Beta-agonist Therapy Research Articles

Pleural line slope in point of care ultrasound assessment of paediatric wheeze may reflect respiratory effort.

Asthma scoring systems rely on physical examination findings. Point of care ultrasound may provide an objective means to document improvement in the work of breathing in paediatric lower airway obstruction. Thirty children with wheeze on physical examination (cases) and 15 children presenting with abdominal pain (controls) were studied. Using point-of-care ultrasound, m-mode tracing of lung was recorded above the right hemidiaphragm at the midclavicular line. Pleural line slope and excursion were measured before and after treatment. Twenty patients had a final slope measurement under 20°, and only three were admitted-one for hypoxia that resolved prior to ascending to the ward and another for poor compliance. Average decrease in pleural line slope after treatment was 43% and average decrease in pleural line excursion was 32%. Of the 10 children admitted, 8 had measurements over 25°. The correlation coefficient between pleural slope and pleural excursion was 0.67. All controls had a horizontal m-mode tracing at the pleural line. Oscillation of the m-mode line at the pleura is seen in children with lower airway obstruction and is absent in controls. There appears to be a correlation between beta-agonist therapy and decreased pleural line slope and excursion.

Study protocol: A comparison of mobile and clinic-based spirometry for capturing the treatment effect in moderate asthma.

Several inefficiencies in drug development trial implementation may be improved by moving data collection from the clinic to mobile, allowing for more frequent measurements and therefore increased statistical power while aligning to a patient-centric approach to trial design. Sensor-based digital health technologies such as mobile spirometry (mSpirometry) are comparable to clinic spirometry for capturing outcomes, such as forced expiratory volume in 1 s (FEV1); however, the impact of remote spirometry measurements on the detection of treatment effect has not been investigated. A protocol for a multicenter, single-arm, open-label interventional trial of long-acting beta agonist (LABA) therapy among 60 participants with uncontrolled moderate asthma is described. Participants will complete twice-daily mSpirometry at home and clinic spirometry during weekly visits, alongside continuous use of a wrist-worn wearable and regular completion of several diaries capturing asthma symptoms as well as participant- and site-reported satisfaction and ease of use of mSpirometry. The co-primary objectives of this study are (A) to quantify the treatment effect of LABA therapy among participants with moderate asthma, using both clinical spirometry (FEV1c ) and mSpirometry (FEV1m ); and (B) to investigate whether FEV1m is as accurate as FEV1c in detecting the treatment effect using a mixed-effect model for repeated measures. Study results will help inform whether the deployment of mSpirometry and a wrist-worn wearable for remote data collection are feasible in a multicenter setting among participants with moderate asthma, which may then be generalizable to other populations with respiratory disease.

Emergency Medical Services Management of Bronchospasm in the United States: A Cross-Sectional Analysis and Nationwide Quality Assessment

Background/Objective: Bronchospasm, caused by asthma and other related conditions, is a significant cause of morbidity and mortality commonly managed by emergency medical services (EMS). We aimed to evaluate the quality of prehospital management of bronchospasm by EMS in the US. Methods: The National EMS Information System Public Release Research dataset, a nationwide convenience sample of prehospital patient care report data from 2018 to 2019, was used to capture 9-1-1 activations where patients aged ≥2 years were treated and transported by EMS for suspected bronchospasm. First, we described the extent to which EMS care met eight quality measures identified from available statewide EMS protocols, existing quality measures, and national guidelines. Second, we quantified the extent of risk-standardized agency-level variation in administration of inhaled beta agonists and systemic corticosteroids using logistic regression models, accounting for patient characteristics, severity, and clustering by agencies. Third, we compared rates of completed prehospital interventions between pediatric (age <18 years) versus adult patients using two-sample t-tests. Results: A total of 1,336,988 EMS encounters for suspected bronchospasm met inclusion criteria. Median age of patients was 66 years, with only 4% pediatric; 55% were female. Advanced life support (ALS) units managed 94% of suspected bronchospasm. Respiratory rate (98%) and pulse oximetry (96%) were documented in nearly all cases. Supplemental oxygen was administered to hypoxic patients by 65% of basic life support (BLS) and 73% of ALS units. BLS administered inhaled beta-agonist therapy less than half the time (48%), compared to 77% by ALS. ALS administered inhaled anticholinergic therapy in 38% of cases, and systemic corticosteroids in 19% of cases. Pediatric patients were significantly less likely to receive supplemental oxygen when hypoxic, inhaled beta-agonists, inhaled anticholinergics, or systemic corticosteroids. Conclusions: We found important gaps in recent EMS practice for prehospital care of suspected bronchospasm. We highlight three targets for improvement: inhaled beta-agonist administration by BLS, systemic corticosteroid administration by ALS, and increased interventions for pediatric patients. These findings indicate important areas for research, protocol modification, and quality improvement efforts to improve EMS management of bronchospasm.

