Supported by the Air Next Spirometer
FDA 510(k) Cleared | CE Mark
Strados supports both investigator-site primary endpoints and continuous at-home spirometry clinical trial endpoints. Same device, same data quality, one integrated workflow.
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ATS/ERS 2005 & 2019 Compliant
All spirometry meets the latest international acceptability and repeatability standards
Expert Overread
Centralized quality review by trained spirometry specialists for every test
In-Clinic & At-Home
Same device supports primary endpoints at site and continuous at-home monitoring
Remote Telehealth Coaching
Real-time video coaching and app-guided instructions for at-home maneuvers
spirometry clinical trials
The Strados Air Next supports both investigator-site primary endpoints and continuous at-home monitoring for spirometry clinical trials.
Investigator-site spirometry that supports primary and key secondary endpoints in clinical trials.
Extend pulmonary function testing into daily life between clinic visits, supported by real-time video coaching and app-guided instructions.
Measures
Comprehensive pulmonary function parameters meeting ATS/ERS 2005 & 2019 acceptability and repeatability standards.
Available Parameters Include:
FEV₁
Key endpointForced Expiratory Volume in 1 second
FVC
Key endpointForced Vital Capacity
FEV₁/FVC
Key endpointTiffeneau-Pinelli index
PEF
Key endpointPeak Expiratory Flow
FEF25-75%
Forced Expiratory Flow at 25–75% of FVC
All measures meet ATS/ERS 2005 & 2019 acceptability and repeatability criteria.
Standards Compliance
Acceptability & repeatability criteria for FVC maneuver
Updated quality grading and back-extrapolation standards
Electronic records & audit trail compliance
Patient data privacy and security
Full-Service Spirometry
Strados delivers a complete spirometry service — from hardware to human expertise.
The Strados Air Next with companion smartphone app for guided maneuver instructions and real-time patient feedback.
Centralized review by trained spirometry specialists. Every test is assessed for acceptability, repeatability, and quality grading.
End-to-end calibration management and QC protocols at every investigator site to maintain data integrity throughout the trial.
Comprehensive training programs for site staff, covering ATS/ERS maneuver technique, device operation, and troubleshooting.
Full validation documentation, IQ/OQ/PQ, and audit-trail support to meet regulatory submission requirements globally.
Real-time video coaching for at-home spirometry sessions, ensuring patients perform maneuvers correctly without clinic visits.
Dedicated support throughout the trial lifecycle — from site activation to patient onboarding and ongoing helpdesk access.
End-to-end device management including shipping, inventory tracking, returns, and replacements across all global trial sites.
Strados spirometry credentials span 55+ clinical trials, 150+ global sites, and 45+ peer-reviewed publications. Strados spirometry capabilities are powered by our 2025 acquisition of NuvoAir's clinical trial business.
55+
Clinical Trials
1,200+
Global Sites
46+
Countries
65+
Publications
The Air Next eliminates the need for fixed workstations — the same FDA-cleared device supports ATS/ERS-validated spirometry at investigator sites, in patients' homes, and anywhere in between.
Virtual patient and visit management with fully integrated video and messaging services, replicating the in-person coaching experience for at-home maneuvers.
Spirometry data connects wirelessly and is securely transferred to the cloud in real-time, enabling immediate quality review, risk-based monitoring, and rapid decision-making.
Beyond spirometry, the platform also supports FeNO, cough monitoring, ePRO/eCOA, pMDI inhaler sensors, and SpO₂ — all within a single unified clinical trial environment.
Strados Air Next: FDA-cleared · CE marked · ISO 13485 certified · Meets ATS/ERS/ISO waveform testing requirements
Strados Intelligence Advantage
The Air Next eliminates the need for fixed workstations — the same FDA-cleared device supports ATS/ERS-validated spirometry at investigator sites, in patients' homes, and anywhere in between.
Endpoint Suite
Continuous cough frequency and lung sound monitoring via the RESP® Biosensor and watch-based options.
Fractional exhaled nitric oxide for airway inflammation assessment.
Electronic clinical and patient-reported outcomes.
Advanced acoustic analysis of lung sounds for respiratory assessment.
Speak with our team to learn how Strados Spirometry can strengthen your pulmonary function endpoints.
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