REG Collaborators' Meeting, 16th May 2015. Denver, Colorado, USA

1. Saturday May 16th, 16.30-18.00 (MST)
Altitude Room; Crowne Plaza, Denver, Colorado
REG Interstitial Lung Disease Working
Group Meeting

2. Agenda
Time Item Lead
7.30–7.40 Welcome & Introductions Richard Martin (Co-Chair)
7.40–7.55 REG Research: update & call for participation David Price
7.55-8.05
Future Plans: staffing & events update
David Price, Thao Le,
Alison Chisholm
• Revised staffing structure: who are your key contacts?
• Working Group & Council Structure: who does what?
• 2015/16 Events: when will we see you next?
o EAACI Events
o ERS Events – AGM & Council Meeting
o 2016 REG Summit
8.05–8.20
Driving Quality Standards
• What else should we be doing?
• ERS Vision – “Real Life Evidence”
Nicolas Roche & Group
Discussion
8.20–8.35
A word from REG’s Supporters
invited Industry perspectives on REG activities & real-life
research priorities
REG supporters
8.35–8.50
PCORI: New funding source for comparative
effective research
Followed by discussion of additional funding opportunities
Jerry Krishnan
(Co-Chair)
8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion
9.00 CLOSE

3. Richard Martin (REG North Americas Lead)
7.30-7.40am
Welcome & Introductions

4. David Price (REG Chairman)
7.40-7.55am
Research & Activity Update
& Call for participation

5. Protocol
development
Data extraction
Phase I
(or baseline)
Phase II
(or results)
Publication
✔ ✔
✔ ✔ ✔ ✔
✔ ✔
✔ ✔ ✔ ✔
✔ ✔ ✔ ✔
✔ ✔
✔ ✔ ✔ ✔
✔ ✔ ✔ ✔ ✔
2013/14 Initiated Studies
Independent risk predictors modeled; risk
predictor tool in development. 1 x abstract
Characteristics that predict step-up
treatment choice – published. CE outcomes
manuscript in print. 3 x abstracts to date
Mapping of different adherence measures over
3 years – complete; bidirectional relationship
between adherence & outcomes to commence
3 abstracts to date
Analysis complete. Manuscript outline
in development: “predictive quality of
database outcomes”. 3 x abstracts
Analysis complete; manuscript
outline reviewed by steering
committee; draft paper by June
Cross-sectional analysis of comorbidities in
refractory asthma patients – complete & ms
written. Longitudinal analysis of comorbidities
associated with os use still to be completed
Collaboration with UK Department
of Health. Paper published in
Lancet Respiratory Medicine
Diagnostic opportunities
Analysis complete. Manuscript in draft;
paediatric abstract presented at REG
Regional Summit; Full report at EAACI 2015

6. Protocol
development
Data
extraction
Phase I
(or baseline)
Phase II
(or results)
Publication
✔ ✔
✔
✔ ✔ ✔ ✔
✔ ✔ ✔
COPD
control
2014/15 Initiated Studies
COPD Triple Therapy
Protocol developed;
Seeking Funding…?
Final voting underway;
publication to follow
shortly
Working group meeting tomorrow to
plan protocol delivery
REALISE
ASIA
Longitudinal Asthma Steps.
Protocol developed; Funding
discussions underway
Proposal to item reduce and
validate a reduced item EXACT-
PRO. Funding under discussion
Supported Asthma UK to
quantify prescribing “Errors” as
defined by national asthma
deaths registry. 1 x abstract
COPD RISK PREDITCORS:
spin off of COPD
eosinophils. Ms in final
pre-submission stages

7. Pin board – funding awards
REG CORE FUNDING TO
COVER TOP 2 RANKED
RESEARCH STUDIES
REG CORE FUNDING TO COVER
DATA EXTRACTION (ONLY) FOR
FURTHER 2 HIGHLY-RANKED
STUDIES

