9/22/2015

1

by

Scott Cerreta, BS, RRT

Director of Education

www.copdfoundation.org

scerreta@copdfoundation.org

Understanding COPD - Recent Research and the Evolving Definition of COPD

for MNACVPR

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.

9/22/2015

2

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

9/22/2015

3

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

• Preventable and treatable

• Airflow limitation that is not fully reversible

• Progressive disease

• Abnormal inflammatory response of the lungs

• Subsets of patients

Chronic bronchitis Emphysema

Asthma

COPD

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

Mild COPD

Early COPD

Pre COPD

Normal-

Small vs.

Abnormal

4L

3L

2L

1L

10-15ml/yr

40-80ml/yr

15-25ml/yr

Inactive Disease Active Disease

50 y/o FEV1 65%p 55 y/o FEV1 40%p

9/22/2015

4

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

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

• 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

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

• Self-designation of non-Hispanic white or African-American

Inclusion Criteria

www.clinicaltrials.gov

9/22/2015

5

COPDGENE

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

Distribution of Subjects in the COPDGene Cohort

GOLD U “Normal”

GOLD 3 GOLD 1

FEV

1/F

VC

Rat

io

FEV1 (percent predicted)

GOLD 2 GOLD 4

COPDGene COPD Distribution by Age

0

500

1000

1500

2000

2500

45 50 55 60 65 70 75+

Nu

mb

er

of

Sub

ject

s

Age

GOLD 2-4

GOLD U/1

GOLD 0

n=10,300

9/22/2015

6

COPDGene COPD Distribution by Age

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

45 50 55 60 65 70 75+

Nu

mb

er

of

Sub

ject

s

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 +)

Subclinical Obstruction in “Normal” Smokers COPDGene GOLD 0 Subjects = 4388

0

2

4

6

8

10

12

14

16

18

20

80 85 90 95 100 105 110 115 120 125 130

Pe

rce

nt

FEV1 % Predicted

9/22/2015

7

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)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

45 50 55 60 65 70 75+

Age One or More Signs or Symptoms

No Signs or Symptoms

COPD – A HETEROGENIOUS DISEASE

9/22/2015

8

Cote & Celli

“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

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

http://www.nature.com/nm/journal/v18/n11/full/nm.2971.html

Jan 1, 2015 - Medicare Gets annual LDCT USPSTF – Grade B

• 55-77 y/o with • 30+ pack year

smoking • Current or previous

smoker that quit <15yrs ago

Huge win for Lung Health and COPD!

SCENARIOS

• Green = Normal

• Yellow = fSAD (functional small airways disease)

• Red = Emphysema

http://www.nature.com/nm/journal/v18/n11/full/nm.2971.html

9/22/2015

9

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

9/22/2015

10

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 O2 Infoline for patients and CAregivers - evaluate whether a peer-led O2 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

9/22/2015

11

PELICAN FLIER

• We need your help

• Oxygen coaching

• Anyone with 24/7 oxygen use

• Be part of the future discoveries in COPD through research

“You might have lost your breath, but you haven’t lost your voice”

Empowering Patients through Research

COPD360SOCIAL & INFOLINE

9/22/2015

12

More patient focused COPD

research is the answer to

finding more effective therapies

and eventually cures to help the

millions of COPD patients.

“After registering I felt

as though I was a part

of a major breakthrough

for COPD.”

“By joining the COPD

PPRN we have nothing

to lose and everything to

gain.”

“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

9/22/2015

13

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