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Use and inhalation technique of inhaled medication in patients with asthma and COPD: data from a randomized controlled trial.

ABSTRACT: BACKGROUND:The burden of asthma and COPD among patients is high and people affected are frequently hospitalized due to exacerbations. There are numerous reasons for the lack of disease control in asthma and COPD patients. It is associated with non-adherence to guidelines on the part of the health care provider and with poor inhalation technique and/or non-adherence to the prescribed treatment plan by the patient. This study aims to present data on inhaler technique and its impact on quality of life (QoL) and symptom control in a typical population of patients with chronic lung disease from a randomized controlled trial on medication adherence. METHODS:For this cross-sectional analysis, 165 asthma and COPD patients were analyzed. Correct application of inhaler devices was tested using pre-defined checklists for each inhaler type. QoL and symptom control were investigated using COPD Assessment Test (CAT) and Asthma Control Test (ACT). Spirometry was used to measure forced vital capacity (FVC) and forced expiratory volume in one second (FEV1). RESULTS:Overall, incorrect inhalation technique ranged from 0 to 53% depending on the type of inhaler. COPD patients with incorrect device application had a higher CAT sum score compared to those with a correct device application (P?=?.02). Moreover, COPD patients with incorrect device application were more likely to suffer from cough (P?=?.03) and were more breathless while walking uphill or a flight of stairs (P?=?.02). While there was no significance found in asthma patients, COPD patients who used their devices correctly had a significantly better mean FEV1% predicted at baseline compared to those who applied their devices incorrectly (P?=?.04). CONCLUSIONS:Correct inhalation of prescribed medication is associated with improved health status and lung function. These findings should encourage health professionals to provide instructions on correct inhalation technique and to regularly re-evaluate the patients' inhalation technique. TRIAL REGISTRATION:ClinicalTrials.gov: NCT0238672 , Registered 14 February 2014.

SUBMITTER: Gregoriano C

PROVIDER: S-EPMC6276152 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Use and inhalation technique of inhaled medication in patients with asthma and COPD: data from a randomized controlled trial.

Gregoriano Claudia C Dieterle Thomas T Breitenstein Anna-Lisa AL Dürr Selina S Baum Amanda A Maier Sabrina S Arnet Isabelle I Hersberger Kurt E KE Leuppi Jörg D JD

Respiratory research 20181203 1

<h4>Background</h4>The burden of asthma and COPD among patients is high and people affected are frequently hospitalized due to exacerbations. There are numerous reasons for the lack of disease control in asthma and COPD patients. It is associated with non-adherence to guidelines on the part of the health care provider and with poor inhalation technique and/or non-adherence to the prescribed treatment plan by the patient. This study aims to present data on inhaler technique and its impact on qual ...[more]

PMID: 30509268

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Project description:IntroductionAbout 70% of patients with asthma and/or chronic obstructive pulmonary disease (COPD) use their inhaled medication incorrectly, leading to reduced disease control, higher healthcare use and costs. Adequate guidance from the pharmacy team from first dispense onwards can benefit patients in the long run. We propose an intervention ('On TRACk') to improve medication adherence and inhaler technique of adult patients with asthma and/or COPD. This intervention focuses on training pharmacy technicians (PTs) in patient-centred communication and inhalation instruction skills. In addition, patients are actively involved in refill consultations at the pharmacy. The aim of this study is to improve inhaler technique and better inhaled medication adherence among patients with asthma and/or COPD. This paper describes the study protocol.Methods and analysisA cluster randomised controlled trial (RCT) with an intervention and control group of 15 pharmacies each will be conducted. Per intervention pharmacy, two PTs will be trained online. Each PT will include five patients who will prepare their second and third dispense counselling sessions by selecting three topics they wish to discuss. Pharmacies in the control cluster provide usual care. In total, 300 patients (150 per group) will be included. Up to 12 months after inclusion, patients complete 3-monthly follow-up questionnaires. Both a process evaluation and a cost-effectiveness analysis will be performed alongside the trial. Trial effectiveness on the patient level will be evaluated after the 12-month follow-up period.Patient data will be collected through questionnaires and pharmacy refill data. Patients' inhaler technique will be visually assessed by PTs. Semistructured interviews with PTs and patients will be conducted regarding implementation and fidelity. Direct and indirect health costs will be collected to assess cost-effectiveness.The primary outcome is adherence to inhalation maintenance medication measured with pharmacy refill data. Secondary outcomes are inhaler technique, persistence, patients' attitudes towards medication, self-efficacy in medication use and communication with their PTs.Ethics and disseminationThe study was approved by the Vrije Universiteit Amsterdam Ethics Committee (number: 2020.358). Results will be presented at (inter)national conferences and published in peer-reviewed journals. If proven to be (cost-)effective, the intervention should be considered for reimbursement and implementation in Dutch community pharmacies.Trial registration numberNL9750.

