CHARM Guidelines for the diagnosis and

\ CHARM Guidelines for the diagnosis and management of COPD City and Hackney CCG Homerton University Hospital NHS Foundation Trust Written by: Miss Hetal Dhruve, Specialist Pharmacist Respiratory Medicine, City and Hackney CCG Checked by: Dr Meena Krishnamurthy, GP Respiratory Lead, City and Hackney Dr Angshu Bhowmik, Consultant Respiratory Medicine, HUHFT Debbie Roots, Cardiorespiratory Nurse Consultant HUHFT. Approved by: Homerton Hospital and City and Hackney CCG Joint Prescribing Group. Date: 12 th February 2018. Review: 12 th February 2019 Version: 5.2

DIAGNOSING COPD Definition of COPD COPD is characterised by airflow obstruction. The airflow obstruction is usually progressive, not fully reversible and does not change markedly over several months. The disease is predominantly caused by smoking. Think of a diagnosis of COPD for patients who are: Over 35 Smokers or ex-smokers Have any of these symptoms o exertion breathlessness o chronic cough o regular sputum production o frequent winter bronchitis or chest infections o wheeze And have no clinical features of asthma (see table below & CHARM asthma guidelines) Perform spirometry if COPD seems likely CXR & FBC at diagnosis Airflow obstruction is defined as: FEV 1<80% predicted or >80% with symptoms And FEV 1/FVC< 70 Consider asthma if >12% FEV 1 reversibility with bronchodilator or corticosteroids. If still doubt about diagnosis consider the following pointers: Clinically significant COPD is not present if FEV 1 and FEV 1/FVC ratio return to normal with drug therapy. Asthma may be present if: o there is a >400ml response to bronchodilators & also >12% reversibility o serial peak flow measurements show significant diurnal or day-to-day variability o there is a >400ml response to 30mg prednisolone daily for 2 weeks Refer for more detailed investigations if needed If still in doubt, consider other possible diagnosis and/or refer for further advice If confirmed COPD: Classify COPD and then start treatment (see flowchart) Severity - Post bronchodilator FEV1/FVC FEV1% Stage < 0.7 > 80% Mild < 0.7 50 79% Moderate < 0.7 30-49% Severe < 0.7 <30% Very Severe Reassess diagnosis in view of response to treatment Clinical features differentiating COPD and asthma COPD Asthma Smoker or ex-smoker Nearly all Possibly Symptoms under age 35 Rare Common Chronic productive cough Common Uncommon Breathlessness Persistent and progressive Variable Night-time waking with breathlessness and/or wheeze Uncommon Common Significant diurnal or day-to-day variability of symptoms Uncommon Common For CXR and FBC at ANY time if blood in sputum / weight loss / change in cough

Aim of treatment Reduce symptoms: - Relieve symptoms - Improve exercise tolerance - Improve health status Reduce Risk: - Prevent disease progression - Prevent and treat exacerbations - Reduce mortality Treatment 1. Smoking cessation Smoking cessation has the greatest capacity to influence the natural history of COPD. If effective resources and time are dedicated to smoking cessation, long term quit success rates of up to 25% can be achieved. Refer to stop smoking clinics as listed below or a community pharmacy stop smoking service. 2. Vaccinations All patients should be offered the annual flu vaccination and the pneumococcal vaccination once in their lifetime, unless otherwise instructed. 3. Right medication, right inhaler

