Background & Aim

According to GINA 2022 guidelines, asthma treatment is adjusted in accordance with patients? response in both symptom control and risk. The NOTOS study objective was to evaluate asthma control at 3 and 6 months from treatment initiation 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. Asthma control was evaluated using the validated Greek version of Asthma Control Questionnaire (ACQ-6).

Results

At baseline, the mean (SD) score of ACQ was 2.16±0.99. After 6 months of treatment, ACQ score was reduced by 1.55 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 was observed in patients who received 6-month maintenance treatment with higher dose of BUD/FOR (-1.76, p<0.001) independently of the rescue treatment use. In addition, improvement in lung function was observed after 3- and 6-month maintenance or as-needed treatment. The mean (SD) FEV₁ value was 2.45±0.90lt at baseline and 2.72 ±0.92lt in 6 months (0.35 points of difference, p<0.001).

Conclusion

The NOTOS study showed statistical significant improvement in both asthma control (expressed as decrease in ACQ-6 score) and lung function (expressed as increase in FEV₁ value) in patients receiving FDC Budesonide/Formoterol (Elpenhaler^®) regardless of the maintenance or as-needed use.