John Haughney

Choosing inhaler devices for people with asthma: Current knowledge and outstanding research needs

Recommendations in asthma guidelines presuppose that practitioners have the evidence, information, knowledge, and tools to select inhaler devices appropriate for individual patients. Randomised controlled trials usually exclude patients with suboptimal inhaler technique. There is therefore little evidence on which to base inhaler selection in the real world, where patients often use their inhalers incorrectly. The lung deposition of inhaled drug varies according to inhaler device, drug particle size, inhalation technique, and pattern of inspiratory flow. Even with training, not all patients can use their inhalers correctly and maintain inhaler technique; patients may have inability to handle the inhaler, strong negative preferences, or natural breathing patterns that do not match their prescribed inhaler. Therefore, matching device to the patient may be a better course of action than increasing therapy or training and retraining a patient to use a specific inhaler device. Several research questions require answers to meet the goal of helping prescribers make a more informed choice of inhaler type. Is the level of drug deposition in the lungs a key determinant of clinical short- and long-term outcomes? What should be measured by a clinical tool designed to check inhaler technique and therefore help with device selection? If we have a tool to help in individualising inhaler choice, will we achieve better asthma outcomes? Do we have to refine inhaler device choice for each individual, or will we get better outcomes if we select our current best option in light of current knowledge and apply this on a population level?

The value of self-report assessment of adherence, rhinitis and smoking in relation to asthma control

AIMS To explore the utility of self-report measures of inhaled corticosteroid (ICS) adherence, degree of rhinitis and smoking status and their association with asthma control. METHODS Patients prescribed ICS for asthma at 85 UK practices were sent validated questionnaire measures of control (Asthma Control Questionnaire; ACQ) and adherence (Medication Adherence Report Scale), a two-item measure of smoking status, and a single-item measure of rhinitis. RESULTS Complete anonymised questionnaires were available for 3916 participants. Poor asthma control (ACQ >1.5) was associated with reported rhinitis (OR = 4.62; 95% CI: 3.71-5.77), smoking (OR = 4.33; 95% CI: 3.58-5.23) and low adherence to ICS (OR = 1.35; 95% CI: 1.18-1.55). The degree of rhinitis was important, with those reporting severe rhinitis exhibiting the worst asthma control, followed by those reporting mild rhinitis and then those reporting no rhinitis symptoms (F(2, 3913)=128.7, p<.001). There was a relationship between the number of cigarettes smoked each day and asthma control (F(5,655)=6.08, p<.001). CONCLUSIONS Poor asthma control is associated with self-reported rhinitis, smoking and low medication adherence. These potentially modifiable predictors of poor asthma control can be identified through a brief self-report questionnaire, used routinely as part of an asthma review.

The Brussels Declaration: the need for change in asthma management

Asthma is a highly prevalent condition across Europe and numerous guidelines have been developed to optimise management. However, asthma can be neither cured nor prevented, treatment choices are limited and many patients have poorly controlled or uncontrolled asthma. The Brussels Declaration on Asthma, sponsored by The Asthma, Allergy and Inflammation Research Charity, was developed to call attention to the shortfalls in asthma management and to urge European policy makers to recognise that asthma is a public health problem that should be a political priority. The Declaration urges recognition and action on the following points: the systemic inflammatory component of asthma should be better understood and considered in assessments of treatment efficacy; current research must be communicated and responded to quickly; the European Medicines Agency guidance note on asthma should be updated; “real world” studies should be funded and results used to inform guidelines; variations in care across Europe should be addressed; people with asthma should participate in their own care; the impact of environmental factors should be understood; and targets should be set for improvement. The present paper reviews the evidence supporting the need for change in asthma management and summarises the ten key points contained in the Brussels Declaration.

Inhaler devices for asthma: a call for action in a neglected field

The Brussels Declaration, published in the European Respiratory Journal in 2008 1, recognises the high prevalence of patients with poorly controlled asthma and calls for changes in asthma management across Europe. Prescribing an appropriate inhaler device for asthma, a device that the patient accepts and can handle correctly, is one key element in this process. Inhaler mishandling is very common in real-world clinical practice and can contribute to poor asthma control 2–5. The International Primary Care Respiratory Group (IPCRG) is committed to identifying reasons for poor asthma control and to promoting interventions to help patients achieve asthma control 6–9. An international panel of healthcare providers (HCPs), academics and a patient representative was convened under the auspices of IPCRG to discuss and challenge the science behind inhaler therapy, and to propose practical solutions to real-life problems related to inhaler choice and mishandling. The focus was on the problems confronting clinicians in prescribing a suitable inhaler for each individual and those confronting patients in using their inhalers. Until recently, inhaler therapy and devices have been marginal topics of clinical investigation and research in the field of asthma, mainly confined to a limited circle of experts, and lacking evidence for practical application. Thus, we propose this call for action, given: 1) the importance of inhaler technique for effective inhaled therapy; 2) the critical gaps in knowledge that need still to be addressed; and 3) the lack of solid evidence supporting HCPs in making clinical decisions regarding inhalers for asthma treatment. Correct inhaler technique is fundamental for effective inhaled therapy. Errors in inhaler technique are very common 10–13 and can impact drug delivery to the lungs, thereby compromising bronchodilation in the short term and asthma control in the long term, depending on the drug considered …

