Correct patient performance through training and smart technology – combined with overread consistency – drives high quality data

ERT has been a trusted partner for over forty years that you can rely on in Respiratory clinical trials. Offering the broadest range of pulmonary function testing equipment, specialized training and overread, global site support, and experience in every therapeutic area, ERT’s Respiratory expertise delivers the data and service quality that will propel your trial to new drug approval success.

Regulatory Guidance: Standardize your trial

The largest source of subject variability within a respiratory clinical trial is the improper performance of a test. Noise in pulmonary function testing or inconsistencies between sites can restrict the ability to find important clinical signals relating to treatment effects. The American Thoracic Society (ATS) and European Respiratory Society (ERS) set the standards for respiratory clinical trials to regulate equipment performance criteria and measurement procedures so that endpoint assessments provide the most consistent data.

Regulatory Guidance: Standardize your trial

The largest source of subject variability within a respiratory clinical trial is the improper performance of a test.

OVER

500
studies and
15000000
-plus flow volume loops

 – and counting…

Devices standardized and customized for your protocol

Using the same equipment across all investigator sites that enforce ATS/ERS standards is the foundation to producing consistent, quality data and reduce variability. Since ERT manufactures many of our respiratory devices, we have control in customizing workflows based on your protocol. Explore many of the devices used in an ERT Respiratory trial (and please inquire about additional device choices for other endpoints):

Devices standardized and customized for your protocol

Spirometers

Home Monitoring

Other Devices

The Highest Quality of Data

After selecting and customizing the right respiratory devices, education and training programs are available for site test administrators so your study has the most informed, knowledgeable individuals calibrating equipment correctly and coaching patients to achieve the necessary performance. ERT’s Pulmonary Specialist Overreaders each with nearly 20 years of clinical experience perform a Best Test Review (BTR) of flow-volume loops that deselects unacceptable data, applies a quality grade to the data, and issues consistent feedback to each investigator site. Our best practice project management process SOPs keep trials moving forward efficiently and support audit readiness. The results? As a member of the Metrics Champion Consortium, ERT constantly grades our quality to push for higher standards. 98% usable, conclusive, reproducible data is achievable, leading to reduced sample sizes, outliers, and fraud to support future regulatory approval.

The Highest Quality of Data

As a member of the Metrics Champion Consortium, ERT constantly grades our quality to push for higher standards. 98% usable, conclusive, reproducible data is achievable, leading to reduced sample sizes, outliers, and fraud to support future regulatory approval.

Explore Respiratory Solutions for Your Trial

Forced/Slow Spirometry

Today’s prevalence of Chronic Obstructive Pulmonary Disease (COPD), Asthma, and Cystic Fibrosis are increasing and as a result, spirometry is becoming an irreplaceable tool in diagnosis, pulmonary function screening and clinical research data collection. Spirometry answers two major research questions: What is the lung volume that can be inspired or expired? And how long does it take to exhale this volume (flow rate)? The parameters FEV1, FVC and Inspiratory Capacity (IC) are important spirometry values used to determine efficacy and safety of an experimental drug. The FVC is the volume delivered during maximal expiration starting from a deep inspiration and FEV1 is the volume delivered in the first second of the FVC maneuver. Like all other pulmonary function values, these parameters are subject to the great amount of variability inherent in the nature of the testing. As a result, the ATS/ERS has published guidelines regarding the standardization of spirometry testing. In order to increase the rate of usable data and reduce variability, spirometry requires high quality data collection, patient compliance and consistent clinician training. To this end, ERT provides site training and centralizes the overread process of your study’s PFT data. ERT also offers various standardized devices such as MasterScope™, FlowScreen®, and AM3® to conduct spirometry testing.

Dynamic IC Measurements

Inspiratory capacity (IC) is the maximum amount of air that can be inhaled after a normal expiration. It can also be described as the tidal volume and the inspiratory residual volume added together. Measuring this form of lung capacity helps us understand COPD progression better and gives us a better understanding of hyperinflation and how treatments affect patient outcomes. As COPD progresses, air trapping and hyperinflation develop. Hyperinflation can be confirmed with the measurement of lung volumes, including Inspiratory Capacity. IC is a dependable and highly reproducible measurement of hyperinflation and in fact, better correlated with dyspnea than FEV1. Collecting respiratory data in clinical trials is challenging because the lung functions of patients entering the study are already compromised, introducing variability from the start. This is why training clinicians to appropriately coach patients and better controlling the quality of IC data with a centralized process are extremely important aspects of Respiratory clinical trials.