Induced sputum eosinophilia and pulmonary function tests in ex-smokers with asthma controlled with an inhaled steroid and long-acting beta-agonist therapy.

This study aims to investigate the relationship between induced sputum eosinophilia and pulmonary functions in ex-smoker asthma patients controlled with an ICS/LABA therapy. Asthma patients who are known to use ICS/LABA regularly for at least three months, without an attack in the last month, quit smoking (5-20 pack-years) and have asthma under control (ACT> 20), and concurrent with induced sputum cytology who had spirometry and lung volume measurements were included in the study. Cytology results, induced sputum eosinophil and neutrophil counts, FEV1 (L), FEV1 (%), FVC (L), FVC (%), RV (L), RV (%) and RV/TLC (%) values of all patients were recorded. The relationship between sputum neutrophil and eosinophil count and pulmonary function test parameters was evaluated. Seventeen (68%) of the patients were female, eight (32%) were male, and the mean age was 49.7 ± 13.6 years. The mean sputum eosinophil percentage was 9.4 ± 16.7, and the neutrophil percentage was 71.4 ± 20.5. A positive correlation was found between induced sputum eosinophil percentage values and FEV1 (L) (r= +0.472; p= 0.01) and FVC (L) (r= +0.502; p= 0.01). No correlation was found between the FEV1/FVC%, FEV1%, FVC%, RV (L), RV%, and RV/TLC% values and the percentage of induced sputum eosinophils (p> 0.05). It was observed that controlled asthmatic patients with induced sputum eosinophilia treated with ICS/LABA and who quit smoking had high FVC (L) and FEV1 (L) levels.

Symptom-driven inhaled corticosteroid/long-acting beta-agonist therapy for adult patients with asthma who are non-adherent to daily maintenance inhalers: a study protocol for a pragmatic randomized controlled trial

BackgroundWhile inhaled corticosteroids (ICS) are considered the essential foundation of most asthma therapy, ICS inhaler nonadherence is a notoriously common problem and a significant cause of asthma-related morbidity. Partially acknowledging the problem of nonadherence, international organizations recently made paradigm-shifting recommendations that all patients with mild-to-moderate persistent asthma be considered for symptom-driven ICS-containing inhalers rather than relying on adherence to traditional maintenance ICS inhalers and symptom-driven short-acting beta-agonists (SABA). With this new approach, asthma patients are at least exposed to the important anti-inflammatory effects of ICS-containing inhalers when their symptom reliever inhaler is deployed due to acute symptoms.MethodsThis study will (Part 1) complete a pragmatic randomized controlled trial to evaluate if an inhaler strategy that utilizes symptom-driven ICS inhalers is particularly beneficial in maintenance ICS inhaler non-adherent asthma patients, and (Part 2) use a dissemination and implementation (D&I) science conceptual framework to better understand patients’ and providers’ views of inhaler nonadherence. This study, which will have an option of taking place entirely remotely, will use a Food and Drug Administration (FDA)-approved electronic sensor (Hailie® sensor) to monitor inhaler adherence and includes semi-structured interviews guided by the Consolidated Framework for Implementation Research (CFIR).DiscussionThis study is assessing the problem of nonadherence using a D&I implementation science research lens while testing a new inhaler approach to potentially ameliorate the detrimental consequences of maintenance inhaler nonadherence. We hypothesize that the use of a symptom-driven ICS/LABA management strategy, as compared to traditional maintenance ICS treatment and symptom-driven SABA, will lead to improved adherence to an asthma treatment strategy, decreased asthma-related morbidity, less cumulative ICS exposure, and greater patient satisfaction with an inhaler approach.Trial registrationClinicalTrials.gov NCT05111262. Registered on November 8, 2021.

