COPD Cases and Conversations by Integritas Communications

FACULTY Joel J. Heidelbaugh, MD, FAAFP, FACG

Charles P. Vega, MD, FAAFP

Professor, Family Medicine and Urology Director, Medical Student Education Department of Family Medicine University of Michigan Medical School Ann Arbor, Michigan

Fernando J. Martinez, MD, MS Prerecorded

Chief, Pulmonary and Critical Care Medicine Bruce Webster Professor of Medicine Joan and Sanford I. Weill Department of Medicine Weill Cornell Medical College New York - Presbyterian Hospital/Weill Cornell Medical Center

New York, New York

Health Sciences Clinical Professor University of California (UC) Irvine Department of Family Medicine Associate Dean for Diversity and Inclusion UC Irvine School of Medicine Executive Director, UC Irvine Program in Medical Education for the Latino Community Irvine, California

Barbara P. Yawn, MD, MSc, FAAFP Researcher Adjunct Professor, Department of Family and Community Health University of Minnesota Rochester, Minnesota

TARGET AUDIENCE This activity is intended for primary care providers (PCPs), including internists, family medicine physicians, nurse practitioners (NPs), and physician assistants (PAs), involved in the management of patients with chronic obstructive pulmonary disease (COPD).

PROGRAM OVERVIEW The medical and socioeconomic burdens of COPD in the United States are significant. Exacerbations of COPD are associated with high mortality rates, rapid decreases in lung function, and poor patient quality of life. In that respect, exacerbations of COPD are the equivalent of “heart attacks” of the lungs. This COPD Cases and ConversationsTM program has been designed specifically to empower PCPs—frontline clinicians who manage 80% of COPD cases―with the necessary tools to effectively impact the outcomes of their patients with COPD. The interactive, small group, casebased format supported by video conferencing technology will allow for meaningful face-to-face discussions among faculty and participants that not only captures common challenges surrounding the management of COPD in the primary care setting but also provides strategies to overcome them. Key topics will include longitudinal patient assessment, risk mitigation, evidence-based maintenance regimens, exacerbation prevention, and multimodal patient care.

EDUCATIONAL OBJECTIVES After completing this activity, the participant should be better able to: • Assess patients with COPD over time to characterize disease phenotypes, exacerbation risks, and treatment responses • Describe recent clinical trial data for combination maintenance therapy in COPD and updates to evidence-based guidelines • Tailor maintenance regimens for patients with COPD to reflect disease severity, minimize exacerbation risks, and account for comorbidities and patient preference • Engage patients with COPD on the need for appropriate physical activity, exacerbation avoidance, and treatment adherence

This activity is jointly provided by Global Education Group and Integritas Communications. This activity is supported by an educational grant from AstraZeneca.

PHYSICIAN ACCREDITATION STATEMENT This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Global Education Group (Global) and Integritas Communications. Global is accredited by the ACCME to provide continuing medical education for physicians.

PHYSICIAN CREDIT DESIGNATION Global Education Group designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

NURSE PRACTITIONER CONTINUING EDUCATION This activity has been planned and implemented in accordance with the Accreditation Standards of the American Association of Nurse Practitioners (AANP) through the joint providership of Global Education Group and Integritas Communications. Global Education Group is accredited by the American Association of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number: 110121. This activity is approved for 1.0 contact hour(s) (which includes 0.0 hour(s) of pharmacology.

INSTRUCTIONS TO RECEIVE CREDIT In order to receive credit, the participant must complete the preactivity assessment, participate in the live workshop, and complete the posttest assessment and evaluation.

GLOBAL CONTACT INFORMATION For information about the accreditation of this program, please contact Global at 303-395-1782 or cme@globaleducationgroup.com.

INTEGRITAS COMMUNICATIONS CONTACT INFORMATION For all other questions about this workshop, please contact Integritas Communications at info@exchangecme.com.

FEE INFORMATION & REFUND/CANCELLATION POLICY There is no registration fee for attending this workshop, however, attendance is limited and will be on a first-come, firstserved basis. Preregistration does not guarantee entrance. We recommend logging in early.

DISCLOSURE OF CONFLICTS OF INTEREST Global adheres to the policies and guidelines, including the Standards for Integrity and Independence in Accredited CE, set forth to providers by the Accreditation Council for Continuing Medical Education (ACCME) and all other professional organizations, as applicable, stating those activities where continuing education credits are awarded must be balanced, independent, objective, and scientifically rigorous. All persons in a position to control the content of an accredited continuing education program provided by Global are required to disclose all financial relationships with any ineligible company within the past 24 months to Global. All financial relationships reported are identified as relevant and mitigated by Global in accordance with the Standards for Integrity and Independence in Accredited CE in advance of delivery of the activity to learners. The content of this activity was vetted by Global to assure objectivity and that the activity is free of commercial bias. All relevant financial relationships have been mitigated.

