Strados Air Next
Site-Based Spirometry
Regulatory-Grade Spirometry Across Every Investigator Site
Standardized workflows, ATS/ERS-compliant testing, centralized expert overread, and global operational support deliver consistent, submission-ready pulmonary endpoints — from equipment and investigator training to AI-assisted quality review.
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Capabilities
Key Features
Built for Primary Endpoints
Supports FEV₁, FVC, FEV₁/FVC, and PEF as primary and key secondary endpoints — with validation documentation ready for global regulatory submissions.
Standardized Across Every Site
Consistent equipment, workflows, and training ensure data from Site A is comparable to Site Z — reducing the variability that weakens multi-center trials.
AI-Assisted Expert Overread
Centralized review combines ArtiQ AI assessment with certified respiratory expertise, catching quality issues early rather than at database lock.
Global Operational Support
End-to-end device logistics, training, calibration, and site support across 150+ sites in 30+ countries — so your team can focus on the science.
Regulatory Confidence
Full validation documentation, IQ/OQ/PQ, and 21 CFR Part 11 audit trails meet FDA, EMA, and global regulatory submission requirements.
Flexible Study Designs
The same Air Next supports site-based, home, and hybrid designs — one workflow, one data standard, simplified study execution.
Clinical Value
Why sponsors choose Strados
Sponsors aren't buying spirometers — they're choosing a partner to deliver consistent, regulatory-grade spirometry across global investigator sites. Strados provides the standardized equipment, workflows, and oversight that confidence requires.
Standardized Pulmonary Endpoints
Consistent equipment, workflows, and ATS/ERS grading deliver endpoint data sponsors can trust across every site and visit.
Reduced Site Variability
Centralized overread and standardized training minimize the technique-driven variability that weakens multi-center trial signal.
Simplified Study Execution
A single partner manages devices, training, calibration, and support — streamlining operations across global investigator sites.
Regulatory Confidence
Validation documentation, audit trails, and expert oversight meet the requirements of FDA, EMA, and global regulatory submissions.
One Device. Every Study Design.
The same Air Next, from clinic to home
Using one device throughout a study simplifies investigator training, minimizes variability between settings, and creates a consistent participant experience — whether endpoints are captured in the clinic, at home, or both.
Site-Based
Investigator-site spirometry for primary and key secondary endpoints in pivotal trials.
Home
Between-visit FEV₁ monitoring in decentralized and hybrid studies.
Hybrid
Seamless transition between clinic and home within a single study — one workflow, one data standard.
Why one device matters
- Simplified investigator training — one device, one workflow
- Minimized variability between clinic and home settings
- Consistent participant experience across every visit
Explore
Home Spirometry for Clinical TrialsSee how the same Air Next extends pulmonary function testing into patients' daily lives for decentralized and hybrid trials.
Centralized Spirometry Overread
AI accelerates review. Certified experts ensure confidence.
Centralized overread is one component of the overall site-based spirometry solution. Every session moves through a hybrid workflow — automated ATS assessment and ArtiQ AI quality review accelerate screening, while certified respiratory experts ensure regulatory confidence. AI never replaces expert judgment; it helps experts focus where it matters most.
Faster Turnaround
AI-accelerated review surfaces quality issues in hours, not days — before poor-quality data accumulates across sites.
Consistent ATS/ERS Grading
Automated assessment applies the same acceptability and repeatability criteria to every maneuver, at every site.
Reduced Site Variability
Centralized expert review and standardized grading minimize the technique-driven variability that weakens multi-center signal.
Earlier Issue Identification
Risk-based monitoring highlights trends, protocol deviations, and sites needing additional support in real time.
Actionable Site Feedback
Investigators receive specific, timely guidance to correct technique before the next patient is tested.
Greater Endpoint Confidence
Hybrid AI + expert review gives sponsors confidence that pulmonary endpoint data is submission-ready.
How It Works
Five steps to regulatory-grade site spirometry
Every session follows the same standardized workflow across all sites — so data is consistent, comparable, and submission-ready.
Calibrate
Daily calibration with certified syringes at every investigator site ensures device accuracy before any patient is tested.
Instruct
Trained technicians guide patients through proper posture, breathing, and maximal effort per ATS/ERS standards.
Assess
Patients perform standardized FVC maneuvers with real-time acceptability feedback on the Air Next display.
Grade
Automated ATS/ERS 2005 & 2019 grading flags unacceptable efforts immediately, prompting coached repeats on the spot.
AI-Assisted Expert Overread
Every session benefits from ArtiQ AI-assisted quality assessment and centralized review by certified respiratory experts — accelerating review while ensuring regulatory confidence.
Complete Site Spirometry Services
An operational partner, not just a device
Sponsors evaluate operational partners — not technology alone. Strados manages the full site spirometry lifecycle so your team can focus on the science.
Risk-Based Monitoring, Enabled by AI
AI-assisted quality review identifies trends, protocol deviations, and sites requiring additional attention — enabling more efficient, proactive quality management throughout the study.
Strados Intelligence Advantage
High-quality spirometry data starts with high-quality review
Every spirometry session is first analyzed using AI-powered quality assessment from ArtiQ, which evaluates maneuvers against ATS/ERS quality criteria and identifies potential quality issues. Certified pulmonary function experts then perform centralized overread to confirm quality, review complex cases, and ensure reliable, trial-ready data.
Frequently Asked Questions
Site-based spirometry, answered
Respiratory Endpoint Intelligence
One partner for every respiratory endpoint
Site-Based Spirometry is one component of Strados Respiratory Endpoint Intelligence — bringing together standardized pulmonary function testing, intelligent quality management, centralized overread, and complementary respiratory endpoints within a unified platform.
Home Spirometry
Between-visit FEV₁ monitoring in decentralized and hybrid trials.
Cough Monitoring
Continuous cough frequency and bout analysis.
FeNO
Fractional exhaled nitric oxide for airway inflammation.
Pulse Oximetry
Continuous oxygen saturation and heart rate.
Lung Sounds
Acoustic analysis of adventitious lung sounds.
ePRO / eCOA
Digital diaries, questionnaires, and clinical assessments.
Ready to design your respiratory study?
Tell us about your program and we'll help you design the right respiratory endpoint strategy.
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