Effect of Primary Care on Reducing Rates of Hospitalization Among Chronic Obstructive Pulmonary Disease Patients

The normal course of Chronic obstructive pulmonary disease (COPD) includes a progressive reduction in lung function, exacerbations that necessitate primary care intervention or hospital admission, a steady decline in quality of life, and a shorter life expectancy. COPD is one of the ambulatory or primary care-sensitive illnesses for which it is hypothesized that efficient primary care management will lower the probability of hospital admission. Long-acting beta-agonist and inhaler steroid combination therapy improves spirometric results and overall health while lowering the annual risk of COPD exacerbations. Use of two or more treatment modules based on models designed specifically for chronic care delivery in developed countries have proven successful in lowering hospitalizations as well. Access to other therapies, such as pulmonary rehabilitation, acute exacerbation evaluation programs, and community or hospital-based respiratory specialists, may also be important. The goal of interventions to lessen the prevalence of COPD in underserved areas has to focus on locally driven integrated solutions, such as media campaigns to raise awareness and persuade at-risk individuals to get tested, as well as training for primary care workers on the significance and advantages of earlier detection and effective operation of chronic obstructive pulmonary disease. Importantly, uptake of influenza vaccination has demonstrated a link with hospital admission rates at the practice level. Proposed solutions for lowering hospitalization and reducing exacerbations among patients with COPD include greater access to pulmonary rehabilitative care, more rigorous implementation of smoking cessation programs and availability of modern long-acting medications.

The role of beta-agonist therapy for chronic obstructive airway disease in patients with coexistent atrial fibrillation

Background: New advances have been made in medicine, but the incidence and prevalence of chronic obstructive pulmonary disease (COPD) are evident, and it is established as the fourth cause of death in the United States representing a high cost for the healthcare system. This condition has been related to atrial fibrillation due to the changes in the lungs and vasculature. Based on this history, we seek to evaluate the outcome of AF in the patients with COPD and its relationship with medical therapy utilized to treat this pulmonary condition with the objective of establishing the relationship between the use of beta-agonist therapy for obstructive airway disease in patients with AF. Discussion: Cell receptors participate in multiple reactions and the sympathetic response is received via the alpha- and betareceptors are related to the hemodynamic of the vasculature of the lungs and cardiovascular system. The beta-blockade agents are one of the most common medication classes used for rate control in cardiac arrhythmias, but the side effect could be COPD exacerbation; on the other hand, beta-adrenergic or beta-agonist as a therapy for this pulmonary condition could increase the heart rate leading to AF decompensation. There is a clear dilemma in our patients who have airway disease and AF since the treatment for one might worsen the other. The clear benefit in morbidity and mortality of beta-blocker therapy, especially beta1- selective, outweighs the potential for any pulmonary side-effects related to ex-acerbation of COPD or airway disease. Conclusion: There is clear data showing the evidence of the potential paradoxical side-effect between COPD and AF therapies, given the exacerbation of one due to treatment of the other, benefits versus risks should be discussed and the medical decision should be made based on them. The deteriorated cardiac condition can rapidly predispose to critical complications leading to death, which is why the use of beta-blockade agents will be chosen over possible complications with pulmonary disease. In other words, the benefit should outweigh the risk based on the best outcome for the patient.