The Right Medication, the Right Inhaler If first line recommendation is NOT suitable (for reasons such as lack of dexterity, side effects etc) which device would be most suitable for my patient? Does my patient have enough inspiratory effort/volume to inhale the contents of a dry powder inhaler? Optimal Inspiratory flow rate L/Min None required** High inspiratory effort required Least inspiratory effort required Device MDI/Respimat Zonda/ Handihaler Turbohaler Spiromax Genuair Accuhaler Ellipta Breezhaler NO Consider a soft mist inhaler or a metered dose inhaler with a spacer. LAMA: Spiriva (Tiotropium) Respimat LAMA/LABA: Spiolto (Tiotropium/Olodaterol) Respimat LABA/ICS: Fostair (Beclometasone/Formoterol) MDI YES Prefers twice daily administration? Consider Turbohaler/Spiromax/Accuhaler/Genuair* LAMA: Eklira Aclidinium Genuair* LAMA/LABA: Duaklir (Aclidinium/Formoterol) Genuair* ICS/LABA: Check inspiratory effort/try placebos to find best device for patient - Fostair (Beclometasone/Formoterol) Nexthaler 100/6 - Seretide Fluticasone/Salmeterol 500/50 Accuhaler - Budesonide/Formoterol 200/6 1-2p BD or Budesonide/Formoterol 400/12 1p BD (Spiromax or Turbohaler) Prefers once daily administration? Consider Ellipta LAMA: Incruse (Umeclidinium) Ellipta LAMA/LABA: Anoro (Umeclidinium/Vilanterol) Ellipta LABA/ICS: Relvar (Vilanterol/Fluticasone) Ellipta *This should also be product of choice to optimise bronchodilation over a 24 hour period. Duration of action of once daily preparations varies from 18-24 hours. ** MDI with/out spacer and the Respimat device do not require inspiratory effort but does require co-ordination to ensure sufficient inhalation of dose. The Respimat device cannot be used with a spacer. Try placebos or use an in-check dial if available before initiating inhalers. Check inhaler technique at every opportunity. Also see inhaler standards and competency document to aid assessment and www.rightbreathe.com

