Pharmaco-technological perspectives on innovation in asthma and copd: Integrating technological innovation, clinical validation and behavioural insight within a patient-centred framework

Chronic respiratory diseases (CRDs), particularly asthma and chronic obstructive pulmonary disease (COPD), affect over 545 million people globally and continue to impose a major burden on health systems. Although inhalation therapy remains the cornerstone of treatment due to its targeted delivery and minimal systemic side effects, its real-world effectiveness is often limited by poor adherence and incorrect inhalation technique. Traditional monitoring methods, such as self-reports and pharmacy records, tend to overestimate adherence and fail to capture real-life technique, highlighting the need for more reliable and integrated solutions.
This thesis explores the potential of smart inhaler technologies—Respiro™ and RS01X™—to address these challenges through objective monitoring and real-time feedback. In Part I, the IMAGINE study—a randomized controlled trial in children with uncontrolled asthma—used the Respiro™ add-on to monitor both adherence and inhalation technique. Results from the observational phase showed that these two behaviours are largely independent, with only 21% of participants demonstrating both good adherence and correct technique. This highlights the complexity of asthma management in children and the need for tailored interventions addressing each behaviour separately.
Despite expectations, the randomized intervention phase showed no significant difference in clinical outcomes between the feedback and control groups, though both improved. This suggests that mere participation in a monitoring study may raise illness awareness and drive behavioural change, independent of digital feedback. Improvements in asthma control occurred even without notable gains in adherence or technique, indicating that other factors like disease variability, environment, or delayed behavioural shifts may also contribute.
Part II of the thesis focuses on validating and implementing the RS01X™ smart inhaler system in real-world COPD management. Validation studies confirmed its high technical accuracy and reliability under varied conditions. A pilot usability study demonstrated improved inhalation technique over four weeks, supported by feedback via the Respiro app, though technical challenges and digital literacy barriers were noted. Healthcare providers endorsed the device's integration into clinical workflows, suggesting training and support are crucial for success.
Qualitative interviews with COPD patients revealed that proper inhaler use is often neglected, with adherence and technique rarely systemically assessed by healthcare providers. Many patients were unaware of incorrect use and had limited interaction with pharmacists, especially in institutional settings The findings highlight the need for personalized education, greater pharmacist involvement, and the potential of digital tools to improve inhaler use and reduce hospitalizations.
Part III introduces a novel approach using segmental hair analysis to assess long-term medication use. A pilot study in patients on formoterol maintenance therapy demonstrated stable drug deposition over time and high reproducibility, positioning hair analysis as a promising non-invasive tool for adherence monitoring.
Overall, this work highlights the significant potential of smart inhalers and eHealth tools to enhance CRD management. It calls for a patient-centred, adaptive care model where healthcare professionals, especially pharmacists, play a key role in integrating digital solutions with behavioural insights to support sustained improvements in adherence, technique, and clinical outcomes.