Does your study data sufficiently demonstrate your drug’s effectiveness?

To gain regulatory approval for your new Chronic Obstructive Pulmonary Disease (COPD) drug, your study must demonstrate a core improvement in lung function parameters or exacerbation risk and patient- rated endpoints such as quality of life or key symptoms such as breathlessness or cough. Many studies are undermined by variability in data or a failure to capture sufficient exacerbation events.


ACHIEVE THE HIGHEST DATA QUALITY AND REDUCE VARIABILITY


ACHIEVE THE HIGHEST DATA QUALITY AND REDUCE VARIABILITY

Our respiratory solution experts help you meet your goals and achieve higher quality data, reduced costs, and shortened study timelines.

Experts in Respiratory Solutions


ASTHMA Trials Case Study

Case Study

Global Pharmaceutical Company Proves Efficiency of Bronchodialator for COPD Patients

ERT safety and efficacy solutions integrated with enhanced business intelligence helps secure new drug approval from global regulatory authorities.


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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Thorasys Tremoflo®

(integrates with MasterScope) Using a vibrating mesh to superimpose gentle, multi-frequency oscillations of sound waves on top of normal tidal breathing to measure respiratory impedance as lung resistance (R) and reactance (X). Collects airway resistance measurements.

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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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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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Disease Progression Trials

Lung Safety and Disease Progression Trials

Because decline in respiratory function is a direct result of progression of certain non-pulmonary diseases, demonstrating a treatment benefit on respiratory endpoints may provide evidence of your drug’s effectiveness. ERT enables precise lung function testing integrated with other efficacy data points like patient-reported outcomes (PRO) and more.

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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 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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