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Pioneering Study Reveals No Increased Pneumonia Risk in COPD Patients Using Extrafine Beclometasone Dipropionate in Inhaler Therapy

Singapore, [21 February 2024] – A ground-breaking study conducted by an international consortium of leading respiratory experts sheds new light on the management of chronic obstructive pulmonary disease (COPD). The study, titled "Risk of Pneumonia in Patients with COPD Initiating Fixed Dose ICS/LABD Containing Extrafine Beclometasone Dipropionate," challenges conventional wisdom by demonstrating no increased risk of pneumonia associated with the use of extrafine beclometasone dipropionate (ef-BDP) in inhaler therapy among COPD patients. It has just been published in this month’s issue of the medical journal Pragmatic & Observational Research.

This research was conducted across a diverse UK real-world clinical population by comparing the pneumonia risk among new users of fixed-dose inhaled corticosteroid (ICS)/long-acting bronchodilator (LABD) formulations containing ef-BDP versus patients initiating LABD therapy without any ICS. It involved an international team of academic investigators from nine countries (Singapore, the UK, Brazil, Italy, The Netherlands, France, Turkey, Germany, and Spain).

Professor David B. Price, the lead author and Head of the Observational and Pragmatic Research Institute, emphasized, "Our findings challenge the prevailing understanding of ICS use in COPD management. The risk of pneumonia associated with ICS reported in previous studies may not be relevant when using extrafine beclometasone dipropionate."

The study utilized a propensity-matched historical cohort design and drew data from 23,898 COPD patients. Results indicated that initiation of ef-BDP/LABD therapy did not elevate the risk of pneumonia when compared to LABD therapy alone. The probability of remaining pneumonia-free after initiating ef-BDP/LABD was  98.4% at one year, comparable to the 97.7% observed in LABD therapy alone. Importantly, this was sustained over six years of observation, meeting non-inferiority criteria for both sensitive and specific definitions of pneumonia.

Moreover, the study found an additional benefit associated with ef-BDP/LABD therapy, showing a reduced risk of lower respiratory tract infections (LRTIs) in the propensity-matched cohort, further highlighting the potential advantages of this treatment approach.

Professor Price remarked, "This research provides new findings, suggesting that the risk of pneumonia, a concern associated with ICS use, may not be a significant factor when employing ef-BDP in real-world clinical settings."

This international study is poised to inform clinical practice and shape future guidelines for the management of COPD.

This study was conducted by the Observational and Pragmatic Research Institute (OPRI) Pte Ltd and was funded by Chiesi Farmaceutici S.p.A.

Read the full article here.


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