This activity is jointly provided by Global Education Group and Integritas Communications. This activity is supported by an educational grant from AstraZeneca.

The faculty have the following relevant financial relationships with ineligible companies: Joel J. Heidelbaugh, MD, FAAFP, FACG

Nothing to disclose

Fernando J. Martinez, MD, MS

Consultant: Abbvie Inc., AstraZeneca plc, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol Myers Squibb, CSL Behring, DevPro Biopharma, GlaxoSmithKline plc, IQVIA Inc., Novartis International AG, Polarean Imaging plc, Pulmonx Corporation, Raziel Therapeutics, sanofi-aventis U.S. LLC/Regeneron Pharmaceuticals, Inc., Shionogi Inc., Teva Pharmaceutical Industries Ltd., United Therapeutics Corporation, Varacyte, Inc., Verona Pharma Contracted Research: Afferent Pharmaceuticals/Merck & Co., Inc., Bayer AG, Biogen Inc., CHIESI USA, Inc., GlaxoSmithKline plc, Respivant Sciences, Roche Holding AG Other (DSMB, Event Adjudication): GlaxoSmithKline plc, Medtronic plc

Charles P. Vega, MD, FAAFP

Consultant: GlaxoSmithKline plc

Barbara P. Yawn, MD, MSc, FAAFP

Consultant: AstraZeneca plc, Boehringer Ingelheim Pharmaceuticals, Inc., GlaxoSmithKline plc, Teva Pharmaceuticals USA, Inc., Thermo Fisher Scientific

The planners and managers have the following relevant financial relationships with ineligible companies: Kristin Delisi, NP

Nothing to disclose

Lindsay Borvansky

Nothing to disclose

Andrea Funk

Nothing to disclose

Liddy Knight

Nothing to disclose

Ashley Cann

Nothing to disclose

Celeste Collazo, MD

Nothing to disclose

Rose O’Connor, PhD, CHCP

Nothing to disclose

DISCLOSURE OF UNLABELED USE This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the US Food and Drug Administration. Global and Integritas Communications do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of any organization associated with this activity. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

DISCLAIMER Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed in this activity should not be used by clinicians without evaluation of patient conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

This activity is jointly provided by Global Education Group and Integritas Communications. This activity is supported by an educational grant from AstraZeneca.

CASE 1: Part 1 Let’s Meet Rosa

Rosa is a 60-year-old Hispanic woman who is an established patient at your practice. She presents today with the primary complaint of a “cough” that’s worse than usual. She states that she’s always had a cough from smoking but that it’s gotten more bothersome over the past year. She has a hard time catching her breath most days and even sometimes in the middle of the night. Rosa admits that her sleeping habits have never been great but are also worse now because of increased “stress” at home. She states she’s always “stressed out,” tired, and doesn’t have much energy. Rosa has smoked about 1 pack of cigarettes a day for the past 35 years. Her medical history includes obesity and GERD. Her last visit to your office was 2 years ago.

• Past Medical History – Obesity; BMI 35

• Family History

– GERD x 15 years; PPI, OTC antacids; esophageal dilation s/p 4 years

– Mother; deceased at age 75, MDD, T2DM – Father; deceased at age 55, hypertension; CVD

– No hospitalizations

– 2 adult children; obesity

– NKDA

• Social History – Married; 2 adult children – Community health worker (CHW ); 30 years – Current cigarette smoker; 35 pack-years – Occasional alcohol consumption – No regular physical activity

BMI, body mass index; CVD, cardiovascular disease; GERD, gastroesophageal reflux disease; MMD, major depressive disorder; NKDA, no known drug allergies; OTC, over the counter; PPI, proton pump inhibitor; s/p, status post; T2DM, type 2 diabetes mellitus.

• Past Medical History – Obesity; BMI 35 – GERD x 15 years; PPI, OTC antacids; esophageal dilation s/p 4 years – No hospitalizations – NKDA

• Family History – Mother; deceased at age 75, MDD, T2DM – Father; deceased at age 55, hypertension; CVD – 2 adult children; obesity

• Social History – Married; 2 adult children – CHW; 30 years – Current cigarette smoker; 35 pack-years – Occasional alcohol consumption – No regular physical activity

How will you investigate Rosa’s presenting complaints? What is your differential diagnosis?

FA C U LTY D IS C U S S IO N

CAPTURE

COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk • 5-item questionnaire assesses aExposure aBreathing problems aTiring easily aAcute respiratory illnesses

• Score rangesa – 0 = “no” to all 5 questions – 6 = “yes” to all 5 questions and ≥2 respiratory events during past 12 months CAPTURE scores • 0 to 1 = Low risk of COPD/exacerbation of testing symptomatic risk for exacerbation OR • 2 Identification to 4 = Perform PEF to assessdisease―at if further diagnostic evaluation is indicated

obstruction―has immediate clinical indicated importance • 5 to 6airflow = High likelihood of COPD/exacerbation; spirometry

severe for patients.