8. • Voted REG 2014 Research Pinboard: #1 priority
• Lead Investigator: Jonathan Grigg
• The particle size and delivery characteristics of extra-fine
hydrofluoroalkane beclomethasone [EF HFA-BDP] aerosol may be
particularly relevant for young children in whom a greater proportion
of airways are classified as small
(<2mm in diameter)1 and airways resistance is low.
• There are evidence to suggestion that EF HFA BDP is equivalent to
CFC fliuticasone (FP) in terms of efficacy and safety in adults and
children (5–12 years) with mild-to-moderate asthma.2,3
• Evidence remains lacking as to the role that ICS particle size may
play in the management of asthma/wheeze in younger, pre-school
(<5 years) children.
1. Leach CL, et al. Eur Respir J. 1998;12:1346–1353.
2. Aubier M, et al. Respir Med. 2001;95:212–220.
3. Fairfax A, et al. Ann Allergy Asthma Immunol. 2001;86:575–582.

9. Aims & Objectives
• Aim: to improve understanding of the prescribing of guideline
recommended management approaches, and their
comparative effectiveness, in the routine care of UK children
with wheezing illness in their early (pre-school) years.
• Phase I: a descriptive analysis of treatment patterns in
children aged ≤5 years with wheezing illness
• Part II: a comparative effectiveness analysis of guideline-
recommended treatment options in pre-school children newly
initiating Step 2 therapies:
o 3 x 2-way matched comparative effectiveness analysis: EF
ICS, NEF ICS and LTRA vs SABA
o Relative benefit of EF ICS vs SABA over alternatives

10. Study Design
Outcome Measures:
• Exacerbations
• Database Asthma
control measures
• Acute respiratory
events
• SABA usage
Index Date:
Date of first asthma /
wheeze prescription
Baseline year:
12-months prior to first Step 2
treatment prescription for asthma /
wheeze; patient characterisation and
confounder definition
Secondary (exploratory) 5-year outcome period
Primary 1-year outcome period
EF HFA BDP
Ciclesonide
LTRA
NEF BDP
FP
Eligible patients must:
• Have diagnostic evidence of asthma /
wheeze
• be aged ≤5 years
EF ICS
Control
NEF ICS

11. • Voted REG 2014 Research Pinboard: #2 priority
• Lead Investigator: Nikos Papadopoulos; Clare Murray
• Does the addition of (oral) antibiotics to oral
corticosteroids in an acute asthma exacerbation offer
benefit in terms of:
o Time to next unscheduled GP visit with asthma;
o Time to next oral corticosteroid prescription and use
of SABA of the following 6 months?
• Stratified by antibiotic class

12. • Voted REG 2014 Research Pinboard: #3 priority
• Lead Investigator: Karin Lisspers on behalf of IPCRG’s UNLOCK
• Are pharmacological RCTs relevant to real life asthma
populations?
• Aim: Explore to what extent are the inclusion criteria for people with
asthma in RTCs representative of real life primary care populations
with asthma.
• Method: Compare data from primary care asthma populations at
treatment step 2/3 with those meeting the inclusion criteria for the
RCTs that underpin key asthma guidelines (i.e. GINA, BTS/SIGN,
CTS, AAH).

13. • Voted REG 2014 Research Pinboard: #6 priority
• Lead Investigator: Björn Ställberg on behalf of IPCRG’s UNLOCK
• The prevalence of comorbidities in COPD patients and their
impact on the quality of life and COPD symptoms in primary
care patients
• Aim: To enhance knowledge in terms of prevalence of comorbidities
in COPD patients and their impact on the quality of life and on
COPD symptoms in primary care patients.
• Method: Retrospective cross sectional analysis of primary care data
from different countries. Analysis will include descriptive statistics,
null hypothesis tests such as Chi-Square, factorial analysis of
variance and predictive binary logistic regression models.

14. Call for participation: Checklist
• Delphi to develop an optimum &
minimum checklist for
“research-ready” databases
o Optimum checklist
developed in Rotterdam –
wider validation required
o Delphi item reduction
required to confirm minimum
mandatory criteria

15. Events in 2015: Rotterdam & Singapore
REG 2015 Global Summit
Date: 22–24 January 2015
Rotterdam
REG 2015 Regional Summit
Date: 25–26 April 2015
Singapore

16. Publications in 2015
• Small Airways Working Group:
o Increased Dose of ICS vs. ICS/LABA for Step-Up Therapy in
Asthma1
o Differential effects of ICS in smokers/ex-smokers and non-
smokers with asthma2
o Small-particle ICS as first-line or step-up controller therapy in
childhood asthma3
• Child Health Working Group:
o Initial step-up treatment changes in asthmatic children already
prescribed inhaled corticosteroids: a historical cohort study4
• Breathe Review:
o Commissioned review following REG’s 2014
ERS Symposium: Real-world research and its importance in
respiratory medicine.5
• REG 2015 Rotterdam Summit Abstract Book6
• ARCH Supplement now OPEN ACCESS
1Israel E, et al. Ann Am Thorac Soc 2015 Mar 10. [Epub ahead of print];
2Roche N, et al. Am J Respir Crit Care Med 2015;191:960-964; 3Accepted at JACI: In Practice 23 Apr 2015; 4Price D, et al. Breathe.
2015;11:26-38; 5Accepted at Nature, Primary Care Respiratory Journal. 7 Apr 2015; 6Pragmatic and Observational Research. 2015;
6:13—38; 7Ann Am Thorac Soc. 2014;11:Supplement 2
ALL PUBLICATIONS ARE BEING POSTED ONLINE –
VISIT THE WEBSITE FOR ON-GOING UPDATES &
AUTHOR GUIDELINES

17. Symposia activity in 2015
• WAAC: April 2015 – done!
• EAACI: June 2015 – 2 x sessions:
o Efficacy-based to effectiveness-based
guidelines in asthma: a paradigm
shift?
o Harnessing primary care databases to
unpick the complexities of allergic
obstructive airway disease
• 2015 WAO & APSR session
proposals – submitted!
• EAACI 2016 – session accepted
• ERS 2016: 3 x session proposals
submitted
• But First…ATS
symposium this
Wednesday!

18. Agenda
Time Item Lead
7.30–7.40 Welcome & Introductions Richard Martin (Co-Chair)
7.40–7.55 REG Research: update & call for participation David Price
7.55-8.05
Future Plans: staffing & events update
David Price, Thao Le,
Alison Chisholm
• Revised staffing structure: who are your key contacts?
• Working Group & Council Structure: who does what?
• 2015/16 Events: when will we see you next?
o EAACI Events
o ERS Events – AGM & Council Meeting
o 2016 REG Summit
8.05–8.20
Driving Quality Standards
• What else should we be doing?
• ERS Vision – “Real Life Evidence”
Nicolas Roche & Group
Discussion
8.20–8.35
A word from REG’s Supporters
invited Industry perspectives on REG activities & real-life
research priorities
REG supporters
8.35–8.50
PCORI: New funding source for comparative effective
research
Followed by discussion of additional funding opportunities
Jerry Krishnan
(Co-Chair)
8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion
9.00 CLOSE

19. David Price, Thao Le, Alison Chisholm
Future Plans: staffing & events

20. Staffing: who does what?
John
Haughney
David Price
Alison
Chisholm
David
Price
Trevor
Lambert
Nick
May
Thao Le
Linh Hayman
Contracted as
needed
Mylee
Durack
Agency providers
Contracted as needed
Starting June
Zoe
Mitchell
When David steps down as REG
Chairman, we will be looking to
appoint a Chair of Council…
volunteers welcomed!

21. Strategic Planning
Council responsible for development of an annual strategic plan.
2015 Council Planning Meeting: 25 September 2015

22. REG Support & Research Funding
RESEARCH IDEA
GENERATION
Working Groups
Identify Research
Priorities in their
respective fields of
expertise
SECURING FUNDING
Nature of funding dictates future study course:
• Single commercial funding source: an investigator
initiated study conducted external to REG
• Non-product/brand specific grant(s): an REG
Collaboration carried by REG or in partnership with
REG
REG
Supporters
Non-supporter
& wider
institutional
grants
OR
REG develops idea
in collaboration
with WG /
collaborators &:
(i) Seeks external
support
(ii) Submits for
REG Core
Funding Grant
REG Grants
awarded
at FY end
REG Core Grants
Awarded to Top
Priority Ideas
(subject to
available funding)
Mid October Core
Grant submission
deadline
Ideas prioritised
by REG
Research
Committee
If insufficient REG Funds, continue to look externally

