Nebulizer Treatments Research Articles

Transmission of COVID-19 to Health Care Personnel During Exposures to a Hospitalized Patient - Solano County, California, February 2020.

On February 26, 2020, the first U.S. case of community-acquired coronavirus disease 2019 (COVID-19) was confirmed in a patient hospitalized in Solano County, California (1). The patient was initially evaluated at hospital A on February 15; at that time, COVID-19 was not suspected, as the patient denied travel or contact with symptomatic persons. During a 4-day hospitalization, the patient was managed with standard precautions and underwent multiple aerosol-generating procedures (AGPs), including nebulizer treatments, bilevel positive airway pressure (BiPAP) ventilation, endotracheal intubation, and bronchoscopy. Several days after the patient's transfer to hospital B, a real-time reverse transcription-polymerase chain reaction (real-time RT-PCR) test for SARS-CoV-2 returned positive. Among 121 hospital A health care personnel (HCP) who were exposed to the patient, 43 (35.5%) developed symptoms during the 14 days after exposure and were tested for SARS-CoV-2; three had positive test results and were among the first known cases of probable occupational transmission of SARS-CoV-2 to HCP in the United States. Little is known about specific risk factors for SARS-CoV-2 transmission in health care settings. To better characterize and compare exposures among HCP who did and did not develop COVID-19, standardized interviews were conducted with 37 hospital A HCP who were tested for SARS-CoV-2, including the three who had positive test results. Performing physical examinations and exposure to the patient during nebulizer treatments were more common among HCP with laboratory-confirmed COVID-19 than among those without COVID-19; HCP with COVID-19 also had exposures of longer duration to the patient. Because transmission-based precautions were not in use, no HCP wore personal protective equipment (PPE) recommended for COVID-19 patient care during contact with the index patient. Health care facilities should emphasize early recognition and isolation of patients with possible COVID-19 and use of recommended PPE to minimize unprotected, high-risk HCP exposures and protect the health care workforce.

Effect of nebulized formoterol, ipratropium bromide, and furosemide in combination with fluticasone propionate on arterial blood gases of premature calves with respiratory distress syndrome

The purpose of this study was to determine the clinical effect of nebulized formoterol (FM), ipratropium bromide (IB) and furosemide (FS) with a combination of fluticasone propionate (FP) on the lung function in premature calves with Respiratory Distress Syndrome (RDS). Thirty-six premature calves with RDS were divided into six groups. All groups received the standard treatment, including oxygen and support treatment. The first group (D1) took the standard treatment. The following combinations of nebulized drugs were used: FP for D2, FP+FM for D3, FP+IB for D4, FP+FS for D5, and FP+IB+ FM+FS for D6. The treatment period (72 h) involved the application of FM (15 µg totally/12 h), IB (2 µg/kg/12 h), FS (1 mg/kg/12 h) and FP (15 µg/kg/12 h) for five minutes. A significant increase in blood pH, PaO 2 , SatO 2 and a decrease in PaCO 2 and lactate were seen in all groups that received nebulized treatment. However, in the D1, a statistical difference was observed only in PaCO 2 . D6 showed the highest PaO 2 andlowest PaCO 2 values amongst all the groups at the 72 nd h. No statistical difference was observed between the NG. Nebulized FM, IB and FS with FP combination in premature calves with RDS, in addition to the standard treatment showed a significant curative effect on lung function.

Effect of nebulized formoterol, ipratropium bromide, and furosemide in combination with fluticasone propionate on arterial blood gases of premature calves with respiratory distress syndrome

The purpose of this study was to assess the clinical effect of nebulized formoterol (FM), ipratropium bromide (IB) and furosemide (FS) combined with fluticasone propionate (FP) on l ung function in premature calves with Respiratory Distress Syndrome (RDS). Thirty-six premature calves with RDS were randomly assigned to six different treatment groups (D1 to D6). All groups received the standard treatment, including oxygen and support treatment. Calves in D1 received only the standard treatment. The following combinations of nebulized drugs were used for the other groups: D2: FP, D3: FP+FM; D4: FP+IB; D5: FP+FS and D6: FP+IB+FM+FS. The treatment period (72 h) involved the application of FM (15 μg totally/12 h), IB (2 μg/kg/12 h), FS (1 mg/kg/12 h) and FP (15 μg/kg/12 h) for five minutes. A significant increase over time in blood pH, partial pressure of oxygen (PaO2), oxygen saturation (SatO2) and a decrease in partial pressure of carbon dioxide (PaCO2) and lactate were detected in all groups that received nebulized treatment; while in the D1, a significant change was observed only for PaCO2. Calves in D6 had the highest PaO2 and lowest PaCO2 values amongst all groups at the end of treatment. No statistical difference was observed between the Nebulization Groups (NG). Nebulized FM, IB and FS with FP combination in premature calves with RDS, in addition to the standard treatment showed a significant curative effect on lung function.

