Dr Michael Ho AGENDA. Asthma control requires treating underlying pathophysiology. The goal of asthma management To achieve overall asthma control

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1 Dr Michael Ho Consultant Respiratory & Sleep Physician Dandenong Respiratory Group Director of South Eastern Private Sleep Centre Part 1 AGENDA Generalised asthma management: Stepwise approach Part 2 Inhaler workshop Disclosures Honorariums from Boehringer Ingelheim and GSK Summary The goal of asthma management To achieve overall asthma control Asthma control requires treating underlying pathophysiology Symptoms and exacerbations represent only the tip of the iceberg Overall asthma control Achieve Current control Reduce Future risk Defined by Defined by Symptoms Reliever use Instability/ worsening Exacerbations Activity Lung function Loss of lung function Adverse effects of medication Adapted from Bateman ED et al. J Allergy Clin Immunol 2010; 125: Schematic representation of underlying inflammation and AHR resulting in symptoms and exacerbations of asthma, with the latter representing the tip of the iceberg. Adapted from Currie et al 2004 Why is it important to differentiate COPD and asthma? Inflammation is different in COPD and asthma so requires a different treatment approach: 1,2 Asthma vs COPD Different approaches COPD Neutrophilic inflammation largely unresponsive to corticosteroids ICS is the corner stone treatment in asthma for airway inflammation, remodelling and hyperresponsiveness Asthma Eosinophilic inflammation responsive to corticosteroids LAMA + LABA is the corner-stone treatment in COPD References: 1. Barnes PJ. Am J Respir Crit Care Med 2000;161: Price D et al. Prim Care Respir J 2013;22:

2 DIFFERENCE IN MANAGEMENT PARADIGM BETWEEN ASTHMA VS COPD COPD 2 Inflammation: mainly neutrophils and macrophages 1 Different type of airway inflammation 1 ASTHMA 3 Inflammation: mainly eosinophils, mast cells and T H2 cells 1 NATIONAL GUIDELINES RECOMMEND A STEPWISE APPROACH TO COPD TREATMENT 1 MILD FEV % predicted few symptoms breathless on moderate exertion recurrent chest infections little or no effect on daily activities MODERATE FEV % predicted increasing dyspnoea breathless walking on level ground increasing limitation of daily activities cough and sputum production exacerbations requiring oral corticosteroids and/or antibiotics SEVERE FEV 1 <40% predicted dyspnoea on minimal exertion daily activities severely curtailed experiencing regular sputum production chronic cough exacerbations of increasing frequency and severity Pathway: LAMA or LABA LABA/LAMA For some: ICS/LABA (+ LAMA) Role of SPIRIVA Respimat in COPD: Initial maintenance therapy for COPD patients across all severity stages Pathway: ICS ICS/LABA For some: ICS/LABA + SPIRIVA Respimat Role of SPIRIVA Respimat in asthma 4 Add-on treatment for asthma patients who remain symptomatic on ICS/LABA CHECK DEVICE USAGE TECHNIQUE AND ADHERENCE AT EACH VISIT Short-acting reliever medication: Short-acting ß 2-agonist (SABA) or short-acting muscarinic antagonist (SAMA) Symptom relief Exacerbation prevention - precautions LAMA OR LABA OR LAMA/LABA apply (refer to reference 1) Exacerbation prevention When FEV 1 <50% predicted AND LABA/ICS 2 exacerbations in 12 months 1. Lung Foundation. Stepwise Management of Stable COPD. Available from lungfoundation.com.au. Accessed June National Asthma Council Australia. Australian Asthma Handbook, Version 1.2. National Asthma Council Australia, Melbourne, Website. Available from: Accessed June 20, Gosens R et al. Respir Res 2006; 7: SPIRIVA Respimat Approved Product Information, 13 September Consider low-dose theophylline PBS-eligible symptomatic patients should be stabilised on a combination of LAMA and LABA. Not indicated for the initiation of bronchodilator therapy in COPD. 2,3 References: 1. Lung Foundation Australia. Stepwise management of stable COPD, February Symbicort Rapihaler approved Product Information (March 2017). 3. Seretide Accuhaler approved Product Information (September 2016). 9 GINA Stepwise approach to control asthma symptoms and reduce risk Asthma phenotypes and personalised treatment approaches 1,2 In Australia, Tiotropium Respimat is indicated only for adult patients, as an add-on to ICS ( 800 μg budesonide/day or equivalent) and LABA 1 STEP 5 STEP 1 STEP 2 PREFERRED CONTROLLER CHOICE Low dose ICS Other Consider low Leukotriene receptor antagonists (LTRA) controller dose ICS Low dose theophylline* options STEP 4 *Not for children <12 years STEP 3 Refer for **For children 6-11 years, add-on the preferred Step 3 treatment e.g. treatment is medium dose tiotropium,* Med/high ICS anti-ige, ICS/LABA anti-il5* # For patients prescribed Low dose BDP/formoterol or BUD/ ICS/LABA** formoterol maintenance and reliever therapy Tiotropium by mist inhaler Med/high dose ICS Add tiotropium* Add low is an add-on treatment for Low dose ICS+LTRA High dose ICS + dose OCS patients 12 years with a (or + theoph*) LTRA history of exacerbations (or + theoph*) Severe asthma with high IgE levels or high eosinophil count Phenotype-directed add-on treatment options: biologics RELIEVER As-needed short-acting beta 2-agonist (SABA) As-needed SABA or low dose ICS/formoterol # GINA 2017, Box 3-5 (1/8) 2017 Global Initiative for Asthma, all rights reserved. Use is by express license from the owner Reproduced from the Global Initiative for Asthma (GINA) Pocket Guide for Asthma Management and Prevention. Global Strategy for Asthma Management and Prevention Global Initiative for Asthma (GINA) all rights reserved. Use is by express license from the owner. Available from Accessed June SPIRIVA Respimat Approved Product Information, 13 September Anti-IgE mab: Omalizumab 2,3 Anti-IL-5 mab: Mepolizumab 2,4 Administered by s/c injection every 2 4 weeks Administered by s/c injection every 4 weeks PBS listed for severe uncontrolled allergic asthma PBS listed for severe uncontrolled eosinophilic asthma Must be treated by specialist physician Must be treated by specialist physician ICS: inhaled corticosteroids; IgE: immunoglobulin E; Anti-IL-5 mabs: anti interleukin-5 monoclonal antibody. 1. Wenzel S. Nature Med 2012; 18: National Asthma Council Australia. Australian Asthma Handbook, Version 1.2. National Asthma Council Australia, Melbourne, Available from: Accessed June Omalizumab Product Information. March Mepolizumab Product information. May Australian guideline recommendations for a stepwise approach in asthma Other personalised therapies Bronchial thermoplasty! Before considering stepping up, check symptoms are due to asthma, inhaler technique is correct, and adherence is adequate Allergen immunotherapy : sub-lingual vs sub-cut Consider stepping up if good control is not achieved When asthma is stable and well controlled for 2 3 months, consider stepping down (e.g. reducing inhaled corticosteroid dose, or stopping longacting beta 2 agonist if inhaled corticosteroid dose is already low Macrolide antibiotics National Asthma Council Australia. Australian Asthma Handbook, Version 1.2. National Asthma Council Australia, Melbourne, Available from: Accessed June 20,

3 Choosing appropriate treatment/ device was a challenge for 60% of GPs surveyed 1 INHALER CHOICE 14 Reference: 1. Australian Doctor Group. How do you distinguish between COPD and asthma? Survey. August Evolution of inhaler devices 1 Up to 9/10 patients do not use their inhaler correctly 1 Pressurised metereddose inhalers (pmdis) Dry powder inhalers (DPIs) e.g. Accuhaler,TH,Handihaler;Breezhaler;Genuair,Ellipta Soft mist inhalers e.g. Respimat Patients may say they are using their inhaler correctly when they are actually not. 1 ~ 1/10 patients use it correctly Even after learning how to use it correctly, they can lose their skills within 2-3 months. 1 Ellipta is a registered trademark of GlaxoSmithKline group of companies; Breezhaler is a registered trademark of Novartis Pharmaceuticals AG; Genuair is a registered trademark of Almirall, S.A. Reference: 1. Stein SW, Thiel CG. J Aerosol Med Pulm Drug Deliv 2017; 30: National Asthma Council Australia. Inhaler Technique for people with asthma or COPD ARE THERE DIFFERENCES BETWEEN INHALER CLASSES? Factors to guide inhaler choice Up to 90% of patients don t use their device correctly 1 pmdis Active device 1 Aerosol cloud of high velocity and short duration 2 Requires significant coordination 2 DPIs Breath-actuated (passive) devices 2 Delivered dose and particle size dependent on inspiratory flow 2,3 Requires a forceful inhalation 2,3 Minimum coordination required 2 Soft Mist TM Inhaler Active device 4 Slow-moving aerosol cloud vs pmdis 5 Requires a slow inhalation 2 Improved coordination vs pmdis 4-6 No propellants Patient factors which may affect inhaler technique and adherence: 3 Age Dexterity Inspiratory capacity (ease of inhalation) Cognitive ability Health literacy Ease of use Patient preferences Patient perceptions It s important that prescribers match inhaler devices to individual patient needs 1-3 References: 1. Laube B et al. Eur Respir J 2011; 37: Newman S. Eur Respir Rev 2005; 14: 96, Newman S and Busse W. Resp Med 2002; 96: Dalby R et al. Int J Pharm 2004; 283: Hochrainer D et al. J Aerosol Med 2005; 18: Hodder R et al. Int J Chron Obstruct Pulmon Dis 2009; 4: References: 1. National Asthma Council Australia. Inhaler technique for people with asthma or COPD. Information paper for health professionals Available from Accessed July Price D et al. World Allergy Org J 2015;8: Hodder R, Price R. Int J COPD 2009;4:

4 WHAT ARE THE ATTRIBUTES OF AN IDEAL INHALER? Multiple doses Easy to use SELECTED ATTRIBUTES OF AN IDEAL INHALER 1,2 Robust Efficient delivery of medication to the lungs THE EFFICACY OF INHALED THERAPIES IS DEPENDENT ON EFFICIENT DRUG DELIVERY TO THE LUNGS 1,2 Accurate and consistent dose delivery Liked by patients REFERENCES: 1. Rau JL. Respir Care 2005; 50: Moroni-Zentgraf P. RDD Europe 2013; 1: REFERENCES: 1. Newman SP. Eur Respir Rev 2005; 14: Vincken W et al. Prim Care Respir J 2010; 19: The EFFICACY of INHALED therapies is DEPENDENT on the EFFICIENT drug DELIVERY to the LUNGS 1,2 Key factors affecting lung deposition include: 3-5 DRUG DELIVERY TO THE LUNGS Lung deposition scintigraphy study in asthma patients comparing Respimat, Turbuhaler and CFC-pMDI 1,2 RESPIMAT Soft Mist Inhaler 51.6% Lung deposition CFC-pMDI 8.9% lung deposition (p<0.001*) Turbuhaler DPI (flow rate 60 L/min) 28.5% lung deposition (p<0.001*) A low aerosol velocity to reduce oropharyngeal deposition 5,6 Long aerosol cloud duration may facilitate coordination of actuation with inhalation 5,6 A high fine particle fraction particles 5.8 µm in diameter are ideal to travel into the lungs 6 Patient factors can the patient use the device correctly? 1 References: 1. Newman SP. Eur Respir Rev 2005; 14: Vincken W et al. Prim Care Respir J 2010; 19: Hochrainer D, et al. J Aerosol Med 2005;18: Scichilone N et al. Pulm Pharmacol Ther 2015; 31: Ganderton D. J Aerosol Med 1999; 12(suppl 1): S3 S8. 6. Dalby RN et al. Med Devices (Auckl) 2011; 4: Adapted from Pitcairn et al and Anderson ,2 *vs Respimat. Lung deposition (% of metered dose ex-valve, mean) measured by gamma scintigraphy. Test drug budesonide (Respimat and Turbuhaler ) or beclomethasone (pmdi). Asthma patients (n=14). CFC, chlorofluorocarbon; pmdi, pressurised metered-dose inhaler; DPI, dry powder inhaler. References: 1. Anderson P. Int J COPD 2006; 1: Pitcairn G et al. J Aerosol Med 2005; 18: Poor inhalation technique and critical errors associated with worsened clinical outcomes Large observational study (n=1664) COPD 52%; asthma 42% MDI: n=843; DPI: n=1113 INHALER TECHNIQUE Inhaler misuse associated with significantly increased risk of* Hospitalisation (OR: 1.47; P=0.001) ER visits (OR: 1.62; P<0.001) Oral corticosteroid use (OR: 1.54; P<0.001) Antimicrobial use (OR: 1.50; P<0.001) *P 0.001; based on logistic regression analysis for the relationship between risk of at least one critical inhaler error and self-report of unscheduled healthcare resource use in the previous year. COPD, chronic obstructive pulmonary disease; DPI, dry powder inhaler; ER, emergency room; MDI, metered dose inhaler; OR, odds ratio 28 Adapted from Melani AS et al. Respir Med. 2011;105:

5 SELECTING A SUITABLE INHALER DEVICE FOR YOUR PATIENTS GOOD COORDINATION OF ACTUATION WITH INSPIRATION POOR COORDINATION OF ACTUATION WITH INSPIRATION Inspiratory flow >30 L/min Inspiratory flow <30 L/min Inspiratory flow >30 L/min Inspiratory flow <30 L/min pmdi Breath-actuated pmdi DPI pmdi pmdi with spacer Breath-actuated pmdi DPI pmdi with spacer Respimat SMI Respimat SMI Respimat SMI Respimat SMI Adapted from Chapman pmdi, pressurised metered-dose inhaler; DPI, dry powder inhaler; SMI, soft mist inhaler. How to train patients to use inhalers properly Watch, don t just ask Don t rely on patients own assessment of their inhaler technique, even for experienced inhaler users. In an Australian study, 75% patients using an inhaler for an average of 2 3 years reported they were using their inhaler correctly but, on objective checking, only 10% showed the correct technique. Show, don t just tell The best way to train patients to use their inhalers correctly is one-to-one training by a healthcare professional (e.g. nurse, pharmacist, GP), that involves both verbal instruction and physical demonstration (using a placebo inhaler if available). Repeat, don t just prescribe or dispense Even after achieving correct technique through training, patients can lose these skills within 2 3 months. Inhaler technique must be rechecked and training must be repeated regularly. Adherence and inhaler technique should be assessed on a regular basis to ensure patients maintain correct device technique. 2,3 National Asthma Council Australia. Inhaler technique for people with asthma or COPD. National Asthma Council Australia, Melbourne, REFERENCES: 1. Chapman KR et al. Eur Respir Rev 2005; 14: Yang I et al, on behalf of Lung Foundation Australia. The COPD-X Plan: Australian and New Zealand Guidelines for the management of Chronic Obstructive Pulmonary Disease. Version 3.02, August Abramson M et al. COPD-X concise guide for primary care. Brisbane. Lung Foundation Australia Version 3.032, August We Can Always Do Better General inhaler principles Ensure that device is current (mdi needs to be primed) Shake mdi, but don t shake DPI and SMI Breathe out away from device Long deep breathe in with head tilted back Breath-hold for 5 seconds Breathe out slowly via nose Close cover after use Rinse mouth after steroid inhalers Refer to inhaler technique for people with asthma or COPD on nationalasthma.org.au Upper Airway Anatomy Pressurised Metered Dose Inhaler +/- Spacer

6 Autohaler Metered Dose Inhaler For DPIs, a rapid and forceful inhalation is needed 1,2 Some patients may not be able to inhale forcefully through DPIs 1-4 Sub-optimal flow through a DPI can result in drug not dispersing throughout the lungs References: 1. National Asthma Council Australia. Inhaler technique for people with asthma or COPD. Information paper for health professionals Available from Accessed June Laube et al. Eur Respir J 2011;37: Price D et al. J Allerg Clin Immunol 2017;5: Usmani OS et al. Respir Res 2018; 19: Haidl P et al. Respir Med 2016; 118: Dalby RN et al. Med Devices (Auck) 2011:4: Wachtel H et al. Pulm Ther 2017;3: Accuhaler dry powder inhaler BREO Ellipta dry powder inhaler 1 Two 30 dose foil blister strips for combination products BREO ELLIPTA dry powder inhaler 3 main steps: 1. Click to open 2. Breathe 3. Close For full device instructions, refer to Breo Ellipta Product Information Sequence of Numbers and Flags in Viewing Window (30 dose): 1. Breo Ellipta Approved Product Information. 1. Breo Ellipta Approved Product Information (Version 3.0). 6

