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Keypoints: Between 2007 and 2022, the FDA received 119 US-based reports mentioning budesonide nasal irrigation. Most reports were submitted by patients and alerted FDA to off-label usage of budesonide. Notable adverse events reported to the FDA included headache, dyspnea, and blurred vision., (© 2023 ARS-AAOA, LLC.)

Background: Pathophysiology-targeting treatments exist for aspirin-exacerbated respiratory disease (AERD) through aspirin desensitization and biologics, such as dupilumab. With increasing attention paid to these treatments, which may be associated with significant side effects and/or cost, there is little description of chronic rhinosinusitis with nasal polyps (CRSwNP) response to treatment with intranasal corticosteroids and saline irrigations in AERD., Objective: To determine the effect of intranasal budesonide irrigations for the treatment of CRSwNP in AERD., Methods: This is an observational study of 14 AERD patients presenting to a rhinology clinic for CRS who were treated with twice daily high volume, low pressure irrigations with 240 mL of saline to which a 0.5 mg/2 mL respule of budesonide was added. All participants completed a 22-item Sinonasal Outcome Test (SNOT-22) at enrollment and at follow up 1 to 6 months later. Polyp scores were also calculated at each time point., Results: SNOT-22 scores ranged from 26 to 98 (median: 40.5) at enrollment and 3 to 85 (median: 38.5) at follow-up. Polyp scores ranged from 2 to 6 (median: 4) at enrollment at 0 to 6 (median: 2) at follow-up. Over the treatment period, change in SNOT-22 score ranged from -38 to 16 (median: -18) and change in polyp score ranged from -2 to 0 (median: -0.5). Approximately 57% of participants experienced at least 1 minimal clinically important difference in SNOT-22 score and 21% of participants had a SNOT-22 score <20 at follow-up., Conclusion: Medical management with intranasal corticosteroids and saline irrigations alone leads to significant improvement in sinonasal symptomatology in a subset of AERD.

Objective: We sought to determine if chronic rhinosinusitis (CRS) patients with nasal polyps (CRSwNP) differentially perceived CRS symptom burden compared to patients without nasal polyps (CRSsNP) and to what extent CRS symptom severity was associated with quality of life (QOL) and patient-reported symptom control in the 2 groups., Methods: A total of 600 patients (266 CRSwNP and 334 CRSsNP) presenting with CRS were recruited. CRS symptom burden was assessed with the 22-item Sinonasal Outcome Test (SNOT-22). SNOT-22 nasal, sleep, ear/facial discomfort, and emotional subdomain scores were calculated. General health-related QOL was assessed with the visual analog scale of the 5-dimensional EuroQol questionnaire (EQ-5D VAS). Patients rated their CRS symptom control on a 5-point scale., Results: SNOT-22 scores did not differ between CRSwNP (mean: 35.6) and CRSsNP (mean: 36.3). There were no differences in nasal, sleep, and emotional subdomains of the SNOT-22. CRSsNP had higher ( P  = .003) ear/facial subdomain scores than CRSwNP, while CRSwNP reported greater hyposmia ( P  < .001). EQ-5D VAS was significantly lower ( P  = .011) in CRSsNP (mean: 68.9) compared to CRSwNP (mean: 73.2). However, CRSwNP patients reported significantly less symptom control, compared to CRSsNP, in association with nasal and emotional symptoms., Conclusion: CRSwNP and CRSsNP have differences in symptom profile, effect on health-related QOL, and patient-perceived symptom control. CRSsNP experience significantly greater burden of ear/facial discomfort, while CRSwNP report greater hyposmia. Although CRSsNP reports lower general health-related QOL overall, CRSwNP patients had lower levels of CRS symptom control for every incremental increase in symptom burden suggesting greater sensitivity/intolerance to CRS symptoms.