Continuous Albuterol With Benzalkonium in Children Hospitalized With Severe Asthma

The albuterol dropper bottle used to prepare solutions for continuous nebulization contains the preservative benzalkonium chloride (BAC). BAC, by itself, has been shown to cause bronchospasm. We hypothesized that BAC would decrease the therapeutic efficacy of albuterol in patients with acute asthma exacerbations. We performed a retrospective cohort study comparing the clinical outcomes of patients <18 years of age receiving continuous nebulized albuterol with and without BAC. For the primary end point (duration of continuous albuterol nebulization), we compared the 2 groups with Kaplan-Meier estimate of survival curves, conducted a log-rank test of difference, and adjusted for baseline characteristics using multivariable Cox regression. A P value <.05 was considered significant. A total of 477 patients were included in the analysis (236 exposed to BAC and 241 controls). The duration of continuous nebulization was significantly longer in the BAC group than in the control group (median of 9 vs 6 hours; 15.7% required continuous nebulization compared to 5.8% of controls at 24 hours). The control group was 79% more likely to stop continuous nebulization at any particular point in time (hazard ratio 1.79; 95% confidence interval: 1.45 to 2.22; P < .001) and 43% more likely to stop additional respiratory support (hazard ratio 1.43; 95% confidence interval: 1.16 to 1.75; P < .001). BAC is a functional albuterol antagonist associated with a longer duration of continuous albuterol nebulization treatment and additional respiratory support, suggesting that preservative-free albuterol formulations are safer for use in continuous nebulization.

Physiotherapy in hospitalised patients with COVID-19 disease: what we know so far

International Journal of Therapy and RehabilitationVol. 27, No. 3 EditorialPhysiotherapy in hospitalised patients with COVID-19 disease: what we know so farMassimiliano PolastriMassimiliano PolastriCorrespondence to:E-mail Address: [email protected]Medical Department of Continuity of Care and Disability, Physical Medicine and Rehabilitation, St Orsola University Hospital, Bologna, ItalySearch for more papers by this authorMassimiliano PolastriPublished Online:10 Apr 2020https://doi.org/10.12968/ijtr.2020.0035AboutSectionsView articleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail View article References Ambrosino N, Makhabah DN. Comprehensive physiotherapy management in ARDS. Minerva Anestesiol. 2013;79(5):554–563 Google ScholarBBC News. Virus surges in US as death toll passes 1,000. https://www.bbc.co.uk/news/live/world-52044452 (accessed26 March 2020) Google ScholarChinese Association of Rehabilitation Medicine, Respiratory Rehabilitation Committee of Chinese Association of Rehabilitation Medicine, Cardiopulmonary Rehabilitation Group of Chinese Society of Physical Medicine and Rehabilitation. Recommendations for respiratory rehabilitation of COVID-19 in adults. Chinese Journal of Tuberculosis and Respiratory Diseases. 2020;43(0):E029. https://doi.org/10.3760/cma.j.cn112147-20200228-00206 Google ScholarEuropean Centre for Disease Prevention and Control. Situation update for the EU/EEA and the UK, as of 23 March 2020. 2020. https://www.ecdc.europa.eu/en/cases-2019-ncov-eueea (accessed25 March 2020) Google ScholarHui DS, Chow BK, Chu L et al.. Exhaled air dispersion and removal is influenced by isolation room size and ventilations settings during oxygen delivery via nasal cannula. Respirology. 2011;16(6):1005–1013. https://doi.org/10.1111/j.1440-1843.2011.01995.x Crossref, Google ScholarHui DS, Chow BK, Chu L et al.. Exhaled air dispersion during coughing with and without wearing a surgical or N95 mask. PLoS One. 2012;7(12):e50845. https://doi.org/10.1371/journal.pone.0050845 Crossref, Google ScholarHui DS, Chow BK, Lo T et al.. Exhaled air dispersion during non invasive ventilation via helmets and a total facemask. Chest. 2015;147(5):1336–1343. https://doi.org/10.1378/chest.14-1934 Crossref, Google ScholarLazzeri M, Lanza A, Bellini R et al.. Respiratory physiotherapy in patients with COVID-19 infection in acute setting: position paper of the Italian Association of Respiratory Physiotherapists (ARIR).. Monaldi Arch Chest Dis. 2020;90:1285. https://doi.org/10.408/monaldi.2020.1285 Crossref, Google ScholarLi Q, Guan X, Wu P et al.. Early transmission dynamics in Wuhan, China, of novel coronavirus-infected pneumonia. N Engl J Med. 2020. https://doi.org/10.1056/NEJMoa2001316 Crossref, Google ScholarSimonds AK, Hanak A, Chatwin M et al.. Evaluation of droplet dispersion during non-invasive ventilation, oxygen therapy, nebuliser treatment and chest physiotherapy in clinical practice: implications for management of pandemic influenza and other airborne infections. Health Technol Assess. 2010;14(46):131–172. https://doi.org/10.3310/hta14460-02 Crossref, Google ScholarWorld Health Organization. Coronavirus disease (COVID-2019) situation reports. 2020. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200322-sitrep-62-covid-19.pdf?sfvrsn=f7764c46_2 (accessed25 March 2020) Google ScholarYang F, Liu N, Wu JY et al.. Pulmonary rehabilitation guidelines in the principle of 4S for patients infected with 2019 novel coronavirus (2019-nCoV). Zhonghua Jie He He Hu Xi Za Zhi. 2020;43(0):E004. https://doi.org/10.3760/cma.j.issn.1001-0939.2020.0004 Google ScholarZhu N, Zhang D, Wang W et al.. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med. 2020;382(8):727–733. https://doi.org/10.1056/NEJMoa2001017 Crossref, Google Scholar FiguresReferencesRelatedDetailsCited byCOVID-19: emerging challenges in maintaining physical function in patients who have had haematopoietic cell transplantsJaleel Mohammed, Anne Gonzales, Hadeel R Bakhsh, Jayanti Rai, Nnenna Chigbo, Shahrukh K Hashmi2 October 2020 | International Journal of Therapy and Rehabilitation, Vol. 27, No. 9Developing patient information and clinician education resources for venous thromboembolism in a physiotherapy department in response to the COVID-19 pandemicChris Drake, Nicola Hicks, Leanne Atkin2 October 2020 | International Journal of Therapy and Rehabilitation, Vol. 27, No. 9A new way forwardVicki Williams2 October 2020 | International Journal of Therapy and Rehabilitation, Vol. 27, No. 9 2 March 2020Volume 27Issue 3ISSN (online): 1759-779X Metrics History Published online 10 April 2020 Published in print 2 March 2020 Information© MA Healthcare LimitedPDF download

