## 4 Discussion  
The performed IIS shows that COPD patients prescribed with the second entry product--Salflumix Easyhaler(r), a new DPI on the Polish market--achieved clinical improvement in the daily clinical settings. The study enrolled both newly diagnosed and recently switching from other devices, mostly due to the therapy's ineffectiveness. During the 86 days period of therapy, the percentage of patients with a big and very big impact on life (CAT > 20 pts) decreased from 60.7% to 15.2% at the third visit, and a significant improvement (at least 2 pts decrease in CAT) was noted in 87.1% of the study cohort. Concordantly, the percentage of subjects with high scores of dyspnea (mMRC \(\geq\) 2) decreased from 57.5% to 22.6%. Exacerbations from the first to the third visit were reported in 10.2% of patients. It is hard to compare the obtained data with the TORCH trial [4]. Our study was designed to analyze survival and FEV1 decline. Moreover, the analysis of the reduction in the rate of exacerbation is difficult due to the short period of follow-up. Proportionally converting the frequency of exacerbations from 86 days to a year, we may suppose a \begin{table}
\begin{tabular}{l c c c c c} \hline \hline  & \multicolumn{3}{c}{**VISIT**} & \multicolumn{3}{c}{**ANOVA**} \\ \cline{2-6}  & **I** & **II** & **III** & \multicolumn{2}{c}{_p_**Values**} \\ \cline{2-6}  & **[N = 440]** & **[N = 439]** & **[N = 433]** & **II vs. I** & **III vs. I** \\ \hline Patient’s satisfaction with use of the DPI [pts] & 3.2 \(\pm\) 0.7 & 3.4 \(\pm\) 0.7 & 3.5 \(\pm\) 0.6 & \textless{}0.001 & \textless{}0.001 \\ \hline Physician’s assessment [pts]: & & & & & \\ \hline The applied therapy is effective. & 5.8 \(\pm\) 1.1 & 6.0 \(\pm\) 0.9 & 6.4 \(\pm\) 0.8 & \textless{}0.001 & \textless{}0.001 \\ \hline The patient has no problems with the correct use of the inhaler [pts]. & 6.0 \(\pm\) 1.1 & 6.2 \(\pm\) 0.9 & 6.5 \(\pm\) 0.7 & 0.001 & \textless{}0.001 \\ \hline The treatment does not affect the patient’s feeling of being burdened with treatment [pts]. & 6.0 \(\pm\) 1.1 & 6.2 \(\pm\) 0.9 & 6.4 \(\pm\) 0.8 & 0.01 & \textless{}0.001 \\ \hline Treatment-related AEs are rare [pts]. & 6.2 \(\pm\) 1.0 & 6.3 \(\pm\) 0.9 & 6.5 \(\pm\) 0.9 & 0.33 & \textless{}0.001 \\ \hline \hline \end{tabular}  
* AEs—adverse events; DPI—dry powder inhaler.  
\end{table} 
Table 3: Patients’ and physicians’ assessment of the use of Salflumix Easyhaler®. reduction rate from 67.7% during the last 12 months prior to the initiation of the therapy with Salflumix Easyhaler(r) to approximately 43.2% during its use. The decreasing frequency of exacerbation was reflected by the increased percentage of patients with CAT \(\leq\)20 pts during the subsequent visits. This supports the efficacy of Salflumix Easyhaler(r). Concordantly, as much as 87.1% of the study patients had a significant decrease in the CAT score (at least 2 pts). We also used the mMRC dyspnea scale as widely used to assess symptom burden in COPD, showing a decline in the percentage of patients with dyspnea (mMRC \(\geq\) 2) to 22.6% at the third visit. The observed improvement was caused mostly by the escalation of therapy. The analysis of the effect of DPI substitution was not possible among the patients who switched from the other inhalers as data concerning prescribed doses of inhaled medications before the commencement of Salflumix Easyhaler(r) were not collected. Of note, in only 5.2% of highly symptomatic, newly diagnosed patients at a high risk of future exacerbations (GOLD D), ICS/LABA should be considered as initial therapy, according to the current GOLD strategy [2]. Our finding supports previous evidence that ICS-containing DPI therapy is prescribed for patients across all GOLD classes in real-life settings [11]. Such overuse of ICS-containing therapy may expose to the unnecessary risk of pneumonia. Older age (>65 years old), low FEV1 (<50% of the predicted value), higher dose, and long-time ICS use were identified as the risk factors in one of the most recent meta-analyses [12].