Achieving compliance in asthma management

Up to three million asthma patients take their medication using a metered dose inhaler. The drive to reduce the world-wide use of chlorofluorocarbons (CFCs) has resulted in the development of CFC-free metered dose inhalers. Nurses have an important part to play in managing the transition to CFC-free inhaler devices. This will provide an opportunity to improve levels of compliance with treatment and reduce asthma-induced morbidity and mortality     

Extrafine beclomethasone dipropionate breath-actuated inhaler (400 micrograms/day) versus budesonide dry powder inhaler (800 micrograms/day) in asthma

Hydrofluoroalkane-134a beclomethasone dipropionate extrafine aerosol breath-actuated inhaler (Qvar Autohaler; BDP-AH) provides an alternative to chlorofluorocarbon metered dose inhalers or dry powder inhalers (DPIs). The aim of this six-week, open-label study was to determine whether BDP-AH demonstrates equivalent asthma control to twice the dose of budesonide (BUD)-DPI (Pulmicort Turbuhaler). Adults with symptomatic asthma inadequately controlled on BUD-DPI 400 micrograms/day and beta-agonist were enrolled. Patients (n = 193) were randomised to receive 400 micrograms/day BDP-AH (n = 98) (two puffs of 100 micrograms/actuation inhaler twice daily) or 800 micrograms/day BUD-DPI (n = 95) (two puffs of 200 micrograms/actuation inhaler twice daily). Both groups showed a statistically significant change from baseline in morning (a.m.) peak expiratory flow (PEF) at weeks 5-6 (p < 0.01), indicating study treatment improved a.m. PEF over prestudy 400 micrograms/day BUD. Changes from baseline in a.m. PEF at weeks 5-6 were 15.9 l/min for BDP-AH and 14.2 l/min for BUD-DPI; the groups were statistically equivalent (90% CI -7.02-10.44; p < -0.001 [equivalence = within +/- 25 l/min]). Other efficacy assessments (evening PEF, FEV1, asthma symptoms, beta-agonist use) confirmed the treatments were clinically equivalent. Thirty-nine (40%) patients on BDP-AH and 35 (37%) on BUD-DPI experienced at least one adverse event (p = 0.767). Four (4%) patients on BDP-AH and 3 (3%) on BUD-DPI reported increased asthma symptoms. BDP-AH at half the daily dose provided equivalent asthma control to BUD-DPI; both treatments were well tolerated.     

Similar efficacy following four weeks treatment of asthmatics with formoterol 12 micrograms b.d. delivered by two different dry powder inhalers: differences in inhaler handling

This randomised, multicentre, parallel-group study compared the clinical efficacy and ease of handling of two dry powder inhalers delivering the long-acting beta 2-agonist formoterol. After run-in, 200 asthmatics on treatment with inhaled corticosteroids and still presenting with suboptimal asthma control were randomised to receive 12 micrograms formoterol twice daily via either the Aerolizer inhaler (Foradil Aerolizer) or the Turbuhaler inhaler (Oxis Turbuhaler) for four weeks. Study variables included the mean morning pre-medication peak expiratory flow (PEF) during the last seven days of treatment and the correct inhaler handling according to inhaler-specific checklists. The mean difference in the effect on morning pre-medication PEF was 13.86 l/min in favour of formoterol via the Aerolizer inhaler (90% confidence interval 2.50, 25.21) in the intent-to-treat population. Eighty-six per cent of the patients under treatment with formoterol via the Turbuhaler inhaler performed correctly all the essential inhalation manoeuvres, whereas 98% of those on the Aerolizer inhaler did so. These results strongly suggest similar clinical efficacy with twice daily treatment of formoterol 12 micrograms metered dose delivered either by the Aerolizer, or the Turbuhaler device. They also suggest that handling the Aerolizer is easier than that of the Turbuhaler.     

Real-life use of inhaler devices for chronic obstructive pulmonary disease in primary care

The correct use of inhalation devices is an inclusion criterion in many comparative studies. However, patients can make errors, thus compromising the effectiveness of their own inhaler. The aim of the study is to evaluate inhaler use by patients with chronic obstructive pulmonary disease (COPD) [n = 984]. General practitioners assessed inhalation technique, using a specific checklist previously established for each inhaler model (Aerolizer, Autohaler, Diskus, a pressurised metered-dose inhaler (pMDI) or a Turbuhaler). A total of 24% of the patients using a pMDI did not make an error compared with 34-40% of those using breath-actuated devices. The frequency of critical errors varied according to the device: 11.5-14.9% of the subjects using an Aerolizer, Autohaler or Diskus versus 37.4% and 38.1% of the patients using a pMDI and a Turbuhaler, respectively. The proper use of the Turbuhaler is often overestimated (24.7%) compared with the pMDI (2.1%). The development of educational programmes for patients and prescribers is needed to improve the management of COPD.     