Investigating the Temporal Relationships between Symptoms and Nebuliser Adherence in People with Cystic Fibrosis: A Series of N-of-1 Observations.

Treatment adherence in adults with cystic fibrosis (CF) is poor. One of the reasons identified for lack of adherence to nebulised treatments is that patients may not experience any immediate relief in their symptoms or notice changes as a result of taking their treatment, thus many report that they do not perceive there to be consequences of non adherence. The aim of the study was to investigate the temporal relationships between symptoms and adherence to nebulised treatments in adults with CF using an N-of-1 observational design. Six participants were recruited for a six-week period during which time they completed a daily online respiratory symptom questionnaire. Adherence to treatment was measured throughout the duration of the study using an eTrack® nebuliser that logged date and time of treatments taken. Data generated from each participant was analysed separately. There were significant relationships between pain and adherence for three participants, tiredness and adherence for one participant and cough and adherence for one participant. For all of these findings, the symptom and adherence were experienced on the same day. Extending the monitoring period beyond six weeks may provide increased insight into the complex relationship between symptoms and adherence in CF.

COVID-19 Patient with Multifocal Pneumonia and Respiratory Difficulty Resolved Quickly: Possible Antiviral and Anti-Inflammatory Benefits of Quercinex (Nebulized Quercetin-NAC) as Adjuvant

Background: SARS-CoV-2 (COVID-19) is a viral pandemic with no current vaccine or effective treatment. Hydroxychloroquine and azithromycin are not without cardiovascular risk or complications, and these treatments can fail to aid in full recovery from COVID-19. As new treatments become approved for the pandemic, an inexpensive, non-toxic, and safe adjunctive therapy is needed. Case Presentation: A 59-year-old male presented with respiratory symptoms. Chest X-ray revealed classic indications of COVID-19 pneumonia. A PCR nasopharyngeal swab test confirmed a COVID-19 infection and hospital doctors prescribed Rocephin, azithromycin, and hydroxychloroquine. The patient was then prescribed Quercinex, a nebulized formula of quercetin-(cyclodextrin) (20 mg/mL) and N-acetylcysteine (100 mg/mL) three times daily for 14 days by physicians at Envita Medical Center for continued COVID-19 respiratory symptoms. Following 30 minutes after each nebulization treatment, the patient experienced immediate deep breathing relief that lasted for multiple hours. Within the following 48 hours after the first treatment, respiratory symptoms continued to diminish and resolve quickly. Finally, post-treatment follow-up chest X-rays revealed no pulmonary fibrosis (scarring) and clear lung fields. Conclusion: The Quercinex formula appeared to greatly alleviate the unresolved respiratory symptoms rapidly. Several mechanisms of the formula, namely antiviral and anti-inflammatory action, with direct administration via nebulizer to the deep lung tissue, could potentially explain the fast and complete recovery. We recommend that the Quercinex formula be considered for further clinical study as an adjuvant or on its own for COVID-19 and possibly other viral pulmonary conditions.

The use of nebulized pharmacotherapies during the COVID-19 pandemic.

