The Aerosol Drug Management Improvement Team ADMIT Slide Deck 2018

Part 2 Performance of inhalers in real life Clinical outcomes related to inhalers and technique Mark Levy

Misuse of corticosteroid pMDI is associated with decreased asthma stability AIS = Asthma Instability Score Giraud, European respiratory Journal. 2002;19(2):246-51

Misuse of corticosteroid pMDI is associated with decreased asthma stability AIS = Asthma Instability Score Giraud, European respiratory Journal. 2002;19(2):246-51

Inhaler mishandling associated with reduced disease control Cross sectional observational study N=1664; > 14yr, mean age 62 yr; July–Sep 2008 Outpatient Chest Clinic - Asthma (42%); COPD (52%) Regular inhaler users (daily for > 1mth, last 3 mths) 843 pMDIs 1113 DPIs (Aerolizer, Diskus, Handihaler, Turbohaler) 2 consecutive eligible patients recruited / clinic Outcomes: Inhaler technique (single trained investigator / center) Asthma control (ACT), COPD mMRC, Unscheduled attendances & Admissions, A/biotics, systemic corticosteroids Melani (GENEBI) Resp Med 2011;105:930-938

Exhale before inhalation 50 Inhaler mishandling associated with reduced disease controlInhaler mishandling associated with reduced disease control – pMDI Technique pMDI Remove cap 0.2 Shake inhaler 37 Exhale before inhalation 50 Not holding upright 9 Forceful inhalation 52 Actuate against teeth lips or tongue 0.7 Press only once per inhalation 19 Actuation in 2nd half inspiration 18 Activation after end of inhalation 5 Stopping inhalation immediately after actuation 10 Inhalation through nose while & after actuation 2 No or short breath hold (2-3 seconds) 53 Critical errors Melani (GENEBI) Resp Med 2011;105:930-938

Aerolizer/Handihaler Inhaler mishandling associated with reduced disease control - DPI Technique Aerolizer/Handihaler Diskus Turbohaler Failure of Priming Remove cap/ turn cover 0.65 Insert Capsule /Pierce Capsule 12 Failure of loading Load dose 7 14 Hold inhaler upright (< 450) 23 Exhaling into mouthpiece before actuation 19 22 Stopping inhaling prematurely 26 29 Inhaling through nose while using device 2 1 Not sealing lips round mouthpiece 5 4 Slow and not forceful inhalation 24 28 Exhale into Mouthpiece after inhalation 21 11 No Breath holding after inhalation 25 32 Doesn't check capsule empty after inhalation 30 Critical errors Melani (GENEBI) Resp Med 2011;105:930-938

Diskus and Handihaler performed better than Turbohaler Inhaler mishandling associated with reduced disease control Results: 2288 observations of inhaler technique 4% pMDI users had spacers At least one critical error in: MDI (12%), Diskus (35%), Handihaler (35%), Turbohaler (44%) OR increased risk of critical errors compared with pMDI: Diskus (3.4), Handihaler (3.1), Turbohaler (6) Diskus and Handihaler performed better than Turbohaler Melani (GENEBI) Resp Med 2011;105:930-938

Inhaler mishandling associated with reduced disease control Results: Risks of making errors: Single inhaler (NS), Little perceived benefit (1.4) Gender (NS) Low ACT Score risk of critical error (1.53; p<0.0001) Critical errors in inhaler technique: Increased risk of Hospital admissions (1.47, p<0.001) ER Visits (1.62, p<0.001) Use of antibiotics (1.50, p<0.001) Systemic steroids (1.54, p<0.001) Those who had > 1 inhaler check had lower risk of critical errors Melani (GENEBI) Resp Med 2011;105:930-938