7 Spiromax dry powder inhaler (Duoresp) - Three steps Activate + Breathe + Close Handihaler dry powder inhaler Breezhaler dry powder inhaler Genuair dry powder inhaler Foradile Aerolizer dry powder inhaler RESPIMAT SOFT MIST INHALER A NEW GENERATION INHALER How Respimat Soft Mist Inhaler works 46 7

8 RESPIMAT SOFT MIST INHALER THREE STEPS FOR DAILY USE (T.O.P.) 1 Thunderstorm ASTHMA Melbourne is the global capital WHAT? - Rare potentially catastrophic allergic event whereby aeroallergens (rye and fungal spores) with thunderstorm activity cause acute bronchospasm in susceptible people WHY? - Wet spring allowed lush rye grass growth around northern Melbourne. Thunderstorm lift pollens into charged storm clouds, where the grains absorb moisture and rupture to disperse over 700 particles per grain; strong winds to funnel the pollens into Melbourne dome PERFECT STORM WHEN? - November 1984/ 1987/ 1989/ 2003/ 2010/ 2011/ 2016 in Melbourne. Also documented in UK, USA, Canada, Iran. On : 2000 calls in 5hrs (201 bet 7pm-7.15pm or 1 call every 4.5 seconds), 8500 ED visits and sadly TEN deaths. REFERENCE: 1. Placebo Respimat inhaler package leaflet; instructions for demonstration. Boehringer Ingelheim International. September Thunderstorm ASTHMA Plan and Prepare WHO? - Mean age 36. Mostly male, 90% hayfever + pollen allergy, >50% undiagnosed asthma, >50% overseas-born. Among asthmatics: 1/3 on ICS, >50% without action plan Tended to be allergic to rye grass (serum RAST or skin prick test) HOW? - Critical period between October and December *New State Health Emergency Response that sets out responsibilities of various health & emergency services. *Real- Time Emergency Dept Info Trending System (REDIT) for early recognition of emergency surges in ED, communicating & directing ambulance and health services. *Local hospitals have disaster planning with adequate medical supplies, as well as ensure staff is aware how to manage their asthma. *Medical clinics need to have a disaster plan with local pharmacies to have reasonable stock of bronchodilators, steroids and adrenaline. *Potential patients reminded to be compliant on Preventive Inhalers or Anti-Histamines; ALWAYS carry Reliever Inhalers; stay indoors on very high to extreme pollen count days; aware of daily forecast pollen counts available ( remember rule of 4 in emergency (1 puff in spacer + 4 breaths, every 4 mins till help arrives); review asthma action plan. SUMMARY Summary Uncontrolled asthma remains a problem in the community Asthma control can be achieved with stepwise approach, with ICS as corner-stone of treatment (whilst LAMA + LABA is the corner-stone of treatment for COPD) Key considerations in asthma control Each patient is different Each patient s asthma is different Choice of appropriate Drug and Dose is dependent on Doctor Choice of Inhaler device is largely dependent on Patient Personalise the choice of inhaler and provide education about the correct way of use : WATCH + SHOW + REPEAT Well controlled asthma can be achieved if appropriately managed 1. Bleecker ER et al. J Allergy Clin Immunol Prac 2014: 5: Breo Ellipta Product Information 8

9 ASSESSING INHALER TECHNIQUE 1 Up to 90% of asthma and COPD patients incorrectly use their inhaler device 2,3 check adherence and inhaler technique ideally at each visit 4 Diagnosis is not the end, but the beginning of medical practice 1 Patient demonstrates inhaler technique 2 Demonstrate correct technique highlighting steps that need correction 3 Patient re-demonstrates inhaler technique repeat until all steps performed correctly ~ Dr Martin H. Fischer ( ) References: 1. National Asthma Council. Australian Asthma Handbook, Lavorini F et al. Respir Med 2008; 102: Melani AS et al. Respir Med 2011; 105: Abramson M et al. COPD-X concise guide for primary care. Brisbane: Lung Foundation Australia, THANK YOU 560 9