Home Spirometry

Some trials require spirometry measurements be taken at the patient’s home rather than as an in-clinic assessment, this process is also referred to as ambulatory spirometry. Home spirometry allows daily measurements of FEV1 and forced vital capacity (FVC), depending on the device choice, to efficiently and effectively obtain diagnostic quality measurements through portable and easy-to-use devices from subjects at home. Collecting spirometry data from the patient’s home during your clinical study with the AM3® or AM1+® provides a richer data set than simply performing these tests during site visits, which can have a positive effect on your clinical outcomes.

Integrated Peak Flow and eDiary

Many clinical studies today incorporate peak flow measurements with eDiary data collection to measure the efficacy of their compound as well as to document symptoms. An expert panel of the National Asthma Education and Prevention Program recommends long term monitoring for moderate to severe, persistent or worsening asthma. To follow this recommendation and comply with FDA guidance, respiratory clinical studies record periodic assessments of pulmonary function by spirometry or peak flow rate monitoring, combined with quality of life assessments. Throughout these clinical studies, compliance issues have been noted both in recording peak flow data and entering symptoms on paper questionnaires.  However, studies have shown that patient compliance greatly improves by simultaneously using an electronic diary device. ERT’s Clean Peak Flow Meter allows patients to test their peak flow measurements to record, track and monitor their condition.  In addition, ERT’s integrated spirometer with eDiary solutions, both the AM3® or AM1+®, collect electronic data for pulmonary function testing, symptom questionnaires, and other clinical outcome assessments to provide more information and better context for the subsequent peak flow data analysis.

Body Box (Body Plethsmography)

While spirometry is the standard method for measuring most relative lung volumes, its data does not provide information on absolute volume of air in the lungs. In addition to spirometry, Body Plethsmography is needed to measure residual volume, functional residual capacity, and total lung capacity.  This method, in which patients are asked to sit in an enclosed box and breathe through a pneumotachograph, remains to be the gold standard for measuring lung volumes, especially for patients who have air spaces in the lung that do not communicate with the bronchial tree.   This test can be performed quickly and gives absolute values. Body Plethsmography has many advantages over standard tests such as getting faster and more accurate lung volume measurements and enhanced diagnosis of airway obstruction. On the other hand, body box is a large and heavy piece of equipment, costly and complex, and may not be appropriate for all clinical trials. ERT’s Respiratory Consultants can help determine which approach is right for your study, patient population, and budget.

Fractional Exhaled Nitric Oxide (FeNO)

Fractional Exhaled Nitric Oxide (FeNO) testing is a relatively fast and easy way to measure inflammation in the bronchial tubes of the lungs. This test may be used in asthma diagnosis, chronic cough evaluations, and medication efficacy such as steroid responsiveness.  FeNO is performed by the patient drawing a large breath in and then breathing out slowly into the device.  In a clinical setting, FeNO measurement adds a new dimension in the assessment of airway diseases with its repeatability and ease-of-use for patient populations where other pulmonary function tests may be difficult to perform. ERT has integrated the NIOX VERO for FeNO collection into the MasterScope platform with automated workflows for enhanced FeNO quality monitoring, protocol compliance, and patient performance as well as reduced investigative site burden.

Energy Expenditure and Activity Monitoring

According to the latest research, daily physical activities are an important predictor of mortality and hospital admission in COPD patients — making activity data a significant endpoint in COPD clinical trials. Traditionally, daily physical activity was measured by paper questionnaires filled out by patients. These methods are subjective and rely on patients’ memory, introducing recall and design biases to clinical studies. Today, more modern instruments such as electronic activity monitors are gaining momentum in clinical trials to measure physical activity. These devices contain pedometers and accelerometers which record objective data and transmit that data wirelessly to a central location for evaluation. The ease of use, increased patient compliance and consistent associations with certain COPD disease characteristics (grade of fatigue, degree of emphysema, exacerbation rate, etc.) make activity monitors an ideal addition as a valid outcome to respiratory clinical trials.