Background: A short-course oral corticosteroid taper and topical intranasal corticosteroids may be used to maximize the success of medical management for chronic rhinosinusitis with nasal polyps (CRSwNP). In this study, we sought to identify characteristics that would be predictive of efficacy for this combination regimen., Methods: Sixty-four patients with CRS, bilateral polyps, a polyp score of at least 3, and a 22-item Sino-Nasal Outcome Test (SNOT-22) score ≥20 were prospectively enrolled and uniformly treated with a 15-day prednisone taper and twice daily dilute budesonide irrigations. Participants were assessed at enrollment and at follow up, 2 to 5 months later. Clinical and demographic characteristics were assessed at enrollment. At both time points, CRS symptoms were assessed with SNOT-22, and polyp score (range, 0 to 6) was assessed endoscopically. Associations were determined with regression., Results: Pretreatment SNOT-22 score (adjusted β = -0.83; 95% CI, -1.08 to -0.58; p < 0.001) and comorbid asthma (adjusted β = 15.75; 95% CI, 4.74 to 26.75; p = 0.007) were associated with a change in SNOT-22 experienced over the study period. Achieving a greater-than-1 minimal clinically important difference (MCID) improvement in SNOT-22 score was also associated with pretreatment SNOT-22 score (adjusted OR = 1.09; 95% CI, 1.04 to 1.14; p < 0.001) and comorbid asthma (adjusted OR = 0.13; 95% CI, 0.03 to 0.72; p = 0.019). SNOT-22 score ≥47 had 81.5% sensitivity and 78.4% specificity to detect patients experiencing 1 MCID improvement. Pretreatment polyp score was not associated with any outcome metric., Conclusion: In treatment of CRSwNP with prednisone and budesonide irrigations, pretreatment endoscopy was not informative of treatment response. Pretreatment SNOT-22 and comorbid asthma may be more predictive., (© 2019 ARS-AAOA, LLC.)

Background: Differentiating the non-sinogenic headache from chronic rhinosinusitis (CRS) remains a significant clinical challenge due to the extensive overlap in symptoms. The objective of this study was to evaluate the 22-item Sino-Nasal Outcome Test (SNOT-22) score patterns in patients with confirmed non-sinogenic headache in order to develop negative predictors of CRS., Methods: Institutional Review Board (IRB)-approved, retrospective review of patients diagnosed with CRS or non-sinogenic headache defined as patients with a chief complaint of headache, facial pain, and facial pressure in the absence of both endoscopic and computed tomography (CT) evidence of inflammation. The optimal cutoff points of potential predictors of non-sinogenic headache by SNOT-22 score were quantified by receiver operating characteristic (ROC) curve. The negative predictive values (NPVs) for CRS were calculated in a discovery population and then validated in an independent population., Results: A total of 724 (164 non-sinogenic headache and 560 CRS) and 412 (88 non-sinogenic headache and 324 CRS) patients were recruited in the discovery and validation populations, respectively. Domain 3 (Ear/facial) and domain 4 (Psychological dysfunction) were significantly higher in patients with non-sinogenic headache as compared with CRS while domain 1 (Rhinologic) and domain 2 (Extranasal rhinologic) were significantly lower. The top 4 predictors of non-sinogenic headache were the domain 3 (Ear/facial)/domain 1 (Rhinologic) ratio, item 12, domain 3 (Ear/facial), and (item 12 + item 10)/(item 4 + item 5) ratio, with areas under the ROC curve (AUCs) ranging from 0.637 to 0.720 by ROC curve. A domain 3 (Ear/facial)/domain 1 (Rhinologic) ratio over 0.66 performed as the best negative predictor of CRS with the highest NPVs of 0.880 and 0.889 in the discovery and validation populations, respectively., Conclusion: Patients with non-sinogenic headache have distinct SNOT-22 score patterns compared with patients with CRS. A domain 3 (Ear/facial)/domain 1 (Rhinologic) ratio greater than 0.66 is a strong negative predictor of CRS, which can be used to aid in patient counseling and potentially limit the use of unnecessary sinonasal therapeutics., (© 2018 ARS-AAOA, LLC.)

