Strados Labs · Clinical Research Abstract · ATS 2025 / ERS 2025
The Strados Respiratory Endpoint Suite: A Fully Integrated, Multi-Modal Digital Measurement Platform for Interventional Respiratory Clinical Trials
Delmonico N¹, Powers R¹, Au YK MD¹, Krauss S¹, McCarty M¹, deLaubenfels T PhD¹, Hollatz R RRT¹ · ¹Strados Labs, Inc., Philadelphia PA & Atlanta GA, USA
stradoslabs.com · sales@stradoslabs.com
Background & Objective
Respiratory clinical trials increasingly require objective, real-world endpoints feasible in decentralised settings and acceptable to regulatory agencies. Fragmentation across multiple technology vendors introduces operational complexity, data incompatibility, and sponsor burden. We describe an integrated digital endpoint platform offering five validated modalities — spirometry, FeNO, acoustic cough & lung sound monitoring, wrist-worn cough surveillance, and eCOA — delivered through a single partner with unified cloud infrastructure, human expert overread, and regulatory-grade data governance across 40+ completed interventional trials spanning 42 countries.
Methods · Platform Architecture
The RESP® platform integrates all five modalities through a single companion mobile app, RESP® Cloud (GxP-validated, TLS 1.3 encrypted), and a real-time sponsor portal. All modalities are protocol-configurable with unified CDISC-ready data delivery.
Device passively captures sensor data in the patient's real-world environment.
TLS 1.3 encrypted; patient ID de-identified at source via BLE/Wi-Fi.
CoughCheck™ DNN + AI QA grading; privacy-preserving speech filter applied.
Certified RT/MD review of flagged events; ATS/ERS 2019 spirometry grading.
CDISC SDTM/ADaM export · EDC push (Rave, Vault) · Real-time compliance alerts.
Regulatory & Compliance Framework
FDA 510(k)
RESP® Biosensor, AirNext®
CE Mark
EU MDR compliant
ISO 13485
QMS — Medical devices
SOC 2 Type II
Data security posture
21 CFR Part 11
Electronic records
GCP / ICH E6(R2)
Trial conduct standards
GDPR & HIPAA
Patient data privacy
CDISC Ready
SDTM/ADaM datasets
Therapeutic Area Applications
Spirometry · Cough · eCOA
Spirometry · FeNO · Cough · Lung Sounds · eCOA
Cough · Spirometry · eCOA
Spirometry · eCOA
Cough · Lung Sounds · eCOA
RESP® Watch · Biosensor · eCOA
RESP® Watch · eCOA
Results · Endpoint Modalities & Analytical Performance
AirNext® Spirometry
Digital Spirometer · Home & Clinic
Measures
FEV₁, FVC, FEV₁/FVC, PEF, FEF₂₅₋₇₅ Flow-volume loops · Volume-time curves
Key Evidence
ICC = 0.98 vs. in-clinic spirometry Ped. Pulmonol. 2023; DOI:10.1002/ppul.26147 ATS 2024 Abstract A2623
Regulatory
FDA Cleared · CE Mark · ATS/ERS 2019
Indications
CF · ALS · ILD/SSc · COPD · Asthma
NObreath® FeNO
Airway Inflammation Biomarker · In-Clinic or At-Home
Measures
Fractional exhaled NO (ppb) T2 inflammation phenotype (≥25/≥40 ppb)
Key Evidence
5.5× T2 detection vs. single clinic FeNO Beeh KM et al. Pulm Ther. 2025;12(1):283–300
Regulatory
CE Mark · GINA/ATS guideline-aligned
Indications
Asthma · Eosinophilic Disease · Biologics
RESP® Biosensor
Chest-Worn Wearable · Ambulatory 24-hr
Measures
Cough freq. · Wheeze · Crackles · Rhonchi RR · HR · Body position · Activity
Key Evidence
CoughCheck™: 97.3% precision, 233,000+ events ATS 2023 Abstract A4821; FDA CDER · EMA · NMPA accepted
Regulatory
FDA 510(k) Cleared · CE Mark
Indications
IPF · Chronic Cough · Asthma · COPD · ICI Pneumonitis
RESP® Watch
Wrist-Worn Monitor · BYOD or Provisioned
Measures
Cough events · SpO₂ · HR · Sleep quality Activity · ECG strip · Blood pressure
Key Evidence
AP = 0.90; edge-first ML on-device ERS Annual Congress 2024; Abstract OA3412
Regulatory
Samsung Galaxy Watch 8 · Clinical-grade validated
Indications
OSA · COPD · Chronic Cough · Longitudinal surveillance
eCOA & ePRO Platform
Electronic Outcomes · App-Based · Multilingual
Measures
ACQ · CAT · SGRQ · mMRC · LCQ EQ-5D · CFQ-R · BDI/TDI · VAS/NRS
Key Evidence
77% patients more likely to remain in trial 73% more likely to enroll (digital vs. paper eCOA)
Regulatory
21 CFR Part 11 · GCP · ISPOR ePRO standards
Indications
All respiratory indications · QoL · Symptom diaries
Key Performance Metrics
40+
Completed sponsored trials
42
Countries deployed
97.3%
CoughCheck™ precision
ICC 0.98
Home vs. clinic spirometry
95%
Patient compliance 7-day wear
2,500+
Global kit shipments
233k+
Validated cough events
5
Continents deployed
Conclusions
Across 40+ completed sponsored studies spanning 42 countries, the Strados Endpoint Suite demonstrated:
High patient compliance (95%) over 7-day ambulatory RESP® Biosensor wear across 32+ countries.
Reproducible home spirometry (ICC = 0.98 vs. in-clinic) enabling decentralised primary endpoint collection.
CoughCheck™ algorithm precision of 97.3% on 233,000+ expert-validated events; accepted by FDA CDER, EMA, and NMPA.
5.5× improvement in T2 airway inflammation detection via serial home FeNO vs. single clinic measurement.
Improved patient enrollment (73%) and retention (77%) with integrated eCOA vs. paper instruments.
Consolidating five endpoints through a single partner reduces operational complexity and enables cross-endpoint correlation, supporting richer endpoint packages for regulatory submissions.
Selected References
- Delmonico N et al. Home spirometry in paediatric patients. Pediatr Pulmonol. 2023; DOI:10.1002/ppul.26147.
- Beeh KM et al. Serial home FeNO monitoring. Pulm Ther. 2025;12(1):283–300.
- Hollatz R et al. CoughCheck™ precision validation. ATS Int. Conf. 2023; Abstract A4821.
- Powers R et al. RESP® Watch cough detection AP = 0.90. ERS 2024; Abstract OA3412.
- Au YK et al. Decentralized spirometry feasibility in ALS & CF. ATS 2024; Abstract A2623.
Strados Labs®
Making Every Breath Count™
Disclosures: All authors are employees of Strados Labs, Inc. · Funding: Strados Labs, Inc., Philadelphia, PA
© 2025 Strados Labs, Inc. All rights reserved. Strados Labs®, RESP®, CoughCheck™, AirNext® are registered trademarks of Strados Labs, Inc.
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