Primary Care management

Chronic obstructive pulmonary disease

Implementing NICE Guidance and Quality Standards

Outcomes StrategyAdditional information can be found at

www.copdeducation.org.uk

On behalf of the Southampton COPD Group

Outcomes strategy

• July 2011• Asthma as well as COPD• Improve Respiratory Health• Reduce number who develop COPD• Reduce premature death• Improve QOL• Safe and effective care• Asthmatics: free of Symptoms; Action Plans• QOF mMRC, SaO2 and PR• NICE quality standards

COPD Main Components

• Smoking

• Immunology

• Microbiology – Bacteria and Virus

• Individual – activity, co morbidities, BMI

NICE STANDARDS

• Diagnostic Quality Standards

• Therapy Quality Standard

• Exacerbation Quality Standard

• Assessment Quality Standard

• Rehabilitation Quality Standard

• End of life Quality Standard

NICE Quality outcome - spiro

• People with COPD have one or more indicative symptoms recorded, and have the diagnosis confirmed by post-bronchodilator spirometry carried out on calibrated equipment by healthcare professionals competent in its performance and interpretation.

Competencies

• What level?• Education for health• Respiratory Education UK• Skills for Health

• http://www.skillsforhealth.org.uk/service-area/copd/

Definition of COPD

• Airflow obstruction is defined as reduced FEV1/FVC ratio (< 0.7)

• It is no longer necessary to have an FEV1 < 80% predicted for definition of airflow obstruction

• If FEV1 is ≥ 80% predicted, a diagnosis of COPD should only be made in the presence of respiratory symptoms, for example breathlessness or cough

FEV1 = forced expiratory volume in 1 second FVC = forced vital capacity

Diagnose COPD: 1

• The presence of airflow obstruction should be confirmed by performing post-bronchodilator spirometry [new 2010]

• All health professionals involved in the care of people with COPD should have access to spirometry and be competent in the interpretation of the results [2004]

Diagnose COPD: 2

• Assess severity of airflow obstruction using reduction in FEV1

NICE clinical guideline 12

(2004)

ATS/ERS 2004 GOLD 2008 NICE clinical guideline 101

(2010)

Post-bronchodilator

FEV1/FVC

FEV1 % predicted

Post-bronchodilator

Post-bronchodilator

Post-bronchodilator

< 0.7 80% Mild Stage 1 (mild) Stage 1 (mild)*

< 0.7 50–79% Mild Moderate Stage 2 (moderate)

Stage 2 (moderate)

< 0.7 30–49% Moderate Severe Stage 3 (severe) Stage 3 (severe)

< 0.7 < 30% Severe Very severe Stage 4 (very severe)**

Stage 4 (very severe)**

* Symptoms should be present to diagnose COPD in people with mild airflow obstruction** Or FEV1 < 50% with respiratory failure

[new 2010]

Asthma or COPD

• To help resolve cases where diagnostic doubt occurs, or both COPD and asthma are present, the following findings should be used to help identify asthma:

• 1. a large (> 400 ml) response to bronchodilators

• 2. a large (> 400 ml) response to 30 mg oral prednisolone daily for 2 weeks

• 3. Serial peak flow measurements showing 20% or greater diurnal or day-to-day variability. (NICE 2010)

Other tests to confirm the diagnosis in the new patient

CXR – excludes other conditions

BMI – Big predictor in mortality terms but only in moderate and severe disease

FBC - Polycythaemia Anaemia

“It has generally been assumed that individuals with the lowest FEV1 were also progressing the fastest as they had ‘‘clearly’’ lost more function than individuals with more normal lung function. However, evidence is accumulating that this assumption is in error, making it essential to distinguish between severity and activity”

JØRGEN VESTBO 2010

What is the decline in mls/yr ?

TORCH UPLIFT

Gold II 60 49

Gold III 56 41

Gold IV 34 31

ECLIPSEEvaluation of copd longitudinally to identify

predictive surrogate endpoints

NEJM 2011

ECLIPSE

• 2138 Patients• Followed up for 3 years• Baseline, 3,6,12,18, 24, 30, 36 months• Hypothesis was that there was a frequent

exacerbation phenotype• Cost >£300m

Results

• Best predictor of an exacerbation in the first year was

• A treated exacerbation in the year before study entry OR 4.30

• MRC Score OR 1.83• GOLD Stage OR 1.74• Fibrinogen 1.35

FEV1 ECLIPSE

Assessment

• People with COPD have a comprehensive clinical and psychosocial assessment, at least once a year or more frequently if indicated, which includes degree of breathlessness, frequency of exacerbations, validated measures of health status and prognosis, presence of hypoxaemia and comorbidities.