Background: Patient-reported control of chronic rhinosinusitis (CRS) symptoms is associated with the quality of life impact of CRS. We sought to determine if 22-item Sino-Nasal Outcome Test (SNOT-22) score is predictive of patient-perceived CRS symptom control., Methods: Prospective cross-sectional study of 202 patients with CRS. Participants were asked to rate their CRS symptom control as "not at all," "a little," "somewhat," "very," and "completely." The severity of patient CRS symptomatology was measured using the SNOT-22. The relationship between SNOT-22 score and patient-reported CRS symptom control was determined using regression, analysis of variance (ANOVA), and receiver operating characteristic (ROC) curve analysis., Results: SNOT-22 was negatively associated with patient-reported CRS symptom control (adjusted β = -0.03; 95% CI, -0.04 to -0.02; p < 0.001), after controlling for demographic and clinical characteristics. There was a significant difference in SNOT-22 scores of participants reporting each level of symptom control (p < 0.001) with the greatest differences between participants who rated their CRS symptom control as "not at all," "a little," and "somewhat," which we deem poor CRS symptom control, and the group who described their level of CRS symptom control described as "very" and "completely," which we deem well-controlled CRS symptoms. These results were true across all SNOT-22 subdomains scores as well. Using ROC analysis, a SNOT-22 score of 35 identified patients reporting poor vs well-controlled CRS symptom control with 71.4% sensitivity and 85.5% specificity., Conclusion: SNOT-22 score is associated with how well patients feel their CRS symptomatology is controlled. Moreover, SNOT-22 score can be used to accurately distinguish patients with poor vs well-controlled CRS symptoms., (© 2017 ARS-AAOA, LLC.)

Background: Risk factors in adult patients with cystic fibrosis (CF) associated with surgical intervention have not been delineated., Objective: To identify characteristics of adult patients with CF and with chronic rhinosinusitis that predict surgical intervention with endoscopic sinus surgery (ESS)., Methods: Patients were identified in a tertiary sinus center by the International Classification of Diseases, Ninth Revision codes 277.00-277.03, which represent CF. Charts were reviewed for the CF transmembrane conductance regulator (CFTR) gene mutation, Lund-Mackay score (LMS), the 22-item Sino-Nasal Outcome Test (SNOT-22) score, previous ESS, and occurrence of ESS after presentation. The Fisher exact test was used to test frequency of events between the groups, and the Mann Whitney U test and the t-test were used to compare means among LMS, SNOT-22, and age. The Cox proportional hazard analysis was used to calculate hazard ratios (HR) for the impact of LMS, SNOT-22 score, previous ESS, and CFTR gene mutation status on the occurrence of ESS after presentation., Results: One hundred and fifteen patients met the inclusion criteria for the study. Patients with a history of surgery more often underwent ESS after presentation (p ≤ 0.01). The LMS and the SNOT-22 score were not significantly different between the groups of previous ESS and no previous ESS (p = 0.23 and p = 0.28, respectively). A severe mutation genotype was predictive of ESS after presentation (p = 0.03). SNOT-22 scores did not differ between the severe and mild groups (36.0 and 32.4, respectively; p = 0.57), but the mean LMS was significantly higher in the severe mutation group (12.5 and 9.7; p ≤ 0.01). Univariate Cox proportional hazard analysis revealed an increased occurrence of ESS for patients with severe mutations (HR, 3.6; p ≤ 0.01) or a history of ESS (HR, 2.3; p ≤ 0.01)., Conclusion: The occurrence of ESS in adult patients with CF was predicted by previous ESS intervention as well as the severity of CFTR mutation.