Project description:BackgroundIncorrect use of inhalers is a problem associated with poor patient outcomes. Despite improvement in the technique after verbal educations, this deteriorates over-time requiring re-enforcement through different educative strategies. This study aimed to assess the impact of a novel video-based teach-to-goal (TTG) educational intervention on: mastery of inhaler technique, disease control, medication adherence and disease-related quality of life (QoL) over-time among asthma and COPD patients.MethodsThis prospective, open-label, randomized controlled trial was registered in ClinicalTrials.gov: Identifier NCT05664347. After baseline assessment participants received either a verbal (control group) or a video-based (intervention group) TTG strategy. After 3-month the intervention was assessed for impact on the intended outcomes. Inhaler technique was assessed using standardized checklists, disease control using the Asthma control test and COPD assessment test respectively for asthma and COPD patients while adherence using the Morisky Green Levine scale. For QoL, the mini asthma quality of life questionnaire and the St. George respiratory questionnaire were used for asthmatic and COPD patients, respectively. Differences in outcomes between intervention-control groups were analyzed using either Chi-Square (X2)/Fisher Exact or Mann Whitney test. The impact of intervention on outcomes over-time was examined using either McNemar or Wilcoxon test.ResultsAt baseline, intervention (n = 51) and control (n = 52) groups had comparable demographic/clinical characteristics. At follow-up, inhaler technique improved among intervention group compared to control group (93.4% vs 67%) and to baseline (93.4% to 49.5%), (P<0.05). Similarly, medication adherence ameliorated among the intervention group in comparison to control group (88.2% to 61.5%) and to baseline (88.2% to 66.7%), (P<0.05). In regards to disease control, results showed an amelioration among the intervention group compared to baseline (35.3% to 54.9%) (P<0.05). QoL scores improved significantly among asthma patients (intervention group) at follow-up vs baseline. Better scores were also observed for COPD patients compared to controls, (P<0.05).ConclusionVideo-based (TTG) was effective in enhancing inhaler technique over time as well as improving disease control, medication adherence, and QoL.Trial registrationClinicalTrials.gov: NCT05664347. https://clinicaltrials.gov/ct2/show/NCT05664347.

