Disease Progression Trials Return to the Respiratory homepage LUNG SAFETY AND DISEASE PROGRESSION TRIALS Disease Progression Trials Learn how respiratory data can effectively measure lung safety and disease progression.

HOW DO YOU ACCURATELY MEASURE YOUR DRUG’S IMPACT ON PATIENTS’ PULMONARY FUNCTION?

Non-respiratory indications, like Amyotrophic Lateral Sclerosis (ALS), Systemic Sclerosis, Crohn’s Disease and Pompe’s Disease impair the respiratory muscles and eventually progress to respiratory dysfunction or failure. Alpha-1 antitrypsin deficiency (A1AD) is a genetic disease that eventually lead to lung disease, like COPD. Pulmonary function tests (PFT), including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), maximal inspiratory pressure (MIP), and maximal expiratory pressure (MEP) are used as measurement of disease progression.


ERT’S Integrated Respiratory Safety and Disease Progression Solution

ERT enables precise lung function testing to measure both the drug effect and progress of the disease using purpose-built devices and software customized to your protocol workflow for nearly 100% acceptable data in real time.


Non-Respiratory Diseases That Affect the Lungs

Indications that impair respiratory muscles and include pulmonary function testing to monitor disease progression include:

  • Amyotrophic Lateral Sclerosis
  • Systemic Sclerosis
  • Crohn’s Disease
  • Pompe’s Disease
  • Duchenne Muscular Dystrophy
  • Rheumatoid Arthritis
  • Multiple Sclerosis
  • Pulmonary Hypertension
  • Graft Versus Host Disease
  • Guillain- Barre Syndrome
  • Myathemia Gravis

Experts in Respiratory Solutions


Lung Safety and Disease Progression

Indication Sheet

Lung Safety and Disease Progression

Identify potential lung safety concerns as early as possible.



LEARN MORE ABOUT HOW ERT CAN SUPPORT YOUR CLINICAL TRIAL WITH AN INTEGRATED SOLUTION

Hover over a test below to see the device.

Template (Maximal Inspiratory/Maximal Expiratory Pressure) measure maximal strength of respiratory muscles. MIP/MEP Integrated Hub for Spirometry that measures lung function and cardiac safety endpoints, and integrates with Imaging endpoint collection and eCOA. MasterScopeTM (Forced Expiratory Volume at one second) is a strong indicator of future exacerbation in asthma patients. FEV1 (Diffusing Capacity for CO) measures the lung's ability to transfer gas from inhaled air to the red blood cells. DLCO (Forced Vital Capacity) provides information about the level of airflow restriction in patients. FVC (Electrocardiogram) is a simple intuitive method for clinical trial sites to collect high quality 12L ECGs. ECG MasterScope is an Integrated hub for Spirometry, 12-lead ECG, FeNO, FOT and Home FEV1/PEF/eDiary MasterScope is an Integrated hub for Spirometry, 12-lead ECG, FeNO, FOT and Home FEV1/PEF/eDiary Ndd EasyOne Pro® Single breath DLCO system MasterScope is an Integrated hub for Spirometry, 12-lead ECG, FeNO, FOT and Home FEV1/PEF/eDiary MasterScope is an Integrated hub for Spirometry, 12-lead ECG, FeNO, FOT and Home FEV1/PEF/eDiary ECG Electrocardiogram

sUPPORTING DEVICES

sITE SUPPORT

MasterScope

Integrated Hub for Spirometry that measures lung function and cardiac safety endpoints, and integrates with Imaging endpoint collection and eCOA. Collects FEV1, PEF, ECG, FENO, and AOS

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SpiroSphere®

Smart, portable, and affordable system for the measurement, recording, and assessment of accurate lung function parameters. Collects FEV1 and PEF

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Ndd EasyOne Pro® LAB

(integrates with MasterScope) – Portable, easy to use DLCO used in detecting, characterizing, and quantifying the severity of lung disease. Collects DLCO

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HOME SUPPORT

AM3™

AM3

Easy-to-use home spirometer and electronic diary (eDiary) measures and saves all relevant expiratory flow-volume parameters and records symptoms, events and medication. Collects FEV1 and PEF

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iSpiro®

iSpiro®

A home spirometry sensor in conjunction with the iSpiro App collects full spirometry at home, enabling remote collection of pulmonary endpoints. Collects FEV1 and PEF.

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eCOA

Collects respiratory patient questionnaires for real-time insights into patient safety and study performance.

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Cardiac Safety

Captures, reads, and stores ECGs centrally to avoid the risk of false or inaccurate data.

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Imaging

Measures and analyzes imaging endpoints like chest computed tomography (CT) to provide in-demand evidence of drug safety and efficacy.

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ASTHMA Trials

Asthma Trials

Capture pulmonary function test data along with symptoms of asthma exacerbations, like breathlessness, chest pain, cough, and wheezing to help improve patients’ quality of life. ERT’s integrated solution will ensure you are collecting acceptable data for your study’s regulatory submissions.

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COPD Trials

COPD Trials

Demonstrate your Chronic Obstructive Pulmonary Disease (COPD) study’s efficacy in improving lung function and quality of life symptoms with improved data acceptability and exacerbation event capture. ERT’s respiratory solution helps you meet your study goals.

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Cystic Fibrosis Trials

Cystic Fibrosis Trials

Identify the right endpoints for your complex cystic fibrosis (CF) trials. ERT has solutions that measure multiple lung function parameters and can be integrated with other endpoint measurement data solutions.

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Idiopathic Pulmonary Fibrosis

IPF Trials

Measure lung diffusion to monitor your Idiopathic Pulmonary Fibrosis (IPF) drug’s efficacy. Managing data variability is critical in demonstrating your compound improves clinically-measured outcomes. ERT’s lung function testing devices, software and services will ensure acceptable data.

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Home Spirometry

Home Spirometry

Spirometry collection at home, by patient or with home nurse, that integrates with other ERT at-home solutions to keep patients safe and studies on track.

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RESOURCES

Slide Other indications that impair respiratory muscles and include pulmonary function testing to monitor disease progression

Data Sheet

Quality/Outlier Report

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Actionable insights to increase study power and reduce variability.

Slide Respiratory-Spirosphere

Data Sheet

Respiratory Solutions for Lung Safety and Disease Progression

Speed regulatory approval with accurate lung safety data.

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Slide CYSTIC FIBROSIS Trials

Podcast

An Inside Look at the Latest ATS/ERS Guidelines

Learn about the 2019 ATS/ERS spirometry updates to pulmonary function testing guidance.

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Slide Case study: Continuous Monitoring of Turning in Parkinson’s disease

Blog

How to Improve Respiratory Data Quality in Non-Respiratory Clinical Trials

Centralized data collection and analysis processes ensures the highest quality data for your study.

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