Background: The mechanism of airway remodeling in chronic rhinosinusitis with nasal polyposis (CRSwNP) remains unknown. We wished to determine whether profibrotic transforming growth factor beta 1 (TGF-β1) and activin A and their downstream signaling proteins are increased in CRSwNP and if they are regulated in epithelial cells by noxious or inflammatory stimuli., Methods: Frozen tissue from CRSwNP patients, healthy control (HC) middle turbinates, and sinus tissue from CRS without NP (CRSsNP) patients were immunostained for TGF-β1, activin A, and downstream signaling proteins. Primary nasal epithelial cells (PNECs) from HCs and CRSwNP patients were cultured in media, cigarette smoke extract (CSE), or double-stranded RNA (dsRNA) (a ligand for Toll-like receptor-3) and examined for inflammatory and profibrotic genes using real-time polymerase chain reaction (PCR)., Results: CRSwNP patients showed increased TGF-β1 and activin A in the stroma, increased TGF-β1 signaling (phosphorylated Smad2/3) in the stroma and epithelium, and increased Smad3-dependent Snail1 in the stroma. Immunostaining for TGF-β1, pSmad2/3, and Snail1 in CRSwNP patients was highly correlated. Immunostaining for pSmad2/3 and Snail1 was similar in CRSwNP and CRSsNP patients. Compared to HCs, PNECs from CRSwNP patients were more responsive to CSE and dsRNA in terms of TGF-β1 and activin A and more strongly induced by dsRNA in terms of chemokines., Conclusion: Increased TGF-β1 and activin A and increased downstream TGF-β1 signaling is present in CRSwNP patients, primarily in the stroma. This may contribute to features of airway remodeling previously described. PNECs from CRSwNP patients are induced to produce TGF-β1 and activin A by CSE and dsRNA, suggesting that cigarette smoke and viral infection might also contribute to airway remodeling., (© 2015 ARS-AAOA, LLC.)

Background: High-density paranasal sinus opacities are often deemed consistent with fungal elements. No studies of objective quantitative radiographic density measures have been performed to support this assertion., Methods: A consecutive series of 120 patients with chronic rhinosinusitis who underwent maxillary antrostomy with microbiological evaluation of contents within 60 days of sinus computed tomography scanning was investigated. Radiographic density characteristics of opacities in cultured maxillary sinuses (minimum, maximum, average, and standard deviation of Hounsfield units [HUstd]) were recorded. Receiver operator characteristic (ROC) curves were used to analyze the accuracy of radiographic characteristics in predicting fungal opacities., Results: Of 133 maxillary sinus opacities, 22 were ultimately consistent with noninvasive fungal disease: 11 allergic fungal rhinosinusitis and 11 fungal balls. Fungal balls had higher-density components and were more heterogeneous and allergic fungal mucin was generally more radiodense. These findings were reflected by statistically significant ROC curves for maximum HU (p = 0.019) and HUstd (p = 0.023) for fungal balls and for average HU (p = 0.002) for allergic fungal mucin. A maximum HU cutoff of 334.0 detected fungal balls with 90.9% sensitivity and 72.7% specificity. An average HU cutoff of 42.9 HU detected allergic fungal mucin with 100% sensitivity and 46.3% specificity, although specificity improved to 73.2% with inclusion of nasal polyposis as a second requirement., Conclusion: Higher average HU more accurately predicts allergic fungal mucin whereas heterogeneity/high-density components more accurately predict fungal balls. No objective radiographic density measure, in isolation, is both sensitive and specific in predicting noninvasive fungal sinusitis.