6 Minute Walk Test (6MWT)

In clinical settings, the six-minute walk test is widely used for measuring the response to therapeutic interventions for pulmonary and cardiac disease.  In March 2002, American Thoracic Society Pulmonary Function Standards Committee published guidelines for the 6MWT.  In this test, patients are asked to walk as far as possible for 6 minutes. The primary measurement of the 6MWT is the distance walked, while secondary measurements can be fatigue and dyspnea.  In addition, Pulse Oximetry, which measures the oxygen saturation of a patients’ blood, is an essential component in the 6MWT.  ERT will support the 6 minute walk test in your next respiratory study protocol.

DLCO Diffusion Test

The carbon monoxide diffusing capacity test (DLCO) is a commonly used pulmonary function test that measures the gas exchange ability of the lungs. Repeated measures of DLCO aid in determining disease progression or therapy efficacy and enables clinicians to identify diagnostic details that are not visible by spirometry alone. In order to obtain usable data, the DLCO instrument needs to be perfectly calibrated, and patients must be coached throughout the procedure. Due to these aspects, DLCO diffusion testing requires a specially trained technician. According to a study published in Respiratory Care, DLCO measurements of the same patient in different labs vary as much as 50%. In an effort to reduce these differences, the American Thoracic Society (ATS) has published the standardized testing procedures and equipment recommendations for DLCO. ERT offers Centralized DLCO Services to reduce DLCO data variability during collection with real-time inclusion/exclusion alerts and other benefits.

Bronchial Provocation Tests

Bronchial provocation tests refer to challenge tests using medication or osmotic stimuli. The most commonly used provocation tests employ histamine and methacholine. These are known as the “direct provocation tests” because they act directly on certain receptors of the bronchial smooth muscle and cause it to contract. During testing, patients are introduced to increasing amounts of methacholine or histamine, inhaled through a nebulizer. Before and after inhaling the substance, spirometry readings are taken to evaluate changes in lung function. These tests have been shown to be safe, reliable, and reproducible. Methacholine challenge testing is a valuable method of assessing airway responsiveness and is an indispensable tool used in clinical research. The main uses of methacholine challenge testing are measuring therapeutic efficacy, asthma diagnosis, and examination of disease pathophysiology.

Interpreting bronchial provocation tests are known to be challenging due to the arbitrary nature of the cut-off values used to identify a positive response. These cut off values can change from lab to lab which make it a challenge for physicians to draw a definite conclusion. Centralization of challenge test data by ERT greatly reduces variability and enhances the quality of your data.

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Therapy Area Experience

Our Respiratory Solutions team has a broad range of experience in multiple therapy areas, including non-respiratory therapy areas.

Efficacy and Monitoring of Disease Progression

  • Asthma (plus eCOA expertise)
  • Chronic Obstructive Pulmonary Disease (COPD) (plus eCOA expertise)
  • Idiopathic Pulmonary Fibrosis (IPF)
  • Cystic Fibrosis (CF)
  • Rhinitis
  • Amyotrophic Lateral Sclerosis (ALS)
  • Smoking cessation
  • Allergies
  • Non-respiratory indications

Pulmonary Function Safety Endpoints

  • Graft-versus-host disease (GVHD)
  • Inhaled Insulin: Diabetes Mellitus
  • Systemic Lupus Erythematosus
  • Any inhaled treatment across lung safety therapy groups

Exclusion Criteria

  • Relapsing Multiple Sclerosis

Therapy Area Experience

Our Respiratory Solutions team has a broad range of experience in multiple therapy areas:

Efficacy/Monitoring and Early Detection of Diseases

  • Asthma
  • Idiopathic Pulmonary Fibrosis (IPF)
  • Cystic Fibrosis (CF)
  • Rhinitis
  • Amyotrophic Lateral Sclerosis (ALS)
  • Smoking cessation
  • Allergies
  • Non-respiratory indications

Pulmonary Function Safety Endpoints

  • Graft-versus-host disease (GVHD)
  • Inhaled Insulin: Diabetes Mellitus
  • Systemic Lupus Erythematosus
  • Any inhaled treatment across lung safety therapy groups

Exclusion Criteria

  • Relapsing Multiple Sclerosis

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