Humidified and standard oxygen therapy in acute severe asthma in children (HUMOX): A pilot randomised controlled trial.

BACKGROUND: Oxygen (O2) is a mainstay of treatment in acute severe asthma but how it is administered varies widely. The objectives were to examine whether a trial comparing humidified O2 to standard O2 in children is feasible, and specifically to obtain data on recruitment, tolerability and outcome measure stability. METHODS: Heated humidified, cold humidified and standard O2 treatments were compared for children (2-16 years) with acute severe asthma in a multi-centre, open, parallel, pilot randomised controlled trial (RCT). Multiple outcomes were assessed. RESULTS: Of 258 children screened, 66 were randomised (heated humidified O2 n = 25; cold humidified O2 n = 21; standard O2 n = 20). Median (IQR) length of stay (hours) in hospital was 37.9 (29.1), 52 (35.4) and 49.1 (29.7) for standard, heated humidified and cold humidified respectively and time (hours) on O2 was 15.9 (9.4), 13.6 (14.9) and 13.1 (14.9) for the three groups respectively. The mean (standard deviation) time (hours) taken to step down nebulised to inhaled treatment was 5.6 (14.3), 35.1 (28.2) and 32.7 (20.1). Asthma Severity Score decreased in all three groups similarly, although missing data prevented complete analysis. Humidified O2 was least well tolerated with eight participants discontinuing their randomised treatment early. An important barrier to recruitment was research nurse availability. CONCLUSION: Although, the results of this pilot study should not be extrapolated beyond the study sample and inferential conclusions should not be drawn from the results, this is the first RCT to compare humidified and standard O2 therapy in acute severe asthmatics of any age. These findings and accompanying screening data show that a large RCT of O2 therapy is feasible. However, challenges associated with randomisation and data collection should be addressed in any future trial design.

Patient's awareness on COPD is the strongest predictor of persistence and adherence in treatment-naïve patients in real life: a prospective cohort study.

BACKGROUND: There is little evidence about the factors that predict persistence/adherence in treatment-naïve patients with COPD in clinical practice. The aim of this study was to evaluate persistence and adherence levels among treatment-naïve patients diagnosed with COPD who had a prescribed inhaled medication, using data from real-world clinical practice. METHODS: Multicentric study with a 6 month-followed-up period. Patients were considered persistent if they collected all their inhaler refills. In a random sample of patients, we evaluated adherence using the Test of Adherence to Inhalers (TAI). We assessed Health Related Quality of Life (HRQL) with St George's Respiratory Questionnaire (SGRQ). RESULTS: Of the 114 patients included, 46 (40.4%) were defined as persistent. Patients who had awareness about COPD (adjusted RR 2.672, 95% CI 1.125-6.349) were more likely to be persistent; patients with multidose DPI were less likely to be persistent that those with single dose DPI (adjusted RR 0.341, 95% CI 0.133-0.877). Higher levels of SGRQ total were associated with a lower probability of persistence (adjusted RR 0.945, 95%CI 0.894-0.998). Patients who had had an appointment with their GP in the previous six months were more likely to be persistent (adjusted RR 3.107, 95% CI 1.022-9.466). Patients who had awareness about COPD and those with lower symptom SGQR score were more likely to be adherent (24/25, 96.0% vs 16/22, 72.7%, p = 0.025, and mean 29.1, sd 19.4 vs mean 41.4, sd 15.9, respectively, p = 0.026, respectively). CONCLUSIONS: Less than 50% of patients were defined as persistent. Patients' awareness of their disease and levels of HRQL were associated with high rate of persistence and adherence. In addition, frequent visits to general practitioner, increases the rate of persistence to treatment.

Spatio-temporal associations of air pollutant concentrations, GP respiratory consultations and respiratory inhaler prescriptions: a 5-year study of primary care in the borough of Lambeth, South London.