Coronavirus disease 2019 (COVID-19), caused by the highly contagious novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in a worldwide pandemic and currently represents a major public health issue. COVID-19 has highlighted the need for clear and accurate guidance on the use of aerosol-generating procedures, such as nebulization, for the treatment of patients with respiratory diseases with or without COVID-19. Despite the lack of evidence, there is heightened concern about the potential risk of transmission of SARS-CoV-2 in the form of aerosolized respiratory droplets during the nebulized treatment of patients with COVID-19. Consequently, the use of metered-dose inhalers (MDIs) has risen considerably as an alternative to nebulized therapy, which has led to inadequate supplies of MDIs in some parts of the United States. In this article, we review and discuss the role of nebulization in patients with SARS-CoV-2 and the treatment of noninfected patients with chronic respiratory diseases. The following two important questions are addressed: (1) should nebulized therapy be used in hospital or home settings by patients infected with SARS-CoV-2; and (2) should nebulized therapy be continued in patients already using it for chronic respiratory disease management in hospital or home settings? The reviews of this paper are available via the supplemental material section.

Effects of nebulized dexamethasone on the respiratory microbiota and mycobiota and relative equine herpesvirus-1, 2, 4, 5 in an equine model of asthma.

BackgroundProlonged exposure to environmental antigens or allergens elicits an immune response in both healthy horses and those with mild asthma. Corticosteroids often are used to treat lower airway inflammation.ObjectiveTo investigate the changes in equine herpesvirus (EHV)‐1,2,4,5 glycoprotein B gene expression and changes in respiratory bacterial and fungal communities after nebulized dexamethasone treatment of horses with asthma.AnimalsHorses with naturally occurring mild asthma (n = 16) and healthy control horses (n = 4).MethodsProspective, randomized, controlled, blinded clinical trial. Polymerase chain reaction amplification of EHV‐1,2,4,5 in bronchoalveolar lavage fluid, and 16S (microbiome) and ITS2 (mycobiome) genes with subsequent sequencing was performed on DNA extracted from nasal swabs and transendoscopic tracheal aspirates before and after 13 days treatment with nebulized dexamethasone (15 mg q24h) and saline (control).ResultsNebulized dexamethasone treatment decreased microbial diversity; relative abundance of 8 genera in the upper respiratory tract were altered. For both the microbiota and the mycobiota, environment had a dominant effect over treatment. Alternaria, an opportunistic pathogen and allergen in humans recognized as a risk factor for asthma, asthma severity, and exacerbations, was increased with treatment. Treatment affected relative quantification of the equine gamma herpesviruses (EHV‐2 and ‐5); EHV‐2 DNA levels increased and those of EHV‐5 decreased.ConclusionsNebulized dexamethasone treatment affected the upper respiratory tract microbiota, but not the mycobiota, which was overwhelmed by the effect of a sustained dusty environment.

Application of extracorporeal membrane oxygenation technique in patients with acute respiratory failure caused by ammonia poisoning

Acute severe ammonia inhalation can seriously affect oxygenation and ventilation function of patients, and even cause acute respiratory distress syndrome (ARDS). Extracorporeal membrane oxygenation (ECMO) technology is increasingly used in treating patients with ARDS caused by infection, cardiogenic shock, trauma, and drowning with achieved certain effects, but its usage for ARDS caused by ammonia is rarely reported. On July 7, 2018, a case of ARDS caused by ammonia inhalation was admitted to the emergency ICU of the First Affiliated Hospital of Zhengzhou University. After admission, the patient was treated with ECMO immediately on the basis of anti-infection, anti-oxidation, suctioning and nebulization treatments. After 8 days, he was weaned from ECMO and transferred to a general ward for continued rehabilitation. After 23 days, his condition improved and was discharged without complaining of any discomfort during the follow-up till March 2019. The successful experience was summarized in order to provide reference for the treatment of such patients in the future.

Maintained therapeutic effect of revefenacin over 52\u2009weeks in moderate to very severe Chronic Obstructive Pulmonary Disease (COPD)

