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FOR SPONSORS & CROS

Home Spirometry for Clinical Trials

Built on years of proven innovation, Air Next combines validated home spirometry with decentralized and hybrid clinical trial workflows to help sponsors collect reliable pulmonary endpoint data beyond the clinic.

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FDA 510(k) Cleared

CE Mark

ATS/ERS Compliant

SOLUTION OVERVIEW

Air Next: Proven Home Spirometry for Clinical Trials

The Strados home spirometry solution combines the clinically proven Air Next spirometer with a guided patient app and a clinician-side quality control dashboard, capturing pulmonary function tests with strong fidelity and accuracy compared to in-clinic spirometry.1 Live coaching and centralized expert overread turn every remote session into reliable, trial-ready lung function data for hybrid and decentralized trials.

Measures:

FEV₁

FVC

FEV₁/FVC

PEF

FEF₂₅–₇₅

FEF₂₅/₅₀/₇₅

FEV₆

FIVC

PIF

FET

Live Coaching

Real-time guidance every session.

App-Guided Maneuvers

Visual and audio prompts walk patients through each step.

ATS/ERS Compliant

Standardized grading applied at home.

Validated in Real-World Use

Trusted across 40+ clinical trials.

More Frequent Assessment

Capture lung function between visits.

Same Device, Same Quality

One device and workflow for in-clinic endpoints and at-home monitoring.

Technical Specifications

1.

Pradhan, A., Pollington, J., Saralaya, D., Martin, M. J., Hughes, R., Arya, N., Sanders, N., Sharifian, H., Locke, K., Bonam, M., & Harrison, T. W. (2025). COMPAIR: A comparison of directly supervised clinic versus virtually supervised home spirometry. ERJ Open Research, 11(5), 01130-2024. https://doi.org/10.1183/23120541.01130-2024

Why include home spirometry in your study?

1

Richer Longitudinal Lung Function Data

Collect spirometry more frequently than site visits alone, providing a more complete view of lung function and treatment response over time.

2

Capture Changes Between Site Visits

Monitor lung function throughout the study to provide additional insight between scheduled clinic visits.

3

Reduce patient burden

Eliminates travel, improving retention and access for pediatric, elderly, and geographically dispersed patients.

4

Support hybrid & decentralized trials

Patients test at home on their schedule, enabling hybrid and decentralized designs without sacrificing endpoint or data quality.

SAME DEVICE, SAME QUALITY

One Device. Less Variability.

Use the same validated Air Next spirometer and standardized workflow across site-based, hybrid, and decentralized study visits. A unified platform helps simplify operations while supporting consistent pulmonary function data throughout the trial.

Consistent Data Quality

The same validated spirometer and workflow across clinic and home support comparable data throughout the study.

Seamless Participant Experience

One familiar device throughout the trial reduces training and supports confident participation.

Simplified Study Operations

Standardize equipment and workflows across site, hybrid, and home designs.

Reliable Longitudinal Assessment

Measuring with the same device helps reduce variability when tracking lung function over time.

CLINICAL VALIDATION

Air Next Metrics-at-a-Glance

0.95–0.981

ICC VS. CLINIC SPIROMETRY

COMPAIR study, excellent agreement between home and clinic FEV₁

>90%

ADHERENCE TO WEEKLY SPIROMETRY

Patients consistently completed weekly home spirometry sessions throughout remote monitoring

95%1

FIND IT EASY TO USE

95% of patients found the Air Next easy to use and were willing to continue using it

1.

Pradhan, A., Pollington, J., Saralaya, D., Martin, M. J., Hughes, R., Arya, N., Sanders, N., Sharifian, H., Locke, K., Bonam, M., & Harrison, T. W. (2025). COMPAIR: A comparison of directly supervised clinic versus virtually supervised home spirometry. ERJ Open Research, 11(5), 01130-2024. https://doi.org/10.1183/23120541.01130-2024

2.

Pradhan, A., Pollington, J., Saralaya, D., Martin, M. J., Hughes, R., Arya, N., Sanders, N., Sharifian, H., Locke, K., Bonam, M., & Harrison, T. W. (2025). COMPAIR: A comparison of directly supervised clinic versus virtually supervised home spirometry. ERJ Open Research, 11(5), 01130-2024. https://doi.org/10.1183/23120541.01130-2024

ATS/ERS Quality

Every maneuver, reviewed live

REAL-TIME COACHING

A respiratory specialist in every home

The challenge with home spirometry has always been technique. Strados solves this with an integrated telehealth platform, live video coaching that brings the expertise of a respiratory therapist directly to the patient's living room.

Improves First-Attempt Quality

Live guidance helps patients produce acceptable maneuvers on their first try.

Corrects Errors in Real Time

Coaches confirm posture, mouthpiece seal, and effort before a session is complete.

Reduces Repeat Testing

Immediate feedback prompts coached repeat maneuvers on the spot.

Minimizes Missing Data

App-guided prompts plus expert oversight mean fewer unusable or missing sessions.

AIR NEXT SPIROMETER AT HOME

How it Works

Every Air Next spirometer session moves through the same standardized workflow, so remote spirometry data holds up to regulatory and clinical standards.

1

Instruct

The companion app guides patients through each maneuver with visual and audio prompts before testing begins.

2

Coach

Live respiratory specialists provide real-time guidance, correcting technique before poor-quality data is captured.

3

Assess

Patients perform ATS/ERS-grade maneuvers at home with immediate acceptability feedback on every effort.

4

Grade

Automated acceptability and repeatability grading flags substandard sessions in real time, not days later.

5

Quality Control

Centralized expert overread reviews data before it reaches your database, ensuring trial-grade confidence.

FOR HEALTHCARE PROVIDERS

Looking for home spirometry to monitor patients outside of clinical trials?

Explore our Healthcare Home Spirometry solution for remote respiratory care, chronic disease management, and EMR-integrated monitoring.

Explore Home Spirometry for Healthcare

PART OF THE STRADOS ENDPOINT SUITE

One component of the Strados Respiratory Endpoint Suite

Remote spirometry integrates with in-clinic spirometry, cough monitoring, FeNO, pulse oximetry, lung sound analysis, and eCOA, so care teams can build a complete picture of respiratory disease between visits.

Explore the Full Endpoint Suite

Let's bring clinical-grade spirometry home

We'll help you build a home spirometry approach that delivers reliable, trial-ready lung function data for your hybrid or decentralized clinical trial.

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