COPD, chronic obstructive pulmonary disease; PEF, peak expiratory flow; aCAPTURE alone (score ≥2) displayed a sensitivity 95.7% & specificity 67.8% for differentiating cases from no-COPD controls. Martinez FJ, et al. Am J Respir Crit Care Med. 2017;195(6):748-756.

ROSA’S RESULTS • Vitals

• Labs

– Temperature: 97.3 F

– CBC w/diff: normal

– Pulse: 100 – Respiratory rate: 20

• eos: 350 cells/µL – BNP: 95 pg/mL

– SpO 2: 94%

• Chest X-ray – Nonspecific lung markings – ‘Hyperexpansion’

• Focused physical exam – HEENT: oropharynx slightly erythematous – Lungs: mild bilateral expiratory wheezing, no accessory muscle use – Heart: S1S2, RRR, no murmurs/gallops, 2+ pedal edema

• Spirometry – Post-bronchodilator: FEV 1/FVC: 0.68 – FEV 1: 65% predicted

BNP, brain natriuretic peptide; CBC, complete blood count; CC, chief complaint; FVC, forced vital capacity; HEENT, head, eyes, ears, nose, and throat; HPI, history of present illness; PMH, past medical history; S1S2, first and second heart sounds; RRR, regular rate and rhythm; SH, social history; SpO2, oxygen saturation.

Given the results of your questioning and initial workup, what is your clinical impression of Rosa? Are there other assessment tools or information you would use to inform your management plan?

Rosa’s Results 60-year-old woman CC:

Worsening cough, tiredness, low energy

HPI:

Chronic, productive cough exacerbated by smoking, worse at night; 2 visits to urgent care over the past few months PMH: GERD x 15 years, PPI, antacids, esophageal dilation s/p 4 years; obesity, BMI 35; no hospitalizations SH: Current smoker, 35 pack-year; no regular physical activity Spirometry: FEV 1/FVC: 0.68; FEV 1: 65% predicted Labs: BNP: 95 pg/mL; eos: 350 cells/µL mMRC:

Grade 2

COPD Assessment Test (CAT) I never cough I have no phlegm (mucus) in my chest at all My chest does not feel tight at all When I walk up a hill or one flight of stairs, I am not breathless I am not limited doing any activities at home I am confident leaving my home despite my lung condition

I sleep soundly

I have lots of energy

Total Score

I cough all the time My chest is completely full of phlegm (mucus) My chest feels very tight When I walk up a hill or one flight of stairs, I am very breathless I am very limited doing activities at home I am not at all confident leaving my home because of my lung condition I don’t sleep soundly because of my lung condition I have no energy at all

FA C U LTY D IS C U S S IO N

60-year-old woman CC: Worsening cough, tiredness, low energy HPI: Chronic, productive cough exacerbated by smoking, worse at night; 2 visits to urgent care over the past few months – cough treated with short course of antibiotics and albuterol inhaler which she continues to use PMH: GERD x 15 years, PPI, antacids, esophageal dilation s/p 4 years; obesity, BMI 35; no hospitalizations SH: Current smoker, 35 pack-year; no regular physical activity

Spirometry: FEV 1/FVC: 0.68; FEV 1: 65% predicted Labs: BNP: 95 pg/mL; eos: 350 cells/µL

COPD Assessment Test (CAT) I never cough I have no phlegm (m ucus) in m y chest at all

I cough all the tim e M y chest is com pletely full of phlegm (m ucus)

M y chest does not feel tight at all

M y chest feels very tight W hen I walk up a hill or one flight of stairs, I am very breathless

W hen I walk up a hill or one flight of stairs, I am not breathless

I am not lim ited doing any activities at hom e

I am very lim ited doing activities at hom e

I am confident leaving m y hom e despite m y lung condition

I am not at all confident leaving m y hom e because of m y lung condition

I sleep soundly

I don’t sleep soundly because of m y lung condition

I have lots of energy

I have no energy at all

Total Score

FA C U LTY D IS C U S S IO N

60-year-old woman CC: Worsening cough, tiredness, low energy HPI: Chronic, productive cough exacerbated by smoking, worse at night; 2 visits to urgent care over the past few months PMH: GERD x 15 years, PPI, antacids, esophageal dilation s/p 4 years; obesity, BMI 35; no hospitalizations SH: Current smoker, 35 pack-year; no regular physical activity

mMRC: Grade 2

How will you treat Rosa’s current symptoms? What initial maintenance therapy(ies) will you recommend for her COPD?

2021 GOLD Recommendations Initial Pharmacologic Treatment

≥2 moderate exacerbations or ≥1 leading to hospital admission

≤1 moderate exacerbation (not leading to hospital admission)

Group C

Group D LAMA

Group A

LAMA or LAMA + LABAa or ICS + LABAb

Group B

Bronchodilator

Long-Acting Bronchodilator (LABA or LAMA)

mMRC 0-1; CAT <10

mMRC ≥2; CAT ≥10

aConsider

if highly symptomatic, eg, CAT >20);bConsider if eosinophils ≥300 cells/µL. Global Initiative for Chronic Obstructive Lung Disease (GOLD), 2021 report. https://goldcopd.org/wp-content/uploads/2020/11/GOLD-REPORT-2021-v1.1-25Nov20_WMV.pdf. Accessed May 19, 2021.

60-year-old woman CC: HPI:

SH: Spirometry: Labs: CAT: mMRC:

Does Rosa’s smoking impact your treatment selection? Why or why not?

FA C U LTY D IS C U S S IO N

PMH:

Worsening cough, tiredness, low energy Chronic, productive cough exacerbated by smoking, worse at night; 2 visits to urgent care over the past few months GERD x 15 years, PPI, antacids, esophageal dilation s/p 4 years; obesity, BMI 35; no hospitalizations Current smoker, 35 pack-year; no regular physical activity FEV1 /FVC: 0.68; FEV1 : 65% predicted BNP: 95 pg/mL; eos: 350 cells/µL 26 Grade 2

60-year-old woman CC: HPI:

SH: Spirometry: Labs: CAT: mMRC:

FA C U LTY D IS C U S S IO N

PMH:

Is Rosa’s case a typical presentation of COPD? Are there characteristics that may help identify patients with COPD earlier within the disease course?

60-year-old woman CC: HPI:

SH: Spirometry: Labs: CAT: mMRC:

FA C U LTY D IS C U S S IO N

PMH:

How will you manage Rosa’s comorbidities? Is there an association between her COPD, comorbidities, and risk of exacerbations?

60-year-old woman Worsening cough, tiredness, low energy Chronic, productive cough exacerbated by smoking, worse at night; 2 visits to urgent care over the past few months PMH: GERD x 15 years, PPI, antacids, esophageal dilation s/p 4 years; obesity, BMI 35; no hospitalizations SH: Current smoker, 35 pack-year; no regular physical activity Spirometry: FEV1/FVC: 0.68; FEV1: 65% predicted Labs: BNP: 95 pg/mL; eos: 350 cells/µL CAT: 26 mMRC: Grade 2

How will you educate Rosa on mitigating her risks of COPD exacerbations?

FA C U LTY D IS C U S S IO N

CC: HPI:

SCOPEX

A Score to Predict Short-term (6-Month) Risk of COPD Exacerbations • Predictors1,a:

COPD Risk Calculator –

q £ maintenance medications National Jewish Health2 E nter gender: Female q £ mean daily reliever use N um ber of C O P D 1 q £ exacerbations in m aintenance m edications: previous year FE V /FV C on spirom etry: 0.68 q ¤ FEV1/FVC N um ber of inhalations per day of short-acting q Female sex 5-10 bronchodilator (albuterol): 1

The strongest predictor for COPD exacerbations is

A PREVIOUS HISTORY OF EXACERBATIONS. aBest

predictors of future exacerbation in a cohort of patients with moderate-to-very severe COPD and ≥1 exacerbation in the previous year. 1. Make B, et al. Int J Chron Obstruct Pulmon Dis. 2015;10:201-209; 2. National Jewish Health. COPD Calculator. https://www.nationaljewish.org/research-science/programsdepts/medicine/pulm-critical/copd-calculator.

COPD Action Plan My COPD Action Plan

Warning Signs! Yellow - Warning Signs

Red - Emergency Signs

COPD Foundation. https://www.copdfoundation.org/Learn-More/Educational-Materials-Resources/Downloads.aspx#MyCOPDActionPlan. Accessed May 19, 2021.

Key Takeaways for Exacerbations a Exacerbations should not be considered the normal course of COPD a Management strategies can significantly reduce the risk of exacerbations a Educating patients and their family members to recognize signs of an impending exacerbation (or worsening COPD symptoms) is critical a Comorbid conditions that contribute to COPD and exacerbations should be addressed

FA C U LTY D IS C U S S IO N

CC: HPI:

Which vaccinations should you recommend to Rosa?

60-year-old woman CC: HPI:

SH: Spirometry: Labs: CAT: mMRC:

FA C U LTY D IS C U S S IO N

PMH:

Are there potential barriers to Rosa’s care plan that you should address? How can you overcome challenges to follow-up, adherence, or continuity of care; especially in lowincome communities of color?

60-year-old woman CC: HPI:

SH: Spirometry: Labs: CAT: mMRC:

When will you schedule Rosa’s follow-up appointment? Would you consider telemedicine for this visit or future visits? Why or why not?