Fist Test (n=2483) Second Test (n=2458) Third Test (n=1129) criteria Results of the first (before training), and second and third Vitalograph Aerosol Inhalation Monitor (AIM) tests after training Fist Test (n=2483) Second Test (n=2458) Third Test (n=1129) Failed in at least one criterion (%) 1437 (58%) 1282 (52%) 421 (38%) criteria Flow 40% 34% 31% Synchronisation 58% 53% 42% Breath holding 22% 18% Single inhaler (NS) Little perceived benefit (1.4) Gender (NS) Levy et al, Prim Care Resp J. 2013;22(4):406-11

pMDI Techique AIM 1st Test pMDI technique using the Vitalograph Aerosol Inhalation Monitor (AIM) and GINA Control pMDI Techique AIM 1st Test Gina Control Fail Pass Total Controlled 476 (41%) 697 (59%) 1173 Partly Controlled 634 (71%) 263 (29%) 897 Uncontrolled 325 (79%) 85 (21%) 410 1435 1045 2480 Single inhaler (NS) Little perceived benefit (1.4) Gender (NS) Levy et al, Prim Care Resp J. 2013;22(4):406-11

Patient preference and ability? Role of clinician in selecting teaching and monitoring patients technique Patient preference and ability? N=50 (29 asthma, 21 COPD) Diskus (Accuhaler) and Turbohaler handling Mean age 49 40 previous instruction (1-7yrs ago) Rotahaler, Diskhaler, pMDI, Inhaler Ingelheim Shown inhaler & read leaflet → tested Van der Palen, Journ Asthma 1998;35(2):147-152

Patient preference and ability? Diskus/Accuhaler Checklist (essential) Turbohaler Checklist (essential) Open inhaler (100%) Remove cap from Inhaler (100%) Push lever back completely (92%) Keep inhaler upright (88%) Exhale to residual volume Rotate grip until click (86%) Exhale away from mouthpiece Mouthpiece between teeth and lips Inhale forcefully and deeply (100%) Hold breath for 5 sec Close Inhaler Replace cap Single inhaler (NS) Little perceived benefit (1.4) Gender (NS) Van der Palen, Journ Asthma 1998;35(2):147-152

Patient preference and ability? Loading DA 97.3%; TH 93.5% (p<0.05; 0.09-7.58) Patients performing all items correctly DA 50% ; TH 46% (NS) Patients performing all essential items correctly DA 92%; TH 74% (p=0.023) Patient preference DA 34% ; TH 50% ; None 16% Van der Palen, Journ Asthma 1998;35(2):147-152

35 controls; 34 inhaler technique – verbal, leaflet & movie The Effects of Training on Inhaler Technique and Quality Of Life in Patients with COPD Randomised OPD, COPD 35 controls; 34 inhaler technique – verbal, leaflet & movie Patients performing all items correctly 3 mth follow up Intervention Control Used correctly 82% 0% Attacks, emergency attendances and hospitalisations 6%, 3%, 3% 46% , 20%, 11% Quality of Life Improved SGRQ effect, symptoms & activity Fewest mistakes were made with Diskus/Accuhaler followed by Aerolizer and Turbohaler Goris, J Aer Med &Pulm Drug Del: DOI: 10.1089/jamp 2012.1017

RCT - two strategies hospitalized patients with asthma or COPD (n=50) Teaching the use of respiratory inhalers to hospitalized patients with asthma or COPD: a randomized trial RCT - two strategies hospitalized patients with asthma or COPD (n=50) Brief intervention [BI]: single-set of verbal and written step-by-step instructions, or Teach-to-goal [TTG]: BI + repeated demonstrations of inhaler use and participant comprehension assessments (teach-back) Outcomes: Primary: pMDI misuse post-intervention (<75% steps correct). Secondary: Diskus/Accuhaler misuse, self-reported inhaler technique confidence and prevalence of 30-day health-related events. Press, Jnl of Gen Int Med 2012;27(10):1317-25

Teach to Goal (TTG) educational strategy Repeated rounds of assessment and education 12/12 steps correct for pMDI 10/10 steps correct for Diskus/Accuhaler TTG (repeated up to 2X) Trained blinded Research Assistants to evaluate participants’ baseline inhaler technique. Trained research educator - Demonstration & reassessment of participants’ technique (i.e. “teach-back”) Written instructions and a pamphlet about asthma/COPD) RA performed a final assessment of participants’ technique Press, Jnl of Gen Int Med 2012;27(10):1317-25