Project description:IntroductionDry powder inhalers (DPIs), a commonly prescribed inhaler type for respiratory diseases, require patients to generate sufficient peak inspiratory flow (PIF) to ensure optimal drug delivery to the airways. Effectiveness of therapy also requires a good inhalation technique and adequate medication adherence. For patients with chronic obstructive pulmonary disease (COPD), recent studies conducted in tertiary care suggest that DPI users with suboptimal PIF have poorer COPD-related health status and increased exacerbation risk versus those with optimal PIF. The PIFotal study will investigate the impact of PIF, inhalation technique and medication adherence on patient-reported outcomes in patients with COPD in primary care using a DPI for their maintenance therapy.Methods and analysisThis cross-sectional observational study will assess 1200 patients (aged ≥ 40 years, diagnosed with COPD and using a DPI for COPD maintenance therapy for ≥ 3 months) from the Netherlands, Spain, Portugal, Poland, Greece and Australia. Assessments will consist of (1) PIF measurements (usual patient inhalation manoeuvre, maximal PIF against resistance of own inhaler, and maximal PIF against low resistance); (2) Clinical COPD Questionnaire (CCQ), COPD Assessment Test and Test of Adherence to Inhalers scores; and (3) video recordings of patient inhalation technique. Dependent variables include health status (CCQ score), number of self-reported exacerbations in previous 12 months, and healthcare resource utilisation in previous 6 months. Independent variables include PIF values, inhalation technique errors, medication adherence, and demographic and clinical characteristics. In the primary analysis, the mean difference in CCQ score between patients (1) with optimal/suboptimal PIF, (2) exhibiting/not exhibiting inhalation technique errors, and (3) adhering/not adhering to medication will be examined in a multivariable linear mixed model.EthicsThe study protocol was approved by ethics committees/institutional review boards of all participating sites prior to enrolment; written informed consent was obtained from all study participants.Trial registration numberClinicalTrials.gov: NCT04532853.

Project description:BackgroundThe objective of our study was to identify variables associated with inhaled medication use in smokers with normal spirometry (GOLD-0) and to examine the association of inhaled medication use with development of exacerbations and obstructive spirometry in the future.MethodsWe performed a retrospective multivariable analysis of GOLD-0 subjects identified in data from the COPDGene study to examine factors associated with medication use. Five categories were identified: (1) no medications, (2) short-acting bronchodilator, (3) long-acting bronchodilator; long-acting muscarinic antagonists and/or long-acting β agonist, (4) inhaled corticosteroids (ICS) with or without long-acting bronchodilator, and (5) dual bronchodilator with ICS. Sensitivity analysis was performed excluding subjects with history of asthma. We also evaluated whether long-acting inhaled medication use was associated with exacerbations and obstructive spirometry at the follow-up visit 5 y after enrollment.ResultsOf 4,303 GOLD-0 subjects within the analysis, 541 of them (12.6%) received inhaled medications. Of these, 259 (6%) were using long-acting inhaled medications and 282 (6.6%) were taking short-acting bronchodilator. Female sex (odds ratio [OR] 1.47, P = .003), numerous medical comorbidities, radiographic emphysema (OR 2.22, P = .02), chronic bronchitis (OR 1.77, P < .001), dyspnea (OR 2.24, P < .001), asthma history (OR 15.56, P < .001), prior exacerbation (OR 8.45, P < .001), and 6-min walk distance (OR 0.9, P < .001) were associated with medication use. Minimal changes were noted in a sensitivity analysis. Additionally, inhaled medications were associated with increased total (incidence rate ratio 2.83, P < .001) and severe respiratory exacerbations (incidence rate ratio 3.64, P < .001) and presence of obstructive spirometry (OR 2.83, P = .002) at follow-up.ConclusionsRespiratory symptoms, history of asthma, and radiographic emphysema were associated with inhaled medication use in smokers with normal spirometry. These individuals were more likely to develop obstructive spirometry, which suggests that health care providers may be able to identify obstructive lung disease prior to meeting the current criteria for COPD.

