Respiro brings objective inhaler-use and technique data into respiratory trials, supporting adherence analysis and digital endpoints alongside participant-reported and clinical measures.
Participant reports and clinic visits tell part of the story. Connected inhalers add objective data on dose timing and inhalation technique at home, helping study teams assess adherence and understand how treatment is used between visits.
One platform spans connected-device capture, endpoint definitions, data exports and real-world follow-on, with each study configuration agreed in the protocol.
RS01X and add-on sensors instrument the study inhaler, recording use timing, technique and inhalation profile as device data without changing how participants inhale.
Sensor-derived measures, including recorded inhaler-use events, inhalation technique, duration, volume and peak inspiratory flow, can be structured as digital endpoints with pre-specified analysis.
Complement electronic assessments and patient-reported outcomes with time-stamped inhaler-use and technique data, bringing measured treatment use and reported experience together in your study analysis.
Investigate inhalation profiles and use patterns as candidate digital biomarkers, with their meaning and validation defined for the study question.
Capture inhaler use at home and sync the records remotely, supporting decentralised and hybrid studies within participants' everyday routines.
Extend the research into everyday care with connected-inhaler records of adherence and technique for post-launch real-world evidence programmes.
Select RS01X or a compatible add-on sensor for the study inhaler, define the context of use and set the measurement plan before the study starts.
Collect time-stamped inhaler-use and technique records remotely, with data handling and review defined by the protocol.
Bring structured inhaler records into the study dataset for your data-management and statistics teams, alongside the other protocol measures.
Pharma teams need more than a sensor: reliable measurements, traceable records, usable data exports and practical support for sites and participants. These are the foundations of a connected-inhaler study.
Clear definitions for recorded events, measurement units and analysis windows, with missing-data rules and supporting validation evidence matched to the protocol.
Time-stamped source records and metadata, with access, retention and audit-trail requirements specified for the study.
Give data-management teams structured inhaler records for analysis alongside EDC, eCOA/ePRO and clinical data, with exports and configured APIs matched to the study workflow.
Study setup, pairing guidance and site and participant training materials, with supply, replacement and support arrangements agreed for the programme.
Review record completeness, sync gaps and unexpected values so the study team can resolve data issues before database lock.
Secure data transfer and a clear closeout plan covering retention, access removal and device returns.
Controls, export formats, validation evidence and support are confirmed for each protocol, market and sponsor's procedures.
An independent clinical study found that RS01X on-device readings of inhalation duration, volume and peak inspiratory flow agreed closely with a laboratory reference instrument in the evaluated configuration and study context.
Validation study, Int. J. COPD (2025). See the full evidence base on our research page.
Respiro is developed under an ISO 13485:2016 quality system and delivered on secure cloud infrastructure, with GDPR- and HIPAA-aligned deployments and documentation oriented to EU MDR and FDA digital-health guidance where applicable. Endpoint definitions, validation scope and system configuration are confirmed per study and market.
Tell us about your programme and the measures you need. We'll show how connected inhalers and the Respiro platform can fit your protocol and study operations.