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The effects of extrafine beclometasone/formoterol (BDP/F) on lung function, dyspnea, hyperinflation, and airway geometry in COPD patients: novel insight using functional respiratory imaging.
J Aerosol Med Pulm Drug Deliv. 2015 Apr; 28(2):88-99.JA

Abstract

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.

Authors+Show Affiliations

1 FluidDA NV , 2550 Kontich, Belgium .No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

25004168

Citation

De Backer, Jan, et al. "The Effects of Extrafine Beclometasone/formoterol (BDP/F) On Lung Function, Dyspnea, Hyperinflation, and Airway Geometry in COPD Patients: Novel Insight Using Functional Respiratory Imaging." Journal of Aerosol Medicine and Pulmonary Drug Delivery, vol. 28, no. 2, 2015, pp. 88-99.
De Backer J, Vos W, Vinchurkar S, et al. The effects of extrafine beclometasone/formoterol (BDP/F) on lung function, dyspnea, hyperinflation, and airway geometry in COPD patients: novel insight using functional respiratory imaging. J Aerosol Med Pulm Drug Deliv. 2015;28(2):88-99.
De Backer, J., Vos, W., Vinchurkar, S., Van Holsbeke, C., Poli, G., Claes, R., Salgado, R., & De Backer, W. (2015). The effects of extrafine beclometasone/formoterol (BDP/F) on lung function, dyspnea, hyperinflation, and airway geometry in COPD patients: novel insight using functional respiratory imaging. Journal of Aerosol Medicine and Pulmonary Drug Delivery, 28(2), 88-99. https://doi.org/10.1089/jamp.2013.1064
De Backer J, et al. The Effects of Extrafine Beclometasone/formoterol (BDP/F) On Lung Function, Dyspnea, Hyperinflation, and Airway Geometry in COPD Patients: Novel Insight Using Functional Respiratory Imaging. J Aerosol Med Pulm Drug Deliv. 2015;28(2):88-99. PubMed PMID: 25004168.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effects of extrafine beclometasone/formoterol (BDP/F) on lung function, dyspnea, hyperinflation, and airway geometry in COPD patients: novel insight using functional respiratory imaging. AU - De Backer,Jan, AU - Vos,Wim, AU - Vinchurkar,Samir, AU - Van Holsbeke,Cedric, AU - Poli,Gianluigi, AU - Claes,Rita, AU - Salgado,Rodrigo, AU - De Backer,Wilfried, Y1 - 2014/07/08/ PY - 2014/7/9/entrez PY - 2014/7/9/pubmed PY - 2016/3/29/medline SP - 88 EP - 99 JF - Journal of aerosol medicine and pulmonary drug delivery JO - J Aerosol Med Pulm Drug Deliv VL - 28 IS - 2 N2 - 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. SN - 1941-2703 UR - https://www.unboundmedicine.com/medline/citation/25004168/The_effects_of_extrafine_beclometasone/formoterol__BDP/F__on_lung_function_dyspnea_hyperinflation_and_airway_geometry_in_COPD_patients:_novel_insight_using_functional_respiratory_imaging_ L2 - https://www.liebertpub.com/doi/10.1089/jamp.2013.1064?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -