Asthma/COPD Overlap Syndrome (ACOS) Working Group Meeting

Sunday May 17th, 7.30-9.00am (MST)Altitude Room; Crowne Plaza, Denver, Colorado

REG Asthma/COPD Overlap Syndrome (ACOS) Working Group Meeting

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AgendaTIME AGENDA ITEM

7.30–7.40 Introductions & Interests in ACOS

7.40–7.50 Summary of work to date

7.50-8.45 Proof of Concept Study Planning

7.50–8.108.10–8.258.25–8.45

• Finalize Case Definitions of ACOS• Select Outcome Measures• Define next steps for the ACOS project

o Databaseso Querieso Leadso Timelines

8.45–9.00 Potential future ACOS projects

Introductions & ACOS “interests”

Lead: Jerry Krishnan

• Keith Allan*• Mona Bafadhel• James Bailey*• Neil Barnes*• Marc Berger*• Matthias Binek*• Gary Bird*• Guy Brusselle• Emmanuelle Clerisme-

Beaty*• Walter Cleymans*

• Glenn Crater*• Paul Dorinsky*• Jordi Estruch*• David Evan*• Robert Fogel*• Armin Furtwaengler*

• Maria Gerhardsson*• Gokul Gopalan*• Lynn Hagger*• Brooke Harrow*• Susan Johnson*• Dorothy Keininger*

• Megumi Kizawa*• JWH Kocks• Marek Kokot*

• Jeannine Leuenberger*

• Mark Milton-Edwards*• Marc Miravitlles• Karen Mezzi*• Gabriele Nicolini*• Akio Niimi• Fredrik Nyberg*

• Dirkje Postma• David Price• Elizabeth Regan

• Luca Richeldi

• Nicolas Roche• Guilherme Safioti*• Peter Schweikert*

• Ulla Seppala*• Mark Small*• Joan Soriano• Robert Suruki*• Claus Vogelmeier

• Setareh Williams*

Progress to date: initial discussionsRotterdam Meeting – Working Group Objectives Identified:• General:

o Explore the nature and various forms of ACOSo Explore treatment response in the various forms of ACOSo Compare the characteristics and treatment response of

ACOS and its subgroups with “pure”/”standard” asthma or COPD

• eNO-specific:o Investigate the role of eNO as a diagnostic marker of

ACOS in pts primarily diagnosed as having COPD, taking smoking into account

o Investigate the role of eNO as a predictor for response to treatment with ICS in COPD, taking smoking into account

• BUT FIRST… we have to “COUNT”

Proof of concept study

• To evaluate agreement between case definitions of ACOS to assess the comparability of study populations identified as having ACOS, both:o Within a single database, and

o Across different databases

• Success will:o Answer an important scientific questiono Build relationships for future projects

Prieto-Centurion, Rolle, Au, et al. AJRCCM. 2014;190:989–995

Reference study

Variation considering ICD9 codes only



Variation by case definition

Differences Characteristics of Patients Who Met/

Did Not Meet the Clinical Trial Reference Standard

Characteristic Total Sample (n = 998)

Clinical Trial Reference Standard

Yes* (n = 560) No† (n = 438) P-value

Spirometry, post-bronchodilator, %

FEV1/FVC, 70% 61 100 11 <0.0001

FEV1, 80% predicted 72 86 55 <0.0001

6-minute-walk distance, %**

Distance walked, 350 m 53 52 54 0.67

Comorbid conditions, %

Heart failure 18 16 22 0.01

Depression 42 36 50 <0.0001*(A + D + E + G) and †(B + C + F) in Figure 2.**Data for 6-minute-walk distance missing in 9% patients (9% and 10%)

Function similar despite lung function variability

Clinical differences “beyond the count”


Case Definitions: Proposed

CriterionACOS Case Definition

1a 2a 1b 2b 1c 2c 1d 2d

Age (yrs) >40 >40 >40 >40 >40 >40 >40 >40

Post BD FEV1/FVC <70%

(not used as a criterion) Any

value or no data available

<70%



<70%



<70%



Broncho-dilator response

>400 ml increase in FEV1 post

bronchodilator




bronchodilator




bronchodilator




bronchodilator



PYs smoked

(current or past)

>10 >10 >10 >10 >10 >10 >10 >10

Physician diagnosis (e.g., based on billing diagnosis)

COPD (including

emphysema, COPD, or

chronic bronchitis)

COPD

(i) “ACOS”

(ii) “Asthma COPD

Overlap Syndrome”

(iii) “Asthma” and “COPD”listed at the same visit

(i) “ACOS”

(ii) “Asthma COPD

Overlap Syndrome”

(iii) “Asthma” and “COPD”listed at the same visit

Asthma Asthma

No dx of asthma, ACOS, COPD

No dx of asthma, ACOS, COPD

Definitions with / without lung function data will enable comparison of the differences between these patients

Outcome measures• Number/proportion of patients meeting each case definition • Level of agreement between case definitions• Number/proportion of patients with atopy (any of the following):

o Physician diagnosis of eczemao Physician diagnosis of allergic rhinitis o Eosinophilia (cut off >200/μl; REG COPD blood eosinophilia study used

≥450μl)1 o Positive skin prick testo Positive IgE to ≥1 allergen

• Number/proportion with respiratory-related exacerbations, any of the following:o Physician diagnosis of asthma exacerbation; o Physician diagnosis COPD exacerbation; o ≥1 courses of prednisolone courses in the past 12 months; o ≥1 courses of systemic antibiotics in the past 12 months for lower

respiratory tract infection

• Treatment?

1. Kenneth D. McClatchey.Clinical Laboratory Medicine. Lippincott Williams & Wilkins, 2002

Next Steps…

Database SourcesDatabase Name

National / International coverage

Source of funding Primary WG Contact

SPIROMICS U.S. NHLBI Jerry Krishnan

CONCERT U.S. NHLBI Jerry Krishnan

COSYCONET Germany BMBF Claus Vogelmeier

OPCRD UK RiRL Victoria Carter

MarketScan (US Claims Data)

US AZ Setareh Williams

HealthCore (US Claims Data)


Optum Humedica(EMR)


SIDIAP-Catalonia Catalonia (Spain) Health ministery Marc Miravitlles

COBRA FranceINSERM and multiple

companiesN Roche

COLIBRI France Multiple sponsors N Roche

INITIATIVES France Boehringer Ingelheim N Roche

Dutch Asthma / COPD Service

Netherlands

routine Health care/ University Medical Center Groningen /

CERTE diagnostic lab

Janwillem Kocks

Next steps & timelines

Report back on key issues:

• Suitability of dataset

• Mechanism to obtain access to data sources:

o Data query request form?

o Study outline / protocol?

o Administrative contact

• Roles & responsibilities:

o Query leads

• Working Group Call: early/mid-July

New Ideas and Future Projects

Next Meeting

Homework deadline:

Early / Mid July!

Asthma/COPD Overlap Syndrome (ACOS) Working Group Meeting

Health & Medicine

Transcript of Asthma/COPD Overlap Syndrome (ACOS) Working Group Meeting