• CAT • BODE• mMRC• BMI

• SaO2

Nice outcomes - therapy

• People with COPD have a current individualised comprehensive management plan

• People with COPD are offered inhaled and oral therapies, in accordance with NICE guidance, as part of an individualised comprehensive management plan

Promote effective inhaled therapy

• In people with stable COPD who remain breathless or have exacerbations despite using short-acting bronchodilators as required, offer the following as maintenance therapy:

• if FEV1 ≥ 50% predicted: either LABA or LAMA

• if FEV1 < 50% predicted: either LABA+ICS in a combination inhaler, or LAMA

• Offer LAMA & LABA+ICS to people with COPD who remain breathless or have exacerbations despite taking LABA+ICS,

• Triple therapy not dependent on FEV1

• Inhaler technique and ability to activate the device

ICS = inhaled corticosteroidLABA = long-acting beta2 agonist

LAMA = long-acting muscarinic agonist[new 2010]

Therapy

New treatment

New documents

Self Management plan

Self Management plan

• Target airflow limitation → bronchodilating by altering airway smooth muscle tone

• Improve emptying of the lung

• Ideally: reduce hyperinflation at rest and during exercise

GOLD 2011. Available from: www.goldcopd.org Spencer et al. Cochrane Database Syst Rev 11;10:CD007033

Bronchodilators are the cornerstoneof COPD treatment

GOLD 2011: Pharmacologic management of COPD*‡

(C) (D)

 LABA+ICS or LAMA   LABA+ICS or LAMA

LABA and LAMALABA+ICS and LAMA or

LABA+ICS and PDE4-inh orLABA and LAMA orLAMA and ICS or

LAMA and PDE4-inh

 SABA or SAMA prn  LABA or LAMA

LABA or LAMA orSABA and SAMA

LABA and LAMA 

(A) (B)

GOLD 1

GOLD 2

GOLD 3

GOLD 4

mMRC ≥2CAT ≥10

mMRC 0−1 CAT <10

Exacerbations per year

≥2

First choice; Second choice

0

1

GOLD 2011

Bronchodilators

Long acting bronchodilators are beneficial in not just in terms of improving FEV1 and reducing exacerbations but also by reducing resting and dynamic hyperinflation

There is a potential benefit in combining long acting bronchodilators from different pharmacological classes in COPD patients (LABA and LAMA)

Dynamic Hyperinflation

Exercise

Overview of bronchodilators approved in the last 5 years and in development for treatment of COPD

QD = once daily; BID = twice daily

Drug Class Route Company Development stage

Indacaterol LABA Inhaled, QD Novartis Approved

Olodaterol LABA Inhaled, QD BI Phase III

Vilanterol LABA Inhaled, QD Theravance/GSK Phase II

Aclidinium LAMA Inhaled, BID Almirall/Forest Approved

Glycopyrronium LAMA Inhaled, QD Novartis Approved

The role of inhaled corticosteroids in COPD

Where do they fit?

GOLD 2011: Pharmacologic management of COPD*‡

(C) (D)

 LABA+ICS or LAMA   LABA+ICS or LAMA

LABA and LAMALABA+ICS and LAMA or

LABA+ICS and PDE4-inh orLABA and LAMA orLAMA and ICS or

LAMA and PDE4-inh

 SABA or SAMA prn  LABA or LAMA

LABA or LAMA orSABA and SAMA

LABA and LAMA 

(A) (B)

GOLD 1

GOLD 2

GOLD 3

GOLD 4

mMRC ≥2CAT ≥10

mMRC 0−1 CAT <10

Exacerbations per year

≥2

First choice; Second choice

0

1

GOLD 2011

Inhaled Corticosteroids

• Recommended prescription in combination with LABA in patients with FEV1<50% and exacerbations

• Reduce exacerbation frequency by approximately 25% in most studies in patients of this phenotype

• They are however overprescribed in COPD (often as monotherapy where there is limited evidence of efficacy)

Clinical trial data show that many patients with moderate COPD are receiving ICS (1)

GOLD

I II III IV

Long-acting bronchodilators 61.8 67.3 69.3 65.1

SAMA 41.7 50.7 59.9 47.6

SABA 68.8 76.3 78.9 73.2

ICS 63.7 67.2 72.5 66.2

Theophyllines 24.7 34.9 36.1 30.5

Tashkin, et al. ATS 2006SAMA = short-acting muscarinic antagonist SABA = short-acting β2-agonist; ICS = inhaled corticosteroid

