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COPD, NICE and the National Clinical Strategy. Harold Hosker Airedale Hospital March 2010. Inflammation.

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Copd nice and the national clinical strategy l.jpg

COPD, NICE and the National Clinical Strategy

Harold Hosker

Airedale Hospital

March 2010


Inflammation l.jpg
Inflammation

  • COPD is a disease state characterised by airflow limitation that is not fully reversible. The airflow limitation is usually both progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases

  • Chronic inflammation is caused by increased numbers of activated inflammatory cells, specifically neutrophils, which can damage lung structure and lead to mucosal oedema and airway narrowing


The impact of copd l.jpg
The impact of COPD

  • More than 30,000 deaths annually in the UK

  • UK – 900,000 diagnosed patients

  • Allowing for underdiagnosis, the true number of patients with COPD in England and Wales is likely to be around 1.5 million

  • Currently the fifth greatest cause of mortality worldwide – over 2.5 million deaths in 2000

  • By 2020, COPD will be the third leading cause of mortality

  • Exacerbations have an impact on patient quality of life and can be life-threatening


The typical copd patient l.jpg
The typical COPD patient

  • Generally over 40 years

  • A smoker or ex-smoker

  • Presentation with:

    • cough

    • excessive sputum production

    • shortness of breath / wheeze


Copd is a heterogeneous disease l.jpg
COPD is a heterogeneous disease

  • Spectrum of clinical disease from ‘pink puffer’ to ‘blue bloater’

  • Several different pathological processes


Inflammatory mechanisms in copd l.jpg

-

Protease

inhibitors

Inflammatory mechanisms in COPD

Cigarette smoke

?

CD8+

lymphocyte

Alveolar macrophage

Neutrophil chemotatic factors,

cytokines (IL-8)

mediators (LTB4)

Neutrophil

Neutrophil elastase

Proteases

1-antitrypsin

Alveolar wall destruction

(emphysema)

mucus hypersecretion

(chronic bronchitis)


What is spirometry l.jpg
What is Spirometry?

Spirometry is a method of assessing lung function by measuring the volume of air the patient can expel from the lungs after a maximal expiration.


Why perform spirometry l.jpg
Why Perform Spirometry?

Measure airflow obstruction to help make a definitive diagnosis of COPD

Confirm presence of airway obstruction

Assess severity of airflow obstruction in COPD

Detect airflow obstruction in smokers who may have few or no symptoms

Monitor disease progression in COPD

Assess one aspect of response to therapy

Assess prognosis (FEV1) in COPD

Perform pre-operative assessment


Spirometry additional uses l.jpg
Spirometry – Additional Uses

Make a diagnosis and assess severity in a range of other respiratory conditions (eg ILD, MND, G-B)

Distinguish between obstruction and restriction as causes of breathlessness

Screen workforces in occupational environments

Assess fitness to dive

Perform pre-employment screening in certain professions


Types of spirometers l.jpg
Types of Spirometers

  • Bellows spirometers:

    Measure volume; mainly in lung function units

  • Electronic desk top spirometers:

    Measure flow and volume with real time display

  • Small hand-held spirometers:

    Inexpensive and quick to use but no print out





Lung volume terminology l.jpg
Lung Volume Terminology

Inspiratory reserve

volume

Inspiratory

capacity

Total

lung

capacity

Tidal volume

Expiratory reserve

volume

Vital

capacity

Residual volume


Standard spirometric indices l.jpg
Standard Spirometric Indices

  • FEV1 - Forced expiratory volume in one second:

    The volume of air expired in the first second of the blow

  • FVC - Forced vital capacity:

    The total volume of air that can be forcibly exhaled in one breath

  • FEV1/FVC ratio:

    The fraction of air exhaled in the first second relative to the total volume exhaled

  • VC - Vital capacity:

    A volume of a full breath exhaled in the patient’s own time and not forced. Often slightly greater than the FVC, particularly in COPD


Normal trace showing fev 1 and fvc l.jpg
Normal Trace Showing FEV1 and FVC

FVC

5

4

FEV1 = 4L

FVC = 5L

FEV1/FVC = 0.8

Volume, liters

3

2

1

1

2

3

4

5

6

1

Time, seconds


Spirogram patterns l.jpg
Spirogram Patterns

Normal

Obstructive

Restrictive

Mixed Obstructive and Restrictive


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Predicted Normal Values

Affected by:

  • Age

  • Height

  • Sex

  • Ethnic Origin


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Criteria for Normal Post-bronchodilator Spirometry

FEV1: % predicted > 80%

FVC: % predicted > 80%

FEV1/FVC: > 0.7


Spirometry obstructive disease l.jpg
Spirometry: Obstructive Disease

5

4

Normal

3

Volume, liters

FEV1 = 1.8L

FVC = 3.2L

FEV1/FVC = 0.56

2

Obstructive

1

1

2

3

4

5

6

Time, seconds


Diseases associated with airflow obstruction l.jpg
Diseases Associated With Airflow Obstruction

  • COPD

  • Asthma

  • Bronchiectasis

  • Cystic Fibrosis

  • Sarcoidosis

  • Lung cancer (greater risk in COPD)

  • Obliterative Bronchiolitis


Slide23 l.jpg

Spirometry: Restrictive Disease

Normal

5

4

3

Volume, liters

Restrictive

FEV1 = 1.9L

FVC = 2.0L

FEV1/FVC = 0.95

2

1

1

2

3

4

5

6

Time, seconds


Diseases associated with a restrictive defect l.jpg
Diseases Associated with a Restrictive Defect

Pulmonary

  • Fibrosing lung diseases

  • Pneumoconioses

  • Pulmonary edema

  • Parenchymal lung tumors

  • Lobectomy or pneumonectomy

Extrapulmonary

  • Thoracic cage deformity

  • Obesity

  • Pregnancy

  • Neuromuscular disorders

  • Fibrothorax


Spirometry l.jpg
Spirometry

  • In COPD and asthma, spirometry is preferred to peak flow (PEFR) readings

  • Serial PEFR readings can confirm / exclude variability (asthma)

  • Chest X-ray excludes other pathologies but does not usually diagnose COPD


Flow volume curve l.jpg
Flow Volume Curve

Standard on most desk-top spirometers

Adds more information than volume time curve

Less understood but not too difficult to interpret

Better at demonstrating mildairflow obstruction


Flow volume curve27 l.jpg
Flow Volume Curve

Maximum expiratory flow (PEF)

Expiratory flow rate

L/sec

FVC

RV

TLC

Inspiratory flow rate

L/sec

Volume (L)








Bronchodilator reversibility testing l.jpg
Bronchodilator Reversibility Testing

  • Provides the best achievable FEV1(and FVC)

  • Helps to differentiate COPD from asthma

    Must be interpreted with clinical history - neither asthma nor COPD are diagnosed on spirometry alone


Slide35 l.jpg

Bronchodilator Reversibility Testing in COPD

  • Results

  • An increase in FEV1 that is both greater than 200 ml and 12% above the pre-bronchodilator FEV1 (baseline value) is considered significant

  • It is usually helpful to report the absolute change (in ml) as well as the % change from baseline to set the improvement in a clinical context


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Equipment Maintenance

Most spirometers need regular calibration to check accuracy

Calibration is normally performed with a 3 litre syringe

Some electronic spirometers do not require daily/weekly calibration

Good equipment cleanliness and anti-infection control are important; check instruction manual

Spirometers should be regularly serviced; check manufacturer’s recommendations


Other lung function tests l.jpg
Other lung function tests

  • Lung volumes

    • Helium dilution, body box (plethysmography)

    • TLC (RV derived)

  • Gas transfer

    • Single breath carbon monoxide transfer

    • TLCO and KCO (=TLCO/Va)

  • Mouth pressures

    • Indirect measure of muscle / diaphragm strength

    • Pimax, PEmax




Effect of cigarette smoke on airspaces in mice scanning em l.jpg
Effect of cigarette smoke on airspaces in mice (scanning EM)

A: smoke-exposed mice B: matched controls (6 months)