BACKGROUND: Although the associations of outdoor air pollution exposure with mortality and hospital admissions are well established, few previous studies have reported on primary care clinical and prescribing data. We assessed the associations of short and long-term pollutant exposures with General Practitioner respiratory consultations and inhaler prescriptions. METHODS: Daily primary care data, for 2009-2013, were obtained from Lambeth DataNet (LDN), an anonymised dataset containing coded data from all patients (1.2 million) registered at general practices in Lambeth, an inner-city south London borough. Counts of respiratory consultations and inhaler prescriptions by day and Lower Super Output Area (LSOA) of residence were constructed. We developed models for predicting daily PM2.5, PM10, NO2 and O3 per LSOA. We used spatio-temporal mixed effects zero inflated negative binomial models to investigate the simultaneous short- and long-term effects of exposure to pollutants on the number of events. RESULTS: The mean concentrations of NO2, PM10, PM2.5 and O3 over the study period were 50.7, 21.2, 15.6, and 49.9 µg/m3 respectively, with all pollutants except NO2 having much larger temporal rather than spatial variability. Following short-term exposure increases to PM10, NO2 and PM2.5 the number of consultations and inhaler prescriptions were found to increase, especially for PM10 exposure in children which was associated with increases in daily respiratory consultations of 3.4% and inhaler prescriptions of 0.8%, per PM10 interquartile range (IQR) increase. Associations further increased after adjustment for weekly average exposures, rising to 6.1 and 1.2%, respectively, for weekly average PM10 exposure. In contrast, a short-term increase in O3 exposure was associated with decreased number of respiratory consultations. No association was found between long-term exposures to PM10, PM2.5 and NO2 and number of respiratory consultations. Long-term exposure to NO2 was associated with an increase (8%) in preventer inhaler prescriptions only. CONCLUSIONS: We found increases in the daily number of GP respiratory consultations and inhaler prescriptions following short-term increases in exposure to NO2, PM10 and PM2.5. These associations are more pronounced in children and persist for at least a week. The association with long term exposure to NO2 and preventer inhaler prescriptions indicates likely increased chronic respiratory morbidity.

Retrospective analysis of the effect of inhaler education on improvements in inhaler usage.

INTRODUCTION: Various types of inhalation devices have been released, and it is necessary to acquire the skills for using each of them. The factors that have been previously associated with poor inhalator usage include gender, duration of disease, age, and the type of device. However, it is unclear whether these factors also apply to the Japanese population. The number of education sessions needed to acquire inhaler usage skills is also not established. PATIENTS AND METHODS: We performed a retrospective review of the medical records of selected patients and their subjective assessments of their inhaler usage skills between January 2016 and March 2018. The primary outcome was the effect of inhaler education for each inhaler device. The secondary outcomes were the factors affecting the effectiveness of inhaler education, the effects of inhalation education stratified by age, and the number of inhaler education sessions needed to improve inhaler usage skills. RESULTS: Data from 399 patients were analyzed. Age and the type of delivery device affected the mastery of inhaler usage skills. Approximately half of the patients had acquired inhaler usage skills during baseline evaluation. Approximately 90% of patients acquired inhalation usage skills after two education sessions, regardless of the type of inhalation device. Among the older patients, 35.0% had acquired inhaler usage skills during the baseline evaluation, and 86.8% acquired them after two education sessions. CONCLUSIONS: Inhaler usage skills significantly improved, regardless of the device, after inhalation education, and this was also observed in elderly patients after two education sessions.

Competence in metered-dose inhaler technique among healthcare workers of three general hospitals in Mexico: it is not good after all these years.