The role of beta-agonist therapy for chronic obstructive airway disease in patients with coexistent atrial fibrillation: Literature review

Background: New advances have been made in medicine, but the incidence and prevalence of Chronic Obstructive Pulmonary Disease (COPD) are evident, and it is established as the fourth cause of death in the United States representing a high cost for the healthcare system. This condition has been related to atrial fibrillation due to the changes in the lungs and vasculature. Based on this history, we seek to evaluate the outcome of AF in the patients with COPD and its relationship with medical therapy utilized to treat this pulmonary condition with the objective of establishing the relationship between the use of beta-agonist therapy for obstructive airway disease in patients with AF. Discussion: Cell receptors participate in multiple reactions and the sympathetic response is received via the alpha- and beta-receptors are related to the hemodynamic of the vasculature of the lungs and cardiovascular system. The beta-blockade agents are one of the most common medication classes used for rate control in cardiac arrhythmias, but the side effect could be COPD exacerbation; on the other hand, beta-adrenergic or beta-agonist as a therapy for this pulmonary condition could increase the heart rate leading to AF decompensation. There is a clear dilemma in our patients who have airway disease and AF since the treatment for one might worsen the other. The clear benefit in morbidity and mortality of beta-blocker therapy, especially beta1-selective, outweighs the potential for any pulmonary side-effects related to ex-acerbation of COPD or airway disease. Conclusion: There is clear data showing the evidence of the potential paradoxical side-effect between COPD and AF therapies, given the exacerbation of one due to treatment of the other, benefits versus risks should be discussed and the medical decision should be made based on them. The deteriorated cardiac condition can rapidly predispose to critical complications leading to death, which is why the use of beta-blockade agents will be chosen over possible complications with pulmonary disease. In other words, the benefit should outweigh the risk based on the best outcome for the patient. Keywords: atrial fibrillation; pulmonary disease; obstructive pulmonary disease; chronic obstructive pulmonary disease (COPD); B-Agonist; B-Block (selective; non-selective); digitalis; other antiarrhythmic.

Effect of Adding Inhaled Corticosteroid to Long-Acting Muscarinic Antagonist/Long-Acting Beta-Agonist Therapy Among Patients With Chronic Obstructive Pulmonary Disease.

BackgroundThe role of inhaled corticosteroid (ICS) in chronic obstructive pulmonary disease (COPD) is unclear. Hence, this study aimed to evaluate the efficacy of ICS as an add-on to long-acting muscarinic antagonist (LAMA)/long-acting beta 2 agonist (LABA), which was assessed using the impulse oscillation system (IOS), in patients with COPD.MethodologyWe included patients with COPD whose treatment was changed from LAMA/LABA (≥four weeks) to ICS/LAMA/LABA between April 2019 and March 2021. To gain insight into the effect and safety of ICS-containing triple therapy for COPD, pulmonary function; Short-Form 36, St. George’s Respiratory Questionnaire, COPD Assessment Test, and modified Medical Research Council scores; and airway resistance assessed using the IOS from one week before LAMA/LABA was switched to ICS/LAMA/LABA therapy until more than eight but less than twelve weeks after switching were evaluated.ResultsIn total, 46 patients with COPD (mean age: 72.28 ± 7.81 years) were included in the study. None of the pulmonary function test parameters significantly changed from baseline values (mean difference in forced expiratory volume in one second [FEV1.0]: +0.032, P = 0.12; percentage FEV1.0 [FEV1.0%]/forced vital capacity [FVC]: −0.58, P = 0.42; and FVC: +0.087, P = 0.058). Meanwhile, the IOS showed that resonant frequency (mean difference from baseline: −2.12, P < 0.0001) and bodily pain scores in the St. George’s Respiratory Questionnaire (mean difference: −7.03, P = 0.031) significantly decreased.ConclusionsSwitching from LAMA/LABA to ICS/LAMA/LABA therapy reduces airway elasticity-to-inertial resistance ratios, which may lead to structural airway improvements in patients with COPD.

Phosphodiesterase 4 mediates interleukin-8-induced heterologous desensitization of the β2 -adrenergic receptor.