BackgroundRevefenacin is a long-acting muscarinic antagonist that was recently approved for the nebulized treatment of chronic obstructive pulmonary disease (COPD). Although shorter duration studies have documented the efficacy of revefenacin in COPD, longer-term efficacy has not been described. In a recent 52-week safety trial, revefenacin was well tolerated and had a favorable benefit-risk profile. Here we report exploratory efficacy and health outcomes in patients receiving revefenacin 175 μg or 88 μg daily during the 52-week trial.MethodsIn this randomized, parallel-group, 52-week trial (NCT02518139), 1055 participants with moderate to very severe COPD received revefenacin 175 μg or 88 μg in a double-blind manner, or open-label active control tiotropium.ResultsOver the 52-week treatment period, both doses of revefenacin, as well as tiotropium, elicited significant (all p < 0.0003) improvements from baseline in trough forced expiratory volume in 1 s (FEV1). The trough FEV1 profile (least squares mean change from baseline) for revefenacin 175 μg ranged from 52.3–124.3 mL and the trough FEV1 profile for tiotropium ranged from 79.7–112.8 mL. In subgroup comparisons, the effect of revefenacin on trough FEV1 was comparable in patients taking concomitant long-acting β-agonists, with or without inhaled corticosteroids, with patients who were not taking these medications. There were statistically significant (p < 0.05) improvements in all measured health status outcomes (evaluated using St. George’s Respiratory Questionnaire, COPD Assessment Test, Clinical COPD Questionnaire and Baseline and Transition Dyspnea Index) from 3 months onward, in all treatment arms.ConclusionsSignificant sustained improvements from baseline in trough FEV1 and respiratory health outcomes were demonstrated for 175-μg revefenacin over 52 weeks, further supporting its use as a once-daily bronchodilator for the nebulized treatment of patients with COPD.Trial registrationNCT02518139; Registered 5 August 2015.

IPRATROPIUM BROMIDE NEBULIZER-ASSOCIATED ANISOCORIA

SESSION TITLE: Tuesday Medical Student/Resident Case Report Posters SESSION TYPE: Med Student/Res Case Rep Postr PRESENTED ON: 10/22/2019 01:00 PM - 02:00 PM INTRODUCTION: Anisocoria, is a rare clinical sign with a long list of differential diagnoses. It is often treated as a form of intracranial pathology until proven otherwise. However, if a patient lacks additional ocular abnormalities or neurological deficits, it is less likely that this clinical sign is due to intracranial pathology. Here, we present a patient with COPD exacerbation who developed anisocoria after inhaled ipratropium bromide treatment. CASE PRESENTATION: 71-year-old female was admitted to the intensive care unit for acute hypoxic respiratory failure due to a COPD exacerbation and pneumonia. The patient was intubated and started on broad spectrum antibiotics. She was later extubated to BiPAP and subsequently transferred to the general medical floor. While on BiPAP, she was receiving nebulized Ipratropium bromide/albuterol sulfate every 4 hours. Shortly after starting one of her nebulizer treatments, the rapid response team was called to evaluate to the patient for a new onset fixed and dilated left pupil. She did not have any other neurological deficits and a CT head was negative for acute intracranial pathology. After further evaluation, the BiPAP face mask was found to have a faulty seal. Patient was given a new face mask with minimal leaks, and the mydriasis resolved within 12 hours. DISCUSSION: Anisocoria is a clinical sign that can warrant concern. Rare but life-threatening diagnoses include uncal herniation, intracranial hemorrhage/mass or posterior-communicating artery aneurysm, that each impair adjacent parasympathetic innervation leading to unopposed sympathetic innervation of the iris. Consequently, this clinical sign is often treated as intracranial pathology until proven otherwise. However, in the absence of other ocular abnormalities or neurological deficits, it is unlikely that this clinical sign is due to intracranial pathology. Pharmacological causes should initially be considered. Ocular anticholinergics that cause temporary mydriasis include atropine, scopolamine, hyoscyamine, and often mis-directed aerosolized ipratropium bromide. In our patient, the mydriasis was a result of nebulized ipratropium with unintentional contact the eye by an improperly fitted nebulizer mask. The use of the pilocarpine eye drop test can help confirm a pharmacological muscarinic blockade if pilocarpine has no miotic effect. Additionally, the subsequent resolution of anisocoria 2-48 hours after discontinuation of nebulized anticholinergic is further support. An alternative diagnosis should be pursued if the pilocarpine test causes miosis, if the mydriasis becomes fixed and persistent, or if there are additional ocular or neurological abnormalities. CONCLUSIONS: With the widespread use of nebulized treatments, it is essential to be aware of this sign as it is important to consider these reversible causes as a potential diagnosis that guides subsequent management. Reference #1: Chaudhry P, Friedman DI, Yu W. Unilateral pupillary mydriasis from nebulized ipratropium bromide: A false sign of brain herniation in the intensive care unit. Indian J Crit Care Med. 2014;18(3):176-7. Reference #2: Yalcin S, Pampal K, Erden A, Oba S, Bilgin S. Do we really need to panic in all anisocoria cases in critical care?. Indian J Anaesth. 2010;54(4):365-6. Reference #3: Yalcin S, Pampal K, Erden A, Oba S, Bilgin S. Do we really need to panic in all anisocoria cases in critical care?. Indian J Anaesth. 2010;54(4):365-6. DISCLOSURES: No relevant relationships by Mirza Ali, source=Web Response No relevant relationships by M Bakir, source=Web Response No relevant relationships by SarahGrace Carbrey, source=Web Response No relevant relationships by Abdisamad Ibrahim, source=Web Response No relevant relationships by Thamer Sartawi, source=Web Response