The ability of A&E personnel to demonstrate inhaler technique.

OBJECTIVE: To determine the ability of accident and emergency (A&E) personnel to demonstrate metered dose inhaler technique. METHODS: 25 senior house officers and 25 nurses working in A&E were individually interviewed and assessed on their knowledge of inhaler technique and competence in demonstrating the correct use of a metered dose inhaler. RESULTS: Demonstration of inhaler technique was generally poor by the staff assessed. Although 22 (88%) of the senior house officers were aware of the British Thoracic Society guidelines, only 10 (40%) routinely checked inhaler technique when discharging asthmatic patients. CONCLUSIONS: The A&E department offers an important opportunity for patient assessment and reinforcement of metered dose inhaler technique. Staff should be made aware of the British Thoracic Society guidelines and be competent at assessing and teaching inhaler technique.     

Assessment of hospice nurses' technique in the use of inhalers and nebulizers

Dyspnea, a common distressing end-of-life symptom, is treated with oral (i.e., opioids and anxiolytics) and inhaled medications (anti-inflammatory and bronchodilator agents). Health care providers and patients have demonstrated an inability to use inhaler devices correctly, which can lead to suboptimal drug delivery and poor symptom relief. Hospice nurses are the primary health care providers educating patients, making it critical that they convey accurate device technique. This study assessed hospice nurses' ability to demonstrate proper inhaler device technique and their knowledge of agents used to treat dyspnea. Forty-seven nurses participated. Participants completed a written questionnaire, which gathered demographic data, as well as information regarding previous training with an inhaler device, administration, pharmacokinetics, mechanism of action, patient assessment, and nursing technique. Additionally, each nurse demonstrated the use of a metered dose inhaler, spacer, dry powder inhaler, and a nebulizer, while being observed by a pharmacist trained in the use of inhalers. A standardized evaluation form was used to ensure consistency between evaluators and subjects. Percentage of steps completed correctly by the study participants ranged from 34.9% with the dry powder inhaler to 67.6% with the metered dose inhaler. Years of experience, presence of hospice certification, personal use of inhaler, and nursing comfort level significantly impacted ability to use inhalation devices. This study demonstrated the existence of knowledge gaps regarding patient assessment, pharmacology and pharmacokinetics of inhaled medications, and inhalation device technique among hospice nurses. Formal education of hospice practitioners regarding inhaled medications and inhalation delivery devices is needed.     

An evaluation of MDI (metered dose inhaler) spacers and adapters: their effect on the respirable volume of medication

The use of a metered dose inhaler (MDI) with an adapter or spacer designed to deliver medication to ventilated patients has been found to produce effects similar to those achieved with small volume nebulizers. For 9 commonly used MDI adapters or spacers, we measured and compared their production of available respirable volume (ARV) of medication. A simulated ventilator circuit was configured to determine ARV as measured by a laser particle-size counter. The adapters or spacers were grouped in three categories: chamber, in-line, and elbow styles. The devices were actuated into the circuit, and ARV was measured 36 separate times with various combinations of medication and medication canister. We found significant differences in ARV between devices, device categories, and medications as compared by ANOVA testing. In this study, chamber-style MDI devices produced greater respirable volume than the in-line- or the elbow-style devices. Of the chamber-style devices, the cone-shaped chamber device provided more respirable volume than did the other two chamber devices. We also found differences among the medications, although we did not anticipate such differences. The possible factors to explain medication differences were not investigated in this study. Because ARV differs according to the design of the individual device used, the choice of device may alter the respirable volume of the medication delivered and, therefore, the effectiveness of the prescribed medication. We conclude that to achieve the desired effects of the medication, practitioners may need to customize the number of MDI actuations according to the device in use.     

Choosing the right inhaler for patients with asthma

This article assesses the suitability of inhaler devices for patients with asthma according to their individual needs. Three main types of inhalers are discussed: pressurised metered dose inhalers, breath-actuated inhalers and dry powder inhalers. The advantages and disadvantages of these devices are discussed in relation to lifestyle, ability and suitability for individuals.     

Inhaler devices: compliance with steroid therapy

Many people with asthma do not take their medication as prescribed. The use of inhaler devices is an important factor in patient compliance with steroid therapy. Some of the features that influence compliance are discussed and the characteristics of inhaler devices are compared.     