Exacerbating patients >2 per year, or 1 leading to hospital admission MRC 1-2 CAT < 10 (FEV1<50%) Management of stable COPD (Based on NICE 2010 clinical guideline and GOLD 2017) All prescribing options to allow prescribing of most appropriate device. Long Acting Beta Agonist+ QUALITY ASSURED SPIROMETRY Post bronchodilator FEV1 1/FVC and FEV 1 %predicted (Classify COPD severity) Exacerbating patient, consider LAMA (as below) as first line, ICS/LABA (or for those with co-morbidity with Asthma) or Ultibro# (LABA/LAMA for COPD patients only if ICS not tolerated or declined. ICS+LABA Inhaled Corticosteroid + Long Acting Beta Agonist If able to use DPI: 1 st : Fostair Nexthaler DPI 100/6 mcg 2 doses BD If requires MDI + spacer 2 nd : Fostair MDI 100/6 mcg 2 doses BD OR depending on patient device preference: Relvar Ellipta DPI 92/22 mcg 1 dose OD OR Duoresp Spiromax DPI 160/4.5 mcg 2 doses BD OR Symbicort Turbohaler DPI 200/6 mcg 2 doses BD OR Seretide 500 Accuhaler DPI 500/50 mcg 1 dose BD Exacerbating and breathless patient, consider ICS/LABA/LAMA ICS+LABA+ LAMA Inhaled Corticosteroid + Long Acting Beta Agonist+ Long Acting Muscarinic Antagonist If able to use DPI: Trelogy Ellipta DPI 92/55/22 1p OD If requires MDI + Spacer: Trimbow MDI 87/5/9 2p BD Patient may also be initiated on a macrolide and/or Roflumilast specialist initiation only Exacerbating patients >2 per year, or 1 leading to hospital admission MRC >3 CAT > 10 (FEV1< 50%) Breathless patients 0-1 exacerbations per year MRC 1-2 CAT < 10 (FEV1>50%) SABA or SAMA Long Acting Beta Agonist or Short Acting Muscarinic Antagonist Salbutamol 100 MDI or 200 Accuhaler, or Bricanyl 500 PRN Or Atrovent 20mcg PRN If continues to be breathless, initiate LAMA or LABA. LAMA Long Acting Muscarinic Antagonist If LAMA started stop the SAMA 1 St : SeeBri Breezhaler DPI 44mcg 1 dose OD OR depending on patient device preference: OR: Braltus Zonda DPI 10mcg 1 dose OD, Incruse Ellipta DPI 55mcg 1 dose OD Eklira Genuair DPI 400mcg 1 dose BD, Spiriva Respimat*Soft Mist 2.5mcg 2 doses OD OR LABA Long Acting Beta Agonist Patients who continue to be breathless despite being on a LAMA or LABA consider dual bronchodilator LAMA+LABA Long Acting Muscarinic Antagonist+ Long Acting Beta Agonist 1 st Ultibro Breezhaler DPI 85/43 mcg 1 dose OD OR depending on patient device preference: Anoro Ellipta DPI 55/22mcg 1 dose OD OR Duaklir Genuair DPI 400/12mcg 1 dose BD OR Spiolto Respimat Soft Mist 2.5/2.5mcg 2 doses OD Breathless patients 0-1 exacerbations MRC >3 CAT >10 (FEV1>50%) 1 st : Onbrez Breezhaler DPI 150-300mcgs 1 dose OD OR Serevent 25mcg 2 doses BD (MDI or Accuhaler), Oxis Turbohaler DPI 12mcg 1 dose BD # Ultibro is currently the only LABA/LAMA that shows evidence of reducing exacerbations when compared to ICS/LABA. *Salbutamol may continue at all stages, SAMA discontinued if LAMA initiated. ** Second line agents to be used in patients who have not tolerated 1st line agents and should be based on device most appropriate for the patient. Consider de-escalation where appropriate. For those with a chronic productive cough, consider trial of mucolytic therapy. Consider referral for long term oxygen therapy if Spo2 <92% on room air and stable MRC: Medical Research Council dyspnoea scale Please refer to the right medication, the right inhaler for more information. For all patients ensure the following: - Inhaler technique and adherence checked at every opportunity - Smoking cessation for all smokers - Flu and Pneumococcal pneumonia vaccinations - Self-management and rescue medication are in place where appropriate - Pulmonary rehabilitation offered to all patients with MRC 3 or MRC =2 with symptoms. - Advice on exercise and nutrition -Consider advance care planning and referral to Breathing Space Clinic in more advanced COPD Written by: Hetal Dhruve (Specialist Respiratory Pharmacist) City and Hackney CCG Checked by: Dr Angshu Bhowmik, Consultant Respiratory Medicine, HUHFT, Debbie Roots, Cardiorespiratory Nurse Consultant, HUHFT, Dr Meena Krishnamurthy, GP Respiratory Lead, City and Hackney CCG Approved by: JPB. Date of approval: 12/02/18, Date of revision: 12/02/19 Version: 5.2