Patient confidence in their technique: Teaching the use of respiratory inhalers to hospitalized patients with asthma or COPD: a randomized trial Patient confidence in their technique: Of the 72% who were confident in their MDI technique, more than two-thirds (69%) used their MDIs incorrectly. Almost all participants (94%) were confident in their Diskus/Accuhaler technique. Among these participants, three-quarters (76%) used their device incorrectly. Press, Jnl of Gen Int Med 2012;27(10):1317-25

pMDI Diskus/Accuhaler Teaching the use of respiratory inhalers to hospitalized patients with asthma or COPD: a randomized trial Percentage of patients demonstrating incorrect use of inhaler (MDI) before and after either a brief intervention (BI) or TTG intervention pMDI Diskus/Accuhaler Press, Jnl of Gen Int Med 2012;27(10):1317-25

It is worth teaching inhaler technique while in hospital? Teaching the use of respiratory inhalers to hospitalized patients with asthma or COPD: a randomized trial TTG took 3X longer than BI Secondary Outcomes: Participants with 30-day acute health-related events were less common in the group receiving TTG vs. BI (1 vs. 8, p=0.02) There were 6 participants with ED visits and/or hospitalizations (BI n=5, TTG n=1) 3 separate participants who died (BI n=3, TTG =0) prior to 30 days post-discharge It is worth teaching inhaler technique while in hospital? Press, Jnl of Gen Int Med 2012;27(10):1317-25

Repeated instruction: inhaler technique in asthma Cross-sectional questionnaire study Understanding factors - patient-related aspects of adherence to inhalation therapy 176 (146) consecutive adults (>16 yr) - Physician diagnosed asthma (GINA) Regular clinic attendees (every 3 mo) Inhaled treatment >12 months No change in medication 3 months Journal of Asthma, 47:202–208, 2010

No change in medication 3 months Modified Adherence Questionnaire In the last 3 months have you: Been careless about using your inhaler? Ever forgotten to use your inhaler? Ever stopped using your inhaler because you felt better? Used your inhaler less than your doctor prescribed because you felt better? Most of the time Some of the time None of the time 1 2 3 4 5 No change in medication 3 months Journal of Asthma, 47:202–208, 2010

Repeated instruction: inhaler technique in asthma Journal of Asthma, 47:202–208, 2010

Repeated instruction: inhaler technique in asthma Journal of Asthma, 47:202–208, 2010

Repeated instruction: inhaler technique in asthma Journal of Asthma, 47:202–208, 2010

Repeated instruction: inhaler technique in COPD Cross-sectional questionnaire study Understanding factors – patient -related aspects of adherence to inhalation therapy 88 (55) consecutive adults; >10 pack yr; respiratory physician diagnosed COPD (confirmed – GOLD) Regular clinic attenders (every 3 months) Inhaled treatment >12 months No change in medication 3 months International Journal of COPD 2011:6 97–104

Good adherence: mean score was ≥4.0; non-adherence <4 Modified Adherence Questionnaire In the last 3 months have you: Been careless about using your inhaler? Ever forgotten to use your inhaler? Ever stopped using your inhaler because you felt better? Used your inhaler less than your doctor prescribed because you felt better? Most of the time Some of the time None of the time 1 2 3 4 5 Good adherence: mean score was ≥4.0; non-adherence <4 Journal of Asthma, 47:202–208, 2010

Repeated instruction: inhaler technique in COPD International Journal of COPD 2011:6 97–104

Repeated instruction: inhaler technique (Takemura et al) Asthma COPD 25/146 (17% ) had repeated instruction 21/55 had repeated instruction (specific devices, verbal and demonstration) Better adherence scores (4.4 vs 3.9 p = .0016) (4.4 vs 3.9; p=0.032) Less exacerbations (r = −0.19, p =0.021) Better SGRQ Scores (33.7 vs 44.9 p=0.03) Fewer ER visits (r=−0.19, p =0.042) Better SGRQ scores (Total: r = −0.22, p =0.024) Takemura, International Journal of COPD 2011:6 97–104 Takemura, Journal of Asthma, 47:202–208, 2010