FA C U LTY D IS C U S S IO N

PMH:

CASE 1: Part 2 Rosa’s Follow-up

Rosa was last seen in your office 8 years ago. She presents today 7 weeks following an emergency department (ED) visit for an exacerbation of COPD, which was treated with a short course of oral corticosteroids and antibiotics. This was her second ED visit for an exacerbation within the past year. She states she regularly takes her LABA/LAMA inhaler therapy as well as the albuterol inhaler. However, she has increased the frequency of her rescue medication use to about 8 to 10 times daily for the past several weeks, often running out before the pharmacy would refill it. Her main concern is not being able to “breathe easily” and feeling out of breath or not being able to catch her breath. She is very worried and admits that this last ED visit really took its toll on her. W ith respect to smoking, she has made multiple quit attempts throughout the years, without being able to maintain cessation for longer than 2 months. She has, however, managed to cut down to a half pack per day. • Past Medical History

• Family History

• Social History

– C O P D x 8 years; LA B A /LA M A ; S A B A – O besity; B M I 35

– M other; deceased at age 75, M D D , T2D M

– M arried; 2 adult children – C H W ; retired

– G E R D x 23 years; P P I, O TC antacids; esophageal dilation s/p 12 years

– Father; deceased at age 55, hypertension; C V D – 2 adult children; obesity

– C urrent cigarette sm oker; m ultiple quit attem pts

– N o hospitalizations – NKDA

– O ccasional alcohol consum ption – N o regular physical activity

SABA, short-acting β-agonist.

• Past Medical History – Obesity; BMI 35 – GERD x 15 years; PPI, OTC antacids; esophageal dilation s/p 4 years – No hospitalizations – NKDA

• Family History – Mother; deceased at age 75, MDD, T2DM – Father; deceased at age 55, hypertension; CVD – 2 adult children; obesity

• Social History – Married; 2 adult children – CHW; 30 years – Current cigarette smoker; 35 pack-years – Occasional alcohol consumption – No regular physical activity

FA C U LTY D IS C U S S IO N

Rosa was last seen in your office 8 years ago. She presents today 7 weeks following an emergency department visit for an exacerbation of COPD, for which was treated with a short course of oral corticosteroids and antibiotics. This was her second ED visit for an exacerbation within the past year. She states she regularly takes her LABA/LAMA inhaler therapy as well as the albuterol inhaler. However, she has increased the frequency of her rescue medication use to about 8 to 10 times daily for the past several weeks, often running out before the pharmacy would refill it. Her main concern is not being able to “breathe easily” and feeling out of breath or not being able to catch her breath. She is very worried and admits that this last ED visit really took its toll on her. With respect to smoking, she has made multiple quit attempts throughout the years, without being able to maintain cessation for longer than 2 months. She has, however, managed to cut down to a half pack per day.

How will you assess Rosa’s symptoms and the progression of her disease? What information will you collect to inform your next steps?

ROSA’S RESULTS

COPD Assessment Test (CAT) I never cough I have no phlegm (m ucus) in m y chest at all

I cough all the tim e M y chest is com pletely full of phlegm (m ucus)

M y chest does not feel tight at all

M y chest feels very tight W hen I walk up a hill or one flight of stairs, I am very breathless

W hen I walk up a hill or one flight of stairs, I am not breathless

I am not lim ited doing any activities at hom e

I am very lim ited doing activities at hom e

I am confident leaving m y hom e despite m y lung condition

I am not at all confident leaving m y hom e because of m y lung condition

I sleep soundly

I have lots of energy

Total Score

What are key features of Rosa’s evaluation?

I don’t sleep soundly because of m y lung condition I have no energy at all

Previously

FA C U LTY D IS C U S S IO N

68-year-old woman CC: F/U post-ED visit for AECOPD HPI: Breathlessness; increased use of rescue medication; 2 AECOPD in past year PMH: COPD x 8 years, LABA/LAMA, SABA; obesity, BMI 35; GERD x 23 years; PPI, OTC antacids, esophageal dilation s/p 12 years SH: Current smoker, ½ pack/day, multiple quit attempts; no regular physical activity; retired SpO2: 94% PEF: 70% of personal best mMRC: Grade 3 (previously 2) Labs: eos: 350 cells/µL Previous spirometry: FEV1/FVC: 0.68; FEV1: 65% predicted

COPD Assessment Test (CAT) I never cough I have no phlegm (m ucus) in m y chest at all

I cough all the tim e M y chest is com pletely full of phlegm (m ucus)

M y chest feels very tight W hen I walk up a hill or one flight of stairs, I am very breathless

W hen I walk up a hill or one flight of stairs, I am not breathless

I am not lim ited doing any activities at hom e

I am very lim ited doing activities at hom e

I am confident leaving m y hom e despite m y lung condition

I am not at all confident leaving m y hom e because of m y lung condition

I sleep soundly

I have lots of energy

Total Score

I don’t sleep soundly because of m y lung condition I have no energy at all

Previously

How will you determine whether switching to ICS/LABA, escalating to ICS/LABA/LAMA, or add-on therapy (ie, roflumilast, azithromycin, or a mucolytic) is most appropriate for Rosa?

