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. doi: 10.1089/jamp.2013.1064. Epub 2014 Jul 8.


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.

Publication types

  • Clinical Trial

MeSH terms

  • Administration, Inhalation
  • Adrenergic beta-2 Receptor Agonists / administration & dosage*
  • Adrenergic beta-2 Receptor Agonists / chemistry
  • Aerosols
  • Aged
  • Aged, 80 and over
  • Beclomethasone / administration & dosage*
  • Beclomethasone / chemistry
  • Bronchodilator Agents / administration & dosage*
  • Bronchodilator Agents / chemistry
  • Chemistry, Pharmaceutical
  • Dyspnea / diagnosis
  • Dyspnea / drug therapy*
  • Dyspnea / physiopathology
  • Female
  • Forced Expiratory Volume
  • Formoterol Fumarate / administration & dosage*
  • Formoterol Fumarate / chemistry
  • Glucocorticoids / administration & dosage*
  • Glucocorticoids / chemistry
  • Humans
  • Lung / diagnostic imaging
  • Lung / drug effects*
  • Lung / physiopathology
  • Male
  • Middle Aged
  • Multidetector Computed Tomography*
  • Particle Size
  • Pilot Projects
  • Plethysmography, Whole Body
  • Powders
  • Predictive Value of Tests
  • Prospective Studies
  • Pulmonary Disease, Chronic Obstructive / diagnosis
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Pulmonary Disease, Chronic Obstructive / physiopathology
  • Radiographic Image Interpretation, Computer-Assisted
  • Recovery of Function
  • Severity of Illness Index
  • Spirometry
  • Time Factors
  • Treatment Outcome
  • Vital Capacity


  • Adrenergic beta-2 Receptor Agonists
  • Aerosols
  • Bronchodilator Agents
  • Glucocorticoids
  • Powders
  • Beclomethasone
  • Formoterol Fumarate