Most digital-health evidence comes from studies with no comparison group: patients get the tool, patients improve, and you are left unable to say whether the tool did anything or whether they would have improved anyway. A controlled trial is the way past that, and it is the harder evidence to produce. This is the one controlled trial in Respiro's evidence base.
Presented at the European Respiratory Society International Congress 2022 and funded by the European Institute of Innovation and Technology, it was a cluster randomised trial run across 18 community pharmacies, enrolling 68 adults whose asthma was poorly or partially controlled at the start. Every patient received periodic face-to-face pharmacist counselling. One arm also used the Respiro System, with that counselling personalised on the data it captured.
The primary measure was the Asthma Control Test, the validated score clinicians actually treat to. The Respiro arm improved by 5.9 points, against 2.9 points in the counselling-only arm (p=0.007). A 3-point change on the ACT is considered clinically meaningful, so the Respiro arm gained close to twice that, and close to twice what good counselling delivered on its own.
Two further results reached significance: an average saving of €465.71 per patient per year (p=0.04), and, in the Respiro arm, adherence of 82% and correct inhalation technique of 64%, both above the averages usually reported for people with asthma.
Why the comparison is the point
The honest headline is not "+5.9" on its own; it is "+5.9 versus +2.9." The control group improved too, because they also got counselling, and showing both numbers together is what makes the result mean something. It isolates what Respiro adds on top of good care, and a controlled design rules out the "people improve anyway" effect that no single-arm study can. That is the difference between a tool that is associated with better control and one that demonstrably contributes to it.
"A controlled trial is a high bar for a digital tool, and Respiro cleared it on a clinical endpoint. Showing both arms is the whole point: it's how you tell apart what the tool did from what would have happened anyway."
Martijn Grinovero, Chief Commercial Officer, Amiko
The trial is a conference abstract, with the size and follow-up that implies, and it describes a study population rather than promising any individual result. It is also the most defensible single finding we hold, and it sits alongside the rest of the evidence on our evidence page.
Source: Onnis C, Ferri S, van der Palen J. Effect of a pharmacy-supported digital medicine program on asthma control. Eur Respir J 2022;60(suppl 66):4704 (ERS International Congress 2022). Conference abstract; cluster randomised controlled trial, n=68; funded by the European Institute of Innovation and Technology. Describes a study population, not a promise of individual results.