INTRODUCTION: Inhaled medication is the cornerstone of pharmacological treatment for chronic respiratory diseases. Therefore, it is important to use a metered-dose inhaler (MDI) correctly to get the appropriate dosage and benefit from the drug. Health-care workers (HCW) are responsible for teaching the correct MDI technique. Unfortunately, numerous studies consistently show that HCW have poor MDI technique. This study aimed to evaluate the current knowledge of MDI technique in HCW working in three general hospitals. MATERIAL AND METHODS: A hospital-based, cross-sectional descriptive study was conducted in three general hospitals in Aguascalientes, México. Three surveyors simultaneously scored through a 14 dichotomic questions list as bad, regular, good, and very good MDI technique. Data were analyzed with SPSS version 16. Statistical analyses were performed using chi-square test or unpaired t-tests. An analysis of one-way ANOVA was used for comparison of three independent general hospitals. Values of p < 0.05 were considered to indicate statistical significance. RESULTS: A total of 244 HCWs were surveyed: 78.3% were nurses whereas 21.3% were physicians. The inter-observer concor-dance analysis among observers was 0.97. We observed that 32.4% (79) performed a bad technique, 51.6% (126) a regular technique, 13.5% (33) a good one, and 2.5% HCW (6) a very good technique. No difference between gender, labor category, schedule, service, age, seniority, and education degree between the three hospitals was observed. The most common mistakes were "insufficient expiration prior to activation of the device", and "the distance the inhaler was placed for inhalation" (83 and 84% respectively). CONCLUSION: We observed that a high percentage of HCW do not follow the MDI technique correctly, being this percentage even higher than the reported in other studies. These observations suggest the urgent need to establish frequent training programs for the correct use of MDI.

Chemical Elements in Electronic Cigarette Solvents and Aerosols Inhibit Mitochondrial Reductases and Induce Oxidative Stress.

INTRODUCTION: Chemical elements and their toxicity were evaluated in electronic cigarette (EC) solvents, fluids, and aerosols. AIMS AND METHODS: Element identification and quantification in propylene glycol (PG), glycerin (G), refill fluids before and after use, and aerosols was done using inductively coupled plasma optical emission spectrometry. Cytotoxicity and oxidative stress were evaluated using in vitro assays. RESULTS: Seven elements were present in PG, G, and popular refill fluids, and they transferred to aerosols made with ECs. Selenium was in all products (0.125-0.292 mg/L), while arsenic, aluminum, and tin were frequently in solvent and refill fluid samples at lower concentrations. Iron, chromium, copper, nickel, zinc, and lead were only detected in fluid after EC use, indicating they came from heated atomizers. Elements transferred most efficiently to aerosols made with second-/third-generation ECs. Of the elements in fluid, selenium and arsenic were the most cytotoxic to human bronchial epithelial cells (BEAS-2B) and pulmonary fibroblasts in the 3-(4,5-dimethylthiazolyl-2)-2,5-diphenyltetrazolium bromide assay. Selenium increased superoxide production in mitochondria and nucleoli and elevated selenoprotein H in nucleoli of BEAS-2B cells at concentrations found in EC aerosols (10 nM or 0.002 mg/L). CONCLUSIONS: Elements in EC aerosols came from both e-fluids and atomizing units. Within second-/third-generation products, transfer became more efficient as power increased. In vitro responses occurred at concentrations of selenium found in some EC aerosols. Human exposure to chemical elements in ECs could be reduced by regulating (decreasing) allowable EC power and by improving the purity of PG and G. IMPLICATIONS: PG, G, refill fluids, and e-fluids contained potentially toxic chemical elements that transferred to aerosols. Transfer was more efficient in second- and third-generation EC products and increased as power increased. Selenium and arsenic were the most cytotoxic of the elements tested in the 3-(4,5-dimethylthiazolyl-2)-2,5-diphenyltetrazolium bromide assay. Selenium tetrachloride-induced oxidative stress in BEAS-2B cells, but not in human pulmonary fibroblasts. All fluids contained selenium above the concentration that induced oxidative stress in human bronchial epithelial cells. Selenium increased superoxide in mitochondria and nucleoli and increased selenoprotein H, a redox responsive DNA-binding protein that is upregulated by superoxide and an indicator of nucleolar stress. EC users are exposed to elements in aerosols, which may with chronic exposure contribute to diseases associated with oxidative stress.

Nebulised surfactant for the treatment of severe COVID-19 in adults (COV-Surf): A structured summary of a study protocol for a randomized controlled trial.