Effects of mometasone furoate given once daily in the evening on lung function and symptom control in persistent asthma

BACKGROUND: The chronobiology of asthma suggests that, for once-daily dosing, an evening dose may be the most effective treatment paradigm. OBJECTIVE: To evaluate the efficacy and safety of mometasone furoate dry powder inhaler (MF-DPI) administered once daily in the evening or twice daily in patients with asthma previously maintained on twice-daily regimens of inhaled corticosteroids. METHODS: In this 12-week, multicenter, placebo-controlled trial, 268 subjects > or =12 years of age with inhaled corticosteroid-dependent asthma and baseline forced expiratory volume in 1 second (FEV(1)) between 50% and 85% of predicted were randomized to receive treatment with MF-DPI 400 mug once daily in the evening, MF-DPI 200 mug twice daily, or placebo. The primary efficacy variable was mean change in FEV(1) from baseline to endpoint. Other lung function measures, asthma symptoms, quality of life, and rescue medication use also were assessed. RESULTS: At endpoint, mean FEV(1) was significantly improved with both MF-DPI doses compared with placebo (p < 0.001). The 2 active treatment groups were statistically indistinguishable from each other. Secondary efficacy variables, including nocturnal awakenings, asthma worsenings, quality of life, and rescue medication use, were also significantly improved for both MF-DPI treatments compared with placebo. Both dosages were well tolerated; no clinically meaningful changes in laboratory values or vital signs were observed. CONCLUSIONS: MF-DPI 400 mug once daily in the evening was as effective as MF-DPI 200 mug twice daily in improving pulmonary function, asthma symptoms, and quality of life compared with placebo in subjects previously using twice-daily regimens of an inhaled corticosteroid.     

Twice or four times daily beclomethasone dipropionate in mild stable asthma?

A double-blind cross-over study lasting 16 weeks was conducted to establish if a twice daily regimen of beclomethasone dipropionate (BDP) was as effective in controlling asthma as a four times daily regimen. The patient's need for inhaled steroids (100 mcg BDP qds) was confirmed prior to entering the study by deterioration of peak expiratory flow rates and/or increased bronchodilator usage during a single-blind placebo period of 6 weeks. Thirty six asthmatics were eligible to enter the study and completed both treatment periods. Daily record cards of symptom scores, four times daily peak expiratory flow rate measurements and inhaled bronchodilator usage were recorded throughout the study. There was no significant difference between the mean PEFR measurements taken four times each day and the variability in PEFR, between the two treatment groups. Symptom scores for cough, wheeze, breathlessness and overall disability also showed no significant difference. Symptomatic inhaler usage for the two groups was similar. Lung function measurements of FEV1, FVC and VC were almost identical; FEV1 being 2.1 l on twice daily regimen and 2.2 l on four times daily regimen. A slight variation was observed in PEFR taken at the end of each treatment period at the clinic visits, being 361 l/min on twice daily and 380 l/min on four times daily drug dosage. In stable asthmatics, the control of asthma measured both symptomatically and by daily lung function was independent of dosing schedule, but twice daily treatment may well lead to better compliance.     

Evaluation of an Auditory Feedback Equipped Metered Dose Inhaler

BACKGROUND: Although metered dose inhalers are one of the most frequently prescribed drug delivery systems for pulmonary disease, patients usually do not employ ideal technique when using these systems. We studied the effect of a new teaching device, the MDI Tutor (MDI Tutor Inc., Palatine, IL), on patients with unsatisfactory inhalation technique. METHODS: Twelve patients with an average of 10 years' experience with metered dose inhalers (mean age, 41 years) were evaluated by two observers. All patients had deficits in their inspiratory technique such as actuation of inhaler coordinating with the beginning of inhalation cycle, uninterrupted inhalation, and incorrect length of inspiration. Following evaluation, the patients were given metered dose inhalers equipped with a MDI Tutor prototype as well as written instructions on how to use the device most effectively. RESULTS: All patients corrected their inspiratory technique deficits. CONCLUSIONS: Equipping a metered dose inhaler with a MDI Tutor allows patients to rapidly recognize correct the errors in their inspiratory technique.     