Current Control and Future Risk in Asthma Management

Despite international and national guidelines, poor asthma control remains an issue. Asthma exacerbations are costly to both the individual, and the healthcare provider. Improvements in our understanding of the therapeutic benefit of asthma therapies suggest that, in general, while long-acting bronchodilator therapy improves asthma symptoms, the anti-inflammatory activity of inhaled corticosteroids reduces acute asthma exacerbations. Studies have explored factors which could be predictive of exacerbations. A history of previous exacerbations, poor asthma control, poor inhaler technique, a history of lower respiratory tract infections, poor adherence to medication, the presence of allergic rhinitis, gastro-oesophageal reflux disease, psychological dysfunction, smoking and obesity have all been implicated as having a predictive role in the future risk of asthma exacerbation. Here we review the current literature and discuss this in the context of primary care management of asthma.

The distribution of COPD in UK general practice using the new GOLD classification

The new Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011 document recommends a combined assessment of chronic obstructive pulmonary disease (COPD) based on current symptoms and future risk. A large database of primary-care COPD patients across the UK was used to determine COPD distribution and characteristics according to the new GOLD classification. 80 general practices provided patients with a Read code diagnosis of COPD. Electronic and hand searches of patient medical records were undertaken, optimising data capture. Data for 9219 COPD patients were collected. For the 6283 patients with both forced expiratory volume in 1 s (FEV1) and modified Medical Research Council scores (mean±sd age 69.2±10.6 years, body mass index 27.3±6.2 kg·m−2), GOLD 2011 group distributions were: A (low risk and fewer symptoms) 36.1%, B (low risk and more symptoms) 19.1%, C (high risk and fewer symptoms) 19.6% and D (high risk and more symptoms) 25.3%. This is in contrast with GOLD 2007 stage classification: I (mild) 17.1%, II (moderate) 52.2%, III (severe) 25.5% and IV (very severe) 5.2%. 20% of patients with FEV1 ≥50% predicted had more than two exacerbations in the previous 12 months. 70% of patients with FEV1 <50% pred had fewer than two exacerbations in the previous 12 months. This database, representative of UK primary-care COPD patients, identified greater proportions of patients in the mildest and most severe categories upon comparing 2011 versus 2007 GOLD classifications. Discordance between airflow limitation severity and exacerbation risk was observed. GOLD 2011 COPD classification criteria identified more patients in the mildest and more severe groups than GOLD 2007 http://ow.ly/t4uiO

Effectiveness of same versus mixed asthma inhaler devices: a retrospective observational study in primary care.

Purpose Correct use of inhaler devices is fundamental to effective asthma management but represents an important challenge for patients. The correct inhalation manoeuvre differs markedly for different inhaler types. The objective of this study was to compare outcomes for patients prescribed the same inhaler device versus mixed device types for asthma controller and reliever therapy. Methods This retrospective observational study identified patients with asthma (ages 4-80 years) in a large primary care database who were prescribed an inhaled corticosteroid (ICS) for the first time. We compared outcomes for patients prescribed the same breath-actuated inhaler (BAI) for ICS controller and salbutamol reliever versus mixed devices (BAI for controller and pressurised metered-dose inhaler [pMDI] for reliever). The 2-year study included 1 baseline year before the ICS prescription (to identify and correct for confounding factors) and 1 outcome year. Endpoints were asthma control (defined as no hospital attendance for asthma, oral corticosteroids, or antibiotics for lower respiratory tract infection) and severe exacerbations (hospitalisation or oral corticosteroids for asthma). Results Patients prescribed the same device (n=3,428) were significantly more likely to achieve asthma control (adjusted odds ratio, 1.15; 95% confidence interval [CI], 1.02-1.28) and recorded significantly lower severe exacerbation rates (adjusted rate ratio, 0.79; 95% CI, 0.68-0.93) than those prescribed mixed devices (n=5,452). Conclusions These findings suggest that, when possible, the same device should be prescribed for both ICS and reliever therapy when patients are initiating ICS.