OBJECTIVES: SARS-Cov-2 virus preferentially binds to the Angiotensin Converting Enzyme 2 (ACE2) on alveolar epithelial type II cells, initiating an inflammatory response and tissue damage which may impair surfactant synthesis contributing to alveolar collapse, worsening hypoxia and leading to respiratory failure. The objective of this study is to evaluate the feasibility, safety and efficacy of nebulised surfactant in COVID-19 adult patients requiring mechanical ventilation for respiratory failure. TRIAL DESIGN: This study is a dose-escalating randomized open-label clinical trial of 20 COVID-19 patients. PARTICIPANTS: This study is conducted in two centres: University Hospital Southampton and University College London Hospitals. Eligible participants are aged ≥18, hospitalised with COVID-19 (confirmed by PCR), who require endotracheal intubation and are enrolled within 24 hours of mechanical ventilation. For patients unable to consent, assent is obtained from a personal legal representative (PerLR) or professional legal representative (ProfLR) prior to enrolment. The following are exclusion criteria: imminent expected death within 24 hours; specific contraindications to surfactant administration (e.g. known allergy, pneumothorax, pulmonary hemorrhage); known or suspected pregnancy; stage 4 chronic kidney disease or requiring dialysis (i.e., eGFR < 30); liver failure (Child-Pugh Class C); anticipated transfer to another hospital, which is not a study site, within 72 hours; current or recent (within 1 month) participation in another study that, in the opinion of the investigator, would prevent enrollment for safety reasons; and declined consent or assent. INTERVENTION AND COMPARATOR: Intervention: The study is based on an investigational drug/device combination product. The surfactant product is Bovactant (Alveofact®), a natural animal derived (bovine) lung surfactant formulated as a lyophilized powder in 108 mg vials and reconstituted to 45 mg/mL in buffer supplied in a prefilled syringe. It is isolated by lung lavage and, by weight, is a mixture of: phospholipid (75% phosphatidylcholine, 13% phosphatidylglycerol, 3% phosphatidylethanolamine, 1% phosphatidylinositol and 1% sphingomyelin), 5% cholesterol, 1% lipid-soluble surfactant-associated proteins (SP-B and SP-C), very low levels of free fatty acid, lyso-phosphatidylcholine, water and 0.3% calcium. The Drug Delivery Device is the AeroFact-COVID™ nebulizer, an investigational device based on the Aerogen® Solo vibrating mesh nebulizer. The timing and escalation dosing plans for the surfactant are as follows. Cohort 1: Three patients will receive 10 vials (1080 mg) each of surfactant at dosing times of 0 hours, 8 hours and 24 hours. 2 controls with no placebo intervention. Cohort 2: Three patients will receive 10 vials (1080 mg) of surfactant at dosing times of 0 hours and 8 hours, and 30 vials (3240 mg) at a dosing time of 24 hours. 2 controls with no placebo intervention. Cohort 3: Three patients will receive 10 vials (1080 mg) of surfactant at a dosing time of 0 hours, and 30 vials (3240 mg) at dosing times of 8 hours and 24 hours. 2 controls with no placebo intervention. Cohort 4: Three patients will receive 30 (3240 mg) vials each of surfactant at dosing times of 0 hours, 8 hours and 24 hours. 2 controls. 2 controls with no placebo intervention. The trial steering committee, advised by the data monitoring committee, will review trial progression and dose escalation/maintenance/reduction after each cohort is completed (48-hour primary outcome timepoint reached) based on available feasibility, adverse event, safety and efficacy data. The trial will not be discontinued on the basis of lack of efficacy. The trial may be stopped early on the basis of safety or feasibility concerns. Comparator: No placebo intervention. All participants will receive usual standard of care in accordance with the local policies for mechanically ventilated patients and all other treatments will be left to the discretion of the attending physician. MAIN OUTCOMES: The co-primary outcome is the improvement in oxygenation (PaO2/FiO2 ratio) and pulmonary ventilation (Ventilation Index (VI), where VI = [RR x (PIP - PEEP) × PaCO2]/1000) at 48 hours after study initiation. The secondary outcomes include frequency and severity of adverse events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs), change in pulmonary compliance, change in positive end-expiratory pressure (PEEP) requirement of ventilatory support at 24 and 48 hours after study initiation, clinical improvement defined by time to one improvement point on the ordinal scale described in the WHO master protocol (2020) recorded while hospitalised, days of mechanical ventilation, mechanical ventilator free days (VFD) at day 21, length of intensive care unit stay, number of days hospitalised and mortality at day 28. Exploratory end points will include quantification of SARS-CoV-2 viral load from tracheal aspirates using PCR, surfactant dynamics (synthesis and turnover) and function (surface tension reduction) from deep tracheal aspirate samples (DTAS), surfactant phospholipid concentrations in plasma and DTAS, inflammatory markers (cellular and cytokine) in plasma and DTAS, and blood oxidative stress markers. RANDOMISATION: After informed assent, patients fulfilling inclusion criteria will be randomised to 3:2 for the treatment and control arms using an internet-based block randomization service (ALEA tool for clinical trials, FormsVision BV) in combination with electronic data collection. Randomisation will be done by the recruiting centre with a unique subject identifier specific to that centre. BLINDING (MASKING): This is an open-labelled unblinded study. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The total sample size is 20 COVID-19 mechanically ventilated patients (12 intervention; 8 control). TRIAL STATUS: Current protocol version is V2 dated 5th of June 2020. The recruitment is currently ongoing and started on the 14th of October 2020. The anticipated study completion date is November 2021. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04362059 (Registered 24 April 2020), EUDAMED number: CIV-GB-20-06-033328, EudraCT number: 2020-001886-35 (Registered 11 May 2020) FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