Systemic pharmacokinetics and safety of high doses of nebulized colistimethate sodium in critically ill patients with hospital-acquired and ventilator-associated pneumonia

To assess the pharmacokinetics of formed colistin in plasma and the safety of two different high doses of colistimethate sodium administered via nebulization in critically ill surgical patients with hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP). Formed colistin plasma concentrations were measured in critically ill surgical patients with pneumonia treated with two different doses of nebulized colistimethate sodium (3 MIU/8 h versus 5 MIU/8 h). Adverse events possibly related to nebulized colistimethate sodium were recorded. Twenty-seven patients (15 in the 3 MIU/8 h group and 12 in the 5 MIU/8 h group) were included. Colistin plasma concentrations were unquantifiable (<0.1 mg/L) in eight (53.3%) patients in the 3 MIU/8 h group and in seven patients (58.3%) in the 5 MIU/8 h group. Median (IQR) quantifiable colistin plasma concentrations before nebulization and at 1, 4 and 8 h were 0.17 (0.12-0.33), 0.20 (0.11-0.24), 0.17 (0.12-0.23) and 0.17 (0.11-0.32) mg/L, respectively, in the 3 MIU/8 h group and 0.20 (0.11-0.35), 0.24 (0.12-0.44), 0.24 (0.10-0.49) and 0.23 (0.11-0.44) mg/L, respectively, in the 5 MIU/8 h group, with no differences between the two groups at any time. Renal impairment during nebulized treatment was observed in three patients in each group, but was unlikely to be related to colistimethate sodium treatment. Nebulized colistimethate sodium therapy was well tolerated and no bronchospasms or neurotoxicity events were observed. In this limited observational case series of critically ill patients with HAP or VAP treated with high doses of nebulized colistimethate sodium, systemic exposure was minimal and the treatment was well tolerated.

When Is Forgetting Not Forgetting? A Discursive Analysis of Differences in Forgetting Talk Between Adults With Cystic Fibrosis With Different Levels of Adherence to Nebulizer Treatments.

Forgetting is often cited as a reason why people struggle to adhere to treatments for chronic conditions. Interventions have tried to improve forgetting behavior using reminders. We used a discursive psychological approach to explore differences in how high and low adherers constructed forgetting their nebulizer treatments for cystic fibrosis. Interviews were conducted with 18 adults from a cystic fibrosis center in the United Kingdom. High adherers constructed forgetting treatments as occasional lapses in automaticity and temporary lapses in memory that they found easy to repair. Low adherers utilized forgetting to normalize more consistent nonadherence to treatments. However, it is important to contextualize forgetting as a discursive resource that helped these participants to negotiate moral discourses around adherence to treatment that reminder interventions cannot address; we therefore recommend a more behavioral, patient-focused, theory-driven approach to intervention development.

Understanding patient activation and adherence to nebuliser treatment in adults with cystic fibrosis: responses to the UK version of PAM-13 and a think aloud study

BackgroundPatient activation refers to patients’ knowledge, skills, and confidence in self-managing health conditions. In large cross-sectional studies, individuals with higher patient activation are observed to have better health outcomes with the assumption that they are more engaged in health self-management. However, the association between patient activation and objectively measured self-care indicators in individuals can be inconsistent. This research investigated the role of patient activation as measured by the UK Patient Activation Measure (PAM-13) in adults with Cystic Fibrosis (CF). The aims were twofold: to explore how adults with CF interpret and respond to the PAM-13; and to investigate the association between PAM-13 and objectively measured nebuliser adherence in UK adults with CF.MethodsThis article describes two studies which examined the PAM-13 from different perspectives. Study 1 comprised ‘think aloud’ interviews with 15 adults with CF. The data were analysed using an a priori coding framework. Study 2 examined the association between PAM-13 and objectively measured nebuliser adherence in 57 adults with CF.ResultsStudy 1 showed that adults with CF encountered several difficulties while completing the PAM-13. The difficulties were related to understanding how to interpret aspects of CF in order to respond (i.e., control over the condition, ability to exercise) and item wording. Some adults with CF responded to the PAM-13 in an optimistic way in relation to what they thought they should do rather than what they actually do. These findings were echoed by the results of Study 2, which showed that PAM-13 scores were not significantly correlated with objective medication adherence in a different sample. This article synthesises the results of both studies, providing insights into influences and associations of patient activation as measured by the UK PAM-13 in adults with CF.ConclusionsThere were some significant difficulties created by the wording of the UK PAM-13 for adults with CF. This may partly explain the finding that PAM-13 scores were not related to objectively measured nebuliser adherence in this study. The UK PAM-13 would benefit from further research to verify its validity and reliability in different patient populations against objective measures of behaviour rather than simply self-report.

