Patient Delivery System Research Articles

O01 First-in-human study of TAR-210 erdafitinib intravesical delivery system in patients with non–muscle-invasive bladder cancer with select FGFR alterations

O01 First-in-human study of TAR-210 erdafitinib intravesical delivery system in patients with non–muscle-invasive bladder cancer with select FGFR alterations

Inhaled colistimethate sodium in patients with bronchiectasis and Pseudomonas aeruginosa infection: results of PROMIS-I and PROMIS-II, two randomised, double-blind, placebo-controlled phase 3 trials assessing safety and efficacy over 12 months

Chronic lung infection with Pseudomonas aeruginosa is associated with increased exacerbations and mortality in people with bronchiectasis. The PROMIS-I and PROMIS-II trials investigated the efficacy and safety of 12-months of inhaled colistimethate sodium delivered via the I-neb. Two randomised, double-blind, placebo-controlled trials of twice per day colistimethate sodium versus placebo were conducted in patients with bronchiectasis with P aeruginosa and a history of at least two exacerbations requiring oral antibiotics or one requiring intravenous antibiotics in the previous year in hospitals in Argentina, Australia, Belgium, Canada, France, Germany, Greece, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Spain, Switzerland, the UK, and the USA. Randomisation was conducted through an interactive web response system and stratified by site and long term use of macrolides. Masking was achieved by providing colistimethate sodium and placebo in identical vials. After random assignment, study visits were scheduled for 1, 3, 6, 9, and 12 months (the end of the treatment period); and telephone calls were scheduled for 7 days after random assignment and 2 weeks after the end of treatment. The primary endpoint was the mean annual exacerbation rate. These trials are registered with EudraCT: number 2015-002743-33 (for PROMIS-I) and 2016-004558-13 (for PROMIS-II), and are now completed. 377 patients were randomly assigned in PROMIS-I (177 to colistimethate sodium and 200 to placebo; in the modified intention-to-treat population, 176 were in the colistimethate sodium group and 197 were in the placebo group) between June 6, 2017, and April 8, 2020. The annual exacerbation rate was 0·58 in the colistimethate sodium group versus 0·95 in the placebo group (rate ratio 0·61; 95% CI 0·46-0·82; p=0·0010). 287 patients were randomly assigned in PROMIS-II (152 were assigned to colistimethate sodium and 135 were assigned to placebo, in the modified intention-to-treat population), between Feb 12, 2018, and Oct 22, 2021. PROMIS-II was then prematurely terminated due to the effect of the COVID-19 pandemic. No significant difference was observed in the annual exacerbation rate between the colistimethate sodium and placebo groups (0·89 vs 0·89; rate ratio 1·00; 95% CI 0·75-1·35; p=0·98). No major safety issues were identified. The overall frequency of adverse events was 142 (81%) patients in the colistimethate sodium group versus 159 (81%) patients in the placebo group in PROMIS-I, and 123 (81%) patients versus 104 (77%) patients in PROMIS-II. There were no deaths related to study treatment. The data from PROMIS-I suggest a clinically important benefit of colistimethate sodium delivered via the I-neb adaptive aerosol delivery system in patients with bronchiectasis and P aeruginosa infection. These results were not replicated in PROMIS-II, which was affected by the COVID-19 pandemic and prematurely terminated. Zambon.

Tailoring oleogel-in-hydrogel pickering emulsion fluid gels as an oral delivery system for different levels of dysphagia: From microstructure to rheological properties

Dysphagia-affected populations are facing crucial challenges on oral administration of medicines and health products because of swallowing malfunction with a high risk of aspiration. The current countermeasures that relied mainly on modification of existing formulations with thickened liquids comes with potential hazards, e.g., bioavailability alterations and unsatisfactory safety. Thus, dysphagia-specific oral delivery system is in critical need of development. Herein, a swallowing dynamics-inspired, oleogel-in-hydrogel Pickering emulsion fluid gel was proposed as a versatile oral delivery system for patients with dysphagia. With the dual structure of high acyl gellan gum (HAG) fluid gel and whey protein isolate (WPI) stabilized oleogel-in-hydrogel Pickering emulsion gel, the novel system demonstrated the potential to tackle both swallowing and drug encapsulation challenges. Specifically, it displayed good shear flowability during shearing and appropriate extensional capabilities after shearing which are well-matched with swallowing dynamics to facilitate ease and safe swallowing. Moreover, the oleogel-in-hydrogel Pickering emulsion gel structure enables its versatile loading potential for both hydrophilic and lipophilic substances. Remarkably, the microstructure and the related rheological properties of this novel system could be tailored by controlling critical determinants in the formation of fluid gels, namely HAG content and process mixing rate. By adjusting these two parameters, the fluid gels could be customized as preparations with different thickness level for mild, moderate and severe dysphagia, respectively. In conclusion, this proposed approach offers a promising rheologically-tunable oral delivery system for administering bioactives to patients with different levels of dysphagia.

