TITLE Respiratory Training Session Deepa Tailor Medicines Management Pharmacist NHS Nottingham City Clinical Commissioning Group DATE: Tuesday 12th June 2018

Content What is COPD? GOLD 2017 NICE APC COPD Guideline Which 2 Drugs for dual therapy? Inhalers on COPD formulary What is Asthma? BTS/SIGN, NICE Guidelines APC Asthma guideline in adults Inhalers on Asthma formulary

What is COPD? NICE Chronic obstructive pulmonary disease (COPD) is a condition characterised by airflow obstruction, which is usually progressive, not fully reversible and does not change markedly over several months GOLD “a common, preventable a treatable disease that is characterised 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”

GOLD 2017 – How to categorise risk Spirometrically confirmed diagnoses Assessment of airflow limitation Assessment of symptoms/risk of exacerbation Post-bronchodilator FEV1/FVC <0.7 GOLD A Gold C <2 exacerbations or 0 admissions in the last year AND (MRC score 0-1 or CAT score <10) ≥2 exacerbations or ≥1 admission in last year GOLD B GOLD D <2 exacerbations or 0 admissions in last year (MRC score >2 or CAT score ≥10) ≥2 exacerbations or ≥1 admission in last year AND More symptoms (MRC score ≥2 or CAT score ≥10) Percentage predicted FEV1 GOLD 1 ≥80% GOLD 2 50-70% GOLD 3 30-49% GOLD 4 <30% Global initiative for chronic obstructive Lung Disorder (GOLD)

MRC Dyspnoea Scale The Medical Research Council Scale designed to assess the severity of COPD symptoms. The higher the score the worse the symptoms. The higher up the treatment scale you would start.

COPD Assessment Tool (CAT) 8-item questionnaire, designed to assess patient symptoms and the impact of their condition on activities e.g. stairs, moving around the home and sleep. Total score 40 (higher score the worse symptoms/impact if the condition) Score <10 = low impact 10-20 suggests medium impact >20 suggests COPD is stopping the person from doing most things they want to. Most people’s score should not change by more than 1 point /year A change of 2 or more over 2-3 months suggest significant difference in health status. Linked to GOLD guidelines.

GOLD 2017 – Suggested treatments • category A: bronchodilator (short or long acting); consider switching to another depending on response;   • category B: long-acting bronchodilator (LAMA or LABA), or both LAMA and LABA if symptoms not controlled on one drug; • category C: LAMA; consider switching to LAMA+LABA or to LABA+ICS if further exacerbations occur (LAMA+LABA now preferred over LABA+ICS); • category D: LAMA+LABA initially (unless high blood eosinophil counts or people with asthma-COPD overlap syndrome (ACOS), in which case LABA+ICS may be preferred); consider triple therapy if symptoms persist. The aims of COPD treatment is to reduce long-term lung function decline prevent and treat exacerbations reduce hospitalizations and mortality relieve disabling dyspnoea improve exercise tolerance and health-related quality of life prevent and treat complications (1,2)

NICE Post-bronchodilator spirometry should be used to make diagnosis. Pulmonary Rehab is an important component of care. Trial therapy and if no objective/subjective improvement – Don’t be afraid to stop it.

NICE SABA or SAMA prn TRIAL OF TRIPLE THERAPY ICS + LABA + LAMA Start LAMA continue SABA (if using) stop SAMA (if using) Add LABA Consider SABA or SAMA AND if FEV1 <50% add LABA with ICS in combined inhaler If addition of LABA insufficient, add ICS, even if FEV1 ≥50% (use combined inhaler) Regardless of severity, consider LABA & LAMA if ICS not tolerated/wanted. Clinical trials have shown that absolute benefit with triple therapy was small (preventing one exacerbation every 5-8 years!). TRIAL OF TRIPLE THERAPY ICS + LABA + LAMA Absolute benefits small: reduction of 1 exacerbation over 8 years (Lancet 2016;388:963).

NNT = 2 to improve exercise tolerance, 4 to reduce re-admission 6/12 Single best interventions is to encourage smoking cessation. Pulmonary rehab is an important component of care: Refer everyone unless patient can not walk, unstable angina or recent M.I. Re-refer if frequent exacerbations or more than a year since last course Nottingham City CCG have secured 2500 licenses for My COPD app. Currently unknow which patients will meet the criteria to receive free subscription, however this is an NHS digital approved web based app which can be accessed through any device. Includes inhaler technique videos Evidence based pulmonary rehab exercises Air quality Diary Reminders Patients can purchase life-time subscription for a single cost of £20. Encourages Pulmonary rehab at home and shown to be equally effective as face to face session. 2-3 sessions a week for 6-8 weeks. NNT = 5 prevent death at age 70