Pathological processes in emphysema l.jpg
Pathological processes in emphysema

  • Loss of alveolar surface area

  • Loss of lung elasticity

  • Hyperinflation causing mechanical inefficiency

  • Muscle weakness / cachexia

  • Small airways collapse

  • Dynamic hyperinflation




Pathological processes in chronic bronchitis l.jpg
Pathological processes in chronic bronchitis COPD

  • Bronchoconstriction

  • Airway mucosal inflammation / oedema

  • Airway remodelling / fibrosis

  • Mucus hypersecretion

  • Epithelial / ciliary dysfunction

  • Ventilation - perfusion mismatch

  • Hypoxic pulmonary vasoconstriction

  • Cor pumonale


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The role of exacerbations in disease progression COPD

  • Following an exacerbation, the likelihood of further exacerbation increases

  • Exacerbations are closely associated with cumulative reduction in health status

  • High frequency of COPD exacerbations is associated with a rapid decline in lung function and increased risk of hospitalisation

  • Up to 70% of patients admitted to hospital with an exacerbation are re-admitted within a year


Copd guidelines l.jpg

The British Thoracic Society (BTS) guidelines for the management of COPD 1997

Global Strategy for the Diagnosis, Management and Prevention of COPD (GOLD), last update in 2001 and are constantly under peer review (www.goldcopd.com)

NICE guidelines were published in 2004, due for revision 2010

COPD Guidelines

1. COPD Guidelines Group of the Standards of Care Committee of the BTS.1997.

2. Pauwels RA et al. 2001.


Nice bts recommendations l.jpg

Diagnose COPD management of COPD 1997

Stop Smoking

Effective inhaled therapy

Pulmonary Rehabilitation

NIV

Manage exacerbations

Multi-disciplinary working

NICE/BTS Recommendations


Inhaled steroids in copd l.jpg
Inhaled steroids in COPD management of COPD 1997

  • No evidence of benefit in mild / moderate COPD

  • Do not affect the rate of decline in FEV1

  • Beneficial effect on quality of life and exacerbation rate in moderate / severe disease

  • Dose response and long term safety in COPD are not known1


Drug therapy in copd l.jpg
Drug therapy in COPD management of COPD 1997

  • Combination therapy

    • Inhaled steroid plus long-acting B2 agonist

    • Several studies show additive benefit using fluticasone / salmeterol or budesonide / eformoterol

    • Benefits include FEV1 change, exacerbation rates, symptom scores and health status improvements

    • New combinations (including triple combinations and ultra-long acting beta agonists) are on their way

    • Roflumilast (PDE-4 inhibitor) due 2010


Torch study design l.jpg
TORCH: study design management of COPD 1997

3-year study duration (6,112 patients)1

(sub-cut population 4,511 patients2)

Full study

Sub-cut data

SeretideTM 500 Accuhaler™

n=1,533

n=1,117

Fluticasone propionate 500 mcg

n=1,126

n=1,534

2 week

run-in

Salmeterol 50mcg

n=1,142

n=1,521

Control group

n=1,524

n=1,126

1 Year

2 Years

3 Years

  • Vestbo et al. Eur Respir J 2004

  • GSK Data on File SERTCODOF012


Slide55 l.jpg

SALM management of COPD 1997

FP

All-cause mortality at 3 years

Probability of death (%)

18

16

14

12

10

8

6

4

2

0

Placebo

SALM/FP

0

12

24

36

48

60

72

84

96

108

120

132

144

156

Time to death (weeks)

Number

alive

1524

1533

1521

1534

1464

1487

1481

1487

1399

1426

1417

1409

1293

1339

1316

1288

Vertical bars are standard errors


Premature study drug discontinuation l.jpg
Premature study drug discontinuation management of COPD 1997

Probability of withdrawal (%)

HR 0.69, p< 0.001

SFC

Control

0

12

24

36

48

60

72

84

96

108

120

132

144

156

Time to withdrawal from study medication (weeks)

SFC = salmeterol/fluticasone propionate combination

Calverley et al. NEJM 2007


Rate of moderate and severe exacerbations over three years l.jpg
Rate of moderate and severe exacerbations over three years management of COPD 1997