Acute respiratory distress syndrome (ARDS) is a life-threatening illness characterized by decreased alveolar-capillary barrier function, pulmonary edema consisting of proteinaceous fluid, and inhibition of net alveolar fluid transport responsible for resolution of pulmonary edema. There is currently no pharmacotherapy that has proven useful to prevent or treat ARDS, and two trials using beta-agonist therapy to treat ARDS demonstrated no effect. Prior studies indicated that IL-8-induced heterologous desensitization of the beta2-adrenergic receptor (β2 -AR) led to decreased beta-agonist-induced mobilization of cyclic adenosine monophosphate (cAMP). Interestingly, phosphodiesterase (PDE) 4 inhibitors have been used in human airway diseases characterized by low intracellular cAMP levels and increases in specific cAMP hydrolyzing activity. Therefore, we hypothesized that PDE4 would mediate IL-8-induced heterologous internalization of the β2 -AR and that PDE4 inhibition would restore beta-agonist-induced functions. We determined that CINC-1 (a functional IL-8 analog in rats) induces internalization of β2 -AR from the cell surface, and arrestin-2, PDE4, and β2 -AR form a complex during this process. Furthermore, we determined that cAMP associated with the plasma membrane was adversely affected by β2 -AR heterologous desensitization. Additionally, we determined that rolipram, a PDE4 inhibitor, reversed CINC-1-induced derangements of cAMP and also caused β2 -AR to successfully recycle back to the cell surface. Finally, we demonstrated that rolipram could reverse CINC-1-mediated inhibition of beta-agonist-induced alveolar fluid clearance in a murine model of trauma-shock. These results indicate that PDE4 plays a role in CINC-1-induced heterologous internalization of the β2 -AR; PDE4 inhibition reverses these effects and may be a useful adjunct in particular ARDS patients.

The Role of Pediatric Health-care Providers in Promoting Students' Asthma Health.

The Role of Pediatric Health-care Providers in Promoting Students' Asthma Health.

Consistent Dosing Through the Salmeterol-Fluticasone Propionate Easyhaler for the Management of Asthma and Chronic Obstructive Pulmonary Disease: Robustness Analysis Across the Easyhaler Lifetime.

Background: Easyhaler (registered trademark by Orion Corporation) is a multidose dry powder inhaler (DPI) for the treatment of asthma and chronic obstructive pulmonary disease (COPD), designed to be simple and easy to use. Salmeterol–fluticasone propionate (S-F) Easyhaler (50/250 and 50/500 μg per dose), available in several European countries, provides combined inhaled corticosteroid and long-acting beta agonist therapy for the management of asthma and COPD. A requirement of the European Committee for Medical Products for Human Use guidelines is to demonstrate product performance under conditions that mimic real-life patient use. Therefore, our aims were to assess the robustness of the S-F Easyhaler by assessing the delivered dose (DD) and fine particle dose (FPD) throughout the inhaler lifespan and under simulated environmental stress conditions.Methods: This was a noncomparative exploratory in vitro study. Two batches and six to nine inhalers per batch from both dose strengths were used to assess drug delivery performance over the inhaler lifespan (doses 1–60). For determining the impact of simulated environmental stress (tests for exposure of dropping, vibration, moisture, and freeze–thawing) on DD and FPD, one batch and three inhalers per batch from both dose strengths were used per test, respectively. Aerodynamic particle size distribution was evaluated during the simulated dropping and vibration tests.Results: DD and FPD from both dose strengths of S-F Easyhaler performance remained consistent through the inhaler lifespan and simulated environmental stress did not affect its performance. Similar DD and FPD values were observed with or without dropping, vibration, exposure to moisture, and freeze–thawing, and no inhaler breakages occurred during the simulated tests.Conclusions: The in vitro performance of S-F Easyhaler at both dose strengths suggests that reliable dosing and robustness can be achieved under real-life stress conditions; S-F Easyhaler is a durable DPI for the management of asthma and COPD.

Parental administration of inhaled short-acting beta agonists in the pediatric emergency department:a survey of family perspectives.

