COPD GOLD Guidelines & Barnet inhaler choices. Dr Dean Creer, Respiratory Consultant, Royal Free London NHS Foundation Trust

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1 COPD GOLD Guidelines & Barnet inhaler choices Dr Dean Creer, Respiratory Consultant, Royal Free London NHS Foundation Trust

2 GOLD 2017 Report: Chapters 1. Definition and Overview 2. Diagnosis and Initial Assessment 3. Evidence Supporting Prevention & Maintenance Therapy 4. Management of Stable COPD 5. Management of Exacerbations 6. COPD and Comorbidities

3 COPD Definition Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases.

4 COPD Etiology, Pathobiology & Pathology

5 GOLD 2017 Report: Chapters 1. Definition and Overview 2. Diagnosis and Initial Assessment 3. Evidence Supporting Prevention & Maintenance Therapy 4. Management of Stable COPD 5. Management of Exacerbations 6. COPD and Comorbidities

6 Diagnosis and Initial Assessment 2017 Global Initiative for Chronic Obstructive Lung Disease

7 Diagnosis and Initial Assessment COPD should be considered in any patient who has dyspnoea, chronic cough or sputum production, and/or a history of exposure to risk factors for the disease. Spirometry is required to make the diagnosis; the presence of a post-bronchodilator FEV1/FVC < 0.70 confirms the presence of persistent airflow limitation. The goals of COPD assessment are to determine the level of airflow limitation, the impact of disease on the patient s health status, and the risk of future events (such as exacerbations, hospital admissions, or death), in order to guide therapy.

8 Diagnosis and Initial Assessment Symptoms of COPD Chronic and progressive dyspnoea Cough Sputum production Wheezing and chest tightness Others including fatigue, weight loss, anorexia, syncope, rib fractures, ankle swelling, depression, anxiety Global Initiative for Chronic Obstructive Lung Disease

9 Spirometry 2017 Global Initiative for Chronic Obstructive Lung Disease

10 Classification of severity of airflow limitation 2017 Global Initiative for Chronic Obstructive Lung Disease

11 Choice of breathlessness assessments COPD Assessment Test (CAT TM ) Chronic Respiratory Questionnaire (CCQ ) St George s Respiratory Questionnaire (SGRQ) Chronic Respiratory Questionnaire (CRQ) Modified Medical Research Council (mmrc) questionnaire

12

13 Assessment of Exacerbation Risk COPD exacerbations are defined as an acute worsening of respiratory symptoms that result in additional therapy. Classified as: Mild (treated with SABDs only) Moderate (treated with SABDs plus antibiotics and/or oral corticosteroids) or Severe (patient requires hospitalization or visits the emergency room). Severe exacerbations may also be associated with acute respiratory failure. Blood eosinophil count may also predict exacerbation rates (in patients treated with LABA without ICS).

14 ABCD Assessment Tool

15 GOLD 2017 Report: Chapters 1. Definition and Overview 2. Diagnosis and Initial Assessment 3. Evidence Supporting Prevention & Maintenance Therapy 4. Management of Stable COPD 5. Management of Exacerbations 6. COPD and Comorbidities

16 KEY POINTS (1 of 3): Evidence Supporting Prevention & Maintenance Therapy Smoking cessation is key. Pharmacotherapy and nicotine replacement reliably increase long-term smoking abstinence rates. Pharmacologic therapy can reduce COPD symptoms, reduce the frequency and severity of exacerbations, and improve health status and exercise tolerance. Each pharmacologic treatment regimen should be individualized and guided by the severity of symptoms, risk of exacerbations, sideeffects, comorbidities, drug availability and cost, and the patient s response, preference and ability to use various drug delivery devices. Inhaler technique needs to be assessed regularly.

17 KEY POINTS (2 of 3): Evidence Supporting Prevention & Maintenance Therapy Influenza vaccination decreases the incidence of LRTI s. Pneumococcal vaccination decreases LRTI s. Pulmonary rehabilitation improves symptoms, quality of life, and physical and emotional participation in everyday activities. In patients with severe resting chronic hypoxemia, long-term oxygen therapy improves survival. In patients with stable COPD and resting or exercise-induced moderate desaturation, long-term oxygen treatment should not be prescribed routinely.

18 KEY POINTS (3 of 3): Evidence Supporting Prevention & Maintenance Therapy In patients with severe chronic hypercapnia and a history of hospitalization for acute respiratory failure, long-term non-invasive ventilation may decrease mortality and prevent re-hospitalization. In select patients with advanced emphysema refractory to optimized medical care, surgical or bronchoscopic interventional treatments may be beneficial. Palliative approaches are effective in controlling symptoms in advanced COPD.

19 Pharmacologic treatment Treatment of Stable COPD

20 Treatment of Stable COPD

21 Pharmacologic treatment: Group A All Group A patients should be offered bronchodilator treatment based on its effect on breathlessness. This can be either a short- or a long-acting bronchodilator. This should be continued if symptomatic benefit is documented Global Initiative for Chronic Obstructive Lung Disease

22 Pharmacologic treatment: Group B Initial therapy should consist of a long acting bronchodilator. LABA s are superior to SABA s taken prn and are therefore recommended. There is no evidence to recommend one class of LABA over another for initial relief of symptoms in this group of patients. In the individual patient, the choice should depend on the patient s perception of symptom relief. For patients with persistent breathlessness on monotherapy the use of two bronchodilators is recommended.

