## 3 Results
### Efficacy  
The analysis covered 86 \(\pm\) 30 days of Salflumix Easyhaler(r) exposure from the first to the third visit. At the first visit, 0.7% of patients had a small (CAT \(<\) 10 pts) and 38.6% had an average (CAT 10-20 pts) impact of the disease on life. Salflumix Easyhaler(r) use decreased the impact of the disease on life. The percentage of patients with a small and an average impact of the disease on life increased to 18.5% and 66.3%, respectively, on the third visit (Table 2). In parallel, the frequency of the disease with a big and very big impact on life (CAT \(>\) 20 pts) decreased from 60.7% at the first visit to 15.2% at the third visit. Concordantly, the percentage of subjects with high scores of dyspnea (mMRC \(\geq\) 2) decreased from 57.5% to 22.6% (_p_ \(<\) 0.001). In addition, the frequency of exacerbations from the previous visit decreased from the 8.4% reported on the second visit to 4.2% on the third visit (_p_ \(<\) 0.01). From the first to the third visit, any exacerbation was reported in 45 patients (10.2%)--allowing for a rough estimation of the exacerbation rate during 12 months at 43.2% (by multiplying by a factor of 4.24 obtained by dividing 365 days by 86). Hospitalizations due to COPD exacerbation were rare (Table 2). During the study period, the prescription of larger doses of Salflumix Easyhaler(r) was steadily decreasing from 61.6% to 49.4% (_p_ \(<\) 0.001)--Table 2. \begin{table}
\begin{tabular}{c c c c c} \hline \hline  & \multicolumn{4}{c}{**VISIT**} \\ \cline{2-5}  & **I** & **II** & **III** & \(\chi^{2}\)**/ANOVA** \\ \cline{2-5}  & **[N = 440]** & **[N = 439]** & **[N = 433]** & \(p\) **Value** \\ \hline Salflumix Easyhaler® dose: & & & & \\ \hline
50/250 ug twice daily [N; \%] & 169; 38.4 & 210; 47.8 & 219; 50.6 & \textless{}0.001 \\ \hline
50/500 ug twice daily [N; \%] & 271; 61.6 & 229; 52.2 & 214; 49.4 & \textless{}0.001 \\ \hline COPD assessment test (CAT) [pts] & 21.5 \(\pm\) 5.3 & 16.1 \(\pm\) 5.6 & 14.5 \(\pm\) 5.2 & \textless{}0.001 \\ \hline At least 2 pts decrease [N; \%] & - & 336; 76.5 & 377; 87.1 & \textless{}0.001 \\ \hline Little impact on life (\textless{} 10 pts) [N; \%] & 3; 0.7 & 60; 13.7 & 80; 18.5 & \\ \hline Average impact on life (10-20 pts) [N; \%] & 170; 38.6 & 282; 64.2 & 287; 66.3 & \\ \hline Big impact on life (21-30 pts) [N; \%] & 248; 56.4 & 97; 22.1 & 66; 15.2 & \textless{}0.001 \\ \hline Very big impact on life (\textgreater{} 30 pts) [N; \%] & 19; 4.3 & 0 & 0 & \\ \hline COPD exacerbation [N; \%] & & 37; 8.4 & 18; 4.2 & - \\ \hline Hospitalizations due to exacerbation [N; \%] & & 3; 0.7 & 0 & - \\ \hline Modified Medical Research Council (mMRC) scale [pts] & 1.6 \(\pm\) 1.0 & 1.1 \(\pm\) 1.0 & 0.8 \(\pm\) 0.9 & \textless{}0.001 \\ \hline mMRC \textless{} 2 pts [N; \%] & 187; 42.5 & 294; 67.0 & 335; 77.4 & \textless{}0.001 \\ \hline mMRC \textless{} 2 pts [N; \%] & 253; 57.5 & 145; 33.0 & 98; 22.6 & \textless{}0.001 \\ \hline Compliance—MAQ \(\leq\) 2 pts [N; \%] & 411; 93.4 & 436; 99.3 & 433; 100 & 0.08 \\ \hline \hline \end{tabular}  
* COPD—chronic obstructive pulmonary disease; MAQ—medication adherence questionnaire; mMRC—modified Medical Research Council scale.  
\end{table} 
Table 2: Changes in the control of COPD during 3 visits (86 \(\pm\) 30 days) in patients treated with Salflumix Easyhaler®. A greater percentage of patients with a big and very big impact on life (CAT > 20 pts) was found among those receiving large drug doses than in those with a small or an average impact on life (64.2% for 50 \(\upmu\)g + 500 \(\upmu\)g vs. 55.0% for 50 \(\upmu\)g + 250 \(\upmu\)g; \(p\) = 0.06).