Evaluating Satisfaction and Quality of Life with Elpenhaler: A Pooled Analysis of Real-Life Studies.

PURPOSE: Patient adherence and satisfaction are critical for effective asthma and chronic obstructive pulmonary disease (COPD) management, as adherence strongly influences symptoms and prognosis. Patient-reported outcomes, including treatment satisfaction and quality of life, provide valuable insights into the effectiveness of therapeutic interventions from the perspective of individual patients. This study evaluated patient satisfaction with the Elpenhaler device and its impact on quality of life in routine clinical practice. PATIENTS AND METHODS: Individual participant data were pooled from seven real-life studies of fixed-dose combinations delivered via the Elpenhaler device (asthma, budesonide/formoterol: BOREAS, SKIRON, COMPLETE, NOTOS; COPD, salmeterol/fluticasone: AEOLOS, AHEAD, RETRIEVE). Patient satisfaction was assessed with the Feeling of Satisfaction with Inhaler (FSI-10) questionnaire in the four studies in which it was administered, and quality of life in asthma with the mini Asthma Quality of Life Questionnaire (mAQLQ) at baseline, 3 and 6 months. The minimum clinically important difference (MCID) was defined as a change of at least 0.5 units in the mAQLQ total score. RESULTS: In 4333 patients with evaluable FSI-10 score, overall satisfaction was high (mean total score 44.1, standard deviation 5.4), with 94.5% of patients expressing confidence in correct usage. Multivariable analysis showed that age ≥65 years, male sex and lower education level were independently associated with lower satisfaction, whereas never smoking predicted higher satisfaction. In 4212 patients with asthma, mAQLQ total score improved from 4.52 at baseline to 6.06 at 3 months and 6.27 at 6 months; the MCID was achieved by 83.4% and 87.8% of evaluable patients, respectively. Never smoking and lower education level predicted MCID achievement. CONCLUSION: Treatment delivered via the Elpenhaler is associated with high patient satisfaction and with significant and sustained improvements in quality of life, supporting its effectiveness in real-world respiratory care. The identification of factors associated with satisfaction and quality of life improvement may help in personalising treatment and optimising care.