23 Pharmacologic treatment: Group B For patients with severe breathlessness initial therapy with two bronchodilators may be considered. If the addition of a second bronchodilator does not improve symptoms, we suggest the treatment could be stepped down again to a single bronchodilator. Group B patients are likely to have comorbidities that may add to their symptomatology and impact their prognosis, and these possibilities should be investigated.

24 Pharmacologic treatment: Group C Initial therapy should consist of a single long acting bronchodilator. In two head-to head comparisons the tested LAMA was superior to the LABA regarding exacerbation prevention, therefore we recommend starting therapy with a LAMA in this group. Patients with persistent exacerbations may benefit from adding a second long acting bronchodilator (LABA/LAMA) or using a combination of a long acting beta 2 -agonist and an inhaled corticosteroid (LABA/ICS). As ICS increases the risk for developing pneumonia in some patients, our primary choice is LABA/LAMA.

25 Pharmacologic treatment: Group D We recommend starting therapy with a LABA/LAMA combination because: In studies with patient reported outcomes as the primary endpoint LABA/LAMA s showed superior results compared to the single substances. If a single bronchodilator is chosen as initial treatment, a LAMA is preferred for exacerbation prevention based on comparison to LABAs (for details see GOLD 2017 Chapter 3). A LABA/LAMA combination was superior to a LABA/ICS combination in preventing exacerbations and other patient reported outcomes in Group D patients (for details see GOLD 2017 Chapter 3). Group D patients are at higher risk of developing pneumonia when receiving treatment with ICS.

26 Pharmacologic treatment: Group D In some patients initial therapy with LABA/ICS may be the first choice. These patients may have a history and/or findings suggestive of asthma-copd overlap. High blood eosinophil counts may also be considered as a parameter to support the use of ICS. In patients who develop further exacerbations on LABA/LAMA therapy we suggest two alternative pathways: Escalation to LABA/LAMA/ICS. Studies are underway comparing the effects of LABA/LAMA vs. LABA/LAMA/ICS for exacerbation prevention. Switch to LABA/ICS. However, there is no evidence that switching from LABA/LAMA to LABA/ICS results in better exacerbation prevention. If LABA/ICS therapy does not positively impact exacerbations/symptoms, a LAMA can be added.

27 Pharmacologic treatment: Group D If patients treated with LABA/LAMA/ICS still have exacerbations the following options may be considered: Add roflumilast. This may be considered in patients with an FEV1 < 50% predicted and chronic bronchitis, particularly if they have experienced at least one hospitalization for an exacerbation in the previous year. Add a macrolide. The best available evidence exists for the use of azithromycin. Consideration to the development of resistant organisms should be factored into decision making. Stopping ICS. A reported lack of efficacy, an elevated risk of adverse effects (including pneumonia) and evidence showing no significant harm from withdrawal supports this recommendation.

28 Triple Inhaler Therapy Trimbow MDI 87/5/9 TRIBUTE Study Trelegy Ellipta 92/55/22 IMPACT Study

29 Non-Pharmacologic Treatment Education and self-management Physical activity Pulmonary rehabilitation programs Exercise training Self-management education End of life and palliative care Nutritional support Vaccination Oxygen therapy