Project description:RationaleSmoking and inflammation contribute to the pathogenesis of chronic obstructive pulmonary disease (COPD), which involves changes in extracellular matrix. This is thought to contribute to airway remodeling and airflow obstruction. We have previously observed that long-term treatment with inhaled corticosteroids can not only reduce bronchial inflammation, but can also attenuate lung function decline in moderate-severe COPD. We hypothesized that inhaled corticosteroids and current smoking modulate bronchial extracellular matrix components in COPD.ObjectiveTo compare major extracellular matrix components (elastic fibers; proteoglycans [versican, decorin]; collagens type I and III) in bronchial biopsies 1) after 30-months inhaled steroids treatment or placebo; and 2) between current and ex-smokers with COPD.MethodsWe included 64 moderate-severe, steroid-naive COPD patients (24/40 (ex)-smokers, 62±7 years, 46 (31-54) packyears, post-bronchodilator forced expiratory volume in one second (FEV1) 62±9% predicted) at baseline in this randomized, controlled trial. 19 and 13 patients received 30-months treatment with fluticasone or placebo, respectively. Bronchial biopsies collected at baseline and after 30 months were studied using (immuno)histochemistry to evaluate extracellular matrix content. Percentage and density of stained area were calculated by digital image analysis.Results30-Months inhaled steroids increased the percentage stained area of versican (9.6% [CI 0.9 to 18.3%]; p = 0.03) and collagen III (20.6% [CI 3.8 to 37.4%]; p = 0.02) compared to placebo. Increased collagen I staining density correlated with increased post-bronchodilator FEV1 after inhaled steroids treatment (Rs = 0.45, p = 0.04). There were no differences between smokers and ex-smokers with COPD in percentages and densities for all extracellular matrix proteins.ConclusionsThese data show that long-term inhaled corticosteroids treatment partially changes the composition of extracellular matrix in moderate-severe COPD. This is associated with increased lung function, suggesting that long-term inhaled steroids modulate airway remodeling thereby potentially preventing airway collapse in COPD. Smoking status is not associated with bronchial extracellular matrix proteins.Trial registrationClinicalTrials.gov NCT00158847.

Project description:Bronchodilator therapy is the backbone of the management of chronic obstructive pulmonary disease. In some patients, inhaled corticosteroids can be prescribed in combination with bronchodilators. Through a subgroup analysis of pooled data from two large phase III clinical trials of bronchodilator therapy according to concomitant inhaled corticosteroid use (user vs. non-user), we sought to evaluate the clinical benefit of adding inhaled corticosteroids to dual bronchodilator therapy in chronic obstructive pulmonary disease. The primary focus of this analysis of pooled data from the phase III ACLIFORM and AUGMENT studies was to evaluate the efficacy of aclidinium/formoterol on lung function stratified by inhaled corticosteroid use. We found that lung-function end points were significantly improved regardless of concomitant inhaled corticosteroid use among patients treated with the dual bronchodilator aclidinium/formoterol 400/12?µg twice daily compared with placebo and both monotherapies. Together with the previously reported observations that aclidinium/formoterol 400/12?µg reduces exacerbations vs. placebo in inhaled corticosteroid users and improves dyspnoea compared to monotherapy in inhaled corticosteroid non-users, these data suggest that both groups achieve lung function improvements, which translates to different clinical benefits depending on whether or not a patient is receiving concomitant inhaled corticosteroids.CHRONIC LUNG DISEASE: 'TRIPLE' THERAPY COULD PROVE BENEFICIAL: A dual bronchodilator therapy taken together with corticosteroid inhalers may benefit patients with severe chronic lung disease. Bronchodilator drugs relax the lungs and widen airways in patients with chronic obstructive pulmonary disease (COPD). While recent studies have shown that a dual bronchodilator therapy containing aclidinium and formoterol significantly improves lung function in COPD, little is known about combining the dual therapy with inhaled corticosteroids (ICSs). Anthony D'Urzo at the University of Toronto, Canada, and co-workers analysed data from 3394 patients with COPD undergoing dual therapy trials. Of these, 1180 were already taking ICSs. The team compared symptoms in the ICS group with those not taking ICSs. The dual therapy improved lung function across both groups regardless of ICS use, though patients gained different clinical benefits depending on ICS use and disease severity.

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Use and inhalation technique of inhaled medication in patients with asthma and COPD: data from a randomized controlled trial.

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Use and inhalation technique of inhaled medication in patients with asthma and COPD: data from a randomized controlled trial.

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