BackgroundThe management of children with an asthma exacerbation includes timely systemic corticosteroids and frequent short-acting beta-agonist therapy. In selected patients, inhaled short-acting beta-agonist administration by parents may promote comfort, constitute an educational opportunity for the family, and safely reduce provider workload. Our objective was to evaluate parental satisfaction and perceived safety of this new approach.MethodThis was a cross-sectional study, conducted in a tertiary pediatric ED. We investigated patient and parent perspectives on a newly implemented parental short-acting beta-agonist administration program. A convenience sample of families participating in this program was approached for study enrolment. The primary outcome was the proportion of parents and children who were satisfied with the program. We also evaluated the program's safety and impact on asthma education as reported by parents.ResultsFrom February 2019 to March 2020, 72 of 74 (97%) families approached for enrolment participated in the survey. A vast majority (95%) of parents appreciated the program and 93% would participate again. Among children > 7 years, 86% preferred receiving inhaled short-acting beta-agonist by their parents rather than by a healthcare provider. Nearly all parents (96%) found the program to be “safe” or “very safe”. Some participants reported improvements in their inhaler administration technique (25%) and ability to recognize their child’s respiratory distress (25%).ConclusionA novel parental short-acting beta-agonist administration program in the pediatric ED was widely appreciated by participating families. Parents perceived it as being safe, educational, and contributing to their child’s comfort.Supplementary InformationThe online version of this article (10.1007/s43678-021-00087-x) contains supplementary material, which is available to authorized users.

Exacerbations of asthma following step-up and step-down inhaled corticosteroid and long acting beta agonist therapy in the managing asthma in pregnancy study

Objective Guidelines for asthma management contain a consensus recommendation that inhaled corticosteroid (ICS) dose should not be stepped down in pregnancy. However, this is not consistent with consumer preferences and pharmacological principles to minimize medication exposure during pregnancy. We investigated exacerbations after changes to ICS and long acting beta agonist (LABA) therapy in pregnant women with asthma. Methods Pregnant women (n = 220) were recruited to a randomized controlled trial (RCT) where maintenance treatment was adjusted monthly based on either symptoms (control group), or fractional exhaled nitric oxide (FeNO, to alter ICS) and symptoms (to alter LABA, FeNO group). Exacerbations were monitored prospectively. Results ICS were used by 137 (62.3%) women at some time during pregnancy. ICS dose remained unchanged in 16 women (11.7%, 95% confidence interval [CI] 7–18%), increased in 37 women (27%, 95%CI 20–35%), decreased in 34 women (24.8%, 95%CI 18%–33%), or both increased and decreased in 50 women (36.5%, 95%CI 29–45%). Exacerbations occurred within 14 days of ICS step-down in 11 women (13%, 95%CI 7.5%–22%). This was not significantly different from exacerbations occurring within 14 days of step-up, in 7 women (8.1%, 95%CI 4%–16%, P = 0.294). There were no differences between management groups. Exacerbations occurred within 14 days of step-down in 14.7% (95%CI 7%–30%) of women in the control group, and in 12% (95%CI 6%–24%) of women in the FENO group. Conclusions ICS step-down could be considered when eosinophilic inflammation or symptoms are low, and may be a useful management approach for women, doctors, and midwives wishing to minimize ICS exposure during pregnancy.

Twenty-five years of Respirology: Advances in asthma.

Twenty-five years of Respirology: Advances in asthma.

