Respiro turns connected inhalers into objective, trial-grade respiratory data: digital endpoints, eCOA/ePRO-ready measures and audit-ready source data for decentralised and site-based respiratory studies, captured remotely without adding burden to sites or patients.
Respiratory trials still lean on self-reported diaries and clinic-visit spirometry: sparse, subjective, and easy to miss between visits. A connected inhaler captures what actually happened: every dose, the inhalation behind it and the technique that shaped it, continuously, at home, as objective digital measures your statisticians can work with.
One platform spans the vocabulary trial teams already procure against: from connected-device capture to regulatory-grade endpoints, data exports and real-world follow-on.
RS01X and add-on sensors instrument the study inhaler, capturing dose timing, technique and inhalation profile as device data, without changing how participants inhale.
Sensor-derived measures (adherence, inhalation technique, duration, volume and peak inspiratory flow) structured as objective digital endpoints, with documentation to support pre-specified analysis.
Inhalation and adherence data is built to sit alongside eCOA workflows, pairing objective device measures with patient-reported outcomes in one study record.
Inhalation quality and usage patterns can support exploratory digital biomarkers for respiratory programmes: a window on treatment use and control between visits, not just at them.
Data is captured at home and syncs with minimal participant effort, supporting decentralised and hybrid clinical-trial designs while keeping participants in their own routine.
The same platform carries from the trial into post-launch real-world evidence: adherence, technique and outcomes at scale, for value-based access and label-supporting studies.
Add RS01X or an add-on sensor to the study inhaler, define the context of use, and lock the measurement plan before first patient in.
Dose, technique and inhalation data flow in remotely: encrypted, time-stamped, monitored for completeness and handled according to the protocol.
Structured endpoint datasets, audit records and closeout exports are prepared for your data-management, statistics and regulatory teams.
Pharma teams do not only buy a sensor. They need a defensible data chain for Digital Health Technologies (DHTs): fit-for-purpose measurement, inspection-ready records, integrations that do not trap the data, and operational support that keeps sites and participants moving.
Define exactly what the device contributes to the protocol: captured events, units, derivation rules, expected use windows, missing-data handling and statistical handoff.
Preserve the evidence chain from remote device capture to durable repository, with secure access, time stamps, metadata and audit records configured to the sponsor's study requirements.
Give data-management teams usable outputs instead of a closed dashboard: study exports, APIs and handoff formats that can feed EDC, eCOA/ePRO, eSource, biostatistics and data warehouses.
Plan the physical study reality: provisioning, labelling, pairing, shipment, replacement, returns and technical support for patients, sites and study teams.
Track completeness, sync status, signal plausibility and protocol adherence while the study is running, so issues can be corrected before the database is locked.
Support the end-to-end data lifecycle: encryption, privacy controls, access revocation, final data transfer, archive package and decommissioning steps.
Specific controls, export formats, system validation evidence and regulatory wording are confirmed for each protocol, market and sponsor SOP. Respiro can support study teams during endpoint planning, vendor qualification and data-transfer design.
An independent clinical study found RS01X's on-device readings of inhalation duration, volume and peak inspiratory flow agreed closely with a laboratory reference instrument, so what the device reports stands up as measurement, not estimate.
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, FDA digital-health-technology guidance, 21 CFR Part 11 expectations and EU computerised-systems guidance where applicable. Endpoint definitions, validation scope, system configuration and regulatory wording are confirmed per study and market.
Tell us about your programme and the endpoints you're chasing. We'll show how connected inhalers and the Respiro platform fit your protocol, your sites and your regulatory plan.