23. Working
Groups
“At a
Glance”
Terms of reference
drafted; initial project
ideas in development
IPCRG’s
UNLOCK Group
Inaugural Meeting
at EAACI 2015
Well underway –
first paper
accepted in April!
Inaugural Meeting in
Rotterdam; Checklist
Delphi & Registry Work
about to commence
Long-established,
successful group, came
under REG in 2014
Still to be established
Committee Meetings
Held in Rotterdam
REG/EAACI
Taskforce leading
current activities
Meeting 7-9am
tomorrow
Inaugural
meeting 4.30-
6pm today!
Pre-cursor Workshops;
Second Workshop 2-
3pm today
Working Group Meeting
tomorrow 4-6pm
Inaugural Meeting
at EAACI 2015
Met in Rotterdam; study
on-going & Expert
(Taxonomy) Meeting at
EAACI 2015

24. Events: what’s coming next…?
Barcelona
June 2015
First meeting of the Allergy Working Group:
2-3pm June 7th, Barcelona
Working Group Lead: Peter Hellings
First meeting of the Biomarkers Working Group:
5-6pm June 7th, Barcelona
Working Group Lead: Leif Bjermer
Adherence Expert Panel Meeting
One-day focused meeting to develop a
Roadmap for Respiratory Adherence Research
June 11th, Barcelona
Working Group Lead: Gene Colice

25. Adherence Expert Panel Meeting
• International panel of experts to review
key topics within respiratory adherence
research.
• Present and discuss key issues
and challenges in adherence research
• Meeting structure:
o Taxonomy
o Placing adherence behaviours in the context of respiratory care
o Considering specific populations and topics.
o Measurement – of adherence behaviours, determinants and
capturing accurate data
o Opportunities to improve adherence – scalable interventions with
proven effect
• Output: themed issue of:
Adherence Roadmap

26. Events: what’s coming next…?
Friday September 25th
• REG Annual General Meeting
immediately followed by…
• REG Council Meeting
(2016 strategic planning)
+ further
working group
meetings

27. Coming up… REG Summit 2016
• Dovetail 2016 Summit
with final ASTROLAB
symposium
o Day 1: ASTROLAB
o Days 2 & 3:
REG WG Meetings
& Summit
• Venue: Lyon
• Date: Late March /
Early April 2016 (to
avoid ATS) – Thurs-
Saturday:
o 30 March – 2 April
o 7–9 April
o 14-16 April
o 21-23 April
An FP7-supported Project to
investigate the safety of
asthma therapy, with a focus
on adherence
ASTROLAB: Assessment of Safety of
LABAs in Asthma routine Care by
Combining Healthcare Databases
and Direct Patient Follow-up
Compare severe exacerbations rates in patients with asthma
treated by LABAs ± concomitant ICS in routine care
Astrolab Meeting Attendance: 50-100
• Regulators
• Scientific societies
• Patients
• Health Care Professionals
• EU representatives
• Partners and Advisory Boards

28. Agenda
Time Item Lead
7.30–7.40 Welcome & Introductions Richard Martin (Co-Chair)
7.40–7.55 REG Research: update & call for participation David Price
7.55-8.05
Future Plans: staffing & events update
David Price, Thao Le,
Alison Chisholm
• Revised staffing structure: who are your key contacts?
• Working Group & Council Structure: who does what?
• 2015/16 Events: when will we see you next?
o EAACI Events
o ERS Events – AGM & Council Meeting
o 2016 REG Summit
8.05–8.20
Driving Quality Standards
• What else should we be doing?
• ERS Vision – “Real Life Evidence”
Nicolas Roche & Group
Discussion
8.20–8.35
A word from REG’s Supporters
invited Industry perspectives on REG activities & real-life
research priorities
REG supporters
8.35–8.50
PCORI: New funding source for comparative
effective research
Followed by discussion of additional funding opportunities
Jerry Krishnan
(Co-Chair)
8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion
9.00 CLOSE