ASO Visual Abstract: Efficacy and Safety of Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma: Results from an Open-Label, Single-Arm, Multicenter, Phase 3 Study.

ASO Visual Abstract: Efficacy and Safety of Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma: Results from an Open-Label, Single-Arm, Multicenter, Phase 3 Study.

Efficacy and Safety of the Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma: Results from an Open-Label, Single-Arm, Multicenter Phase 3 Study

BackgroundUveal melanoma (UM) has a poor prognosis once liver metastases occur. The melphalan/Hepatic Delivery System (melphalan/HDS) is a drug/device combination used for liver-directed treatment of metastatic UM (mUM) patients. The purpose of the FOCUS study was to assess the efficacy and safety of melphalan/HDS in patients with unresectable mUM.MethodsEligible patients with mUM received treatment with melphalan (3.0 mg/kg ideal body weight) once every 6 to 8 weeks for a maximum of six cycles. The primary end point was the objective response rate (ORR). The secondary end points included duration of response (DOR), overall survival (OS), and progression-free survival (PFS).ResultsThe study enrolled 102 patients with mUM. Treatment was attempted in 95 patients, and 91 patients received treatment. In the treated population (n = 91), the ORR was 36.3 % (95 % confidence interval [CI], 26.44–47.01), including 7.7 % of patients with a complete response. Thus, the study met its primary end point because the lower bound of the 95 % CI for ORR exceeded the upper bound (8.3 %) from the benchmark meta-analysis. The median DOR was 14 months, and the median OS was 20.5 months, with an OS of 80 % at 1 year. The median PFS was 9 months, with a PFS of 65 % at 6 months. The most common serious treatment-emergent adverse events were thrombocytopenia (15.8 %) and neutropenia (10.5 %), treated mostly on an outpatient basis with observation. No treatment-related deaths were observed.ConclusionTreatment with melphalan/HDS provides a clinically meaningful response rate and demonstrates a favorable benefit-risk profile in patients with unresectable mUM (study funded by Delcath; ClinicalTrials.gov identifier: NCT02678572; EudraCT no. 2015-000417-44).

Booster visits in the management of the acute musculoskeletal injuries: Transforming care to improve outcomes-A perspective review.

The current healthcare delivery system for patients with acute musculoskeletal injury is failing. Current rehabilitation management of acute musculoskeletal injury typically includes physical therapy, focused on management of impairments, with an eventual transition to functional activities and release to prior level of function. At that point, formal physical therapy is often discontinued, despite the knowledge that a high percentage of patients fail to maintain preinjury level of activity and often reduce participation in regular physical activity. Further, for those who attempt to return to prior levels of pivoting and cutting activities, there is a high second injury rate. The long-term human experience is compromised by the current model of care which terminates at the point of transition to activity. This model of care fails to meet the continued needs of these patients and may result in long term deficits and potential disability. Extended care models include intermittent follow up visits after discharge from an acute episode of care and have been efficacious and cost effective in some patient populations with musculoskeletal conditions. Specifically, a type of extended care model, labeled "booster sessions," represents an opportunity to provide structured, intermittent care to assist in a smooth transition back to function, following an acute episode of care and promote a healthier life outcome. This perspective review will discuss the opportunity to transform acute musculoskeletal care to booster visit care model in an attempt to develop a more efficacious and cost-effective system of care which could be generalizable to all musculoskeletal conditions.

Exploring the effects of His and left bundle branch pacing with stylet-driven lead on tricuspid regurgitation: A short-term follow-up study

The stylet-driven delivery system was replaced with a pre-shaped catheter delivery system for conduction system pacing several years ago, as it offered easier access to the pacing location. However, in several countries, including Indonesia, the availability of catheter systems remains limited. This study aimed to evaluate the occurrence and severity of tricuspid regurgitation when using the stylet-driven lead delivery system in patients undergoing His and Left Bundle Branch (LBB) pacing.

