Efficacy of the exhalation delivery system with fluticasone in patients with chronic rhinosinusitis with nasal polyps whose symptoms recur after sinus surgery.

BACKGROUND: Sinus surgery removes inflamed tissue, restores airflow, and improves delivery of medication into surgically opened spaces. The exhalation delivery system with fluticasone (EDS-FLU; XHANCE® ) uses a novel delivery system to create closed-palate, positive-pressure, bidirectional mechanics that significantly alter the deposition of the topically acting anti-inflammatory medication. We ask whether EDS-FLU efficacy differs for patients with recurrent symptoms after sinus surgery versus patients without surgery. OBJECTIVE: We aimed to compare EDS-FLU treatment responses in patients with recurrent symptoms after endoscopic sinus surgery (ESS) and patients who have never had sinus surgery. METHODS: Data were pooled from two large, controlled trials (NAVIGATE I and II) for exploratory analyses. Chronic rhinosinusitis symptoms, polyp grade, and quality-of-life measures were compared between patients with prior ESS and those without prior ESS. RESULTS: Patients with prior ESS (exhalation delivery system-placebo [n = 53], EDS-FLU 186 µg [n = 52], and EDS-FLU 372 µg [n = 49]) and unoperated patients (exhalation delivery system-placebo [n = 108], EDS-FLU 186 µg [n = 108], and EDS-FLU 372 µg [n = 111]) treated with EDS-FLU reported similar and substantial benefits as measured by multiple symptom and quality-of-life/functioning outcomes (congestion score, 22-Item Sinonasal Outcomes Test [SNOT-22], Rhinosinusitis Disability Index [RSDI], Patient Global Impression of Change) and by nasal polyp grade. In previously operated patients, unlike surgery-naive patients, multiple outcomes (SNOT-22, RSDI, polyp grade) consistently showed numerically but not statistically greater responses to the higher dose. CONCLUSIONS: Patients with recurrent symptoms after sinus surgery who were treated with EDS-FLU demonstrated significant symptom and quality-of-life improvement. Unlike unoperated patients, patients with prior ESS had a numerically but not statistically greater response to the higher dose of EDS-FLU (two sprays per nostril twice a day).

Global and regional drivers of abundance patterns in the hart's tongue fern complex (Aspleniaceae).

BACKGROUND AND AIMS: The hart's tongue fern (HTF) complex is a monophyletic group composed of five geographically segregated members with divergent abundance patterns across its broad geographic range. We postulated hierarchical systems of environmental controls in which climatic and land-use change drive abundance patterns at the global scale, while various ecological conditions function as finer scale determinants that further increase geographic disparities at regional to local scales. METHODS: After quantifying the abundance patterns of the HTF complex, we estimated their correlations with global climate and land-use dynamics. Regional determinants were assessed using boosted regression tree models with 18 potential ecological variables. Moreover, we investigated long-term population trends in the USA to understand the interplay of climate change and anthropogenic activities on a temporal scale. KEY RESULTS: Latitudinal climate shifts drove latitudinal abundance gradients, and regionally different levels of land-use change resulted in global geographic disparities in population abundance. At a regional scale, population isolation, which accounts for rescue effects, played an important role, particularly in Europe and East Asia where several hot spots occurred. Furthermore, the variables most strongly influencing abundance patterns greatly differed by region: precipitation seasonality in Europe; spatial heterogeneity of temperature and precipitation in East Asia; and magnitudes of past climate change, temperature seasonality and edaphic conditions in North America. In the USA, protected populations showed increasing trends compared with unprotected populations at the same latitude, highlighting the critical role of habitat protection in conservation measures. CONCLUSIONS: Geographic disparities in the abundance patterns of the HTF complex were determined by hierarchical systems of environmental controls, wherein climatic and land-use dynamics act globally but are modulated by various regional and local determinants operating at increasingly finer scales. We highlighted that fern conservation must be tailored to particular geographic contexts and environmental conditions by incorporating a better understanding of the dynamics acting at different spatiotemporal scales.

International consensus statement on allergy and rhinology: Olfaction.