Monitoring of inhaler use at home with a smartphone video application in a pilot study.

Inhalation therapy is the basis of the pharmacological management of asthma and COPD. Most patients are trained on the correct use of inhalers by health professionals but after that do patients continue to take them correctly at home remains largely unknown. Video recording of the inhalation technique using a smartphone can be used to evaluate the inhaler technique at home. Through this pilot study, we aimed to understand whether inhaler training given to patients in the outpatient clinic translates into good inhalation practices at home by a video application platform using a smartphone. We recruited 70 newly diagnosed asthma and COPD patients and a pulmonologist trained them to use their inhaler until they were able to use it correctly. Videos of inhaler use were captured by a relative or a friend at home and then sent to an independent reviewer via WhatsApp on Days 1, 7, 14 and 28 (±2). Each step of the inhaler technique was evaluated based on a predetermined checklist with a rating scale of 0 to 10 (10 for all steps done correctly). Out of 70 patients recruited, 30 (42%) sent all videos. We found that, although all patients performed all the steps correctly in the clinic, none of them performed all steps correctly at home even on Day 1 itself of the inhaler use. On Day 1, the steps score reduced from 10 to 6.9 with a downward trend until Day 28. The most common mistakes from Day 1 onwards were incorrect inspiratory flow rates and not gargling after the inhaler use. Also, most patients showed partially effective inhalation as per our scoring method. Remote video monitoring of inhaler use in the home environment is possible with a mobile video application that gives us a better insight into the most common inhaler mistakes performed by patients at home. Inhaler errors start appearing immediately on Day 1 after the training, and incorrect inspiratory flow rates and forgetting to do gargles are common errors. Early detection of inhaler errors at home may be possible through this method.

Mechanisms of Action of a Web-Based Intervention With Health Professional Support to Increase Adherence to Nebulizer Treatments in Adults With Cystic Fibrosis: Qualitative Interview Study.

