Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. Improper inhaler technique is associated with poor asthma control and frequent emergency department visits. Allergy Asthma Clin Immunol. Long-term maintenance of pharmacists' inhaler technique demonstration skills.
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Am J Pharm Educ. Evaluation of a novel educational strategy, including inhaler-based reminder labels, to improve asthma inhaler technique. Patient Educ Couns. Epub Mar 7. Prevalence and etiology of asthma. J Allergy Clin Immunol. The ability of the community pharmacist to learn the proper actuation techniques of inhaler devices.
National Asthma Education and Prevention Program. Erratum in: J Allergy Clin Immunol. Giraud V, Roche N. Misuse of corticosteroid metered-dose inhaler is associated with decreased asthma stability. Eur Respir J. Burden of allergic disease in the UK: secondary analyses of national databases. Clin Exp Allergy. Medical personnel's knowledge of and ability to use inhaling devices.
Metered-dose inhalers, spacing chambers, and breath-actuated dry powder inhalers. Choosing inhaler devices for people with asthma: current knowledge and outstanding research needs. Respir Med. Epub May Achieving asthma control in practice: understanding the reasons for poor control. Epub Sep Inhaler technique maintenance: gaining an understanding from the patient's perspective. J Asthma.
Inhaler devices for asthma: a call for action in a neglected field. Prim Care Respir J. Inhaler competence in asthma: common errors, barriers to use and recommended solutions. Epub Oct BMC Pulm Med. National Library of Medicine U.
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National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Not Applicable. The study was performed in compliance with Good Clinical Practice and in accordance with the principles of the Declaration of Helsinki.
In addition, local National Health Service NHS research governance approval was obtained from all participating practices. No patients had experience of Pulmojet, which remained unavailable for prescription throughout the study. Eligible patients were identified from primary care practices using routine electronic medical record data.
Patients who accepted the mailed invitation to participate in the study were scheduled for a single study visit at which their eligibility was confirmed, written informed consent was recorded, and their inhaler technique was assessed, as described below. Patients were told to withhold their morning medication and to bring their current inhaler devices to the clinic. They underwent assessment of their current inhaler technique, first using their active inhaler device and assessed by trained nurse observers using a predefined error check-list.
Second, patients were then asked to repeat their inhalation manoeuvre using an empty version of their current device containing no drug or placebo formulation , and their inhaler inhalation was assessed by an electronic inhalation profile recorder technology assessment, described below. Patients were allocated into the study comparison according to their current device see Fig. The pMDI users were included in the Pulmojet-Diskus comparison to attain the greater numbers required according to the power calculations see below. The study was conducted by primary care respiratory research nurses who had prior experience and received instruction in inhaler device assessment for the study.
The training video was designed to be representative of a standardised form of optimal training by a qualified nurse. It was reviewed and approved by the full study steering committee. If the research nurse observed no serious errors, testing on the first device was considered to have been completed and the patient was given the second allocated device.
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They then repeated the same process for the second device. Inhaler technique was evaluated by both a a nurse observer qualified to identify serious errors in device handling technique see Additional file 1 for the list of predefined errors and b the measurement of an inhalation profile technology assessment of the inhalation manoeuvre. Inhalation flow against time measurements were downloaded using the inhaler attached to the inlet of a pneumotrac spirometer Vitalograph Ltd, Maids Moreton, Buckingham, UK so that patients were instructed to inhale through the spirometer as though through the inhaler device, as previously described [ 24 ].
All devices were empty and since no active medication was administered, efficacious and safe use were not assessed. The objective of the analyses was to demonstrate non-inferiority, and, if met, to evaluate for superiority of the Pulmojet device compared with Diskus and Turbohaler in terms of ability to achieve inhaler mastery after standardised training.
The sample sizes were calculated using nQuery Advisor 7. Based on primary care audit data from patients, we estimated a success rate of Pulmojet comparison to be 0.
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Thus, it was determined that patients would be randomised to Pulmojet first and a further to Diskus first. Sixty-one patients would, therefore, be randomised to Pulmojet and then Turbohaler and 61 to Turbohaler and then Pulmojet assessments. Subsequent to the completion of the study it was determined that the per-protocol power calculation underestimated the number of patients required.
A post-hoc revised power calculation, using the assumptions noted above, and 2. Baseline data were analysed for all enrolled patients and for the full analysis set, which included all patients who completed an assessment of nurse-observed errors on both study devices. Descriptive statistics were used to summarise patient demographic and baseline clinical characteristics.
All analyses were carried out using the full analysis set, thus permitting a paired analysis of results. To determine non-inferiority in device handling of the Pulmojet compared with the comparator device Diskus or Turbohaler , the proportions of patients achieving an absence of serious errors on each device, and the difference in proportions, were analysed using a conditional binary logistic regression model.
To provide an additional measure of effect size, a conditional logistic regression was used to compare the odds of recording a serious error. The number of nurse-observed inhaler technique errors was summarised and compared between inhaler types using the Wilcoxon matched pair signed-rank test.
A post-hoc sensitivity analysis restricted to errors that were definitely serious ie, those that would definitely preclude adequate dose delivery to the lungs was also conducted. Technology-assessed inhalation errors defined as errors recorded by the pneumotrac spirometer were combined with nurse-observed serious errors excluding inhalation errors.
Although the planned recruitment was patients, patients were actually recruited because of simultaneous recruitment across multiple sites. Patients first randomised to Turbohaler in the Pulmojet vs. Nurse-observed serious errors for Diskus vs. Pulmojet and Turbohaler vs. Pulmojet comparisons: post-patient information leaflet alone and post-leaflet and instructional video. The post-leaflet nurse-observed serious errors categorised into preparation, positioning, inhalation, and general knowledge errors are presented in Fig.
More patients made more general knowledge and inhalation errors with Diskus than with Pulmojet, whereas more patients made preparation errors with Pulmojet than with Diskus. As the Pulmojet device is not subject to positioning error, no positioning errors were identified with Pulmojet. On the other hand, more patients did not know how to determine when the device was empty, which was considered a general knowledge error, with Pulmojet than with Diskus details in Additional file 1 : Tables S1 and S2.
Percentage of patients recording Pulmojet and Diskus errors post-leaflet alone. Percentage of patients recording Pulmojet and Diskus errors post-leaflet and instructional video. Serious errors by type are shown in Fig. In addition to making positioning errors with Turbohaler, more patients made general knowledge, inhalation, and preparation errors with Turbohaler than with Pulmojet Additional file 1 : Tables S3 and S4.
Percentage of patients recording Pulmojet and Turbohaler errors post-leaflet alone. Percentage of patients recording Pulmojet and Turbohaler errors post-leaflet and instructional video. The sensitivity analysis examining errors that were definitely serious those that would definitely preclude adequate dose delivery to the lungs; see Additional file 1 : Tables S1—S4 found that non-inferiority remained for both comparisons Pulmojet vs.