Texas’ Impact on Exhaled Biomarker Research Study of the Effects of Education on Patients With Chronic Obstructive Pulmonary Disease David Kaminsky, MD,

Texas’ Impact on Exhaled Biomarker Research

Study of the Effects of Education on Patients With Chronic Obstructive Pulmonary Disease

David Kaminsky, MD, University of Vermont , Stephanie Burns, Melissa Brock

Study Type: Interventional

Sites: Baylor College of Medicine, Houston, TX and The Vermont Lung Center, Colchester VT

Description: • The investigators hypothesize that education will improve exercise capacity, symptoms and quality of life in

patients with chronic obstructive pulmonary disease (COPD). In addition, the investigators are interested in determining how education might alter various chemicals in the blood and exhaled breath that reflect inflammation in the lungs and the body as a whole.

Primary Outcome Measures:• Exercise tolerance: Exercise tolerance will be measured by 6 min walk distance at baseline and again after 12

weeks of the intervention

Secondary Outcome Measures:• Dynamic hyperinflation: Dynamic hyperinflation will be measured by changes in inspiratory capacity that occur

before and after the 6 min walk test, at baseline, and then again at 12 weeks.• Oxidative stress: Oxidative stress will be measured by levels of H2O2, 8-isoprostane, and glutathione in exhaled

breath condensate (EBC) at baseline and again at 12 weeks.• Systemic inflammation: Systemic inflammation will be assessed by plasma levels of CRP, IL-6 and red cell

distribution width at baseline and at 12 weeks.• Lung mechanics: Lung mechanics will be assessed by measurement of respiratory system impedance using the

forced oscillation technique at baseline and at 12 weeks.• Dyspnea: Dyspnea will be assessed by questionnaires (Borg, MRC, BDI/TDI) at baseline and at 12 weeks.• Quality of Life: Quality of life will be assessed by the St. George Respiratory Questionnaire at baseline and at 12

weeks.

This multi-center trial is a collaborative effort between The Vermont Lung Center and Baylor College of Medicine. For more information please contact Stephanie Burns at [email protected] or Melissa Brock at [email protected]

2nd AnnualClinical & Translational Research ForumFebruary 12, 2014

T1: Translation to Humans - Proof of concept, testing basic science discoveries for clinicaleffect and/or applicability (Phase 1), new methods of diagnosis, treatment and preventionInstitute/Center: Institute for Translational Sciences

Presented by: Aaron, Emily L, B.S.SOM Student

Exploring the Consistency and Reproducibility of the Chemical Profile of Exhaled Breath Condensation among

Healthy, Non- Smoking IndividualsAaron, E L, UTMB School of Medicine Calhoun, W J, Pulmonary and Critical Care Ho, S A,Allergy and Immunology Spratt, H PMCH Administration Baker, W Research Scientist

INTRODUCTION: Exhaled Breath Condensate (EBC) is a relatively novel biosample sourcethat may reflect airway biology and disease status due to entrained microparticles of airway lining fluid in expired air. One area our study is focused on the variation of the chemical spectrum of the EBC of healthy, non-smoking, non-asthmatic adults in relation to a few basic demographic parameters (age, race, gender). We hypothesize that subject characteristics may influence the spectra.

METHODS: Thirty adults, aged 18-65, were recruited. Exclusion criteria included a smoking history of more than 5 years total and less than 10 years since quitting, history of any procedure within the thoracic cavity, uncontrolled reflux, and current symptoms of acute or chronic rhino-sinusitis, and asthma. EBC was collected utilizing a commercial Rtube, according to manufacturer’s directions. Patients breathed the entire cycle of normal tidal breaths through the Rtube for seven minutes. Condensate was stored at -70C. Immediately following EBC collection, subjects underwent spirometry to establish their baseline lung function. A second EBC and spirometry wereobtained a month later. The samples were analyzed via nuclear magnetic resonance spectroscopy.

RESULTS: Consistent chemical shift signatures were observed in our healthy subjects, some of which appear to be consistent between tests. Further analysis will establish the molecular species associated with the shifts, and the reproducibility of each specific species.

DISCUSSION: A key first step in validating a new biomarker is to assess the performance characteristics over time. Our data will provide a foundation to develop disease-discriminating tests for asthma or COPD.

Source: http://www.its.utmb.edu/ctr_forum/forum_documents/Aaron_CTRForumAbstract2014.pdf

Texas’ Impact on Exhaled Biomarker Research

Discussion: This is the first study to look at seasonal changes in asthma self-management and associated lung measures. While the lung inflammation did not demonstrate longitudinal changes, what we found were seasonal changes when asthma triggers are higher.

EBC allowed us to collect biological data non-invasively – from children (a group notoriously averse to blood draws) in a community based sample.

Discussion: This is the first study to look at seasonal changes in asthma self-management and associated lung measures. While the lung inflammation did not demonstrate longitudinal changes, what we found were seasonal changes when asthma triggers are higher.

EBC allowed us to collect biological data non-invasively – from children (a group notoriously averse to blood draws) in a community based sample.

Introduction: Asthma is the most common chronic illness in childhood – affecting 7 million children or 11% of school-aged children (ages 6-12). Asthma is characterized by chronic airway inflammation that reduces airflow and increases “twitchiness” of the airways, so that during exacerbations there is also bronchial muscle hyper-reactivity to stimuli (asthma triggers).

