Background & Aim

Asthma, as chronic disease, affects the patients? quality of life (QoL) that is also affected by multimorbidity. The NOTOS study objective was to evaluate asthma patients? QoL following 3- and 6-month maintenance and/or as-needed treatment with the Fixed Dose Combination (FDC) of budesonide/formoterol (BUD/FOR) via the Elpenhaler^® device.

Methods

Multicenter, prospective, non-interventional, observational study (NCT04835961). Data were collected at baseline, 3- and 6-month follow-up visits. QoL was evaluated using the validated Greek version of Mini Asthma Quality of Life Questionnaire (MiniAQLQ).

Results

At baseline (V₁), the mean (SD) score of MiniAQLQ was 4.54±1.12. After 6 months of treatment (V₃), MiniAQLQ score was increased by 1.76 points (p<0.001) regardless of the maintenance FDC BUD/FOR 200/6, 400/12mcg or as-needed FDC BUD/FOR 200/6mcg treatment. Greater improvement (?2.00 points, p<0.001) was observed in patients that received 6-month maintenance treatment with higher dose of BUD/FOR regardless of the rescue treatment use. Furthermore, patients with comorbidities had worse QoL in V₁ (4.43±1.16) and showed higher improvement in V₃ [change from V₁: 1.82 (95% CI 1.73-1.92)], compared to patients without comorbidities (MiniAQLQ V₁: 4.70±1.06, V₃: 6.36±0.57, change from V₁: 1.66, p<0.001).

Conclusion

The NOTOS study demonstrated an improvement in QoL in patients receiving FDC Budesonide/Formoterol (Elpenhaler^®) in real-life, regardless of the maintenance or as-needed use and the presence of comorbidities.