Chiesi’s carbon minimal inhalers reach innovation milestone as phase III trials now underway

• Chiesi Group announces major step forward in the development of carbon minimal inhalers with the initiation of a phase III safety trial.[1]
• The trial comes after the completion of two short-term clinical safety studies.[2]^,[3]
• The global TRECOS study includes five UK sites across Manchester, Portsmouth, Bradford and London.

Manchester, UK, 4^th April 2024 – Chiesi, the international research-focused biopharmaceutical and healthcare group, has announced that its phase III clinical safety trial for the development of an innovative carbon minimal inhaler platform is underway.¹ The carbon minimal inhaler will replace the current hydrofluorocarbon propellant (HFC 134a) with the low global warming potential propellant (HFC 152a) as part of a €350 million investment into low global warming solutions to treat respiratory conditions.

The global phase III TRECOS study follows the completion of two short term clinical trials assessing the safety of the propellant.^2,3 This milestone follows the successful completion of similar studies in 2022.[4]

Around 1.3 million people are living with COPD in the UK, and around 5.4 million are living with asthma.[5]^,[6] COPD and asthma patients require access to a range of inhaler options depending on their individual needs including pressurised metered dose inhalers (pMDIs).[7] International guidelines for the treatment of both asthma and COPD support the concept of choosing the right medication and appropriate device for the patient to reduce their risk of severe exacerbations.[8]^,[9]

The development and availability of Chiesi’s carbon minimal inhaler platform will enable the company to reduce its emissions related to current products by up to 90% when compared to existing metered dose inhalers (MDIs), with significant reductions expected both in terms of direct emissions (production processes) and indirect (use of pMDIs).[10] This is a key step in the company’s journey to achieve Net Zero greenhouse gas emissions by 2035 while preserving asthma and COPD patients’ needs.⁹

“Following our announcement to invest in the development of ‘green innovation’ for respiratory conditions, we’re delighted to report on the progress of our carbon minimal inhaler platform. Phase III trials are now well underway, with UK sites having begun recruiting in December 2023,” said Ralph Blom, General Manager, Chiesi UK and Ireland. “We look forward to working together with patients, clinicians, and regulatory authorities to ensure this innovative technology provides much needed choice for those living with COPD and asthma in the UK and across the world.”  

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About Chiesi Group   

Chiesi is an international, research-focused biopharmaceuticals group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment.

By changing its legal status to a Benefit Corporation in Italy, the US, and France, Chiesi’s commitment to create shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, we’re part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035.

With over 85 years of experience, Chiesi is headquartered in Parma (Italy), operates in 31 countries, and counts more than 6,500 employees. The Group’s research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden.

For further information please visit www.chiesi.uk.com.

[1] Clinical Trials.Gov. Comparison Between CHF5993 pMDI 200/​6/​12,5mg HFA-152a VS CHF5993 pMDI 200/​6/​12,5mg HFA-134a in Subjects With Asthma (Trecos) (TRECOS). Available at https://clinicaltrials.gov/study/NCT06264674?term=HFC%20152a%20&cond=asthma&rank=14. Last accessed April 2024.

[2] Clinical Trials.Gov. Study to Assess the Effect of the New HFA-152a Propellant on Mucociliary Clearance. Available at https://clinicaltrials.gov/study/NCT05875025. Last accessed April 2024.

[3] Clinical Trials.Gov. Study to Compare the Effects of Two Propellants in Adults With Mild Asthma. Available at https://clinicaltrials.gov/study/NCT05472662. Last accessed April 2024.

[4] Chiesi Group. First carbon minimal pMDI is on track with the goal to benefit patients and planet. Available at https://www.chiesi.com/en/first-carbon-minimal-pmdi-is-on-track-with-the-goal-to-benefit-patients-and-planet/. Last accessed April 2024.

[5] Asthma + Lung UK. What is Chronic Obstructive Pulmonary Disease (COPD)? Available at https://www.asthmaandlung.org.uk/conditions/copd-chronic-obstructive-pulmonary-disease/what-chronic-obstructive-pulmonary-disease. Last accessed April 2024.

[6] Asthma + Lung UK. What is asthma? Available at https://www.asthmaandlung.org.uk/conditions/asthma/what-asthma. Last accessed April 2024.

[7] Usmani OS. Choosing the right inhaler for your asthma or COPD patient. Ther Clin Risk Manag. 2019; 15: 461–472.

[8] Global Initiative for Chronic Obstructive Pulmonary Disease. 2024 Gold Report. Available at https://goldcopd.org/2024-gold-report/.  Last accessed April 2024.

[9] Global Initiative for Asthma. 2023. Gina Main Report. Available at https://ginasthma.org/2023-gina-main-report/. Last accessed April 2024.

[10] Chiesi. Action over Words. Available at https://actionoverwords.co.uk. Last accessed April 2024.