2021 GOLD Recommendations Initial Pharmacologic Treatment FACTORS TO CONSIDER WHEN INITIATING ICS TREATMENT Factors to consider when initiating ICS treatment in combination with 1 or 2 long-acting bronchodilators (note the scenario is different when considering ICS withdrawal): STRONG SUPPORT

CONSIDER USE

• History of hospitalization(s) for exacerbations of COPD a • ≥2 moderate exacerbations of COPD per year a

AGAINST USE

• 1 moderate exacerbation of COPD per year a • Blood eosinophils 100-300 cells/µL b

• Repeated pneumonia events • Blood eosinophils <100 cells/µL b • History of mycobacterial infection

• Blood eosinophils >300 cells/µL b • History of, or concomitant, asthma aDespite

appropriate long-acting bronchodilator maintenance therapy; bBlood eosinophils should be seen as a continuum, quoted values represent approximate cut-points, eosinophil counts are likely to fluctuate. Global Initiative for Chronic Obstructive Lung Disease (GOLD), 2021 report. https://goldcopd.org/wp-content/uploads/2020/11/GOLD-REPORT-2021-v1.1-25Nov20_WMV.pdf Accessed May 19, 2021.

2021 GOLD Recommendations Follow-up Pharmacologic Treatment

Dyspnea Pathway

Exacerbation Pathway LA B A or LA M A

LA B A or LA M A

b LA B A + IC S a LA B A + LA M A

LA B A + LA M A

a • C onsider sw itching inhaler device or m olecules

LA B A + LA M A + IC S

Consider if eos <100

Consider if eos ≥100

LA B A + IC S a

LA B A + LA M A + IC S

• Investigate (and treat) other causes of dyspnea R oflum ilast FEV1 <50% and chronic bronchitis aConsider

bConsider

In former smokers A zithrom ycin

de-escalation of ICS or switch if pneumonia, inappropriate original indication, or lack of response to ICS; if eos ≥300 cells/µL or eos ≥100 cells/µL AND ≥2 moderate AECOPD/1 hospitalization. Global Initiative for Chronic Obstructive Lung Disease (GOLD), 2021 report. https://goldcopd.org/wpcontent/uploads/2020/11/GOLD-REPORT-2021-v1.1-25Nov20_WMV.pdf. Accessed May 15, 2021.

FA C U LTY D IS C U S S IO N

M y chest does not feel tight at all

68-year-old woman CC: HPI:

FA C U LTY D IS C U S S IO N

Follow-up appointment post-ED visit for AECOPD Breathlessness; increased use of rescue medication; 2 AECOPD in past year PMH: COPD x 8 years, LABA/LAMA, SABA; obesity, BMI 35; GERD x 23 years, PPI, OTC antacids, esophageal dilation s/p 12 years SH: Current smoker, ½ pack/day, multiple quit attempts; no regular physical activity; retired SpO2: 94% PEF: 70% of personal best mMRC: Grade 3 (previously 2) CAT: 29 (previously 26) Labs: eos: 350 cells/µL Previous spirometry: FEV1 /FVC: 0.68; FEV1 : 65% predicted

How will you manage Rosa’s chronic tobacco dependence?

2021 GOLD Recommendations

Treating Tobacco Use and Dependence1

• Tobacco dependence is a chronic condition that warrants repeated treatment until long-term or permanent abstinence is achieved • Clinicians and health care delivery systems must operationalize the identification, documentation, and treatment of every tobacco user at every visit • Brief smoking cessation counseling is effective and should be offered at every visit – There is a strong dose-response relation between the intensity of counseling and its effectiveness – Practical counseling and social support can be especially effective

• Effective treatments for tobacco dependence exist and all tobacco users should be offered the treatments – First-line pharmacotherapies for tobacco dependence are effective and at least one should be prescribed in the absence of contraindications • Varenicline, bupropion sustained release, nicotine gum, nicotine inhaler, nicotine nasal spray, and nicotine patch

• Tobacco dependence treatments are cost-effective interventions • Financial incentive programs for smoking cessation may facilitate smoking cessation

It may take 30 or more quit attempts before being successful.2 1. Global Initiative for Chronic Obstructive Lung Disease (GOLD), 2021 report. https://goldcopd.org/wp-content/uploads/2020/11/GOLD-REPORT-2021-v1.1-25Nov20_WMV.pdf Accessed March 19, 2021; 2. Chaiton M, et al. BMJ Open. 2016;6(6):e011045.

68-year-old woman CC: HPI:

Is Rosa a candidate for pulmonary rehabilitation?

