Understanding COPD - Recent Research and the Evolving Definition of COPD for MNACVPR

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Understanding COPD - Recent Research and the Evolving Definition of COPD for MNACVPR by Scott Cerreta, BS, RRT Director of Education www.copdfoundation.org scerreta@copdfoundation.org

CONFLICT OF INTEREST I have no financial conflict of interest that relates to this presentation. Any use of brand names is not in any way meant to be an endorsement of a specific product, but to merely illustrate a point of emphasis.

OBJECTIVES 1. Discuss current literature and research that warrants the need to change COPD definitions and guidelines. 2. Describe current research that challenges the current definition of COPD today and treating patients with seven severity domains. 3. Describe concepts of mild-copd, early-copd and pre-copd. 4. Identify how these changes will someday impact future diagnosis and treatment recommendations.

NHLBI DEFINITION Chronic Obstructive Pulmonary Disease Serious lung disease that over time makes it hard to breathe Emphysema Chronic Bronchitis Blocked (obstructed) airways make it hard to get air in and out

COPDF DEFINITION Chronic Obstructive Pulmonary Disease Serious lung disease that over time makes it hard to breathe Emphysema Chronic Bronchitis Refractory Asthma and Some forms of bronchiectasis Blocked (obstructed) airways make it hard to get air in and out

GOLD DEFINITION COPD, a common preventable and treatable disease, is characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. Exacerbations and comorbidities contribute to the overall severity in individual patients. Alpha-1 testing for young and/or low tobacco use or environmental exposures

ATS, ERS, ACP, ACCP STATEMENT Chronic Obstructive Pulmonary Disease (COPD) is a preventable and treatable disease state characterised by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Alpha-1 testing for all with diagnosed COPD

COPD: DEFINITIONS OF 21ST CENTURY Chronic bronchitis Emphysema Preventable and treatable Airflow limitation that is not fully reversible Progressive disease Abnormal inflammatory response of the lungs Subsets of patients COPD Asthma Box = FEV1/FVC < 70% or < LLN American Thoracic Society European Respiratory Society: Standards for the Diagnosis and Management of Patients with COPD, 2004. download manual: http://www.thoracic.org/sections/copd

4L 3L 2L Pre COPD Normal- Small vs. Abnormal Mild COPD 50 y/o FEV1 65%p 55 y/o FEV1 40%p 10-15ml/yr 15-25ml/yr 1L Early COPD Active Disease 40-80ml/yr Inactive Disease

EVOLUTION OF UNDERSTANDING COPD Where were we? Physiology Registries Where are we? Current Research COPDGene SPIROMICS Registries Where are we going? Patient Powered Research Networks Genetic phenotyping Stem Cell Therapy

Spiromics Dr Rennard Identifying subsets of people with COPD Why do some COPD patients respond to treatment while others do not? Collection & analysis of phenotypic, biomarker, genetic, genomic, and clinical data from subjects with COPD 3,200 subjects CURRENT RESEARCH COPDGene Dr. Crapo Why do some smokers get COPD while others don t Are there different types of COPD Using HRCT and identified a large number of people with emphysema despite normal spirometry 10,300 subjects

COPDGENE At least 10 pack-years of cigarette smoking Spirometry that meets one of four Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages or normal (FEV1 greater than 80% of predicted level and forced expiratory volume in 1 second/forced vital capacity [FEV1/FVC] greater than 0.7) No Grade U Inclusion Criteria Self-designation of non-hispanic white or African- American www.clinicaltrials.gov

COPDGENE GOLD 4 NO EMPHYSEMA GOLD 0 (FEV1 =90%) 5% Emphysema

FEV 1 /FVC Ratio Distribution of Subjects in the COPDGene Cohort GOLD U Normal GOLD 4 GOLD 3 GOLD 2 GOLD 1 FEV 1 (percent predicted)

Number of Subjects 2500 2000 1500 COPDGene COPD Distribution by Age n=10,300 GOLD 2-4 GOLD U/1 GOLD 0 1000 500 0 45 50 55 60 65 70 75+ Age

Number of Subjects COPDGene COPD Distribution by Age 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 45 50 55 60 65 70 75+ Age GOLD 2-4 GOLD U/1 GOLD 0

Smokers Without Obstruction (GOLD 0) Are they really normal? Chronic Airway Obstruction (FEV1 & FEV1/FVC) Dyspnea (MMRC Dyspnea Score) Exercise Capacity (6 MW) Emphysema (CT) Gas Trapping (Expiratory CT) Exacerbations (Antibiotics/Steroids/Hosp) Co-morbidities (CVD, Osteo, Depression +)

Percent Subclinical Obstruction in Normal Smokers COPDGene GOLD 0 Subjects = 4388 20 18 16 14 12 10 8 6 4 2 0 80 85 90 95 100 105 110 115 120 125 130 FEV1 % Predicted