Leptospermum honey – A medicinal wonder for periodontal health

Antibacterial therapy has always been included effectively in the regimen of periodontitis. The inability to access periodontal disease-causing organisms within periodontal pockets has limited the effectiveness of mechanical plaque removal and the use of antibacterial agents. The drug’s systemic administration results in therapeutic concentrations at the site of infection, but only in the short term, necessitating repeated dosing over longer periods. Topical antibiotics have been studied for their ability to overcome the limitations of conventional therapy. It is of interest to use sustained release formulations to deliver antimicrobial agents to the site of infection (periodontal pocket). At much lower doses, these products provide long-term treatment at the site of infection. From time immemorial, honey is not only considered as a natural sweetener but is also used for its healing power. It is used in traditional folk and tribal medicines and 93% of the consumers of honey use it for its medicinal value. Active Leptospermum Honey (ALH) is the most researched medical grade honey for wound and burn treatment. This article documents the efficacy of ALH as a topical drug delivery system in patients with chronic periodontal disease.

Laser Vaporization of Mouth Lesions, an Overview

Lasers are utilized in dentistry as a therapeutic tool or as an auxiliary tool. The major purpose of employing lasers in dentistry is to overcome the difficulties that are currently observed in traditional dental treatment treatments. The laser is used in hard tissue applications such as caries prevention, bleaching, restorative removal and curing, cavity preparation, dentinal hypersensitivity, growth modulation, and diagnostics, whereas soft tissue applications include wound healing, removal of hyperplastic tissue to uncover impacted or partially erupted teeth, photodynamic therapy for malignancies, and photo-stimulation of herpetic lesions. Lasers' capacity to perform minimally invasive operations with minimum patient discomfort has proven effective in the patient delivery system in dentistry practice. The availability of lasers with various wavelengths has produced a surgical panacea, and laser technology has replaced traditional surgical techniques in many oral surgical operations.

LBA104 First safety and efficacy results of the TAR-210 erdafitinib (erda) intravesical delivery system in patients (pts) with non–muscle-invasive bladder cancer (NMIBC) with select FGFR alterations (alt)

LBA104 First safety and efficacy results of the TAR-210 erdafitinib (erda) intravesical delivery system in patients (pts) with non–muscle-invasive bladder cancer (NMIBC) with select FGFR alterations (alt)

Needle phobia among adult Jordanians: General awareness, prevalence; and exploring microneedles as a promising solution.

Needle phobia remains a major drawback of conventional injectable medications, leading to avoidance and low adherence among a reasonable portion of patients. Despite this, there is a limited number of studies investigating needle phobia prevalence and symptoms. In this survey, we studied the knowledge and prevalence of needle phobia and its manifestations among 1182 adult Jordanians. Moreover, we assessed the feasibility of microneedles delivery systems as an alternative approach to conventional injectable methods. The results revealed that 28.5% of the participants identified themselves with needle phobia, with a notably higher prevalence among females compared to males (p-value < 0.001). The overall prevalence of needle phobia based on its measured manifestations was found to be 27.4%. The survey also found that 68% of the population were unfamiliar with the concept of microneedles despite the reasonable proportion of the population who were aware of the disadvantages of conventional injectable medications. Furthermore, the survey identified four significant predictors of needle phobia through hierarchical linear regression analysis. Gender, occupation, and negative past experiences with needle injections accounted for 3%, 1%, and 1% of the variance in needle phobia, respectively. In addition, the participants' preference for microneedles over conventional injectables medications appeared as another significant predictor, contributing 5% of the variance. Overall, the model explained 10% of the variance in needle phobia. Collectively, this study provides an insight into needle phobia prevalence and manifestations in Jordan, while also exploring microneedles as an alternative drug delivery system for patients with needle phobia.

