06-24 | AstraZeneca | Results Breztri Aerosphere significantly reduced rate of moderate or severe COPD exacerbations in Phase III ETHOS trial astrazeneca.com ↗
Compared with Bevespi Aerosphere (glycopyrronium/formoterol fumarate), Breztri Aerosphere achieved a 24% reduction (p<0.001) in exacerbations. |
| 2019-06-19 | AstraZeneca | Regulatory Breztri Aerosphere (PT010) approved in Japan for patients with chronic obstructive pulmonary disease astrazeneca.com ↗
AstraZeneca today announced that Breztri Aerosphere (budesonide/glycopyrronium/ formoterol fumarate), formerly PT010, has been approved in Japan as a triple-combination therapy to relieve symptoms of chronic obstructive pulmonary disease (COPD). |
| 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 ↗
The data were presented today at the European Respiratory Society (ERS) International Congress 2018 in Paris, France, and published in The Lancet Respiratory Medicine . |
| 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. |
| 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. |
| 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 ↗
Today, the US Food and Drug Administration (FDA) released final label revisions for respiratory medications that contain an active ingredient known as a long-acting beta-agonist (LABA). |
| 2009-03-02 | AstraZeneca | Regulatory FDA Approves Symbicort for Chronic Obstructive Pulmonary Disease astrazeneca.com ↗ |
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 NCT00255255 ↗ |
| Route | Inhaled | “1, 2 or 4 inhalation b.i.d.” NCT00255255 ↗ |