Non-Pharmacological Treatments Stop smoking APC COPD GUIDELINE Non-Pharmacological Treatments Stop smoking Pulmonary Rehab Pharmacological Treatments Influenza Vaccination Inhalers Oxygen – O2 Sats ≤ 92% - more than once when stable on optimal medication or 8 weeks after exacerbation Oral steroids - A significant steroid load is >1g over a year. NICE recommend 30mg/d for 7-14d. So 1g is 33d at 30mg/d. The risk of fracture (typically vertebral) rises immediately oral steroid are started and returns to normal about 12m after stopping. The extent depends on the dose used and duration of treatment (DTB 2010;48(9)). Oral steroids…..Avoid excessive ordering. If requiring 2 or more courses in a year, likely to require specialist input. If oral steroid load is significant, consider bone assessment. NICE suggest 30mg/day for 7-14 days. In asthma higher doses for shorter periods. 40-50mg for 5 days or until recovery. Consider bone prophylaxis if 3 or more courses. Should NOT be put on repeat. If they are maximum 2 issues before a review.

APC COPD Guidelines When it comes to ICS use, The Nottinghamshire APC guideline follows GOLD guideline ICS/LABA (prescribed by brand) should only be introduced at time of clinical stability in patients with FEV1≤50% AND ≥2 exacerbations in the last year. In COPD doses above 800mcg-1000mcg have not shown to offer additional benefit Scope to review all patients on Seretide DPI 500 Accuhalers 1 puff twice a day, which is licensed in COPD = 2000mcg daily. Consider formulary choice ICS/LABA IF one is warranted. This will improve patient safety by reducing ICS load. DO NOT abruptly stop ICS/LABA therapy for those who have taking HIGH doses, they will require weaning down. Never remove ICS component in patients with Asthma/COPD overlap.

Which 2 drugs for dual therapy? A 12m study of people with COPD who had had an exacerbation in the previous 12months compared LABA+LAMA (indacterol + glycopyrronium) with LABA+ICS (Salmeterol + fluticasone) (NEJM 2016;374:2222). The results showed: The two arms were non-inferior. In a modified intention to treat analysis there were fewer exacerbations in the LABA+LAMA arm, but the DTB review of the trial reminds us: 75% of exacerbations were mild (25% required treatment) There was no reduction in hospital admissions (DTB 2016;58(8):88).

Seretide 500mcg Accuhaler – Usually prescribed in COPD patients at 1 puff twice a day. This is a 2000mcg daily dose equivalent to BDP. High doses of ICS can cause systemic absorption – cataracts, diabetes, osteoporosis, adrenal suppression. Limited evidence in COPD that doses above 1000mcg offer additional SAFETY IMPLICATION!!!

APC COPD Guidelines These are the formulary inhalers on the APC COPD Guideline SAMA & LAMA inhalers have been associated with increased CVD risk. Especially around tiotropium – MI in last 6 months, unstable or life-threatening arrhythmia's, arrhythmia's requiring change in meds in the last 12m. Warn patients to report any worsening of cardia symptoms, when starting on tiotropium. Ensure periodically to ensure medication continues to be appropriate. Fractures: ICS, 80 people treated over 3yrs = 1 fracture Pneumonia: No evidence to suggest any one steroid increases risk. ICS do increase risk of pneumonia in COPD (up to 10% of px may be affected).

Inhalers Several types of devices of which the below are on COPD guideline pMDI – Salbutamol, ipratropium, Fostair 100/6 ,Symbicort 200/6 Respimat – Olodaterol, Tiotropium, Spiolto Easyhaler – Salbutamol and formeterol Handihaler – Tiotropium (Recently changed to Zonda Inhaler (Braltus®)) Turbohaler – Terbutaline, Formoterol, Symbicort Genuair – Aclidinium (Eklira®), Duaklir® (aclinidinium/formeterol) Ellipta – Umeclinidium (Incruse®), Anoro®(umeclidinium/vilanterol), Relvar® (fluticasone fuorate/vilanterol) NEXThaler – Fostair® (beclometasone extrafine/formoterol) Spiromax – Duoresp® (budesonide/formeterol) Remember when selecting inhalers Use devices that require similar inspiratory effort AND check the patient has sufficient inspiratory effort to use it. You should all have a in-check device to assess inspiratory flow rate and to aid with teaching inhaler technique. Use devices that operate in similar ways Test inhaler technique regularly Similar regimes e.g. once daily or twice daily. Appreciate that this may not always be possible.

Inhalers Forceful, steady and deep inhalation action Gentle prolonged and deep inhalation action Avoid generic prescribing as same combination medication available in different devices - Patients may end up with a device that they do not know how to use.