FA C U LTY D IS C U S S IO N

Telehealth-Delivered PR

Considerations for a Successful Program q Reliable and high-speed internet connectivity q Availability of sessions during evening and weekend hours q Options for caregivers to participate

q Assistance for electric costs during hot/cold months for underserved communities q Time efficient/minimally burdensome protocols for reclearance following rehospitalizations

Less than 2% of COPD patients complete standard PR PR, pulmonary rehabilitation. Ordonez K, et al. Am J Respir Crit Care Med. 2020;201:A2202. https://doi.org/10.1164/ajrccm-conference.2020.201.1_MeetingAbstracts.A2202

68-year-old woman Follow-up appointment post-ED visit for AECOPD Breathlessness; increased use of rescue medication; 2 AECOPD in past year

PMH:

COPD x 8 years, LABA/LAMA, SABA; obesity, BMI 35; GERD x 23 years, PPI, OTC antacids, esophageal dilation s/p 12 years

SH:

Current smoker, ½ pack/day, multiple quit attempts; no regular physical activity; retired

SpO2:

94%

PEF:

70% of personal best

mMRC: CAT:

Grade 3 (previously 2) 29 (previously 26)

Labs:

eos: 350 cells/µL

FA C U LTY D IS C U S S IO N

CC: HPI:

Previous spirometry: FEV 1/FVC: 0.68; FEV 1: 65% predicted

How soon would you follow up with Rosa to reassess her symptoms and the effectiveness of treatment?

68-year-old woman Follow-up appointment post-ED visit for AECOPD

HPI:

Breathlessness; increased use of rescue medication; 2 AECOPD in past year

PMH:

COPD x 8 years, LABA/LAMA, SABA; obesity, BMI 35; GERD x 23 years, PPI, OTC antacids, esophageal dilation s/p 12 years

SH:

Current smoker, ½ pack/day, multiple quit attempts; no regular physical activity; retired

SpO2:

94%

PEF:

70% of personal best

mMRC:

Grade 3 (previously 2)

CAT:

29 (previously 26)

Labs:

eos: 350 cells/µL

Previous spirometry: FEV 1/FVC: 0.68; FEV 1: 65% predicted

Under what circumstances would you consider escalation OR de-escalation of therapy?

FA C U LTY D IS C U S S IO N

CC:

68-year-old woman CC: HPI:

Under what circumstances would you refer Rosa to pulmonology specialty care?

Summary • COPD can be managed successfully in primary care practice • Exacerbations significantly increase patient morbidity and risk of death • Alleviation of symptoms and prevention of exacerbations are key objectives in both the short-term and long-term treatment of COPD • Simple and reliable questionnaires (eg, CAT, mMRC) should be used in routine practice to assess symptoms, risk of exacerbations, and patient health status • Evidence-based guidelines for COPD management are also available and regularly updated • Maintenance therapy should be matched to individual patient needs • Supportive clinician and patient resources are available

FA C U LTY D IS C U S S IO N

GUIDELINES Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2021 report. 4 https://goldcopd.org/wp-content/uploads/2020/11/GOLD-REPORT-2021-v1.1-25Nov20_WMV.pdf

Pharmacologic management of chronic obstructive pulmonary disease: an official American Thoracic Society clinical practice guideline. Nici L, et al. Am J Respir Crit Care Med. 2020; 201(9):e56-e69. 4 https://www.atsjournals.org/doi/pdf/10.1164/rccm.202003-0625ST

COVID-19 clinical management: living guidance. World Health Organization. January 2021. 4 https://www.who.int/publications/i/item/WHO-2019-nCoV-clinical-2021-1

Prevention of COPD exacerbations: a European Respiratory Society/American Thoracic Society guideline. Wedzicha JA, et al. Eur Respir J. 2017;50(3):1602265. 4 https://www.thoracic.org/statements/resources/copd/prevention-copd-exacerbations.pdf

SUGGESTED READING GOLD COVID-19 guidance. Global Initiative for Chronic Obstructive Lung Disease (GOLD). 4 https://goldcopd.org/gold-covid-19-guidance/

Reducing chronic obstructive pulmonary disease hospital readmissions. An official American Thoracic Society workshop report. Press VG, et al. Ann Am Thorac Soc. 2019;16(2):161-170. 4 https://www.atsjournals.org/doi/full/10.1513/AnnalsATS.201811-755WS#_i25

Predicting acute exacerbations in chronic obstructive pulmonary disease. Samp JC, et al. J Manag Care Spec Pharm. 2018;24(3):265-279. 4 https://pubmed.ncbi.nlm.nih.gov/29485951/

Triple versus dual inhaler therapy in moderate-to-severe COPD: a systematic review and metaanalysis of randomized controlled trials. Zayed Y, et al. Clin Respir J. 2019;13(7):413-428. 4 https://onlinelibrary.wiley.com/doi/epdf/10.1111/crj.13026

Once-daily single-inhaler triple versus dual therapy in patients with COPD. Lipson DA, et al. N Engl J Med. 2018; 378(18):1671-1680. 4 https://www.nejm.org/doi/10.1056/NEJMoa1713901?url_ver=Z39.882003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dwww.ncbi.nlm.nih.gov

This activity is jointly provided by Global Education Group and Integritas Communications. This activity is supported by an educational grant from AstraZeneca.