Effects of Stress Management Skills Training on the Resilience of Family Caregivers of Heart Failure Patients: A Quasi-experimental Study

Background: Heart failure disrupts the lives of patients and their caregivers. Resilience is a dynamic process for adaptation in traumatic or disastrous events. As teaching stress management skills increases people’s adaptation in stressful situations, this study was determined the effects of stress management skills training on the resilience of family caregivers of heart failure patients. Objectives: To determine the effects of stress management skills training on the resilience of family caregivers of heart failure patients. Methods: This quasi-experimental study conducted in 30 family caregivers of patients with heart failure hospitalized in the cardiac care unit (CCU) of Amir al-Mominin Ali (AS) hospital in Zabol, Iran. They were randomly divided into two groups, intervention and control. Data was collected using a demographic characteristics questionnaire and Connor Davidson questionnaire of resilience which were completed before and after the intervention. Results: Independent t-test did not show a significant difference between the two groups before the intervention (P &gt; 0.05). However, the mean score of the resilience was significantly different after intervention (P &lt; 0.001). Conclusions: The intervention of stress management skills training can be effective for family caregivers of heart failure patients in a sample of Iranian society. The results are consistent with the results of other studies. It is absolutely necessary and effective to provide such educational services in the healthcare service delivery system for patients’ caregivers.

Personalizing Selection of Inhaled Delivery Systems in Chronic Obstructive Pulmonary Disease.

It can be challenging for healthcare professionals (HCPs) to prescribe inhaled therapy for patients with chronic obstructive pulmonary disease (COPD) because of the multiple individual and combinations of inhaled medications available in numerous delivery systems. Guidance on the selection of an inhaled delivery system has received limited attention compared with the emphasis on prescribing the class of the inhaled molecule(s). Although numerous recommendations and algorithms have been proposed to guide the selection of an inhaled delivery system for patients with COPD, no specific approach has been endorsed in COPD guidelines/strategies or by professional organizations. To provide recommendations for an inhaler selection strategy at initial and follow-up appointments, we examined the impact of patient errors using handheld inhalers on clinical outcomes and performed a focused narrative review to consider patient factors (continuity of the inhaled delivery system, cognitive function, manual function/dexterity, and peak inspiratory flow) when selecting an inhaled delivery system. On the basis of these findings, five questions are proposed for HCPs to consider in the initial selection of an inhaler delivery system and three questions to consider at follow-up. We propose that HCPs consider the inhaled medication delivery system as a unit and to match appropriate medication(s) with the unique features of the delivery system to individual patient factors. Assessment of inhaler technique and adherence together with patient outcomes/satisfaction at each visit is essential to determine whether the inhaled medication delivery system is providing benefits. Continued and repeated education on device features and correct technique is warranted to optimize efficacy.

Abstract #1163816: Adults With Type 1 Diabetes on Multiple Daily Injections Can Achieve Better Glycemic Control Without Worsening Hypoglycemia Using The MiniMed 670G Hybrid Closed-loop System

The MiniMed 670G hybrid closed-loop (HCL) system was the first FDA-approved automated insulin delivery system for patients with type 1 diabetes (T1D). We aimed in this study to evaluate a 10-day initiation protocol in adults with T1D from multiple daily injections (MDI) to MiniMed 670G HCL system in achieving glycemic control.

Amelioration of ligamentum flavum hypertrophy using umbilical cord mesenchymal stromal cell-derived extracellular vesicles

Ligamentum flavum (LF) hypertrophy (LFH) has been recognised as one of the key contributors to lumbar spinal stenosis. Currently, no effective methods are available to ameliorate this hypertrophy. In this study, human umbilical cord mesenchymal stromal cell-derived extracellular vesicles (hUCMSC-EVs) were introduced for the first time as promising vehicles for drug delivery to treat LFH. The downregulation of miR-146a-5p and miR-221-3p expressions in human LF tissues negatively correlated with increased LF thickness. The hUCMSC-EVs enriched with these two miRNAs significantly suppressed LFH in vivo and notably ameliorated the progression of transforming growth factor β1(TGF-β1)-induced fibrosis in vitro after delivering these two miRNAs to mouse LF cells. The results further demonstrated that miR-146a-5p and miR-221-3p directly bonded to the 3′-UTR regions of SMAD4 mRNA, thereby inhibiting the TGF-β/SMAD4 signalling pathway. Therefore, this translational study determined the effectiveness of a hUCMSC-EVs-based approach for the treatment of LFH and revealed the critical target of miR-146a-5p and miR-221-3p. Our findings provide new insights into promising therapeutics using a hUCMSC-EVs-based delivery system for patients with lumbar spinal stenosis.