Useful Links APC COPD Guidelines http://www.nottsapc.nhs.uk/media/1063/copd-guideline.pdf APC Asthma Guidelines http://www.nottsapc.nhs.uk/media/1049/adult-asthma-guideline.pdf?UNLID=5949407842018511154545 Inhaler technique http://www.nottinghamcity.nhs.uk/news-projects/inhaler-technique.html In-check training http://www.nottinghamcity.nhs.uk/portal-for-general-practice/practice-resources/inhaler-technique.html

What is Asthma? WHO: Can affect anyone in any age group. Characterized by recurrent attacks of breathlessness and wheezing, which vary in severity and frequency from person to person. This condition is due to inflammation of the air passages in the lungs and affects the sensitivity of the nerve endings in the airways so they become easily irritated. In an attack, the lining of the passages swell causing the airways to narrow and reducing the flow of air in and out of the lungs.

Diagnosis TAKE A GOOD HISTORY No gold standard diagnostic testing – Influence probability, but do not prove diagnosis Spirometry can be performed on anyone ≥5years Peak flow diary – Twice daily OR Four times daily if occupational asthma suspected FeNO testing TAKE A GOOD HISTORY Symptoms – Wheeze, breathlessness, chest tightness, cough Spirometry - With hold inhaler/smoking 4-6hrs: SABA 12h: LABA 24hrs: Smoking, tiotropium, theophylline and oral b2-agonists Adults: Improvement in FEV1 of 12% or more AND an increase in FEV1, volume of 200ml or more – possibility of asthma Improvement in FEV1 of more than 400mls is strongly suggestive of asthma. Note: Some with COPD have significant reversibility, and some with asthma have normal spirometry when asymptomatic. In children: improvement in FEV1 of 12% or more is regarded as a positive test. Peak Flow – Normal variability is up to 20%. So likelihood of asthma if 30% variability. Occupations: Food processing e.g. pastry, baking Lab work Metal work, welding/soldering Chemical processing Farming Spray painting Dental Woodwork Textiles/Rubber/plastics manufacturing Feno Test: Positive (40 parts/billion or 35 parts/billion in school children) – increases possibility of asthma, but not conclusive. Negative – Does not rule out asthma Raised FeNO in large, tall men, people with allergic rhinitis, rhinovirus infection, increased diet with nitrates e.g green leafy veg & beetroot. Lower FeNO in children, smokers, steroids (inhaled & oral).

Asthma Review Smoking Inhaler Technique Maintenance therapy Pharmacotherapy Lifestyle Education Single best intervention is to stop smoking ICS is important treatment Flu Vaccination Patients still dying due to NSAID & b-blockers co-prescribed Identify any occupational hazards, trigger factors PAAP – Personalised Asthma Action Plans. Perhaps remind patient they can have up to 10 puffs (30sec) gap between each one and if they are not experiencing benefit, it’s likely to be an emergency. 4 puffs via spacer, then 2 puffs every 2 mins (tidal breathing) – Max 10 puffs. Review within 2 weeks of admission – address contributable factors. Scenario where your patient is using inhalers as prescribed, but gets breathless as walking up the stairs. Things don’t seem to be improving - to book for a GP/Nurse app.

BTS Guidelines – Management NICE Asthma 2017 have suggested started Leukotriene inhibitor after initiating ICS, before introducing LABA – Received a lot of criticism for this. Likely to be revised. Only 15-20% of patients respond to montelukast – best in allergic base Likelihood of asthma – start treatment, stop re-challenge. SABA IF you need it. Take emphasis off using blue inhaler more. Get people to recognize the importance of ICS treatment.

Largely based on BTS guidelines. Inhalers are also shown Aim is to achieve: No regular symptoms No limitations of activity/exercise No need for rescue medication No attacks Normal Lung function Crucial to step down treatment, consider 25-50% reduction every 3months. Do NOT step down patients in the following category Ongoing symptoms Pregnancy Exacerbation, steroid course in the last year 3 months/under specialist Masoli and Holt study - 90% of therapeutic benefit achieved at 400mcg BDP daily 200mcg Fluticasone daily. Therefore additional ICS dose is only likely to increase risk of s/e with only a further 10% benefit. Smokers are likely to require a higher dose of ICS.

Single Inhaler Therapy for Maintenance and Relief (SIT) Use of SABA should be discouraged. Formeterol onset is as quick as salbutamol and therefore can be used in SIT therapy. Salmeterol has a plateaued onset therefore can’t be. Duoresp and Fostair currently only have a license for 18+ Symbicort has SIT license for 12+

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