The effect of exacerbation history on outcomes in the IMPACT trial. Halpin DMG, et al. Eur Respir J. 2020;55(5):1901921. 4 https://erj.ersjournals.com/content/erj/55/5/1901921.full.pdf

Triple inhaled therapy at two glucocorticoid doses in moderate-to-very-severe COPD. Rabe KF, et al. N Engl J Med. 2020;383(1):35-48. 4 https://www.nejm.org/doi/full/10.1056/NEJMoa1916046

Reduced all-cause mortality in the ETHOS trial of budesonide/glycopyrrolate/formoterol for chronic obstructive pulmonary disease. A randomized, double-blind, multicenter, parallel-group study. Martinez FJ, et al. Am J Respir Crit Care Med. 2021;203(5):553-564. 4 https://pubmed.ncbi.nlm.nih.gov/33252985/

A new approach for identifying patients with undiagnosed chronic obstructive pulmonary disease. Martinez FJ, et al. Am J Respir Crit Care Med. 2017;195(6):748-756. 4 https://pubmed.ncbi.nlm.nih.gov/27783539/

Bringing stability to the chronic obstructive pulmonary disease patient: clinical and pharmacological considerations for frequent exacerbators. Gulati S, Wells JM. Drugs. 2017;77(6):651-670. 4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5396463/

Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Puhan MA, et al. Cochrane Database Syst Rev. 2016;12:CD005305. 4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6463852/

A score to predict short-term risk of COPD exacerbations (SCOPEX) Make BJ, et al. Int J Chron Obstruct Pulmon Dis. 2015;10:201-209. 4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4315304/

CLINICAL PRACTICE TOOLS AND RESOURCES The COPD Foundation Pocket Consultant Guide Mobile App The COPD Pocket Guide, provided by the COPD Foundation, contains comprehensive management information as well as resource tools. It can be downloaded onto any mobile device. 4 https://www.copdfoundation.org/Learn-More/I-am-a-Healthcare-Provider/The-COPD-Pocket-Consultant-Guide.aspx

Modified Medical Research Council (mMRC) Dyspnea Scale The mMRC scale, provided by MDCalc, allows for the baseline stratification of dyspnea in COPD, as well as other respiratory diseases. 4 https://www.mdcalc.com/mmrc-modified-medical-research-council-dyspnea-scale

COPD Assessment Test (CAT) The CAT, provided by the American Academy of Family Physicians, allows assessment of the global impact of COPD (cough, sputum, dyspnea, chest tightness) on patient health status. 4 https://www.aafp.org/afp/2013/1115/afp20131115p655-fa.pdf

This activity is jointly provided by Global Education Group and Integritas Communications. This activity is supported by an educational grant from AstraZeneca.

COPD Action Plan The COPD Action Plan, provided by the American Lung Association, is a tool that facilitates the prevention, timely identification, and early and appropriate treatment of COPD exacerbations. 4 http://action.lung.org/site/DocServer/ala-copd-management-plan.pdf

ATS Telemedicine Information Series The American Thoracic Society offers patients educational materials on telemedicine as well as answers to frequently asked questions surrounding this topic. 4 https://www.atsjournals.org/doi/pdf/10.1164/rccm.2020C5

PATIENT RESOURCES AND ADVOCACY ORGANIZATIONS The COPD Foundation Pocket Consultant Guide Patient-Focused Mobile App The COPD Pocket Guide for Patients was designed to improve disease management and communication with a patient’s health care team. It includes patient resources such as inhaler and exercise videos as well as tools such as the wallet card and daily symptom tracker that help collect and share information with the health care team. It can be downloaded onto any mobile device. 4 https://www.copdfoundation.org/Learn-More/The-COPD-Pocket-Consultant-Guide/Patient-Caregiver-Track.aspx

American Lung Association The American Lung Association is the leading organization working to save lives by improving lung health and preventing lung disease through education, advocacy, and research. 4 http://www.lung.org/lung-disease/copd/living-with-copd/copd-management-tools.html

COPD Foundation The COPD Foundation’s mission is to prevent and cure COPD and to improve the lives of all people affected by COPD. 4 http://www.copdfoundation.org/What-is-COPD/Living-with-COPD/Newly-Diagnosed.aspx

Global Initiative for Chronic Obstructive Lung Disease (GOLD) GOLD partners with health care professionals and public health officials to raise awareness of COPD and to improve prevention and treatment of this lung disease for patients around the world. 4 http://goldcopd.org/patients-advocacy-groups/

National Jewish Health National Jewish Health integrates the latest scientific discoveries with coordinated care for lung, heart, and immune diseases. Their Patient Education Program provides many free educational opportunities and support groups to assist patients and caregivers with managing illnesses and chronic conditions, such as COPD. 4 https://www.nationaljewish.org/education-training/patient-education#education

This activity is jointly provided by Global Education Group and Integritas Communications. This activity is supported by an educational grant from AstraZeneca.