news

Breztri Aerosphere Phase III trial meets primary endpoints

0
SHARES

A clinical trial to study a chronic obstructive pulmonary disease treatment has found that the drug is effective and safe.

A Phase III ETHOS trial studying triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate), formerly PT010, has met its primary endpoints. The treatment is to combat moderate to very severe chronic obstructive pulmonary disease (COPD).

 

Reserve your FREE place

 


Address the time-to-result challenge posed by short shelf-life radiopharmaceuticals.

20 November 2025 | 3:00 PM GMT | FREE Virtual Panel Discussion

This webinar showcases the Growth Direct System; an RMM (Rapid Microbial Method) that improves on traditional membrane filtration, delivering increased accuracy, a faster time to result, enhanced data integrity compliance, and more control over the manufacturing process.

Key learning points:

  • Understand the benefits of full workflow microbiology quality control testing automation in radiopharmaceutical production
  • Learn about ITM’s implementation journey and considerations when evaluating the technology
  • Find out how the advanced optics and microcolony detection capabilities of Growth Direct® technology impact time to result (TTR).

Don’t miss your chance to learn from experts in the industry – Register for FREE

 

AstraZeneca (AZ) conducted the randomised, double-blinded, multi-centre, parallel-group, 52-week trial to assess the efficacy and safety of the treatment.

The safety and tolerability of Breztri Aerosphere were consistent with the known profiles of the dual comparators. In the trial, all combination therapies were administered in a pressurised metered-dose inhaler (pMDI).

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AZ, said: “Exacerbations are devastating events for patients and can lead to a permanent loss of lung function. The Phase III ETHOS trial builds on the Phase III KRONOS data which together show Breztri Aerosphere’s ability to reduce exacerbation risk in a broad range of patients with COPD, irrespective of whether they have had an exacerbation in the previous 12 months. We look forward to sharing these results with health authorities as soon as possible.”

The ETHOS trial results will be presented at an upcoming medical meeting. Breztri Aerosphere has been approved in Japan and is under regulatory review in China, where it has been granted Priority Review by the National Medical Products Administration. It is also under regulatory review in the US and EU.

Share via
Share via