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Smarter Respiratory Trials

From Endpoint Design to Submission

Your endpoint strategy is the biggest source of risk in a respiratory program, and it's usually addressed too late. Ametris delivers a suite of fit-for-purpose, trial-ready digital endpoints for respiratory diseases, including COPD, asthma, chronic cough, pulmonary arterial hypertension (PAH), and idiopathic pulmonary fibrosis (IPF).

Capture continuous, objective data on what matters most to patients, like physical activity, mobility, sleep, and cough, through a single connected platform, backed by end-to-end scientific, clinical, and data operations support. So you can focus on building evidence, not the infrastructure behind it.

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Patient with Respiratory Disease
Patient using respirometer

Clinical Measurement Challenges
in Respiratory Diseases

Respiratory diseases carry a heavy, difficult-to-capture symptom burden. Episodic clinic-based assessments and patient diaries may miss the day-to-day variability in physical function, sleep, and cough behavior associated with hospitalization, trial dropout, and program cost – and may be missed by in-clinic performance measures (i.e. 6MWT) and subjective self-report instruments alike.

  • Physical Function: In a Phase 2 IPF trial, actigraphy-based moderate to vigorous physical activity detected a clinically and statistically signficant treatment response that the conventional 6-Minute Walk Test and SpO2 did not.1
  • Cough Frequency: In a study of 97 individuals with persistent cough, a single day of monitoring failed to reliably predict 30-day cough patterns for nearly two-thirds of subjects –day-to-day variability made one-time measurement misleading.2
  1. Bellerophon Therapeutics Phase 2 (inhaled nitric oxide, IPF) - ActiGraph Cardiopulmonary Case Study
  2. Chung et al., Lung, 2024

Ametris Solution for Respiratory Diseases

Continuous Coverage Across Full Disease Trajectory

ActiGraph LEAP™Ametris delivers a comprehensive digital measurement solution purpose-built for respiratory clinical research.  Capturing objective, continuous data across the full spectrum of disease progression. Powered by the FDA-cleared, multi-sensor ActiGraph LEAP®, worn at the ankle, wrist, or upper arm to match each measure's clinical intent, our fit-for-purpose solution captures objective, continuous digital functional measures across respiratory diseases, in the natural environment. 

Domain What It Measures Why It Matters
Physical Activity & Mobility Moderate-to-vigorous physical activity (MVPA), non-sedentary time, step count, walking bouts Activity limitation is the most consistently reported patient burden across COPD, asthma, PAH, and IPF. Daily step count has predicted acute exacerbations and correlates with six-minute walk distance, quality of life, and right ventricular function in PAH
Sleep Total sleep time, wake after sleep onset (WASO), sleep efficiency Sleep disruption is reported across COPD, asthma, and PAH, and the EMA lists nighttime awakenings as a COPD efficacy endpoint. Objective sleep data reveals treatment effects that patients often can't reliably self-report.
Cough Continuous cough frequency (Hyfe algorithm via ActiGraph LEAP audio detection) Cough is a cardinal symptom in IPF, COPD, asthma, bronchiectasis, and chronic cough — and one of the most placebo-susceptible endpoints in respiratory research when measured only periodically
Vital Signs Respiratory rate, oxygen saturation, heart rate Continuous physiological surveillance that complements functional and symptom data, surfacing early signals between scheduled assessments
Digital Spirometry Home-based FEV1, FVC, and related lung function measures (requires third party digital spirometer from Ametris Sensor Library) Decentralizes pulmonary function testing beyond the clinic visit, expanding data volume and participant reach while reducing site burden

Discuss your trial needs with one of Ametris’ digital health technology experts. Schedule a Call

Participant and Nurse two people shaking hands over a desk

Digital Health Monthly

Learn more about the latest research using DHTs to capture continuous and objective data related to the patients with respiratory diseases, providing more detailed data on disease progression and treatment efficacy.

Chronic Obstructive Pulmonary Disease (COPD) Using Continuous Cough Monitoring
Click to play video

Physical Function, Cough, and Exacerbations: Continuous Digital Measures Redefining COPD Assessments

Cough Detection
Click to play video

The Value of Continuous Cough Monitoring and Its Impact on the Placebo Effect

Why Ametris?

Continuous Cough Monitoring

The PROactive accelerometer-based physical activity measure is EMA-qualified as a clinical trial endpoint in COPD. The FDA has separately accepted accelerometer-derived MVPA as a primary endpoint in a Phase 3 pulmonary fibrosis.

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Respiratory Coverage

Physical activity, mobility, sleep, and cough endpoints span COPD, asthma, IPF, PAH, bronchiectasis.

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All-in-One Platform

FDA-cleared wearables, validated algorithms, scientific support, clinical and data operations, and regulatory documentation — all included. No internal DHT expertise required. Faster to first patient by 3–6 months.

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Proven Track Record

  47+ industry-sponsored trials
  1,721 sites in 55 countries
  6,291 participants
  20+ years of study experience

Let's Explore Your Endpoint Strategy

Endpoint decisions early make or break your program. We'll review your protocol and show you exactly where traditional measures leave risk on the table.