BACKGROUND: The efficacy of inhaled corticosteroids (ICS) in moderately severe COPD patients remains unclear. At the same time, the use of extrafine particles in COPD patients is a topic of ongoing research. OBJECTIVES: This study assessed the effect of ICS in steroid-naïve mild COPD patients and the effect of reducing the ICS dose in more severe COPD patients previously using ICS when switching to an extrafine particle BDP/F formulation (Foster using Modulite technology, Chiesi Pharmaceutici, Parma, Italy). METHODS: Novel functional respiratory imaging (FRI) methods, consisting of multi-slice CT scans and Computational Fluid Dynamics, were used in combination with conventional pulmonary function tests and patient reported outcomes. RESULTS: The study showed that the administration of extrafine BDP/F after 4-6 h led to a significant improvement in lung function parameters and hyperinflation as determined by spirometry, body plethysmography, and functional respiratory imaging. After 6 months of treatment, it was observed that, compared to baseline, the hyperinflation on lobar level at total lung capacity was significantly reduced (-1.19±7.19 %p, p=0.009). In addition, a significant improvement in SGRQ symptom score was noted in the entire patient population. Patients who improved in terms of hyperinflation also improved their MMRC dyspnea score. CFD indicated a difference in regional deposition between extrafine and non-extrafine formulations with -11% extrathoracic deposition and up to +4% lobe deposition for the extrafine formulation. CONCLUSIONS: The study showed that the administration of extrafine BDP/F improved lung function parameters and hyperinflation. Patients previously treated with ICS remained stable despite the lower dose, while ICS naïve patients improved in terms of lobar hyperinflation. FRI seems to be a sensitive biomarker to detect clinically relevant changes that are not detected by spirometry. The next step is to confirm these findings in a controlled trial.
BACKGROUND: The efficacy of inhaled corticosteroids (ICS) in moderately severe COPDpatients remains unclear. At the same time, the use of extrafine particles in COPDpatients is a topic of ongoing research. OBJECTIVES: This study assessed the effect of ICS in steroid-naïve mild COPDpatients and the effect of reducing the ICS dose in more severe COPDpatients previously using ICS when switching to an extrafine particle BDP/F formulation (Foster using Modulite technology, Chiesi Pharmaceutici, Parma, Italy). METHODS: Novel functional respiratory imaging (FRI) methods, consisting of multi-slice CT scans and Computational Fluid Dynamics, were used in combination with conventional pulmonary function tests and patient reported outcomes. RESULTS: The study showed that the administration of extrafine BDP/F after 4-6 h led to a significant improvement in lung function parameters and hyperinflation as determined by spirometry, body plethysmography, and functional respiratory imaging. After 6 months of treatment, it was observed that, compared to baseline, the hyperinflation on lobar level at total lung capacity was significantly reduced (-1.19±7.19 %p, p=0.009). In addition, a significant improvement in SGRQ symptom score was noted in the entire patient population. Patients who improved in terms of hyperinflation also improved their MMRC dyspnea score. CFD indicated a difference in regional deposition between extrafine and non-extrafine formulations with -11% extrathoracic deposition and up to +4% lobe deposition for the extrafine formulation. CONCLUSIONS: The study showed that the administration of extrafine BDP/F improved lung function parameters and hyperinflation. Patients previously treated with ICS remained stable despite the lower dose, while ICS naïve patients improved in terms of lobar hyperinflation. FRI seems to be a sensitive biomarker to detect clinically relevant changes that are not detected by spirometry. The next step is to confirm these findings in a controlled trial.
Authors: P Worth Longest; Karl Bass; Rabijit Dutta; Vijaya Rani; Morgan L Thomas; Ahmad El-Achwah; Michael Hindle Journal: Expert Opin Drug Deliv Date: 2018-12-10 Impact factor: 6.648
Authors: Johan Clukers; Maarten Lanclus; Dennis Belmans; Cedric Van Holsbeke; Wilfried De Backer; Dharshan Vummidi; Paul Cronin; Ben R Lavon; Jan De Backer; Dinesh Khanna Journal: J Scleroderma Relat Disord Date: 2021-01-10
Authors: Dave Singh; Massimo Corradi; Monica Spinola; Stefano Petruzzelli; Alberto Papi Journal: NPJ Prim Care Respir Med Date: 2016-06-16 Impact factor: 2.871
Authors: Bita Hajian; Jan De Backer; Wim Vos; Wouter H van Geffen; Paul De Winter; Omar Usmani; Tony Cahn; Huib Am Kerstjens; Massimo Pistolesi; Wilfried De Backer Journal: Int J Chron Obstruct Pulmon Dis Date: 2018-03-06