BACKGROUND: Adherence to nebulizer treatments in adults with cystic fibrosis (CF) is often low. A new complex intervention to help adults with CF increase their adherence to nebulizer treatments was tested in a pilot randomized controlled trial (RCT) in 2 UK CF centers. Patients used a nebulizer with electronic monitoring capabilities that transferred data automatically to a digital platform (CFHealthHub) to monitor adherence over time and to a tailored website to display graphs of adherence data and educational and problem-solving information about adherence. A trained interventionist helped patients identify ways to increase their adherence. OBJECTIVE: This study aims to explore the mechanisms of action underpinning the intervention. METHODS: A qualitative interview study was conducted concurrently with a pilot RCT. In total, 25 semistructured interviews were conducted with 3 interventionists at 2 time points, 14 patients in the intervention arm of the trial, and 5 members of the multidisciplinary teams offering wider care to patients. A framework approach was used for the analysis. RESULTS: The intervention was informed by a theoretical framework of behavior change. There was evidence of the expected behavior change mechanisms of action. There was also evidence of additional mechanisms of action associated with effective telehealth interventions for self-management support: relationships, visibility, and fit. Patients described how building a relationship with the interventionist through face-to-face visits with someone who cared about them and their progress helped them to consider ways of increasing adherence to medication. Rather than seeing the visibility of adherence data to clinicians as problematic, patients found this motivating, particularly if they received praise about progress made. The intervention was tailored to individuals, but there were challenges in how the intervention fitted into some patients' busy lives when delivered through a desktop computer. CONCLUSIONS: The mechanisms of action associated with effective telehealth interventions for self-management operated within this new intervention. The intervention was modified to strengthen mechanisms of action based on these findings, for example, delivery through an app accessed via mobile phones and then tested in an RCT in 19 UK CF centers. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number 13076797; http://www.isrctn.com/ISRCTN13076797.

A cohort study of medication adherence among patients with chronic obstructive pulmonary disease in Egypt.

Chronic obstructive pulmonary disease (COPD), the most common chronic respiratory disease, is expected to become the third leading cause of death worldwide in 2020. A prospective cohort study conducted in 2017 and 2018 aimed to identify factors associated with inhaler treatment adherence in patients with COPD in Cairo (Egypt). Physicians collected data regarding patient deaths, treatment-related adverse events, and patients' social support (no support, patient, support by spouse, children, and siblings) from their patients with COPD. The reason for treatment discontinuation was categorized as per patient decision or per physician decision. Adherence was categorized as treatment continued or treatment stopped. Patients who decided to stop treatment were considered non-adherent to COPD therapy. A total of 1311 patients as well as 98 physicians and 205 pharmacists were included. Pharmacists and social support (spouse, children/siblings) were identified as key positive factors in patients' decisions to adhere to their prescribed COPD treatment regimens. A total of 631 patients (48.1%) stopped the treatment, including 170 (27.0%) due to patient decision and 55 (8.7%) deceased. After Cox model analysis, a low number of patients (6-19) attended by the pharmacist was a significant predictive factor (hazard ratio [HR] = 1.40, 95% confidence interval [CI] = 1.03-1.91, p = 0.03) for deciding to stop treatment. A wife or husband (HR = 0.85, 95% CI = 0.72-1.02, p = 0.07) as well as children or brother/sister (HR = 0.77, 95% CI = 0.57-1.04, p = 0.08) provided a positive effect for continued treatment. Pharmacists are well positioned to play a role as an essential public health resource that can help improve adherence as well as social support that should be considered as an important component to improve adherence to long-term therapy in COPD as well as other chronic non-communicable diseases in low- and middle-income countries.

Use of inhaled devices during a hospital exacerbation of COPD: a summary of an interdisciplinary audit held at ICS Maugeri Pavia, Italy (March-June 2019).

