Saturday May 16th, 16.30-18.00 (MST)Altitude Room; Crowne Plaza, Denver, Colorado

REG Interstitial Lung Disease Working Group Meeting

Saturday May 16th, 7.30-9.00am (MST)Altitude Room; Crowne Plaza, Denver, Colorado

Collaborators’ Meeting

AgendaTime 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 Eventso ERS Events – AGM & Council Meetingo 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

8.20–8.35A word from REG’s Supportersinvited Industry perspectives on REG activities & real-life research priorities

REG supporters

8.35–8.50PCORI: New funding source for comparative effective researchFollowed by discussion of additional funding opportunities

Jerry Krishnan (Co-Chair)

8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion

9.00 CLOSE

Richard Martin (REG North Americas Lead)

7.30-7.40am

Welcome & Introductions

David Price (REG Chairman)

7.40-7.55am

Research & Activity Update & Call for participation

Protocol development Data extraction Phase I

(or baseline)Phase II

(or results) Publication

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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 commence3 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

Protocol development

Data extraction

Phase I (or baseline)

Phase II (or results)

Publication

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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

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

• 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.

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 SABAo Relative benefit of EF ICS vs SABA over alternatives

Study Design

Outcome Measures:• Exacerbations• Database Asthma

control measures• Acute respiratory

events• SABA usage

• 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

• 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).

• 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.

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

Events in 2015: Rotterdam & Singapore

REG 2015 Global SummitDate: 22–24 January 2015Rotterdam

REG 2015 Regional SummitDate: 25–26 April 2015Singapore

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

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!

AgendaTime 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 Eventso ERS Events – AGM & Council Meetingo 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

8.20–8.35A word from REG’s Supportersinvited Industry perspectives on REG activities & real-life research priorities

REG supporters

8.35–8.50PCORI: New funding source for comparative effective researchFollowed by discussion of additional funding opportunities

Jerry Krishnan (Co-Chair)

8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion

9.00 CLOSE

David Price, Thao Le, Alison Chisholm

Future Plans: staffing & events

Staffing: who does what?

John Haughney

David Price

Alison Chisholm

DavidPrice

Trevor Lambert

Nick May

Thao Le

Linh HaymanContracted as

needed

Mylee Durack

Agency providersContracted 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!

Strategic Planning

Council responsible for development of an annual strategic plan.

2015 Council Planning Meeting: 25 September 2015

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

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

Events: what’s coming next…?

BarcelonaJune 2015

First meeting of the Allergy Working Group:2-3pm June 7th, BarcelonaWorking Group Lead: Peter Hellings

First meeting of the Biomarkers Working Group:5-6pm June 7th, BarcelonaWorking Group Lead: Leif Bjermer

Adherence Expert Panel MeetingOne-day focused meeting to develop a Roadmap for Respiratory Adherence ResearchJune 11th, BarcelonaWorking Group Lead: Gene Colice

Adherence Expert Panel Meeting

• International panel of experts to review key topics within respiratory adherence research.

• Present and discuss key issuesand challenges in adherence research

• Meeting structure:o Taxonomyo Placing adherence behaviours in the context of

respiratory careo Considering specific populations and topics. o Measurement – of adherence behaviours, determinants

and capturing accurate datao Opportunities to improve adherence – scalable

interventions with proven effect

• Output: themed issue of:

Adherence Roadmap

Events: what’s coming next…?

Friday September 25th

• REG Annual General Meetingimmediately followed by…

• REG Council Meeting (2016 strategic planning)

+ further working group

meetings

Coming up… REG Summit 2016• Dovetail 2016

Summit with final ASTROLAB symposiumo Day 1:

ASTROLABo Days 2 & 3:

REG WG Meetings & Summit

• Venue: Lyon• Date: Late March /

Early April 2016 (to avoid ATS) – Thurs-Saturday:o 30 March – 2 Aprilo 7–9 Aprilo 14-16 Aprilo 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

Lyon April 2016!

AgendaTime 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 Eventso ERS Events – AGM & Council Meetingo 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

8.20–8.35A word from REG’s Supportersinvited Industry perspectives on REG activities & real-life research priorities

REG supporters

8.35–8.50PCORI: New funding source for comparative effective researchFollowed by discussion of additional funding opportunities

Jerry Krishnan (Co-Chair)

8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion

9.00 CLOSE

Nicolas Roche (REG European Lead)

8.05-8.20am

Driving Quality Standards: REG/EAACI Taskforce Update

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

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

AgendaTime 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 Eventso ERS Events – AGM & Council Meetingo 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

8.20–8.35A word from REG’s Supportersinvited Industry perspectives on REG activities & real-life research priorities

REG supporters

8.35–8.50PCORI: New funding source for comparative effective researchFollowed by discussion of additional funding opportunities

Jerry Krishnan (Co-Chair)

8.50-9.00 Open Discussion: Feedback & Ideas Forum Group Discussion

9.00 CLOSE

Industries view on real-world research priorities

8.20-8.35am

A Word from REG’s Supporters

AgendaTime 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 Eventso ERS Events – AGM & Council Meetingo 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

8.20–8.35A word from REG’s Supportersinvited Industry perspectives on REG activities & real-life research priorities

REG supporters

8.35–8.50New 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

Jerry Krishnan (REG/ATS Liaison)

8.35-8.50am

PCORI: New funding source for comparative effectiveness research

AgendaTime 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 Eventso ERS Events – AGM & Council Meetingo 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

8.20–8.35A word from REG’s Supportersinvited Industry perspectives on REG activities & real-life research priorities

REG supporters

8.35–8.50New 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

All Collaborators & Attendees

8.50-9.00am

Open discussion: new ideas & feedback

And finally…. Join these REG events

TODAY

TOMORROW

NEXT WEEK…

Saturday May 16th, 16.30-18.00 (MST)Altitude Room; Crowne Plaza, Denver, Colorado

REG Interstitial Lung Disease Working Group Meeting

Have a wonderful ATS…

Thank you for your attention