Mean number of exacerbations/year

25% reduction

1.2

1.13

0.97*

0.93*

1

0.85*†‡

0.8

0.6

0.4

0.2

0

Placebo

SALM

FP

SALM/FP

Treatment

*p < 0.001 vs placebo; †p = 0.002 vs SALM; ‡p = 0.024 vs FP

Calverley et al. NEJM 2007


Uplift trial nejm october 2008 l.jpg
UPLIFT trial management of COPD 1997NEJM October 2008

  • A 4 year trial of tiotropium in COPD involving 5993 patients

  • Real life study – all patients allowed to continue all other Rx except inhaled anti-cholinergics

  • 46% patients were GOLD stage II (FEV1 50% – 80% predicted) ie mild disease

  • 44% GOLD stage III, 8% GOLD stage IV

  • 60% patients on LABAs, 62% on ICS, with more than 70% on each by end of trial



Slide60 l.jpg

Kaplan-Meier Estimates of the Probability of COPD Exacerbation and Death from Any Cause


Uplift trial exacerbations l.jpg
UPLIFT trial exacerbations Exacerbation and Death from Any Cause

  • 14% reduced risk of exacerbations (time to 1st exacerbation)(p<0.001) and exacerbations leading to hospitalisations (p=0.002)

  • But no difference in hospital days

  • Seretide and Tiotropium both reduce exacerbations to a similar extent (INSPIRE study)


Uplift safety of tiotropium l.jpg
UPLIFT – safety of Tiotropium Exacerbation and Death from Any Cause

  • UPLIFT shows no increased risk of cardiac death with Tiotropium (significantly reduced risk – 27% risk reduction in CVS death, also stroke)

  • 16% risk reduction in probability of death, p=0.034)

  • No evidence of increased CVS risk from LABAs either


Case study margaret l.jpg
Case study Exacerbation and Death from Any Cause– Margaret

  • Margaret is 52 years old. She works in an office and has two children

  • She has smoked around 25 cigarettes a day for 30 years

  • Her FEV1 is 65% predicted

  • Margaret’s father died 4 years ago of ‘chest disease’

  • She has a productive cough and finds she is breathless on exertion both at work and at leisure

  • Last winter she had a bad chest infection

  • She has tried various inhalers


The stages of copd nice l.jpg
The stages of COPD – NICE Exacerbation and Death from Any Cause

Breathlessness and exercise limitation

Prevention of exacerbations

Mild(FEV150–80%)

Short- and long-acting bronchodilators

2-agonists/anticholinergics

If still symptomatic consider a trial of combination long-acting 2-agonist and inhaled corticosteroid*

In patients suffering two or more exacerbations per year add inhaled corticosteroid usually in combination with long-acting bronchodilators

Moderate(FEV130–49%)

Consider adding theophylline

If still symptomatic despite maximum inhaled bronchodilator consider referral for specialist assessment

Severe(FEV1 <30%)

1. NICE Guideline No.12. Thorax 2004. *Discontinue if no benefit after 4 weeks


Case study margaret age 52 l.jpg
Case study Exacerbation and Death from Any Cause– Margaret (age 52)

  • Diagnosis

    • Margaret has mild/moderate COPD

  • History

    • Has tried to quit smoking

    • Chest infection last winter

    • Prescribed various inhalers

    • FEV1 = 65% predicted normal

  • Symptoms

    • Breathlessness on exertion getting worse

    • Productive cough

  • What do Margaret’s symptoms stop her doing?

    • Enjoying leisure activities with her family

    • Playing bowls


Managing margaret s copd l.jpg
Managing Margaret’s COPD Exacerbation and Death from Any Cause

Smoking

Breathlessness and exercise limitation

Exacerbations

QoL


Managing margaret s copd69 l.jpg
Managing Margaret’s COPD Exacerbation and Death from Any Cause

Smoking

Breathlessness and exercise limitation

Exacerbations

QoL


Managing margaret s copd symptoms l.jpg
Managing Margaret’s COPD symptoms Exacerbation and Death from Any Cause

Smoking

Breathlessness and exercise limitation

Exacerbations

QoL


Further minimising the impact of exacerbations l.jpg
Further minimising the impact of exacerbations Exacerbation and Death from Any Cause

  • The impact of exacerbations should be minimised by:

    • Giving self-management advice on responding promptly to the symptoms of an exacerbation