Inhaler Errors in the CRITIKAL Study: Type, Frequency, and Association with Asthma Outcomes

BACKGROUND Poor inhaler technique has been linked to poor asthma outcomes. Training can reduce the number of inhaler errors, but it is unknown which errors have the greatest impact on asthma outcomes. OBJECTIVE The CRITical Inhaler mistaKes and Asthma controL study investigated the association between specific inhaler errors and asthma outcomes. METHODS This analysis used data from the iHARP asthma review service-a multicenter cross-sectional study of adults with asthma. The review took place between 2011 and 2014 and captured data from more than 5000 patients on demographic characteristics, asthma symptoms, and inhaler errors observed by purposefully trained health care professionals. People with asthma receiving a fixed-dose combination treatment with inhaled corticosteroids and long-acting beta agonist were categorized by the controller inhaler device they used-dry-powder inhalers or metered-dose inhalers: inhaler errors were analyzed within device cohorts. Error frequency, asthma symptom control, and exacerbation rate were analyzed to identify critical errors. RESULTS This report contains data from 3660 patients. Insufficient inspiratory effort was common (made by 32%-38% of dry-powder inhaler users) and was associated with uncontrolled asthma (adjusted odds ratios [95% CI], 1.30 [1.08-1.57] and 1.56 [1.17-2.07] in those using Turbohaler and Diskus devices, respectively) and increased exacerbation rate. In metered-dose inhaler users, actuation before inhalation (24.9% of patients) was associated with uncontrolled asthma (1.55 [1.11-2.16]). Several more generic and device-specific errors were also identified as critical. CONCLUSIONS Specific inhaler errors have been identified as critical errors, evidenced by frequency and association with asthma outcomes. Asthma management should target inhaler training to reduce key critical errors.

Characteristics of patients making serious inhaler errors with a dry powder inhaler and association with asthma-related events in a primary care setting

Abstract Objective: Correct inhaler technique is central to effective delivery of asthma therapy. The study aim was to identify factors associated with serious inhaler technique errors and their prevalence among primary care patients with asthma using the Diskus dry powder inhaler (DPI). Methods: This was a historical, multinational, cross-sectional study (2011–2013) using the iHARP database, an international initiative that includes patient- and healthcare provider-reported questionnaires from eight countries. Patients with asthma were observed for serious inhaler errors by trained healthcare providers as predefined by the iHARP steering committee. Multivariable logistic regression, stepwise reduced, was used to identify clinical characteristics and asthma-related outcomes associated with ≥1 serious errors. Results: Of 3681 patients with asthma, 623 (17%) were using a Diskus (mean [SD] age, 51 [14]; 61% women). A total of 341 (55%) patients made ≥1 serious errors. The most common errors were the failure to exhale before inhalation, insufficient breath-hold at the end of inhalation, and inhalation that was not forceful from the start. Factors significantly associated with ≥1 serious errors included asthma-related hospitalization the previous year (odds ratio [OR] 2.07; 95% confidence interval [CI], 1.26–3.40); obesity (OR 1.75; 1.17–2.63); poor asthma control the previous 4 weeks (OR 1.57; 1.04–2.36); female sex (OR 1.51; 1.08–2.10); and no inhaler technique review during the previous year (OR 1.45; 1.04–2.02). Conclusions: Patients with evidence of poor asthma control should be targeted for a review of their inhaler technique even when using a device thought to have a low error rate.

Clinical and cost effectiveness of switching asthma patients from fluticasone-salmeterol to extra-fine particle beclometasone-formoterol: a retrospective matched observational study of real-world patients

Background: Efficacy trials suggest that extra-fine particle beclometasone dipropionate-formoterol (efBDP-FOR) is comparable to fluticasone propionate-salmeterol (FP-SAL) in preventing asthma exacerbations at a clinically equivalent dosage. However, switching from FP-SAL to efBDP-FOR has not been evaluated in real-world asthma patients. Aims: The REACH (Real-world Effectiveness in Asthma therapy of Combination inHalers) study investigated the clinical and cost effectiveness of switching typical asthma patients from FP-SAL to efBDP-FOR. Methods: A retrospective matched (1:3) observational study of 1,528 asthma patients aged 18–80 years from clinical practice databases was performed. Patients remaining on FP-SAL (n=1,146) were compared with those switched to efBDP-FOR at an equivalent or lower inhaled corticosteroid (ICS) dosage (n=382). Clinical and economic outcomes were compared between groups for the year before and after the switch. Non-inferiority (at least equivalence) of efBDP-FOR was tested against FP-SAL by comparing exacerbation rates during the outcome year. Results: efBDP-FOR was non-inferior to FP-SAL (adjusted exacerbation rate ratio 1.01 (95% CI 0.74 to 1.37)). Switching to efBDP-FOR resulted in significantly better (p<0.05) odds of achieving overall asthma control (no asthma-related hospitalisations, bronchial infections, or acute oral steroids; salbutamol ≤200μg/day) and lower daily short-acting β2-agonist usage at a lower daily ICS dosage (mean −130μg/day FP equivalents; p<0.001). It also reduced mean asthma-related healthcare costs by £93.63/patient/year (p<0.001). Conclusions: Asthma patients may be switched from FP-SAL to efBDP-FOR at an equivalent or lower ICS dosage with no reduction in clinical effectiveness but a significant reduction in cost.