Looking for Sick Smokers in the COPDGene GOLD 0 Cohort BODE > 1 6 MW < 1350 ft. MMRC dyspnea score 2 SGRQ 28 Chronic bronchitis symptoms (cough and sputum) Emphysema > 5% by CT (% HU < -950) Gas trapping > 15% by expiratory CT (% HU < -856) History of one or more exacerbations in prior year

COPDGene: GOLD 0 Sick Smokers (one or more signs/symptoms) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 45 50 55 60 65 70 75+ Age One or More Signs or Symptoms No Signs or Symptoms

COPD A HETEROGENIOUS DISEASE

COPD HETEROGENEITY PT # 1 58 y FEV1: 28 % MRC: 2/4 PaO2: 70 mmhg 6MWD: 540 m BMI: 30 PT # 2 62 y FEV1: 33% MRC: 2/4 PaO2: 57 mmhg 6MWD: 400 m BMI: 21 PT # 3 69 y FEV1: 35% MRC: 3/4 PaO2: 66 mmhg 6MWD: 230 m BMI: 34 PT # 4 Cote & Celli 72 y FEV1: 34% MRC: 4/4 PaO2: 60 mmhg 6MWD: 154 m BMI: 24

COPD PHENOTYPING WITH CT SCANS Low Dose HRCT used in Lung CA screening Jan 1, 2015 - Medicare Gets annual LDCT USPSTF Grade B Huge win for Lung Health and COPD! 55-77 y/o with 30+ pack year smoking Current or previous smoker that quit <15yrs ago http://www.nature.com/nm/journal/v18/n11/full/nm.2971.html

SCENARIOS Green = Normal Yellow = fsad (functional small airways disease) Red = Emphysema http://www.nature.com/nm/journal/v18/n11/full/nm.2971.html

PARAMETRIC RESPONSE MAPPING (PRM) http://www.nature.com/nm/journal/v18/n11/full/nm.2971.html

COPD DISEASE PROGRESSION COPDGene limited to CTs every 5 years COPDGene followed groups of patients not individuals Secondary Study evaluated a trial in 194 patients #1 GOLD 4, FEV1=18%@0, 17%@11m #2 GOLD 2, FEV1=66%@0, 75%@26m Identified that fsad precludes emphysema http://www.nature.com/nm/journal/v18/n11/full/nm.2971.html

PRM FOR INDIVIDUALS Secondary Study evaluated a trial in 194 patients A GOLD 4, FEV1=18%@0, 17%@11m B GOLD 2, FEV1=66%@0, 75%@26m http://www.nature.com/nm/journal/v18/n11/full/nm.2971.html

Despite being the third leading cause of death in the United States, there is very little funding for COPD. COPD is presentable and treatable but the lack of research, awareness and education has resulted in millions of unnecessary hospitalizations, complications and deaths.

PATIENT CENTERED OUTCOMES RESEARCH INSTITUTE Independent research organization authorized by Congress as part of the 2010 Patient Protection and Affordable Care Act Fund comparative clinical effectiveness research that provides patients and their caregivers the information they need to make better informed health care decisions

COPD FOUNDATION PCORI PROJECTS PELICAN: comparative effectiveness of a PEer-Led O 2 Infoline for patients and CAregivers - evaluate whether a peer-led O 2 infoline for patients and caregivers will increase adherence to oxygen prescription and improve health in patients with COPD discharged from the hospital with an oxygen prescription PArTNER: PATient Navigator to reduce Readmissions - focuses on developing and testing a program that combines a community health worker (lay patient advocate, acting as a "Patient Navigator") and a peer-led telephone support line to increase social support, improve self-efficacy and decrease post-discharge acute care use. ClinicalTrials.gov

PELICAN FLIER We need your help Oxygen coaching Anyone with 24/7 oxygen use Be part of the future discoveries in COPD through research

Empowering Patients through Research You might have lost your breath, but you haven t lost your voice

COPD360SOCIAL & INFOLINE

More patient focused COPD research is the answer to finding more effective therapies and eventually cures to help the millions of COPD patients.

By joining the COPD PPRN we have nothing to lose and everything to gain. After registering I felt as though I was a part of a major breakthrough for COPD. Registering for the PPRN is an opportunity for me to contribute to the body of research that may make the key discovery that leads to the cure. Being a part of this program is very empowering and makes me feel like I m doing my part to help.

YOU CAN HELP! Request postcards to share at support groups, clinics, respirator care departments, etc Posters and paper surveys available for some locations. www.copdpprn.org

SUMMARY 1. Implications for treatment of COPD is ever evolving based on the evidence. 2. COPD is involved with several studies and has many programs to improve quality of life for people living with COPD. 3. LDCT lung cancer screening is a win for lung health and COPD early dx. 4. Patients have the power in finding cures. Join the Patient Powered Research Network (PPRN).

scerreta@copdfoundation.org