30 Rehabilitation, Education & Self- Management 2017 Global Initiative for Chronic Obstructive Lung Disease

31

32 Barnet inhaler choices

33 Stable COPD Treatment Guideline Stable COPD Treatment Guidelines Diagnosing COPD Think of diagnosis of COPD for patients who are: over 35 years old cigarette, cannabis or shisha smokers or ex-smokers (>10 pack years) have any of these symptoms: - exertional breathlessness - chronic cough - regular sputum production - freque t i ter bro chitis - wheeze and have no clinical features of asthma (see table below) Exclude other potential diagnoses Physical examination (possible cardiac causes, TB, obstructive sleep apnoea, localised wheeze?lung cancer, clubbing) Chest X-Ray TB / lung cancer Serial peak flow diary 20% or more variation suggests asthma (see below) Bloods i.e. FBC, ESR, TFT (i.e. anaemia, polycythaemia, Hypothyroidism, TB) Consider bronchiectasis if producing large amounts of sputum daily, frequent infections or basal crackles (may also indicate pulmonary fibrosis). (Refer to local bronchiectasis treatment guidelines) Perform spirometry post bronchodilator (see below): Spirometry should be carried out by a healthcare professional competent in its performance. Airflow obstruction is defined as: FEV1/FVC ratio is <0.7 and FEV1 <80% predicted OR FEV1/FVC ratio is <0.7 and FEV1 80% predictedand symptoms present Perform oximetry Diagnose asthma when: serial peak flow measurements show 20% diurnal or day-today variability or spirometry returns back to normal after steroid trial or bronchodilator there is a > 400ml response to bronchodilators (see below) there is a > 400ml response to a steroid trial (see below) READ CODE as ASTHMA H33 Reversibility testing is used to exclude asthma, not diagnose COPD Diagnose COPD when: Diagnose asthma & COPD (ACOS*) when: Consider an alternative Symptomatic Patient has proven airways - At new assessment, the patient responds to diagnosis in: patients under obstruction and bronchodilator / steroid reversibility trial but younger people with age 50: serial peak flow evidence of obstruction remains on spirometry symptoms of COPD COPD rare after treatment optimisation. measurements show no where the FEV1/FVC measure alphasignificant diurnal or day-today variability and - In patients who have been diagnosed with ratiois anti-trypsin COPD, spirometry then found to improve or older people without ask about show variability over time there is a < 400ml response to typical symptoms of cigarette, bronchodilators (see below) or - In patients who have been diagnosed with COPD where the cannabis and asthma, spirometry then found to show fixed there is a < 400ml response to FEV1/FVC ratio is < 0.7 shisha and airway obstruction over time a steroid trial (see below) passive READ CODE as ASTHMA H33 AND smoking READ CODE as COPD H3 COPD H3 (ACOS*) Treat as asthma & COPD *ACOS = Asthma COPD Overlap Syndrome Determine and EMIS Read code disease severity (see table below) Start appropriate treatment (see flowchart overleaf) Reassess diagnosis in view of response to treatment Bronchodilator reversibility Spirometry should be measured before and after an adequate dose of inhaled bronchodilator. Use nebulised bronchodilator 2.5mg 5mg salbutamol. Alternatively, use inhaled bronchodilator (using high doses via a disposable spacer) 4 puffs x 100 micrograms salbutamol. Measure lung function 15 minutes after 2-agonist. Steroid trial to exclude asthma Spirometry must be measured before and within 24 hours of completing an adequate course of steroid. Use oral prednisolone 30mg (non-enteric coated) every morning for 2 weeks. Spirometry Obstructive spirometry is required to make a diagnosis of COPD. NB FEV1/FVC ratio is a net result and obstruction may be masked by obesity. Spirometry is a near patient test and therefore should be performed in the community. Support is available from the Integrated Respiratory Team regarding spirometry services, provision and training. (Refer to local service) Pulse oximetry Measure in any patient with acute or worsening breathlessness to identify new or worsening respiratory failure, the need for admission and to assess the need for referral for Long Term O2 therapy (SaO2 < 92% on air) in stable patients with severe disease (FEV1 < 50%) or new ankle swelling. During acute exacerbations, aim for saturation of 88-92% pending arterial blood gases or range documented on Patient Specific Protocol (PSP). EMIS Read MRC Breathlessness Scale Code 0 No breathlessness 1 Not troubled by breathlessness except on strenuous exertion 173H 2 Short of breath when hurrying or walking up a slight hill 173I 3 Walks slower than contemporaries on level ground because of breathlessness, or 173J has to stop for breath when walking at own pace 4 Stops for breath after walking about 100m or after a few minutes on level ground 173K 5 Too breathless to leave house, or breathless when dressing or undressing 173L Ensure high value treatments are offered to all patients e.g. use the COPD Value Pyramid** as visual prompt **Thorax 2014;69: doi: /thoraxjnl Grading of airflow obstruction Postbronchodilator FEV1 % EMIS Read Post-bronchodilator predicted Code FEV1/FVC ratio <0.7 80% Stage 1 - Mild*** H36 < % Stage 2 - Moderate H37 < % Stage 3 - Severe H38 <0.7 29% Stage 4 Very Severe H39 ***Symptoms should be present to diagnose COPD in people with mild airflow obstruction Produced by the Camden, Haringey and Islington Responsible Respiratory Prescribing Group. Not to be used for commercial or marketing purposes. Strictly for use within the NHS. Page 1 of 4 References: NICE CG101 June 2010 & QS10 February 2016 update: GOLD Guidelines 2017: Camden, Haringey and Islington Stable COPD Treatment Guidelines v5 Updated June 2017; REVIEW DATE: June 2019

34 NCL inhaler choices

35 NCL inhaler choices

36 NCL inhaler choices

37 NCL inhaler choices

38 COPD Mx

39

40 Interventional Therapy in Stable COPD Lung volume reduction surgery (LVRS). LVRS is a surgical procedure in which parts of the lungs are resected to reduce hyperinflation,261 making respiratory muscles more effective pressure generators by improving their mechanical efficiency.

41 Oxygen Therapy & Ventilatory Support in Stable COPD During exacerbations of COPD. NIV is the standard of care for decreasing morbidity and mortality in patients hospitalized with an exacerbation of COPD and acute respiratory failure

42 Palliative, End of Life & Hospice Care In many patients, the disease trajectory in COPD is marked by a gradual decline in health status and increasing symptoms, punctuated by acute exacerbations that are associated with an increased risk of dying. Although mortality rates following hospitalization for an acute exacerbation of COPD are declining, reported rates still vary from 23% to 80%.

OPTIMIZING MANAGEMENT OF COPD IN THE PRACTICE SETTING 10/16/2018 DISCLOSURES I have no financial or other disclosures

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