29. Nicolas Roche (REG European Lead)
8.05-8.20am
Driving Quality Standards:
REG/EAACI Taskforce Update

30. Quality initiatives: REG/EAACI Taskforce
• Review of the CER
asthma literature over the
last 10 years
• Focus on key PICOT
questions that looking at
“gaps” in the evidence
• Development of a quality assessment tool / checklist to
appraise the literature
• Identify CER papers that should be considered by
guideline developers
• Clarify apparent contradictions in the evidence
• Identify as yet unmet research needs

31. What else should we be doing?
• Collaborating with other societies?

32. Agenda
Time Item Lead
7.30–7.40 Welcome & Introductions Richard Martin (Co-Chair)
7.40–7.55 REG Research: update & call for participation David Price
7.55-8.05
Future Plans: staffing & events update
David Price, Thao Le,
Alison Chisholm
• Revised staffing structure: who are your key contacts?
• Working Group & Council Structure: who does what?
• 2015/16 Events: when will we see you next?
o EAACI Events
o ERS Events – AGM & Council Meeting
o 2016 REG Summit
8.05–8.20
Driving Quality Standards
• What else should we be doing?
• ERS Vision – “Real Life Evidence”
Nicolas Roche & Group
Discussion
8.20–8.35
A word from REG’s Supporters
invited Industry perspectives on REG activities & real-life
research priorities
REG supporters
8.35–8.50
PCORI: New funding source for comparative
effective research
Followed by discussion of additional funding opportunities
Jerry Krishnan
(Co-Chair)
8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion
9.00 CLOSE

33. Industries view on real-world research
priorities
8.20-8.35am
A Word from REG’s Supporters

34. Agenda
Time Item Lead
7.30–7.40 Welcome & Introductions Richard Martin (Co-Chair)
7.40–7.55 REG Research: update & call for participation David Price
7.55-8.05
Future Plans: staffing & events update
David Price, Thao Le,
Alison Chisholm
• Revised staffing structure: who are your key contacts?
• Working Group & Council Structure: who does what?
• 2015/16 Events: when will we see you next?
o EAACI Events
o ERS Events – AGM & Council Meeting
o 2016 REG Summit
8.05–8.20
Driving Quality Standards
• What else should we be doing?
• ERS Vision – “Real Life Evidence”
Nicolas Roche & Group
Discussion
8.20–8.35
A word from REG’s Supporters
invited Industry perspectives on REG activities & real-life
research priorities
REG supporters
8.35–8.50
New funding opportunities:
North American Initiatives and Grants for Implementation
Science
Jerry Krishnan
(Co-Chair)
8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion
9.00 CLOSE

35. Jerry Krishnan (REG/ATS Liaison)
8.35-8.50am
PCORI: New funding source for
comparative effectiveness research

36. Agenda
Time Item Lead
7.30–7.40 Welcome & Introductions Richard Martin (Co-Chair)
7.40–7.55 REG Research: update & call for participation David Price
7.55-8.05
Future Plans: staffing & events update
David Price, Thao Le,
Alison Chisholm
• Revised staffing structure: who are your key contacts?
• Working Group & Council Structure: who does what?
• 2015/16 Events: when will we see you next?
o EAACI Events
o ERS Events – AGM & Council Meeting
o 2016 REG Summit
8.05–8.20
Driving Quality Standards
• What else should we be doing?
• ERS Vision – “Real Life Evidence”
Nicolas Roche & Group
Discussion
8.20–8.35
A word from REG’s Supporters
invited Industry perspectives on REG activities & real-life
research priorities
REG supporters
8.35–8.50
New funding opportunities:
North American Initiatives and Grants for Implementation
Science
Jerry Krishnan
(Co-Chair)
8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion
9.00 CLOSE

37. All Collaborators & Attendees
8.50-9.00am
Open discussion:
new ideas & feedback

38. And finally…. Join these REG events
TODAY
TOMORROW
NEXT WEEK…

39. Saturday May 16th, 16.30-18.00 (MST)
Altitude Room; Crowne Plaza, Denver, Colorado
REG Interstitial Lung Disease Working
Group Meeting