The right medication, the right inhaler. Consider your patient: Select device most appropriate for your patient. - What inhalers are they using? - How is the inhaler technique poor/moderate/good. - Does the patient have a history of asthma? - ICS must not be stopped if there is any history of Asthma regardless of severity of COPD Prescribing options Component(s) Brand Dose Device Key inhaler technique* LABA LONG ACTING BETA AGONIST Price/30 days Indacaterol Onbrez 150-300mg 1p OD Breezhaler Long and deep 29.26 Salmeterol Serevent 25mcg 2p BD Available as accuhaler/mdi Accuhaler: Long and deep MDI: Slow and steady 29.26 LAMA LONG ACTING MUSCARINIC ANTAGONIST Formoterol Oxis 12mcg 1p BD Turbohaler Long and deep 24.80 Glycopyrronium Seebri 44mcg 1p OD Breezhaler Long and deep 27.50 Tiotropium Braltus 10mcg 1p OD Zonda Long and deep 28.60 Aclidinium Eklira 400mcg 1p BD Genuair Long and deep 28.60 Umeclidinium Incruse 55mcg 1p OD Ellipta Long and deep 27.50 Tiotropium Spiriva 2.5mcg 2p OD Respimat Slow and steady 23.00 LABA+LAMA LONG ACTING BETA AGONIST + LONG ACTING MUSCARINIC ANTAGONIST Glycopyrronium + Indacaterol Ultibro 85/43 1p OD Breezhaler Long and deep 32.50 Umeclidinium + Vilanterol Anoro 55/22 mcg 1p OD Ellipta Long and deep 32.50 Aclidinium+ Formoterol Duaklir 340/12mcg 1p BD Genuair Long and deep 32.50 Tiotropium + Olodaterol Spiolto 2.5/2.5mcg 2p OD Respimat Slow and steady ICS/LABA INHALED CORTICOSTEROIDS + LONG ACTING BETA AGONIST 32.50 Beclomethasone + Formoterol Fostair 100/6 2p BD MDI Slow and 29.32 steady Beclomethasone + Formoterol Fostair 100/6 2p BD Nexthaler Long and deep 29.32 Fluticasone + Vilanterol Relvar 92/22 1p OD Ellipta Long and deep 22.00 Fluticasone + Salmeterol Seretide 500/50 1p BD Accuhaler Long and deep 40.92 Budesonide + Formoterol Symbicort 200/6 2p BD Turbohaler Long and deep 28 Budesonide + Formoterol Duoresp 160/4.5 2p BD Spiromax Long and deep 27.97 Beclomethasone+ Formoterol + Glycopyrronium Fluticasone + Vilanterol + Umeclidinium ICS+LABA+LAMA Trimbow 87/5/9 2p BD MDI Slow and steady 44.50 Trelegy 92/22/55 1p OD Ellipta Long and deep 44.50 **NOTE Seretide 250 evohaler, Sirdupla 250/25 and Sereflo 250/25 are NOT licensed for use in COPD but may be continued for patients who are already established on treatment and have no history of pneumonia. If a patient is unable to use the long acting muscarinic antagonist, an ipratropium inhaler (SAMA) with spacer may be considered. This would be off-license use. ** Please refer to patient information leaflets/spc s or www.rightbreathe.com for full instruction on inhaler technique. # Prices correct at time of update: 12/02/18. Reference MIMS online.

Quality of Life CAT (COPD ASSESSMENT TEST) SCORE I never cough 0 1 2 3 4 5 I cough all the time I have no phlegm (mucus) in my chest at all 0 1 2 3 4 5 My chest is full of phlegm (mucus) My chest does not feel tight at all 0 1 2 3 4 5 My chest feels very tight When I walk up a hill or one flight of stairs I am not 0 1 2 3 4 5 When I walk up a hill or one flight of stairs I Breathless am very breathless I am not limited doing any activities at home 0 1 2 3 4 5 I am very limited doing activities at home I am confident leaving my home despite my lung Condition 0 1 2 3 4 5 I am not at all confident leaving my home because of my lung condition I sleep soundly 0 1 2 3 4 5 I don t seem soundly because of my lung Condition I have lots of energy 0 1 2 3 4 5 I have no energy at all MRC (MEDICAL RESEARCH COUNCIL) DYSPNOEA SCALE Grade Degree of breathlessness related to activities 1 Not troubled by breathlessness except on strenuous exercise 2 Short of breath when hurrying on the level or walking up a slight hill 3 Walks slower than most people on the level, stops after a mile or so, or stops after 15 minutes walking at own pace. 4 Stops for breath after walking about 100 yards or after a few minutes on level ground 5 Too breathless to leave the house, or breathless when undressing OTHER PHARMACOTHERAPY Oral theophyllines can be considered but they have a high-risk side effect profile and interact with many other medication and cigarette smoke. Theophylline levels should therefore be monitored as per MHRA guidelines to prevent toxicity. Chronic cough productive of viscous sputum - consider 4 week trial of mucolytic agent e.g carbocisteine 750mg 3 times a day initially then 2 times a day; reassess benefit after 4 weeks. Patients who frequently exacerbate may be initiated on macrolide prophylaxis by specialist only.