Opportunities and challenges in closed-loop systems in type 1 diabetes

Commercial automated insulin delivery therapy can improve glucose outcomes by increasing glucose time-in-range (3·9–10·0 mmol/L; 70–180 mg/dL) and reducing hypoglycaemia (<3·9 mmol/L; <70 mg/dL) in people with type 1 diabetes. Commercial closed-loop systems have shown modest improvement in percentage time-in-range, with an increase of 5 percentage points for MiniMed 670G 1 Bergenstal RM Garg S Weinzimer SA et al. Safety of a hybrid closed-loop insulin delivery system in patients with type 1 diabetes. JAMA. 2016; 316: 1407-1408 Crossref PubMed Scopus (377) Google Scholar and of 10 percentage points for Control-IQ 2 Brown SA Kovatchev BP Raghinaru D et al. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. N Engl J Med. 2019; 381: 1707-1717 Crossref PubMed Scopus (266) Google Scholar compared with open-loop therapy. New developments with closed-loop systems are likely to enable further improvements in glucose outcomes while reducing user burden for individuals able to access closed-loop systems. These developments are focused on addressing deficiencies with current closed-loop systems by, for example, reducing or eliminating the requirement of prandial insulin dosing, overcoming the slow kinetics of subcutaneous insulin compared with endogenous insulin production, and improving the handling of insulin before, during, and after exercise. These advances will ideally lead to improved performance and reduced patient burden, and enable more widespread usage.

Role of CO2 Angioplasty as a Safe Option in Endovascular Treatment of Peripheral Arterial Disease in High-Risk Patients Using Dedicated Automated Optimed CO2 Delivery System

Aim: The aim of this study was to emphasize the role of CO2 angioplasty using dedicated automatic OptiMed CO2 delivery system in patients with peripheral arterial disease (PAD) of high-risk group. Iodinated contrast media is harmful in all these patients of renal insufficiency with baseline creatinine &gt;1.5 mg/dl. Methods: The present study is a retrospective analysis from a prospectively collected institutional review board-approved database. From April 2015 to June 2019, 44 patients (29 male patients and 15 female patients with a mean age of 68.5 years) underwent peripheral angioplasty using dedicated CO2 delivery system (OptiMed). All the patients were known diabetic with renal insufficiency due to chronic kidney disease (CKD). Demographic factors, clinical characteristics, and atherosclerotic risk factors were documented. Lesions included proximal and distal superficial femoral artery, popliteal, and below-the-knee vessels. Patients with chronic obstructive pulmonary disease, ventricular septal defects, and pulmonary vascular malformations were excluded from the study. Preliminary diagnosis by duplex scan was done in all the patients. Technical success, periprocedural events, and clinical outcomes were documented in all the patients. Results: Technical success was achieved in 43 cases (97.7%) which is described as successful balloon angioplasty resulting in increased vascularity of the distal limb due to improved distal runoff. Adequate imaging and successful intervention was achieved using OptiMed CO2 delivery system in majority of our patients. In one patient, the lesion could not be crossed and the patient had acute ST-elevation changes in electrocardiogram, and hence, the procedure was abandoned and the patient was shifted to cardiac care unit. Twenty-one patients complained of moderate pain which subsided with intra-arterial lidocaine. Four patients who complained of severe pain were given nerve block and sedation. There were no other intra- and postprocedural adverse events with stable renal parameters monitored up to 48 h. None of the patients required amputation after angioplasty in our study. Conclusion: With increasing burden of PAD in diabetic group, especially in CKD patients, angioplasty with dedicated CO2 delivery system is safe and effective with satisfactory outcome and should be considered as standard choice in this group of patients for limb salvage.

A randomized crossover pilot study comparing the efficacy of an auto-demand oxygen delivery system with that of a conventional demand oxygen delivery system in patients with chronic respiratory failure.

