ASTHMA TRIALS Return to the Respiratory homepage ASTHMA TRIALS ASTHMA TRIALS Measure and collect lung function endpoints like FEV1, PEF, FeNO, and AOS.

HOW CAN YOU ENSURE YOUR STUDY TIMELINE STAYS ON TRACK?

Asthma, a reactive airway disease is not easily defined, nor is there a standard primary endpoint for the assessment of a treatment’s efficacy on asthma. A range of clinical trial endpoint measures can be used, such as lung function measurements including forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF). Home spirometry monitoring is key in capturing exacerbation endpoints and generating automated notifications for high eosinophil count or when a patient is unable to visit a site.




ACHIEVE THE HIGHEST DATA QUALITY AND REDUCE VARIABILITY

Knowing your site and patient selection process is optimized, and data collection and interpretation is garnering quality, acceptable data is paramount to your trial’s success. ERT has partnered with sponsors on over 350 clinical trials for the treatment of asthma.

Experts in Respiratory Solutions


Asthma Case Study

Case Study

Global Pharmaceutical Company Drives Data Acceptability Over 95%

Learn how a global pharmaceutical company drove more than 95% data acceptability resulting in a successful regulatory submission.



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

Hover over a test below to see the device.

Template 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 (Peak Expiratory Flow) provides information about the level of airflow obstruction in asthma patients. PEF (Fractional Concentration of Exhaled Nitric Oxide) determines how much inflammation is present in the lungs. FeNO (Airway Oscillation System) is a noninvasive technique to assess airway obstruction in asthma patients. AOS (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 MasterScope is an Integrated hub for Spirometry, 12-lead ECG, FeNO, FOT and Home FEV1/PEF/eDiary NIOX VERO® Fractional, exhaled Nitric Oxide measurement system Thorasys® Tremeflo® Airwave oscillometry 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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Niox Vero®

(integrates with MasterScope) For assessing lung inflammation using FeNO (fractional exhaled Nitric Oxide) testing to determine airway disease and effectiveness of inhaled steroids. Collects FeNO

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Thorasys Tremoflo®

(integrates with MasterScope) Using a vibrating mesh to superimpose forced oscillations of sound waves on top of normal tidal breathing to measure respiratory impedance as lung resistance (R) and reactance (X). Collects AOS

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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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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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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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Home Spirometry

Home Spirometry

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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RESOURCES

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

Data Sheet

AM3

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Make home monitoring easy with our integrated home spirometer and electronic diary.

Slide ASTHMA SpiroSphere Data Sheet

MasterScope

Minimize risk and uncertainty with our centralized spirometry, ECG, patient-reported outcomes and multi-endpoint platform.

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Slide Respiratory-Spirosphere

Data Sheet

SpiroSphere®

Take your spirometry data to the next level with our smart, portable and affordable spirometer.

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Slide

Data Sheet

iSpiro®

A home spirometry sensor in conjunction with the iSpiro App collects full spirometry at home.

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