A comparison of four tests of cognition as predictors of inability to learn to use a metered dose inhaler in old age

Background: Previous studies have shown that a Mini Mental State Examination (MMSE) score of < 24/30 and inability to copy intersecting pentagons (IP) predict inability to learn to use inhaler devices. We hypothesised that clock drawing tests (CLOX 1 and 2), being validated tests of cognitive executive function, might predict competent inhaler acquisition with a higher sensitivity and specificity than the MMSE or IP. Methods: We studied 80 (63 women) inhaler‐naïve inpatients, mean age 83 years (range 75–97 years). All performed the MMSE, IP, CLOX 1 and 2, before receiving standardised demonstration, instruction and assessment in the use of a metered dose inhaler (MDI). Results: A total of 28/80 (35%) patients were able to acquire a satisfactory MDI technique. Using normative thresholds for impairment, the sensitivity and specificity (% with 95% confidence intervals) of the cognitive scores in predicting inability were: MMSE < 24 sensitivity 57 (42–71), specificity 76 (57–88), p = 0.04; IP sensitivity 75 (60–85), specificity 79 (59–91), p = 0.0000; CLOX1 < 10 sensitivity 83 (69–91), specificity 57 (37–75), p = 0.0004; CLOX2 < 12 sensitivity 58 (43–71), specificity 64 (44–81), p = 0.05. Conclusion: CLOX tests did not perform better than MMSE and IP, to identify patients who are unlikely to be able to acquire MDI technique from a single episode of training. In clinical practice, most patients with an MMSE < 24 or negative IP will not be able to learn MDI technique. In this study, IP had the best overall predictive value.     

MEMORY AND MEDICATION COMPLIANCE

Electronic medication monitors were used to study patients' compliance with a three times daily pilocarpine regimen. In addition, standardized tests were used to measure different aspects of patients' memory performance. The 38 mostly elderly patients varied widely in their compliance and memory scores. However, no significant correlation was found between memory and medication compliance. It is concluded that lack of memory may be less important as a cause of non-compliance than is usually believed.     

The Genuair® inhaler: a novel, multidose dry powder inhaler

This article reviews the Genuair^® inhaler, a novel, multidose, breath‐actuated dry powder inhaler. The inhaler design includes visual and acoustic feedback to reassure patients that they have taken their medication correctly, a dose indicator and a lock‐out mechanism to prevent the use of an empty inhaler. The inhaler has medium airflow resistance and uses an optimised dispersion system to ensure effective deagglomeration of the inhalation powder. In vitro studies have demonstrated that the inhaler delivers a reproducible aerodynamic aerosol quality and is reliable under various thermal and mechanical stress conditions. Further studies in vitro have demonstrated that the total emitted dose and fine particle dose are both consistent over a range of inhalation flows from 45 to 95 l/min, as well as being independent of inhalation volume (2 l vs. 4 l) and storage conditions. In healthy subjects, delivery of aclidinium bromide 200 μg via the inhaler achieved high lung deposition (approximately 30% of the metered dose). A further study has shown that patients with moderate or severe chronic obstructive pulmonary disease can generate sufficient inspiratory airflow through the inhaler to reliably inhale the full dose and reset the inhaler. The inhaler has been used to deliver aclidinium in many clinical trials and the available data indicate that it has high acceptability amongst patients.     

The natural history of medication compliance in a drug trial: limitations of pill counts

To assess medication compliance over time, we prospectively performed pill counts among 121 ambulatory hypertensive subjects for less than or equal to 12 months. Prescribed regimens consisted of pinacidil or hydralazine administered four times a day and of secondary drugs administered up to twice daily. Surreptitious pill counts occurred every 1 to 12 weeks. Among a middle-aged subject group that had been selected for high rates of compliance, we observed mean compliance rates that approximated 100%. We noted marked intrasubject and intersubject variability for any one medication, between medications, and over time. From baseline blood pressures (+/- SE) of 155.5 +/- 1.9/97.3 +/- 1.0 mm Hg, subsequent mean blood pressures varied by compliance subgroup: "hypocompliers" (less than 80%), 151.3/91.0 mm Hg; "hypercompliers" (greater than or equal to 120%), 147.6/91.4 mm Hg; and "eucompliers" (80% to 119%), 143.3/88.5 mm Hg (systolic blood pressure: F1,52 = -220.9, NS; diastolic blood pressure: F1,52 = -121.4, NS). We concluded that weekly pill counts indicated marked intersubject and intrasubject variability, obscured by long-term averages; that compliance lapses appeared to be random; and that excessive medication-taking was the most consistent with "pill dumping."     

INHALER USE IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Inhaler technique is a common problem, particularly in the elderly. We have assessed the ability to use seven common inhaler devices in 20 patients with chronic obstructive pulmonary disease (COPD). Techniques were taught in a standard fashion in random order and assessed immediately and one hour later by two observers. Fourteen patients had a fault that would result in no drug delivery at some time during the study, and such a fault occurred at some point for each inhaler device. These faults were most common with the diskhaler. Accuhaler, autohaler and turbohaler scored highest and diskhaler lowest. Overall scores declined by one hour after instruction. Patients ranked the metered dose inhaler and accuhaler highest for ease of use and preference. These results show that it is useful to have a small range of devices for patients with COPD and that it is important to review inhaler technique regularly.