TREATMENT PATTERNS FOR PATIENTS HOSPITALIZED WITH THE DIAGNOSIS OF ASTHMA OR COPD EXACERBATION

SESSION TITLE: Tuesday Abstract Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: 10/22/2019 01:00 PM - 02:00 PM PURPOSE: The use of long-acting beta agonist (LABA) and long-acting muscarinic antagonist (LAMA) therapy in hospitalized patients with COPD and asthma may prove beneficial due to flatter peak/trough variation in lung function, fewer PRN rescue treatments and easier transition of care for patients. However, the cost of such inhalers has caused hospitals to substitute scheduled short-acting combination (SABD) bronchodilators in place of longer acting medications. COPD guidelines do not address the use of LABA/LAMA in hospitalized patients. Because of conflicting views (efficacy vs cost) we sought to understand our unique hospital's practice habits by determining the difference in scheduled PRN SABD treatments when LABA and/or LAMA was added. METHODS: Patients with the diagnosis of COPD or asthma for at least 12 months and who were hospitalized for an exacerbation were selected for this retrospective chart review. Sixty charts were randomly selected to review respiratory therapy treatments prescribed and administered. The first treatment counted began in the Emergency Department and ended at discharge or at the end of 7 days. The scheduled use of routine, separate or combination, SABA and/or SAMA treatment times given during waking hours, night time hours, and any as needed treatments were collected. LABA and/or LAMA and SABD, scheduled or PRN was recorded. Charts were also reviewed for comorbid conditions. RESULTS: Twenty-five (43%) of the 60 participants were men and the average age was 66 years (58.5,76). The most prevalent diagnosis was COPD (90%), followed by asthma (7%), and asthma + COPD (3%). Comorbidities included heart failure (20%), diabetes mellitus (15%), pneumonia (16%), and hypoxemia (7%). The rates of therapy were SABD (30%), LABA (70%), LAMA (42%). Overall, patients who received both LABA and LAMA had fewer short-acting treatments than those who did not receive either LABA or LAMA. Patients who received both LABA and LAMA had numerically fewer short-acting treatments than patients who did not receive LABA and LAMA; combination LABA/LAMA therapy was associated with a statistically significant reduction in SABD treatments (p=0.03). CONCLUSIONS: Prescribing practices for hospitalized COPD and asthma patients in a large, urban, academic, hospital are heterogeneous. At our hospital, the prescription of LABA/LAMA decreased the number of PRN SABD significantly. From a purely financial perspective, the auto-substitution of scheduled SABD is driven by labor and medication costs. From a health outcome perspective, a larger head-to-head trial is critically needed to help adjudicate questions of real financial cost, length of stay, and hospital readmissions as well as patient safety. CLINICAL IMPLICATIONS: This study implies that LABA/LAMA treatments prescribed for patients hospitalized with the diagnosis of COPD or asthma exacerbation may reduce the number of PRN SABD treatments. DISCLOSURES: Speaker/Speaker's Bureau relationship with Monaghan Medical Corporation Please note: $1-$1000 Added 11/19/2018 by Mary Hart, source=Web Response, value=travel Removed 03/11/2019 by Mary Hart, source=Web Response Advisory Committee Member relationship with AstraZeneca Please note: $1001 - $5000 Added 11/19/2018 by Mary Hart, source=Web Response, value=travel Speaker/Speaker's Bureau relationship with AstraZeneca Please note: $20001 - $100000 Added 03/13/2019 by Mark Millard, source=Web Response, value=Honoraria Research relationship with AstraZeneca Please note: >$100000 Added 03/13/2019 by Mark Millard, source=Web Response, value=Grant/Research Support Speaker/Speaker's Bureau relationship with Boerhinger Ingleheim Please note: $5001 - $20000 Added 03/13/2019 by Mark Millard, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with GSK Please note: $1001 - $5000 Added 03/13/2019 by Mark Millard, source=Web Response, value=Honoraria No relevant relationships by Kristen Tecson, source=Web Response

Asthma Guidelines Priority Topics: Intermittent Inhaled Corticosteroid Therapy and Inhaled Corticosteroids with Long Acting Beta-Agonists as Reliever Therapy.

The National Asthma Education and Prevention Program Guidelines for the Diagnosis and Management of Asthma will update the guidelines on 6 topic areas. This review summarizes the findings for the charge to assess effectiveness of intermittent inhaled corticosteroid therapy with and without long-acting beta-agonist therapy in children 0 to 4 years of age, and children and adults 5 years and older. The complete report can be found on the Agency for Healthcare Research and Quality website.

A mini review of inhaled beta 2 agonists in acute decompensated heart failure requiring respiratory support.

Acute decompensated heart failure (HF) results in over one million hospital admissions per year, many requiring invasive or noninvasive mechanical ventilation for respiratory/cardiovascular support. Inhaled beta-2 adrenergic receptor agonists have been shown to be effective at clearance of extravascular lung water in HF patients. However, studies done in the late 1990s and early 2000s, prior to standardization and wide adoption of guideline directed medical therapy for HF, suggested that inhaled beta-2 agonist use increased admissions for HF exacerbations as well as in-hospital mortality. One study even attempted to utilize intravenous Beta-2 agonists in Acute Respiratory Distress Syndrome patients, however the study was stopped prematurely due to an 11% increased mortality in the treatment group. More recently however, studies examining patients who have concurrent diagnoses of chronic obstructive pulmonary disease (COPD) and HF showed that beta-2 agonist therapy resulted in similar or better outcomes compared to controls. Likewise, in-vitro studies, animal models, and studies utilizing chronic heart failure patients treated with nebulized beta-2 agonists with no concurrent respiratory diagnosis had a therapeutic effect of treatment over controls. These studies have the advantage of being performed with the standardization of guideline directed HF medical therapy. In conclusion, while we continue to recommend the use of Beta-2 agonist therapy in patients with concurrent COPD and HF requiring respiratory support, further studies, preferably single or double blinded prospective trials, will need to be performed to determine whether Beta-2 agonist therapy offers morbidity and mortality benefits in patients with strictly acute decompensated heart failure requiring respiratory support.

