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.

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 FVC, FEV1, PEF, ECG, FeNO, and airway resistance measurements.

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SpiroSphere®

Smart, portable, and affordable system for the measurement, recording, and assessment of accurate lung function parameters. Collects FVC, 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 FVC, 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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心臓安全性中央解析

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

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イメージング

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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自宅で行う肺活量測定

自宅で行う肺活量測定

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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参考資料


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