      Starting appropriate treatment with oral corticosteroids and/or antibiotics

    • Use of non-invasive ventilation when indicated

    • Use of hospital-at-home or assisted-discharge schemes


Managing margaret s copd72 l.jpg
Managing Margaret’s COPD Exacerbation and Death from Any Cause

Smoking

Breathlessness and exercise limitation

Exacerbations

QoL


Managing margaret s copd73 l.jpg
Managing Margaret’s COPD Exacerbation and Death from Any Cause

  • Encourage and help her to stop smoking

  • Check that Margaret's inhaled therapy is in line with her disease severity and that both symptoms and frequency of exacerbations are taken into consideration. This may involve treatment with LAMAs, and / or LABAs

  • Check Margaret is able to use and understands the benefit of the treatments she is prescribed

  • Consider other interventions, e.g. pulmonary rehabilitation

  • Work with Margaret to develop a self-management plan


Stopping smoking slows decline in lung function l.jpg
Stopping smoking Exacerbation and Death from Any Causeslows decline in lung function

Never smoked or not

susceptible to smoke

100

75

50

25

0

Smoked regularly

and susceptible to

its effects

Stopped at 45

FEV1 (% of value at age 25)

Disability

Stopped at 65

Death

25

50

75

Age (years)

Adapted from: Fletcher et al,Br Med J 1977.


Pulmonary rehabilitation l.jpg
Pulmonary rehabilitation Exacerbation and Death from Any Cause

  • Pulmonary rehabilitation is a multidisciplinary programme of care for patients with COPD and is individually tailored to optimise a patient’s physical and social performance1

  • Identify patients who will benefit from pulmonary rehabilitation, usually MRC dyspnoea scale grade 3 or above1

1. NICE guideline No. 12. Thorax 2004.


Recognising an exacerbation l.jpg
Recognising an exacerbation Exacerbation and Death from Any Cause

  • Give written information on recognising worsening symptoms, such as:

    • You get much more breathless than you did before (doing the same thing)

    • You produce more sputum than before

    • Your sputum becomes discoloured

    • You feel feverish or unwell

    • Cough gets worse

1. NICE guideline No. 12. Thorax 2004.


Nice inhaler technique l.jpg
NICE Exacerbation and Death from Any Cause– inhaler technique

  • In most cases bronchodilator therapy is best administered using a hand-held inhaler device (including a spacer device or other aid if appropriate)

  • If the patient is unable to use a particular device satisfactorily or it is not suitable for him/her, an alternative should be found

  • Inhalers should be prescribed only after patients have received training in the use of the device and have demonstrated satisfactory technique

1. NICE guideline No. 12. Thorax 2004.


Case 2 george l.jpg
Case 2 - George Exacerbation and Death from Any Cause

  • 75 year old ex-steel worker

  • Ex-smoker, 45 pack years

  • Chronic productive cough

  • Gradually progressive SOB and wheeze over ten years

  • Regular antibiotics for bronchitis most winters

  • Limited exercise capacity

  • Difficulty shopping, playing with grandkids, walking to pub

  • 15 year history of of ‘asthma’ – bricanyl/beclomethasone

  • No family history of asthma/no pets


Points for discussion l.jpg
Points for discussion Exacerbation and Death from Any Cause

  • Diagnosis

  • Impact on Patient

  • What else do you need to know?

    • What do you need to ask?

    • Examination?

    • What investigations do you need?


How do we exclude asthma l.jpg

How do we exclude asthma? Exacerbation and Death from Any Cause

Spirometry FEV1 = 40% FEV1 /FVC = 50%


George l.jpg
George Exacerbation and Death from Any Cause

  • 75 year old man

  • No night-time wakening

  • No day to day variability in symptoms

  • No acute precipitants

  • No diurnal variation in PEFR

    Therefore no significant asthmatic element



George89 l.jpg
George LOM/SLK/06/28416/1

  • 75 year old man

  • Moderate COPD

  • Enjoyed pulmonary rehabilitation

  • Started combination treatment of ICS and LABA

  • Also on LAMA (tiotropium)

