Drugs / Budesonide/Glycopyrronium/Formoterol
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT06905483 | Apr → Dec 2025 | chronic obstructive pulmonary disease | Thammasat University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-07-24 | AstraZeneca | Regulatory Trixeo recommended for approval in the EU by CHMP for the maintenance treatment of asthma astrazeneca.com ↗ |
| 2026-04-28 | AstraZeneca | Regulatory Breztri approved in the US for asthma as first and only triple therapy for patients 12 years of age and older astrazeneca.com ↗
AstraZeneca’s fixed-dose triple-combination therapy Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) has been approved in the US for the maintenance treatment of asthma in adult and paediatric patients 12 years of age and older. |
| 2025-07-25 | AstraZeneca | Regulatory Trixeo Aerosphere receives positive EU CHMP opinion as first inhaled medicine using next-generation propellant with near-zero Global Warming Potential astrazeneca.com ↗
AstraZeneca’s Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF), already licensed for the treatment of chronic obstructive pulmonary disease (COPD) in adults, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, endorsing it for use in the European Union (EU) with an innovative, next-generation propellant with near-zero Global Warming Potential (GWP). |
| 2025-05-12 | AstraZeneca | Regulatory Trixeo Aerosphere approved in the UK as first inhaled respiratory medicine using next-generation propellant with near-zero Global Warming Potential astrazeneca.com ↗
AstraZeneca’s Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF), already licensed for the treatment of chronic obstructive pulmonary disease (COPD) in adults, has now been approved for use in the UK with an innovative, next-generation propellant with near-zero Global Warming Potential (GWP). |
| 2024-05-01 | AstraZeneca | Results AstraZeneca unveils latest research across key respiratory and immune-mediated diseases at ATS 2024 showcasing strength of its broad pipeline and portfolio astrazeneca.com ↗
ETHOS Phase III trial post-hoc analysis of cardiopulmonary outcomes: the new analysis explores the effect of BGF across a range of cardiopulmonary outcomes beyond traditional COPD endpoints. |
| 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 ↗
Breztri Aerosphere reduced rate of COPD exacerbations across all seasons compared with Bevespi Aerosphere |
| 2019-12-23 | AstraZeneca | Regulatory AstraZeneca’s triple-combination therapy approved in China for patients with COPD astrazeneca.com ↗
AstraZeneca today announced that budesonide/glycopyrronium/formoterol fumarate has been approved in China for the maintenance treatment of chronic obstructive pulmonary disease (COPD). |
| 2019-08-28 | AstraZeneca | Results Breztri Aerosphere Phase III ETHOS trial met its primary endpoint in chronic obstructive pulmonary disease astrazeneca.com ↗
AstraZeneca today announced positive results from the Phase III ETHOS trial for triple-combination therapy Breztri Aerosphere , formerly PT010, in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). |
All press releases naming this drug 8 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/Glycopyrronium/Formoterol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06905483 ↗ |
| Known as | budesonide/glycopyrrolate/formoterol fumarate | “BACKGROUND: We report the long-term effects of triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF) vs glycopyrrolate/formoterol fumarate (GFF) and...” PMID 34171789 ↗ Jun 2021 |
| Route | Inhaled | “BGF (160/7.2/5 mcg) 2 inhalations, twice daily for 4 weeks” NCT06905483 ↗ |