How do you identify the right endpoints For your CF trial?

Clinical trials in cystic fibrosis (CF) continue to investigate new therapies, including gene therapy, anti-inflammatory drugs and anti-infectives. This increases the challenge in identifying the right endpoints, including surrogate endpoints, to conclusively evaluate your compounds. As clinical trial patients are frequently children, getting accurate lung function data is challenging, adding to the study’s complexity.




ERT’s integrated solution ensures highest data quality and reduced variability.

Measure lung function efficacy endpoints like FEV1, lung clearance index (LCI) measurement, and DLCO along with cardiac safety endpoints, like centralized electrocardiograms (ECG) analysis, and imaging endpoints, like chest computer tomography (CT) and overread. Integration with eCOA enables patients to answer questionnaires for real-time insights into patient safety and study performance.

Experts in Respiratory Solutions


Cystic Fibrosis Case Study

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How to Reduce Data Variability in Respiratory Clinical Trials

Discover how the right technology and services can support sites in generating reliable, refined data with low variability.


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


Spirometry

measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled. Includes FVC, FEV1, PEF.

SITE SUPPORT:

HOME SUPPORT:

LCI

(Lung Clearance Index) measured by multiple breath washout is a sensitive measure of ventilation inhomogeneity.

SUPPORTED DEVICES

DLCO

(Diffusing Capacity for CO) measures the lung’s ability to transfer gas from inhaled air to the red blood cells.

SUPPORTED DEVICES

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 on-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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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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