  • Less frequent daily symptoms

  • Less exacerbations requiring antibiotics

  • Better exercise capacity, mild limitation


Case 3 stanley l.jpg
Case 3 - Stanley LOM/SLK/06/28416/1

  • 76 yr old man

  • 10yr history of COPD

  • Ex-smoker, (50 pack years)

  • Current Rx

    • ICS/LABA combination

    • Tiotropium

    • Theophylline

    • Mucolytic


Stanley l.jpg
Stanley LOM/SLK/06/28416/1

  • Housebound

    • Unable to walk to pub

  • Living in sitting room

  • Sleeps in chair

  • Weight loss

  • Declines social services assistance

  • DN noted ankle oedema


Points for discussion92 l.jpg
Points for discussion LOM/SLK/06/28416/1

  • FEV1 = 35%

  • FEV1/FVC = 50%

  • What else do you need to know?

    • What would you ask?

    • Examination?

    • Investigations?


Ltot assessment l.jpg
LTOT Assessment LOM/SLK/06/28416/1

  • Surgery pulse oximetry

    • Sats <92%

    • Measure when COPD stable

    • repeated after 6 weeks

  • Or refer for assessment (ABG)


National clinical strategy for copd l.jpg
National Clinical Strategy for COPD LOM/SLK/06/28416/1

  • Started in 2005 (as an ‘NSF’) following pressure from BLF and BTS; originally scheduled for 2007 publication; then 2008; then launch in spring 2009; then winter 2009; now April 2010……..

  • Currently the final document being shared with ministers

  • 12 week consultation from Dec 2009, including workshops nationally

  • Focus on clinical pathways and managed clinical networks

  • Now includes asthma and home oxygen services (OSA to follow later)


Issues behind the national clinical strategy l.jpg
Issues behind the national clinical strategy LOM/SLK/06/28416/1

  • COPD is a ‘Cinderella’ disease with little funding or strong advocacy

  • A lack of awareness of COPD by healthcare professionals and the public

  • Little focus on prevention and risk reduction

  • Large numbers of people not diagnosed or inaccurately classified

  • No clear or uniform care pathways and models of care provision including for acute and chronic care

  • Varying access to early discharge schemes, pulmonary rehabilitation and supportive care

  • Access to specialist services at end of life is poor


National clinical strategy for copd100 l.jpg
National Clinical Strategy for COPD LOM/SLK/06/28416/1

  • Launch end of Q1 2010

  • New DH Respiratory Programme Board

  • Variety of guidance / educational resources etc

  • Need to reduce:

    • Variation in care / outcomes

    • Unnecessary tests / duplication

    • Ineffective prescribing (25% of oxygen prescriptions are ineffective)


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National Clinical Strategy for COPD: national structure LOM/SLK/06/28416/1

  • National Clinical Leads

  • Respiratory Leads in each of 10 SHAs

  • Trust Medical Directors (acute Trusts and PCTs)

    • Ensure local leadership

    • Promote local respiratory networks


National clinical strategy for copd102 l.jpg
National Clinical Strategy for COPD LOM/SLK/06/28416/1

  • Guidelines on diagnostics and case-finding spirometry

  • Competency framework for HCPs

  • COPD commissioning guidance

  • Metrics for primary and secondary care

  • Tariffs (reduce disincentives)

  • DH – develop ‘Lung Improvement Programme’ to develop managed lung clinical networks, start national pilots, share information, resources etc


Lung improvement programme major areas for piloting l.jpg
‘Lung Improvement Programme’ LOM/SLK/06/28416/1Major areas for piloting

  • Good Lung Health – smoking, case-finding, health checks

  • Diagnostic Hub – accurate diagnostics for COPD, sleep, asthma, oxygen assessment

  • Care closer to home – personal health plans

  • Transforming inpatient care – structured admission, EDS, integrated care, daily respiratory team involvement

  • End of Life care – care plans, carers, death at home / hospice (60% die in hospital)


Oxygen services l.jpg
Oxygen services LOM/SLK/06/28416/1

  • Concern re commissioning, implementation and costs of current national oxygen services

  • Costs £110 M pa

  • 25% prescriptions – no benefit

  • 300 NPSA alerts / SUI and 44 oxygen related deaths

  • Plan to re-commission in 2011