A Retrospective Claims Analysis of Dual Bronchodilator Fixed-Dose Combination Versus Bronchodilator Monotherapy in Patients with Chronic Obstructive Pulmonary Disease.

Patients with chronic obstructive pulmonary disease (COPD) increasingly receive combination bronchodilator therapies. Real world evidence for the benefits of combination therapy compared to monotherapy is lacking. COPD patients aged ≥ 40 years initiating monotherapy (MT) with either a long-acting muscarinic antagonist (LAMA) or long-acting beta2-agonist (LABA) or dual therapy (DT) with a LAMA/LABA fixed dose combination (FDC) between January 1, 2016 and December 31, 2016 were identified from a large U.S. administrative claims database. Patients diagnosed with cystic fibrosis, idiopathic pulmonary fibrosis, or asthma were excluded. Cohorts were propensity score matched 1:1 using baseline measures (e.g., exacerbations, hospitalizations) as proxies for COPD severity to create balanced cohorts. Following propensity score matching (PSM), 1286 patients remained in each cohort for analysis. Patients were followed for approximately 1 year. Patients in the DT versus MT cohort had lower rates of exacerbations leading to hospitalization (incidence rate ratio 0.7886; p=0.019), lower mean COPD-related pharmacy costs per patient per month (PPPM) ($300 versus $379, respectively; p<0.001) and total costs PPPM ($990 versus $1203, respectively; p=0.003). This occurred despite lower mean COPD-related pharmacy fills PPPM in the DT versus MT cohorts (1.41 versus 1.51, respectively; p=0.038). Patients in the DT cohort had lower rates of switching (p<0.001) and augmentation (p<0.001), and higher rates of non-persistence (p<0.001) versus the MT cohort. Rates of discontinuation were similar. Patients in the DT cohort had lower rates of exacerbations leading to hospitalization, lower COPD-related pharmacy and total costs PPPM, and lower rates of switching and augmentation compared to patients in the MT cohort.

USE OF OMALIZUMAB IN FOUR-YEAR-OLD WITH SEVERE PERSISTENT ALLERGIC ASTHMA

Introduction Omalizumab is approved in patients with moderate to severe persistent allergic asthma older than 6 years of age. We report use of omalizumab for the treatment of uncontrolled asthma in a 4-year-old. Case Description Patient is a 4-year-old boy who presented with uncontrolled, severe, persistent asthma despite use of high dose inhaled corticosteroid and long acting beta agonist therapy. In addition to requiring systemic steroids as an outpatient, he had hospitalizations for an asthma exacerbation every month. His IgE was 636 U/ML and eosinophil count was 350/cmm. He was too young to appropriately perform a pulmonary function test. His allergen specific IgE testing showed multiple environmental allergen sensitivities. After starting the treatment with omalizumab, frequency of exacerbations requiring systemic steroids significantly decreased and he has not required hospitalization. Discussion Omalizumab, a monoclonal antibody against IgE, is approved for moderate to severe allergic asthma in children six years and older. There is difficulty in managing children who meet criteria for omalizumab treatment but due to age limit they are unable to qualify for this treatment. To our knowledge, there is limited evidence in the literature for omalizumab treatment in children less than six years of age. After starting omalizumab, the patient has significant improvement in quality of life and required less frequent use of systemic steroids. Omalizumab should be considered in certain circumstances in children younger than 6 years of age for severe persistent asthma unresponsive to conventional treatment to improve quality of life and for its steroid sparing effects.