To date treatment protocols in Respiratory and or Internal departments across Italy for treatment of chronic obstructive pulmonary disease (COPD) patients at hospital admission with relapse due to exacerbation do not find adequate support in current guidelines. Here we describe the results of a recent clinical audit, including a systematic review of practices reported in literature and an open discussion comparing these to current real-life procedures. The process was dived into two 8-hour-audits 3 months apart in order to allow work on the field in between meeting and involved 13 participants (3 nurses, 1 physiotherapist, 2 internists and 7 pulmonologists). This document reports the opinions of the experts and their consensus, leading to a bundle of multidisciplinary statements on the use of inhaled drugs for hospitalized COPD patients. Recommendations and topics addressed include: i) monitoring and diagnosis during the first 24 h after admission; ii) treatment algorithm and options (i.e., short and long acting bronchodilators); iii) bronchodilator dosages when switching device or using spacer; iv) flow measurement systems for shifting to LABA+LAMA within 48 h; v) when nebulizers are recommended; vi) use of SMI to deliver LABA+LAMA when patient needs SABA <3 times/day independently from flow limitation; vii) use of DPI and pre-dosed MDI to deliver LABA+LAMA or TRIPLE when patient needs SABA <3 times/day, with inspiratory flow > 30 litres/min; viii) contraindication to use DPI; ix) continuation of LABA-LAMA when patient is already on therapy; x) possible LABA-LAMA dosage increase; xi) use of SABA and/or SAMA in addition to LABA+LABA; xii) use of SABA+SAMA restricted to real need; xiii) reconciliation of drugs in presence of comorbidities; xiv) check of knowledge and skills on inhalation therapy; xv) discharge bundle; xvi) use of MDI and SMI in tracheostomized patients in spontaneous and ventilated breathing.

A multi-center randomized prospective study on the treatment of infant bronchiolitis with interferon α1b nebulization.

BACKGROUND: The respiratory syncytial virus (RSV) is the main cause of bronchiolitis in infants and interferon (IFN) α is a commercial antiviral drug. The nebulization of IFN α1b could be a viable treatment method. In this study, the therapeutic effects and safety of IFN α1b delivery via nebulization in infant bronchiolitis were investigated in this multi-center prospective study. METHODS AND FINDINGS: Bronchiolitis patients admitted to 22 hospitals who met the inclusion criteria were enrolled and randomly allocated to four groups: control, IFN Intramuscular Injection, IFN Nebulization 1 (1 µg/kg), and IFN Nebulization 2 (2 µg/kg) groups. All patients were observed for 7 days. The therapeutic effects and safety of different IFN delivery doses and delivery modes were evaluated. Coughing severity change, as scored by the researchers and parents, between days 1 and 3 was significantly different between the IFN Nebulization 2 and control groups. Lowell wheezing score change between days 3 and 5 was significantly different between IFN Nebulization 1 and control groups. There were no significant differences among the four groups regarding the number of consecutive days with fever, three-concave sign, fatigue and sleepiness, and loss of appetite. There were no cases of severe complications, no recurrence of fever, and no regression of mental status. CONCLUSIONS: IFN-α1b could more effectively alleviate coughing and wheezing in bronchiolitis. IFN-α1b nebulization had significant advantages in shortening the duration of wheezing and alleviating coughing.

High-Flow Nasal Cannula May Not Reduce the Re-Intubation Rate Compared With a Large-Volume Nebulization-Based Humidifier.

BACKGROUND: High-flow nasal cannula (HFNC) therapy may reduce the re-intubation rate compared with conventional oxygen therapy. However, HFNC has not been sufficiently compared with conventional oxygen therapy with a heated humidifier, even though heated humidification is beneficial for facilitating airway clearance. METHODS: This study was a single-center, open-label, randomized controlled trial. We randomized subjects with respiratory failure after extubation to either HFNC group or to a large-volume humidified nebulization-based nebulizer. The primary end point was the re-intubation rate within 7 d after extubation. RESULTS: We could not recruit enough subjects for the sample size we designed, therefore, we analyzed 69 subjects (HFNC group, 30 subjects; nebulizer group, 39 subjects). The re-intubation rate within 7 d was not significantly different between the HFNC and nebulizer groups (5/30 subjects [17%] and 6/39 subjects [15%], respectively; P > .99). [Formula: see text]/set [Formula: see text] at 24 h after extubation was also not significantly different between the respective groups (264 ± 105 mm Hg in the HFNC group vs 224 ± 53 mm Hg in the nebulizer group; P = .07). CONCLUSIONS: Compared with a large-volume nebulization-based humidifier, HFNC may not reduce the re-intubation rate within 7 d. However, because of insufficient statistical power, further studies are needed to reach a conclusion.