BACKGROUND: The literature regarding clinical olfaction, olfactory loss, and olfactory dysfunction has expanded rapidly over the past two decades, with an exponential rise in the past year. There is substantial variability in the quality of this literature and a need to consolidate and critically review the evidence. It is with that aim that we have gathered experts from around the world to produce this International Consensus on Allergy and Rhinology: Olfaction (ICAR:O). METHODS: Using previously described methodology, specific topics were developed relating to olfaction. Each topic was assigned a literature review, evidence-based review, or evidence-based review with recommendations format as dictated by available evidence and scope within the ICAR:O document. Following iterative reviews of each topic, the ICAR:O document was integrated and reviewed by all authors for final consensus. RESULTS: The ICAR:O document reviews nearly 100 separate topics within the realm of olfaction, including diagnosis, epidemiology, disease burden, diagnosis, testing, etiology, treatment, and associated pathologies. CONCLUSION: This critical review of the existing clinical olfaction literature provides much needed insight and clarity into the evaluation, diagnosis, and treatment of patients with olfactory dysfunction, while also clearly delineating gaps in our knowledge and evidence base that we should investigate further.

Assessing climate change tolerance and the niche breadth-range size hypothesis in rare and widespread alpine plants.

Species range limits often reflect niche limits, especially for ranges constrained along elevational gradients. In this study, we used elevational transplant experiments to test niche breadth and functional trait plasticity in early life stages of narrow-range Nabalus boottii and broad-range N. trifoliolatus plants to assess their climate change vulnerability and the applicability of the niche breadth-range size hypothesis to explain their range size differences. We discovered that the earliest life stage (seed germination) was the most vulnerable and the two alpine taxa, N. boottii and N. trifoliolatus var. nanus, were unable to establish at the warm low elevation site, however non-alpine N. trifoliolatus established at all three elevations, including at the high elevation (beyond-range) site. Niche limits in seed emergence may therefore contribute to range size in these taxa. In contrast, when seedlings were planted we found substantial functional trait plasticity in later life stages (average 44% across ten traits) that was highly similar for all Nabalus taxa, suggesting that differences in plasticity do not generate niche differences or restrict range size in the focal taxa. While this substantial plasticity may help buffer populations faced by climate change, the inability of the alpine taxa to establish at lower elevation sites suggests that their populations may still decline due to decreased seed recruitment under ongoing climate change. We therefore recommend monitoring alpine Nabalus populations, particularly globally rare N. boottii.

Identifying Treatments for Taste and Smell Disorders: Gaps and Opportunities.

The chemical senses of taste and smell play a vital role in conveying information about ourselves and our environment. Tastes and smells can warn against danger and also contribute to the daily enjoyment of food, friends and family, and our surroundings. Over 12% of the US population is estimated to experience taste and smell (chemosensory) dysfunction. Yet, despite this high prevalence, long-term, effective treatments for these disorders have been largely elusive. Clinical successes in other sensory systems, including hearing and vision, have led to new hope for developments in the treatment of chemosensory disorders. To accelerate cures, we convened the "Identifying Treatments for Taste and Smell Disorders" conference, bringing together basic and translational sensory scientists, health care professionals, and patients to identify gaps in our current understanding of chemosensory dysfunction and next steps in a broad-based research strategy. Their suggestions for high-yield next steps were focused in 3 areas: increasing awareness and research capacity (e.g., patient advocacy), developing and enhancing clinical measures of taste and smell, and supporting new avenues of research into cellular and therapeutic approaches (e.g., developing human chemosensory cell lines, stem cells, and gene therapy approaches). These long-term strategies led to specific suggestions for immediate research priorities that focus on expanding our understanding of specific responses of chemosensory cells and developing valuable assays to identify and document cell development, regeneration, and function. Addressing these high-priority areas should accelerate the development of novel and effective treatments for taste and smell disorders.

Deer do not affect short-term rates of vegetation recovery in overwash fans on Fire Island after Hurricane Sandy.

Coastal resilience is threatened as storm-induced disturbances become more frequent and intense with anticipated changes in regional climate. After severe storms, rapid recovery of vegetation, especially that of dune-stabilizing plants, is a fundamental property of coastal resilience. Herbivores may affect resilience by foraging and trampling in disturbed areas. Consequently, assessing the impacts of herbivores on recovering vegetation is important for coastal land management.We combined imagery classification, wildlife monitoring, and trend analysis to investigate effects of white-tailed deer on recovery rates of vegetation four years poststorm in nine overwashed areas. We estimated local deer density with trail cameras, how it relates to an index of primary productivity, and assessed the relationship between deer density and rates of vegetation recovery in overwash fans.Prestorm vegetation cover consisted of shrubs and sporadic patches of beach grass. Poststorm cover was dominated by beach grass. At current rates, vegetation coverage will return to prestorm conditions within the decade, though community transition from grasses to shrubs will take much longer and will vary by site with dune formation.The effect of deer on rates of vegetation recovery was negative, but not statistically significant nor biologically compelling. Although effects of deer trampling on beach grass are evident in classified imagery, deer foraging on beach grass had little effect on its rate of spread throughout overwash fans.While the rate of spread of the primary dune-building grass was not deleteriously affected by deer, locally high deer densities will likely affect the future establishment and development of herbs and shrubs, which are generally more palatable to deer than beach grass.