P432 How physiotherapists improved prescription accuracy for nebuliser treatment: using click analytics from CFHealthHub, a digital adherence system, to monitor quality improvement

P432 How physiotherapists improved prescription accuracy for nebuliser treatment: using click analytics from CFHealthHub, a digital adherence system, to monitor quality improvement

Revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for nebulized therapy: Safety and tolerability results of a 52-week phase 3 trial in moderate to very severe chronic obstructive pulmonary disease

Prior replicate 12-week phase 3 trials demonstrated that once-daily doses of revefenacin inhalation solution at 88 μg and 175 μg produced significant bronchodilation over 24 h post dose in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). The objective was to characterize the safety profile of revefenacin 88 μg and 175 μg over 52 weeks of treatment. In this randomized, parallel-group, 52-week trial (NCT02518139), 1055 participants with moderate to very severe COPD received revefenacin 88 μg or 175 μg in a double-blind manner, or open-label active control tiotropium. Treatment-emergent adverse events (AEs) were comparable across all treatment groups (n [%] patients; revefenacin 88 μg, 272 [74.7%]; 175 μg, 242 [72.2%]; tiotropium, 275 [77.2%]). Numerically fewer COPD exacerbations (n [%] patients) were observed with revefenacin 175 μg (73 [21.8%]) than with 88 μg (107 [29.4%]) or tiotropium (100 [28.1%]). Serious AEs were comparable with revefenacin 88 μg (58 [15.9%] and tiotropium (58 [16.3%]), but were lower with revefenacin 175 μg (43 [12.8%]), and mortality was low. In patients using revefenacin 88 μg or tiotropium with a concurrent long-acting β-agonist (LABA) product, the incidence of AEs was slightly higher than without concurrent LABA. LABA did not affect the incidence of AEs for patients who received revefenacin 175 μg. Revefenacin was generally well tolerated over 52 weeks of treatment, and had a safety profile that supports its use as a long-term once-daily bronchodilator for the nebulized treatment of COPD.

Adherence to medication in adults with Cystic Fibrosis: An investigation using objective adherence data and the Theoretical Domains Framework.

ObjectivesAdherence to nebulizer treatment in adults with Cystic Fibrosis (CF) is poor, and interventions are needed. This research aimed to identify the factors affecting nebulizer adherence using the Theoretical Domains Framework (TDF) and to compare these for participants with different levels of adherence.DesignData‐prompted interviews using the TDF.MethodsEighteen semi‐structured interviews were conducted with adults with CF during which objectively measured adherence data were discussed. Framework analysis was used to code the data into TDF domains, and inductive qualitative content analysis was used to code different beliefs and experiences. Aspects of the TDF that differed between participants with different adherence levels were explored.ResultsFactors influencing adherence to treatment included all 14 domains of the TDF, 10 of which appeared to vary by adherence level: Skills; Memory and decision‐making; and Behavioural regulation; Environmental context and resources; Social influences; Beliefs about consequences; Beliefs about capability; Reinforcement; Social role and identify; Intentions; Optimism; and Emotions.ConclusionsThis study is the first to use objectively measured adherence data in a data‐prompted interview using the TDF framework to systematically assess the full range of factors potentially influencing adherence. The results highlighted that interventions need to consider issues of capability, opportunity, and motivation. Interventions that challenge dysfunctional beliefs about adherence and which support the development of routines or habits and problem‐solving may be particularly useful for adults with CF. Statement of contribution What is already known? Adherence to medication in adults with cystic fibrosis is poor.Previous research has identified a range of contributing factors in relation to subjective reports of adherence.There is a wide discrepancy between self‐reported adherence and objectively measured adherence. What this study adds A data‐prompted interview using objectively measured adherence data enabled the systematic assessment of potential factors that could be targeted in an intervention to increase adherence.There were some differences in the factors that were identified by high and low adherers.There is not one‐size fits all intervention for adherence to medication in cystic fibrosis.

Nebülizatör Tedavisi Alan Üç-Altı Yaş Grubu Çocuklarda Oyuncak Tipi Nebülizatör ile Verilen Eğitimin Etkinliğinin Değerlendirilmesi

Nebülizatör Tedavisi Alan Üç-Altı Yaş Grubu Çocuklarda Oyuncak Tipi Nebülizatör ile Verilen Eğitimin Etkinliğinin Değerlendirilmesi