*Total includes six Stage I (mild) patients

Secondary endpoint:Change from baseline post-bronchodilator FEV1 (L)

-2 10 22 34 46 58 70 82 94 106

Chan

ge in

Pos

t-do

se F

EV1 (

L)

Treatment

TIO

SFC

P=0.2180.01

0.03

0.05

0.07

0.09

0.1

0.02

0.04

0.06

0.08

Wedzicha et al AJRCCM 2008

Time to First Pneumonia adverse event

Cox Hazard Ratio 95% CI p-valueSFC vs TIO 1.94 (1.19, 3.17) 0.008

0 13 26 39 52 65 78 91 104

01

23

456

78

1112

Pro

bab

ility

of

Eve

nt (

%)

Time to Event (Weeks)

Treatment

910

TIO

SFC

Wedzicha et al AJRCCM 2008

Nice outcome - smoking

• People with COPD who smoke are regularly encouraged to stop and are offered the full range of evidence-based smoking cessation support.

Stop smoking

• Encouraging patients with COPD to stop smoking is one of the most important components of their management

• All COPD patients still smoking, regardless of age, should be encouraged to stop, and offered help to do so, at every opportunity

• Record a smoking history, including pack years smoked

• Offer nicotine replacement therapy, varenicline or bupropion (unless contraindicated) combined with a support programme to optimise quit rates [2010]

[2004]

Intervention Stop Smoking

FRESH

• http://www.freshne.com/

• http://www.freshne.com/everybreath/

Nice Outcomes - oxygen

•People with COPD potentially requiring long-term oxygen therapy are assessed in accordance with NICE guidance by a specialist oxygen service.

•People with COPD receiving long-term oxygen therapy are reviewed in accordance with NICE guidance, at least annually, by a specialist oxygen service as part of the integrated clinical management of their COPD

Long term oxygen therapy –who?

•FEV1 < 30% predicted

•Cyanosis

•Polycythaemia.

•Peripheral oedema.

•Raised jugular venous pressure.

•Oxygen saturations < 92% on air.

Ambulatory

• For people with LTOT

• Maximises the hours of oxygen

• Some use in significant de-saturators

• May have use in exercise classes

Nebulisers

• Mainstay of therapy should be by a conventional inhaled route.

• Majority of patients get little added benefit from nebulisers.

• Consider nebulisers if:• Patient lacks dexterity to use

inhalers.• Patient has cognitive

impairment.• Patient has severe COPD and is

still symptomatic despite high dose inhaled bronchodilator therapy.

Nice outcome - rehab

• People with COPD meeting appropriate criteria are offered an effective, timely and accessible multidisciplinary pulmonary rehabilitation programme.

Provide pulmonary rehabilitation

Pulmonary rehabilitation

An individually tailored multidisciplinary programme of care to optimise patients’ physical and social performance and autonomy

Tailor multi-component, multidisciplinary interventions to individual patient’s needs

Hold at times that suit patients, and in buildings with good access

Offer to all patients who consider themselves functionally disabled by COPD

Make available to all appropriate people, including those recently hospitalised for an acute exacerbation

[new 2010]

What does it achieve ?

• Pulmonary rehabilitation• Reduces the number of hospital days• Reduces health-care utilization • Increases exercise tolerance• Reduces need for 02• Reduces exacerbation frequency

NICE outcome - exacerbations

• People who have had an exacerbation of COPD are provided with individualised written advice on early recognition of future exacerbations, management strategies (including appropriate provision of antibiotics and corticosteroids for self-treatment at home) and a named contact.

• People admitted to hospital with an exacerbation of COPD are cared for by a respiratory team, and have access to a specialist early supported- discharge scheme with appropriate community support.

• People admitted to hospital with an exacerbation of COPD and with persistent acidotic ventilatory failure are promptly assessed for, and receive, non-invasive ventilation delivered by appropriately trained staff in a dedicated setting.

• People admitted to hospital with an exacerbation of COPD are reviewed within 2 weeks of discharge.

Managing exacerbations

• Minimise impact of exacerbations by:

•- giving self-management advice on responding promptly to symptoms of exacerbation

•- starting appropriate treatment with oral steroids and/or antibiotics

• The frequency of exacerbations should be reduced by appropriate use of inhaled corticosteroids and bronchodilators, and vaccinations

[2004]

End of life outcome

•People with advanced COPD, and their carers, are identified and offered palliative care that addresses physical, social and emotional needs.