Introduction: When using portable oxygen, a demand oxygen delivery system (DODS), which senses the beginning of inhalation and delivers a bolus of oxygen, is often used. However, conventional DODS may not supply sufficient oxygen when reduced tidal flow fails to trigger the flow sensor. Recently, “auto-DODS,” which detects the negative pressure of inhalation and switches among 3 trigger sensitivity levels (standard, high, and extra high), has been developed to improve the efficacy of oxygenation. An auto-DODS can also supply pulsed-flow oxygen when it detects apnea, whereas a conventional DODS has only standard sensitivity. This randomized, open-label, crossover pilot study compared the performance of an auto-DODS with that of a conventional DODS.Methods: We recruited patients with chronic obstructive pulmonary disease (COPD) or interstitial pneumonia receiving long-term oxygen therapy. Interventions were performed on 2 different days for each participant. On each day, an auto-DODS or a conventional DODS were tested at rest for 30 minutes and during the 6-minute walk test. The primary outcome was mean oxygen saturation (SpO2). Secondary outcomes were the ratios of time for each sensitivity level and pulsed-flow oxygen when using the auto-DODS, total time desaturated below SpO2 90%, percentage of time desaturated below SpO2 90%, minimum SpO2, mean and maximum pulse rate, six-minute walk distance, recovery time after 6-minute walk test, modified Borg scale, comfort, and discomfort index.Results: When using the auto-DODS at rest, a high or extra high sensitivity level was observed in addition to standard sensitivity in 6 of 8 participants. During the 6-minute walk test, only standard sensitivity was observed in 6 participants. Mean SpO2 differences between the auto-DODS and conventional DODS at rest and during the 6-minute walk test were −0.6 [−4.5, 3.4] and 0.0 [−2.5, 2.5] ([95% confidence interval]), respectively, neither of which were significant (P = .73 and P = .99). There were no significant differences in secondary outcomes. There were no adverse events when using the auto-DODS.Conclusions: This study showed that the auto-DODS did not show superiority in oxygenation either at rest or during exercise compared to a conventional DODS. The auto-DODS was shown to supply oxygen safely and detect inhalations with various trigger sensitivities.

New Biodegradable Drug Delivery System for Patients with Dry Eye.

PurposeThis study aimed to develop a new type of drug delivery system (DDS) for treatment of dry eye.MethodsA new lens-type biodegradable DDS was manufactured using gelatin methacryloly, antibiotics, and conjunctival epithelial cells as bio-inks in a Bio X 3D Bioprinter. Gelatin methacryloly was used as a base, and the conditions were analyzed to maintain the overall shape by using a mixture of 0.1%, 0.15%, and 0.3% hyaluronic acid. In addition, an experiment was conducted to measure the appropriate concentration by evaluating its cytotoxicity according to the concentration of antibiotics mixed therein to prevent infection. The degree of degradation according to the storage temperature and post-processing of the new lens-type biodegradable DDS was measured.ResultsOptimal conditions were maintained when using a nozzle pressure of 80 kPa and speed of 4 mm/sec, nozzle pressure of 50 kPa and speed of 3 mm/sec, nozzle pressure of 60 kPa and speed of 8 mm/sec for 0.1%, 0.15%, and 0.3% hyaluronic acid concentrations, respectively. Degradation did not occur at 4°C and all the lenses were degraded at 37°C within 24 hours. In addition, the degradation rate was delayed according to the ultraviolet crosslink treatment time. Tobramycin 1% was used as an antibiotic during manufacture.ConclusionsA new lens-type biodegradable DDS that can control the degree of degradation was designed using a 3-dimentional bioprinter. This DDS will contribute to ease of treatment, protection of the cornea, and regeneration of the epithelium in patients with dry eye.

Effects of Fluticasone Exhalation Delivery System in Patients With Chronic Rhinosinusitis With Nasal Polyps: A Systematic Review.

Nasal sprays with corticosteroids deliver medication to the restricted areas including anterior and inferior parts of the nasal cavity. The fluticasone exhalation delivery system (EDS-FLU) has recently been proved to improve care by increasing superior/posterior intranasal corticosteroid deposition. This study aims to evaluate the efficacy of EDS-FLU in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). A systematic literature review using Pubmed, Embase, Cochrane Library, and Web of Science was conducted to identify studies assessing the effect of EDS-FLU on outcomes in patients with CRSwNP. Of the initial 108 abstracts reviewed, 4 full-text articles were included. The 22-item sinonasal outcome test scores were significantly decreased in patients with CRSwNP after receiving EDS-FLU twice a day (93, 186, or 372 μg) for 16 weeks when compared with exhalation delivery system (EDS)-placebo (all P < .001). Patients with CRSwNP reported significant improvement of smell after receiving twice daily EDS-FLU twice a day (93, or 372 μg) for 4 weeks when compared with EDS-placebo (all P < .05). The proportions of patients achieving ≥1-point improvement in total polyp grade were significantly higher in EDS-FLU group and dose dependent, with the highest rates in the 372 μg group. The proportions of patients achieving polyp elimination were significantly higher in EDS-FLU group with the highest rates in the 372 μg group. This is the first systematic review of the clinical outcomes in patients with CRSwNP treated with EDS-FLU. EDS-FLU produced significant improvements regarding the quality of life, smell, and endoscopic assessment of polyp grade.