Introduction: Asthma is the most common chronic illness in childhood – affecting 7 million children or 11% of school-aged children (ages 6-12). Asthma is characterized by chronic airway inflammation that reduces airflow and increases “twitchiness” of the airways, so that during exacerbations there is also bronchial muscle hyper-reactivity to stimuli (asthma triggers).

Methods: 12-month longitudinal asthma self-management intervention provided to school-aged children and their parents, with data collection in fall, winter, spring, & summer.

Outcome measures: asthma morbidity (asthma severity, hospitalizations, ED visits), lung inflammation, & asthma self-management behaviors.

Methods: 12-month longitudinal asthma self-management intervention provided to school-aged children and their parents, with data collection in fall, winter, spring, & summer.

Outcome measures: asthma morbidity (asthma severity, hospitalizations, ED visits), lung inflammation, & asthma self-management behaviors.

Results: The intervention significantly reduced asthma severity, improved asthma self-management & inhaler skill in the treatment group. Health care utilization was reduced for the whole group with hospital stays decreased 54%, and ED visits decreased 41%.

A lung inflammation biomarker (nitric oxide) was measured in EBC – and did not show longitudinal changes. However, children’s lung inflammation scores were higher in winter and spring and higher in those homes with smokers.

Results: The intervention significantly reduced asthma severity, improved asthma self-management & inhaler skill in the treatment group. Health care utilization was reduced for the whole group with hospital stays decreased 54%, and ED visits decreased 41%.

A lung inflammation biomarker (nitric oxide) was measured in EBC – and did not show longitudinal changes. However, children’s lung inflammation scores were higher in winter and spring and higher in those homes with smokers. Sample:

292 children; 186 boys, 106 girls; (8.8 years, sd=1.2), 57.2% Hispanic, 19.9% African American, &18.8% white

Sample: 292 children; 186 boys, 106 girls; (8.8 years, sd=1.2), 57.2% Hispanic, 19.9% African American, &18.8% whiteAcknowledgement: This work is supported with grant funding from the National Institutes of Health, National Institute of Nursing

Research and National Heart, Lung, & Blood Institute to the authors (R01, NR007770). The content is solely the responsibility of the author and does not necessarily represent the official views of NIH.

Time Fall Winter Spring Summer

M 1.97 2.18 2.32 1.98

SD 2.83 2.69 3.39 3.85

Using Exhaled Breath Condensate to Assess Airway Using Exhaled Breath Condensate to Assess Airway Inflammation in School-aged Children Who Have AsthmaInflammation in School-aged Children Who Have Asthma

Sharon D. Horner, PhD, RN, FAAN, The University of Texas at Austin School of NursingSharon D. Horner, PhD, RN, FAAN, The University of Texas at Austin School of Nursing

Texas’ Impact on Exhaled Biomarker Research

MicroRNA in Exhaled Breath CondensateMicroRNA in Exhaled Breath Condensate

• Pilot study performed in Central Texas using RTube™ Exhaled Breath Condensate Collector

• Preliminary results have confirmed the presence of microRNA in breath condensate

• Next steps would be to optimize procedures, evaluate reproducibility, and assess potential differences in breath condensate microRNA between individuals with and without lung cancer

• For more information contact Gary Latham at [email protected]

Asuragen is a molecular diagnostics company using genomics to drive better patient management through best-in-class clinical testing solutions. With a pioneering position in miRNA, Asuragen has assembled cutting edge technologies to discover, develop and commercialize diagnostic products and clinical testing services.

Texas’ Impact on Exhaled Biomarker Research

The effect of academic exam stress on mucosal and cellular The effect of academic exam stress on mucosal and cellular airway immune markers among healthy and allergic individualsairway immune markers among healthy and allergic individuals

ANA F. TRUEBA,a DAVID ROSENFIELD,a EVA OBERDÖRSTER,b PIA D. VOGEL,b and THOMAS RITZa

aDepartment of Psychology, Southern Methodist University, Dallas, Texas, USAbDepartment of Biological Sciences, Southern Methodist University, Dallas, Texas, USA

Research suggests that psychological stress can exacerbate allergies, but relatively little is known about the effect of stress on mucosal immune processes central to allergic pathophysiology. In this study, we quantified vascular endothelial growth factor (VEGF), interferon gamma (IFN-γ), and interleukin-4 concentrations in saliva (S) and exhaled breath condensate (EBC) during final exams and at midsemester among 23 healthy and 21 allergic rhinitis individuals.

IFN-γS decreased during exams for both groups while VEGFEBC increased (and increases in VEGFS were a trend). Elevated negative affect ratings predicted higher VEGFEBC in allergic individuals. IFN-γEBC increased in healthy individuals early during exams and then decreased, while allergic individuals showed a decrease in IFN-γEBC throughout final exams.

These findings suggest that psychological stress can suppress cellular immune function among allergic individuals while increasing VEGF.11

“World Changers Shaped Here”

Dedman College of Hamanities and Sciences,Department of Psychology

Our department has an outstanding, energetic faculty committed to both research and teaching. Over half have been honored by a national and/or international scientific organizations.

Southern Methodist UniversityDallas, TX

Texas’ Impact on Exhaled Biomarker Research

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Respiratory Research, Inc. is a medical device company based in Austin, Texas. We enable lung research world wide by providing devices for easy, non-invasive collection of aerosolized airway lining fluid, volatile vapors, and exhaled particles. Our products have been used over 200,000 times and extensively referenced in medical journal publications.

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Texas’ Impact on Exhaled Biomarker Research