Objectives: The concept of disease control incorporates independent disease characteristics that are longitudinally reflective of disease status and which can be used to make treatment decisions. Chronic rhinosinusitis (CRS) is a chronic condition for which the determination of disease control by both the patient and the treating physician is important. Our objectives were to determine CRS disease characteristics that are associated with patient‐reported and physician‐rated CRS disease control. Study Type: Cross‐sectional. Methods: A total of 209 participants were prospectively recruited. Participants were asked to rate their global level of CRS control as "not at all," "a little," "somewhat," "very," and "completely." All participants completed a 22‐item Sinonasal Outcome Test (SNOT‐22) and also reported the number of sinus infections, CRS‐related antibiotic courses taken, CRS‐related oral corticosteroid courses taken, and missed days of work or school due to CRS, all in the last 3 months. Clinical and demographic characteristics were also collected from each participant. A Lund‐Kennedy endoscopy score was calculated for each participant from nasal endoscopy. Two rhinologists were then given each participant's SNOT‐22 score (as well as SNOT‐22 nasal, sleep, otologic/facial pain, and emotional subdomain scores), endoscopy score, and the number of sinus infections, CRS‐related antibiotics, CRS‐related oral corticosteroid courses and missed days of work or school due to CRS in the preceding 3 months as reported by the patient. The two rhinologists were blinded to all other participant characteristics and each rhinologist independently rated every participant's global control level as "not at all," "a little," "somewhat," "very," and "completely." Associations were sought between CRS disease characteristics (SNOT‐22 score, endoscopy score, sinus infections, CRS‐related antibiotic usage, CRS‐related oral corticosteroid usage, and lost productivity due to CRS) and patient‐reported CRS control as well as mean physician‐rated CRS control. Results: Patient‐reported global CRS control was associated only with SNOT‐22 (adjusted relative risk [RR] = 0.99, 95% CI: 0.98–0.99, P < .001) but no other CRS disease characteristic. Patient‐reported CRS control was specifically associated only with nasal symptoms and not extra‐nasal symptoms of CRS. Physician‐rated CRS control was associated with SNOT‐22 score (adjusted RR [for each 1‐unit increase of SNOT‐22] = 0.99, 95% CI: 0.98–0.99, P < .001), number of acute bacterial CRS exacerbations—reflected by number of antibiotic courses taken (or sinus infections)—in the last 3 months (adjusted RR = 0.89, 95% CI: 0.82–0.98, P = .014) and the number of CRS‐related oral corticosteroid courses taken in the last 3 months (adjusted RR = 0.87, 95% CI: 0.78–0.97, P = .012). Nasal, sleep, and otologic/facial pain symptoms were all associated with physician‐rated CRS control. Having used at least one course of antibiotics or oral corticosteroids in the last 3 months was the optimal threshold for detecting poorly controlled CRS. Conclusions: Patients and physicians use different criteria to determine the level of CRS control. While both rely on the burden of CRS symptomatology, patients consider primarily nasal symptoms while physicians include nasal and extra‐nasal symptoms of CRS in determining CRS control. Physicians also independently consider CRS‐related antibiotic use, as a reflection of acute bacterial CRS exacerbations, and CRS‐related oral corticosteroid use in the determination of global CRS control. Level of Evidence: 2c. [ABSTRACT FROM AUTHOR]

Background: Despite the significant morbidity associated with chronic rhinosinusitis (CRS) in individuals with asthma (CRSwA), there is a paucity of codified, evidence‐based management strategies for CRS in this population. Methods: Using PubMed, Embase, and Cochrane Review Databases, a systematic review was performed covering management strategies for CRSwA. A total of 5903 articles were screened, and 70 were included for full‐text analysis. After application of exclusion criteria, 53 articles comprised the qualitative synthesis. The level of evidence was graded and benefit‐harm assessments, as well as value judgment and recommendations, were provided Results: Strong evidence confirms the benefit of oral and topical medications on sinonasal‐specific outcomes in individuals with CRSwA; there is low‐grade evidence demonstrating that these agents improve lung function and/or asthma control. Moderate to strong evidence suggests that endoscopic sinus surgery (ESS) improves both sinonasal‐ and asthma‐specific quality of life. Although there is insufficient to low evidence to indicate that ESS improves pulmonary function in this population, data indicate a positive impact of this intervention on asthma control. Biologic medications strongly improve both subjective and objective sinonasal‐ and asthma‐specific outcomes. Conclusion: Evidence supports managing CRS in individuals with CRSwA in a stepwise fashion, starting with traditional nonbiologic oral and topical medication, and escalating to second‐line treatments, such as ESS and biologics. Optimal treatment of individuals who have CRSwA often requires concurrent, directed management of asthma, as not all CRS interventions impact asthma status. [ABSTRACT FROM AUTHOR]