Real life clinical study design supporting the effectiveness of extra-fine inhaled beclomethasone/formoterol at the level of small airways of asthmatics

Control of asthma in adults treated with beclomethasone and formoterol in extrafine particle formulation in a real-life setting in Poland: the CASPER noninterventional, observational trial

“…Another interesting real-life study was performed by Popov et al 22 In their study, patients with uncontrolled asthma treated with ICS/LABA fixed combination in a DPI (FP/S, 250/50 µg twice daily and BUD/F, 160/4.5 µg, 2 inhalations twice daily were switched to BDP/F HFA (100/6 µg, 2 inhalations twice daily ). After 8 weeks of treatment, significant improvements in symptoms and quality of life were observed.…”

Fluticasone furoate/Vilanterol 92/22 μg once-a-day vs Beclomethasone dipropionate/Formoterol 100/6 μg b.i.d. in asthma patients: a 12-week pilot study

“…In phase III studies [24][25][26], performed on adolescents and adults with different levels of asthma not controlled, the combination of luticasone furoate/vilanterol 100/25 or 200/25 mg once a day (approved doses in 'EU) have more effects on lung function compared to placebo or compared to equivalent doses of luticasone furoate or luticasone propionate alone [27,28]. In some works [29,30], it was has been demonstrated similar ef icacy between the combination luticasone furoate/vilanterol 100/25 mg once a day and the association luticasone propionate/salmeterol 250/50 mg twice a day to improve lung function and to reduce the risk of severe exacerbations compared with only luticasone furoate.…”

Small Airways Dysfunction in Asthma: Evaluation and Management to Improve Asthma Control

“…The role of small airways treatment on levels of asthma control has been studied in real-life studies using small particles of ICS monotherapy and also small particles of combination ICS/LABA therapy 84,85,86,87,88,89,90,91. Collectively, these studies support our understanding that (i) aerosol particle size, (ii) the physicochemical properties of the corticosteroid, (iii) the airway drug deposition characteristics (greater lung deposition and lower oropharyngeal deposition) and, (iv) the need for less reliance on an optimal inhalation flow (particularly compared to conventional DPIs) are all important aspects in the effectiveness of these small particle aerosol asthma treatments in real-life clinical practice.…”

“…The effect of combination ICS/LABA small particle aerosol therapy of BDP and formoterol on levels of asthma control has also been studied in the real life setting 87,88,89,90,91. In a large cross-sectional study of adult asthmatic patients from hospital respiratory units in Italy, Allegra and colleagues observed that in a subgroup of patients (n=1,380) receiving small particle aerosol treatment with BDP/Form the proportion of levels of asthma control determined by the Asthma Control Test (ACT) were significantly higher than in those patients receiving Budesonide/Form (76% vs 69%) and at similar levels of control compared to those patients receiving FP/Salm (71% controlled), where treatments has been taken for greater than 1 month 87.…”

“…Investigators have also assessed the effects of changing patients from combination ICS/LABA large particle DPIs to small particle HFA-solution pMDI aerosols in real-life asthmatic populations. Popov and colleagues showed an improvement in quality of life with small particle HFA-solution BDP/Form aerosols compared to when they were on large particle DPI of FP/Salm or Budesonide/Form, and in a subgroup of patients there were significant improvements in FVC and an improvement in inflammatory markers with small particle BDP/Form 90. Brusselle and colleagues have also shown that the benefits of small particle HFA-solution BDP/Form aerosols on improving levels of disease control in non-smoking patients with asthma are also observed in asthmatic patients who currently smoke, reflecting real-life clinical practice, as often smoking asthmatic patients are excluded from randomized controlled clinical trials 91.…”