Plan to attend these poster sessions during ATS to learn about methods, results and conclusions on each topic and rational listed below.
Comparison of time to peak flow with rise time from 10 to 90% of peak flow
An explosive start of forced exhalation has always been a fundamental requirement for a good quality FEV1. In patients that have diminished elastic recoil this is necessary to avoid spuriously elevated FEV1s. Time to peak flow (TPEF) <=0.120s has been widely adopted as an objective criterion defining an explosive start in clinical trials but lacked empirical support. The 2019 ATS/ERS spirometry standards mentioned rise time from 10-90% of the peak expiratory flow rate (RT10-90%) <=0.150s as a possible means for evaluating an explosive start of test. We compared TPEF and RT 10-90% in a clinical trial for COPD.
José Ramos, M.Ed., B.S., RRT – Director, Respiratory Solutions/Business Development at Clario
Comparison of the old (2005) and new (2021) ATS/ERS methods For assessing bronchodilator response (BDR) by FEV1 in a clinical trial for asthma
The ATS/ERS recommended changing the criteria for assessing bronchodilator response (BDR) in 2021. The new method compares the absolute change in FVC or FEV1 to the predicted value instead of the baseline value. It is not currently known how these two methods compare in asthmatics. Inclusion criteria for clinical trials for asthma often includes demonstration of a significant BDR. A significant difference in these methods may impact the inclusion criteria for clinical trials for asthma.
Kevin McCarthy – Director, Respiratory Science at Clario
The impact of learning effect on patient burden for ATS/ERS 2019 compliant forced spirometry within a clinical trial setting
ATS/ERS 2019 spirometry guidelines (GL) introduced a 4th phase that allows objective determination of full inflation. We have previously shown that the implementation of the 2019 GL within clinical trials has increased the average total number of efforts required to meet acceptability criteria from 3.4 in the 2005 GL studies to 4.8 in a similar 2019 GL study (+41%). lnitially, 30% of sessions required 8 efforts but this feil to around 6% after 3 months. We sought to explore if it was patient or technician experience which drove this reduction over time.
Phil Lake, Ph.D. – Senior Director Respiratory Solutions at Clario
Director, Respiratory Solutions/Business Development at Clario
José is a Director of Respiratory Solutions and a leader in the clinical trials industry and has been a student of lung function testing since 1995. He spent most of his career at Cleveland Clinic as a respiratory therapist in the Pulmonary Function Laboratory, as a Technologist, Supervisor, Manager, and then Director before joining Clario. José assisted in the expansion of Pulmonary Function Labs at Cleveland Clinic taking it from 10 rooms at the main facility to over 38 rooms at 23 sites in Greater Cleveland and then expanding that network to satellites in Florida, Abu Dhabi, and London. He has a passion for teaching and enjoys sharing his knowledge of lung function testing. He now brings that passion and knowledge of pulmonary function testing to focus on improving data quality for all clinical trials with respiratory measurements. “I am a strong believer that the proof is in the pudding. The rigorous requirements of clinical trials demand that lung function data be of the highest quality from the beginning to the end”.
Director, Respiratory Science at Clario
Kevin McCarthy has been working in the field of lung function testing since 1973. He was the manager of the Pulmonary Function Laboratories at the Cleveland Clinic Health System for nearly 40 years, retiring in 2016. Kevin’s research experience includes managing the pulmonary function quality control in two NIH-funded registries: patient with severe A1AT deficiency and LAM Registry and was the site manager at Cleveland Clinic for the NETT study.
Kevin has published extensively on the topic of pulmonary function testing. He is a current member of the ATS PFT Committee and the ATS/ERS Task Force to update the standards for Lung Volume testing. He was a member of the ATS/ERS Task Force that updated the standards for Spirometry in 2019. Kevin is also a member of the faculty that presents the annual MGC Diagnostics Cardiorespiratory Diagnostics Seminar which has been providing excellent pulmonary function education for over 25 years.
Kevin has always been passionate about the quality of pulmonary function measurements. This passion has now moved to the clinical trial world where data quality is critical if these measurements are to accurately answer the questions we are asking. He is now the Director of Respiratory Science at Clario for the US West Coast and Australia.
Senior Director, Respiratory Solutions at Clario
Phil Lake, Ph.D. is a respiratory specialist at Clario who supports clients all around the world. Phil has held a variety of roles in drug development for nearly 20 years, predominantly focused on respiratory trials.
Prior to Clario, Phil held positions at SmithKline Beecham and GlaxoSmithKline. There, he worked on a number of anti-inflammatory agents, dual and triple combination therapy, monoclonal antibody studies, anti-infectives and some of the largest mechanistic studies looking at biomarkers within sputum and biopsy samples. He also has experience supporting a number of CROs as a respiratory specialist and as the head of project management. For the last 10 years, he has concentrated extensively on rare respiratory diseases, including Cystic Fibrosis and Idiopathic Pulmonary Fibrosis, covering a variety of drug mechanisms and medical devices. Phil was pivotal to some of the first centralised over read studies and is committed to driving improvements in lung function testing.
He completed his training at University College Cardiff and Southampton University.
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