CARDIOVASCULAR SAFETY OF REVEFENACIN FOR NEBULIZATION: A REVIEW OF RANDOMIZED CONTROLLED TRIAL DATA

SESSION TITLE: Obstructive Lung Diseases 2 SESSION TYPE: Original Investigation Posters PRESENTED ON: 10/10/2018 01:00 PM - 02:00 PM PURPOSE: Revefenacin, a once-daily, lung-selective, long-acting muscarinic receptor antagonist in clinical development for the nebulized treatment of chronic obstructive pulmonary disease (COPD), produces sustained bronchodilation with limited systemic adverse events (AEs). As cardiovascular (CV) disease is highly prevalent in COPD patients, we evaluated CV safety data from 3 randomized trials of revefenacin, and a thorough QT study in healthy subjects. METHODS: CV safety data were assessed in a phase 1, placebo- and positive-controlled thorough QT study in healthy subjects receiving therapeutic (175 μg) and supratherapeutic (700 μg) inhaled single doses of revefenacin (Study 0136, N=48). The potential association between daily nebulized revefenacin 88 μg and 175 μg and CV safety was evaluated in patients with moderate to very severe COPD in 2 identical, 12-week, placebo-controlled, phase 3 trials (Study 0126, N=619; Study 0127, N=611), and an active-controlled, 52-week, phase 3 safety trial (Study 0128, N=699). An independent external clinical events committee (CEC) performed blinded review and adjudication of all prespecified major CV AEs (MACE) in studies evaluating COPD patients. RESULTS: Single doses of revefenacin did not have a clinically meaningful effect on cardiac repolarization (QTcF) in healthy subjects. No clinically meaningful changes in 12-lead ECG recordings were observed with up to 52 weeks of daily revefenacin 88 μg and 175 μg in patients with COPD. The incidences of prolonged QTcF interval (>450 msec) were similar in the placebo (4.9% and 5.8%), revefenacin 88 μg (6.3% and 4.9%) and revefenacin 175 μg (5.1% and 6.7%) arms of Studies 0126 and 0127, respectively. In Study 0128, the incidences of prolonged QTcF were similar in the revefenacin 175 μg (7.7%) and tiotropium (7.3%) groups, and slightly lower in the revefenacin 88 μg group (4.2%). No CV-related treatment-emergent AEs were reported with single-dose revefenacin at doses of 175 μg and 700 μg in healthy subjects. After CEC adjudication, there were 4 MACE in Study 0126 (2, 1, and 1 in the revefenacin 88 μg, revefenacin 175 μg, and placebo groups, respectively), zero MACE in Study 0127, and 26 MACE in Study 0128 (9, 10, and 7 in the revefenacin 88 μg, revefenacin 175 μg, and tiotropium groups, respectively). Only 1 of these MACE was considered related to revefenacin (atrial fibrillation in the revefenacin 175 μg group in Study 0128). CONCLUSIONS: Revefenacin for nebulization does not prolong QT interval. No increased risk of MACE was identified in clinical trials up to 52 weeks in duration. CLINICAL IMPLICATIONS: Once-daily revefenacin over periods of up to 1 year is associated with acceptable CV safety and, thus, may provide beneficial nebulized therapy for patients with COPD. DISCLOSURES: No relevant relationships by Chris Barnes, source=Web Response Consultant relationship with Theravance Biopharma Please note: >$100000 Added 03/09/2018 by Marie Borin, source=Web Response, value=Consulting fee Employee relationship with Theravance Biopharma Please note: >$100000 Added 03/08/2018 by David Bourdet, source=Web Response, value=Salary No relevant relationships by Borje Darpo, source=Web Response Advisory Committee Member relationship with Mylan Inc Please note: $1001 - $5000 Added 03/02/2018 by James Donohue, source=Web Response, value=Honoraria Removed 03/02/2018 by James Donohue, source=Web Response Advisory Committee Member relationship with Sunovion Pharmaceuticals Please note: $1001 - $5000 Added 03/02/2018 by James Donohue, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Mylan Inc Please note: $1001 - $5000 Added 03/02/2018 by James Donohue, source=Web Response, value=Consulting fee No relevant relationships by Gregory Feldman, source=Admin input Employee relationship with Theravance Please note: >$100000 Added 03/02/2018 by Srikanth Pendyala, source=Web Response, value=Salary Research funds to institution relationship with Astra Zeneca Please note: $20001 - $100000 Added 03/09/2018 by Sanjay Sethi, source=Web Response, value=Grant/Research Support Advisory Committee Member relationship with Astra Zeneca Please note: $5001 - $20000 Added 03/09/2018 by Sanjay Sethi, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with Boerhinger Ingelheim Please note: $5001 - $20000 Added 03/09/2018 by Sanjay Sethi, source=Web Response, value=Honoraria Advisory Committee Member relationship with Boerhinger Ingelheim Please note: $1001 - $5000 Added 03/09/2018 by Sanjay Sethi, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Glaxo Smith Kline Please note: $5001 - $20000 Added 03/09/2018 by Sanjay Sethi, source=Web Response, value=Consulting fee Clinical Event adjudication committee relationship with Pulmonx Please note: $5001 - $20000 Added 03/09/2018 by Sanjay Sethi, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Sunovion Please note: $1001 - $5000 Added 03/09/2018 by Sanjay Sethi, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Theravance Please note: $1001 - $5000 Added 03/09/2018 by Sanjay Sethi, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Circassia Please note: $1001 - $5000 Added 03/09/2018 by Sanjay Sethi, source=Web Response, value=Consulting fee