Nonadherence in Home-Based Pulmonary Rehabilitation Program for COPD Patients.

Background: The pulmonary rehabilitation (PR) is beneficial for COPD patients. Due to the poor rate of adherence, we evaluate the factors which will predict the nonadherence of PR. Method: We analyzed the data from a retrospective study of COPD patients who were enrolled to attend the PR program. Patients were classified as the adherence group and the nonadherence group according to completion of over 50% sessions during the 8-week PR program. Demographic characteristics, 6-minute walking distance (6MWD), COPD assessment test (CAT), modified Medical Research Council scale (mMRC), and emotional function were compared between two groups. Univariate and multivariable analyses were performed to determine the factors of poor adherence of PR. Results: Among 418 patients, 170 patients (40.7%) who completed less than 50% sessions of the PR program were categorized as "nonadherence." Compared to completers, "nonadherence" patients had more cigarette consumption, higher emotional score, less 6MWD, more exacerbation, using nebulizer frequently, and higher rate of smoking at enrollment. On multivariate analysis, more exacerbation frequency (odds ratio (OR) = 1.434, 95% confidence interval (CI): 1.191∼1.796, P=0.046) and smoking at enrollment (OR = 3.349, 95% CI: 1.194∼6.302, P=0.012) were predict factors associated with nonadherence of PR. Conclusion: COPD patients with frequent exacerbation and smoking currently were more likely to be nonadherence during PR.

The Utility of Electronic Inhaler Monitoring in COPD Management: Promises and Challenges.

COPD is a common respiratory disorder that poses a major health-care burden with societal and financial ramifications. Although effective inhaled therapies are available, nonadherence is common among patients with COPD and potentially contributes to the burden of this disease. Electronic inhaler monitoring (EIM) is a novel modality that enables real-time assessment of adherence to inhaled therapy and informs the assessment of treatment effectiveness. EIM can be combined with physician feedback, automated audiovisual reminders, and text messaging to bolster adherence. Clinical studies have suggested that EIM can diagnose nonadherence, improve adherence, and predict exacerbations. Using an EIM-guided protocol has the potential to avoid treatment escalation in the nonadherent. Coupling EIM to behavioral intervention is an area of ongoing research with mixed results, with some studies showing benefit and others showing minimal or no significant change in clinical outcomes. Further investigation is necessary to understand the incremental benefits of EIM features, delineate optimal program implementation, and target patient populations that would benefit the most from monitoring.

Choosing the right inhaler for the right patient: Considerations for effective management of patients with chronic obstructive pulmonary disease or asthma.

BACKGROUND AND PURPOSE: Effective management of chronic respiratory disorders such as chronic obstructive pulmonary disease and asthma necessitates that patients inhale their medication. However, lack of detailed guidelines on the technological and mechanical functions of inhalers limits the ability of health care providers (HCPs) to personalize inhaler choice for patients. Numerous types of inhalers are currently available which offer their own distinct advantages and disadvantages. Independent of the drug class, the choice of inhaler may be influenced by many factors (e.g., inhaler attributes and the efficiency with which it delivers the medication, patient characteristics and preferences, dosing regimen, clinical setting, and support available for both patients and HCPs). This article attempts to summarize the inhalation technology and factors influencing inhaler choice and use and to provide an approach for matching the right inhaler to the right patient. CONCLUSIONS: Identifying factors related to inhaler choice is critical to ensuring adherence to treatment and patients' ability to use their inhaler correctly. IMPLICATIONS FOR PRACTICE: This review will help HCPs engage their patients in decision-making for inhaler choice and facilitate selection of the correct inhaler for each patient (i.e., one that they will use).