Abstract Rationale Incorrect inhaler handling and poor adherence remain major barriers to achieving asthma control. Traditional inhaler training is time-consuming, requires repetition, and is often difficult to sustain in routine care. The Kata Inhalation App (Kata) provides real-time training, reminders, and feedback on inhalation technique to support correct device use and treatment adherence. We aimed to evaluate the effect of Kata on inhaler errors and asthma control as co-primary endpoints. Methods A multicenter, randomized, controlled, parallel-group study (KaRe) was conducted at 15 German sites using an adaptive two-stage design. Adults with physician-diagnosed asthma (≥18 years) were randomized 1:1 to 12 weeks of KATA (intervention) or control groups following a 1-week baseline phase. The study was open-label for subjects and investigators, but inhalation recordings were centrally and blindly evaluated. Results We included a total of 147 patients across all levels of asthma severity (27.3% mild, 48.9% moderate, 23% severe). Of the ITT analysis population (N = 139), a total of 59.7% in the intervention (n = 67) and 55.6% in the control (n = 72) groups were uncontrolled at baseline. The app was rated as easy to use by 84% of patients, covering a wide age range from 19 to 87 years (mean 53 ± 16, male/female 65.5/34.5%). Main inhaler types included dry powder (DPI, 48.9%), pressurized metered dose (pMDI, 44.6%) and soft-mist (SMI, 6.5%) with 88.5 % on multi-inhaler therapies. The co-primary endpoint showed a significant 75% reduction in handling errors in the intervention with no difference in the control group (p 0.001). We found significant differences (p = 0.019) in the number of handling errors between DPI (mean 1.4 ± 1.1), pMDI (2.1 ± 1.4) and SMI (3.2 ± 1.5) on baseline showing effective reduction in pMDI and DPI (p 0.001 each). No difference in asthma control test (ACT) was seen between groups (-0.927; CI: -2.392 to 0.537; p = 0.212).Notably, among patients with partially controlled asthma at baseline, a greater proportion in the intervention group (14.9%) shifted to full control compared to the control group (4.2%). Conclusion Kata use resulted in a pronounced and consistent improvement in inhaler technique across all device types, with a sustained reduction of errors over the 12-week study period. In contrast to previous studies where the benefits of single-session inhalation training often diminished, these findings highlight the potential of ongoing digital inhalation support to complement face-to-face education and improve the consistency and durability of inhaler training in real-world asthma care. This abstract is funded by: VisionHealth GmbH
Trinkmann et al. (Fri,) studied this question.
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