PULMONARY REHABILITATION (PR) PR is gold standard symptom based treatment of exercise and education, aimed at promoting long term behaviour change and compliance with health enhancing behaviours. A referral to outpatient PR should be considered for all COPD patients with MRC grade 3-5 or MRC 2 with breathlessness on exertion as per NICE guidance. Post exacerbation PR should be considered for all patients admitted with an acute exacerbation of COPD within 4 weeks of discharge from hospital. To refer to the ACERs Pulmonary Rehabilitation Service email: HomertonCOPD@nhs.net or call 0208 510 5108 for a referral form. OXYGEN ASSESSMENT Refer to ACERS Oxygen Assessment Service, Respiratory Department, Homerton Hospital for long term and ambulatory oxygen assessment if oxygen saturations <92% on air, severe COPD, peripheral oedema. All patients who receive LTOT should be assessed annually with Blood gas analysis inform ACERS on 020 8510 5107 to undertake this assessment DEPRESSION & ANXIETY There is a high prevalence (30-50%) of depression seen in COPD patients with frequent exacerbations. NICE guidelines recommend a high index of suspicion and prompt diagnosis. Treat anxiety and depression with medication, taking time to explain to the patient why this is needed and refer to psychology services if needed END OF LIFE CARE Opiates should be used when appropriate to palliate breathlessness in patients with end stage COPD which is unresponsive to other medical therapy. Patients with end stage COPD and their families should have access to the full range of services offered by the multidisciplinary palliative care teams, including admission to hospices. Prognosis in COPD is difficult, but recognized indicators of a poor outcome are: Hospital admissions Severe disease On long term oxygen therapy Depression, poor quality of life, housebound Co-morbidity, especially heart failure Low BMI Consider asking would I be surprised if my patient were to die in the next twelve months? Consider inclusion on supportive and palliative care register Refer to ACERS for onward referral to the Breathing Space clinic at St Joseph s Hospice ACUTE INFECTIVE EXACERBATION OF COPD : ALL EXACERABTIONS REF TO ACERS TEAM Antibiotics are usually ONLY given if there is a history of increased sputum purulence: 1 st line PO Doxycycline 200mg stat then 100mg once a day for 4 days or PO Clarithromycin 500mg twice a day/po Amoxicillin 500mg three times a day for 5 days if doxycycline contraindicated AND oral steroids Prednisolone 30mg daily for 7 days. Gradual withdrawal of Prednisolone - Should be considered for the following patients - Received more than 40mg of prednisolone daily for more than 1 week - Been given repeat doses in the evening, - Recently received repeated courses (particularly if taken for longer than 3 weeks), - Taken a short course within 1 year of stopping long-term therapy Increase frequency of salbutamol 2 puffs every 4 hours, use spacer - PROTOCOL FOR THE TREATMENT & PREVENTION OF EXACERBATIONS IN COPD

IS IT AN EXACERBATION? Key features typically associated with exacerbation are 2 or more of the following. Worsening breathlessness Increased sputum volume Increased cough Fever Chest tightness Changing sputum colour Wheeze If yes to any If no to all FACTORS PROMPTING CONSIDERATION OF HOME MANAGEMENT VS. HOSPITAL ADMISSION Coping at home Normal level of consciousness Experiencing only mild breathlessness maintaining usual level of activity Eating & drinking normally Little change to usual general condition Easy access to help if required Lack of significant co morbidity If yes to most If no to most MANAGE PATIENT AT HOME & REFER TO ACERS DISCUSS WITH ACERS / ADMIT PATIENT TO HOSPITAL IN EMERGENCY MANAGE ACUTE EXACERBATION Add or increase bronchodilator use Review inhaler technique Prescribe antibiotics if sputum becomes purulent Consider oral corticosteroids Pulse oximetry if severe exacerbation Increase social support if necessary AGREE TO FOLLOW UP & REVIEW PATIENT TO ASSESS THEIR COPD POST EXACERBATION MANAGEMENT PLAN Patient understands personal self management plan, rescue medication should be supplied for future use for patients who have had an exacerbation or at risk of one (where appropriate) as above. Ensure adherence and inhaler technique is optimised.