Advances in Understanding Parosmia: An fMRI Study.

INTRODUCTION: A number of patients with a diminished sense of smell also can suffer from parosmia. These patients with such a qualitative smell disorder are often more severely affected than patients exhibiting only a quantitative smell disorder. Qualitative smell disorders have heretofore been poorly investigated. The focus of the present study was, using functional MRI, to compare the central processing of olfactory stimulation in patients with qualitative smell disorders. MATERIAL AND METHODS: A total of 23 patients were investigated, 12 hyposmic patients without parosmia (HYP group) and 11 hyposmic patients with parosmia (PAR group). Both groups were matched with regard to sex and age. The olfactory smells used were peach and coffee odors. RESULTS: The two groups exhibited different patterns of activation. In HYP patients a stronger activation was observed in the medial orbitofrontal cortex, anterior cingulate cortex, and parahippocampal gyrus, whereas in the PAR group stronger activation in the thalamus and putamen was seen. DISCUSSION: These results are consistent with the hypothesis that there are specific patterns in the central processing of olfactory stimuli which differ in hyposmic patients with and without parosmia.

NAVIGATE II: Randomized, double-blind trial of the exhalation delivery system with fluticasone for nasal polyposis.

BACKGROUND: Chronic rhinosinusitis is common and sometimes complicated by nasal polyps (NPs). Corticosteroid nasal sprays are often unsatisfactory because they are ineffective at delivering medication to high/deep sites of inflammation. OBJECTIVE: We sought to assess whether an exhalation delivery system with fluticasone (EDS-FLU) capable of high/deep drug deposition improves outcomes. METHODS: Patients (n = 323) 18 years and older with moderate-to-severe congestion and NPs were randomized to twice-daily EDS-FLU (93, 186, or 372 µg) or exhalation delivery system (EDS)-placebo for 24 weeks (16 double-blind plus 8 open-label when all received 372 µg). Coprimary end points were change in nasal congestion/obstruction at 4 weeks and summed bilateral polyp grade at 16 weeks. Secondary end points included symptoms, polyp elimination, and functioning. RESULTS: EDS-FLU was superior on both coprimary end points (P < .001 vs EDS-placebo, all doses). Mean polyp grade improved continuously through week 24 (P < .009, all comparisons), with polyps eliminated on at least 1 side in approximately 25% of patients at week 24 versus 8.7% with EDS-placebo (P ≤ .014, all comparisons). Sino-Nasal Outcomes Test scores also improved significantly versus those in patients receiving EDS-placebo (-21.1 to -21.4 vs -11.7 at week 16, P < .05 all doses). At the end of the double-blind period, EDS-FLU (all doses) significantly improved all 4 defining disease symptoms. In most patients (68%), those receiving EDS-FLU reported "much" or "very much" improvement. The number of patients eligible for surgery decreased by 62%-67%. The safety profile was similar to that reported in prior trials evaluating conventional corticosteroid nasal sprays in comparable populations. CONCLUSION: EDS-FLU produces clinically and statistically significant improvement in all 4 diagnostically defining disease symptoms, polyp grade, and quality of life in patients with chronic rhinosinusitis with NPs.

Effects of white-tailed deer (Odocoileus virginianus) exclusion on plant recovery in overwash fans after a severe coastal storm.

We documented the impacts of an abundant deer population on dune vegetation recovering from severe storm surge on a barrier island through use of permanent plots and a repeated measures analysis. Three years after landfall of the storm, vegetation cover was dominated by American beachgrass, Ammophila breviligulata, though we observed 12 plant species among plots surveyed. We documented significantly greater vegetation cover in fenced than unfenced plots in overwash fans in two consecutive years. The difference in species richness between fenced and unfenced plots was significant, though richness was consistently low (≤4 species per plot) and we did not detect a statistically significant difference between years. Both deer trampling and foraging effects were captured in this study, though separation between these effects was not possible. Because trampling effects are often exacerbated on sandy soils, trampling and foraging effects should be isolated and investigated in future assessments of deer impacts on coastal vegetation. Managing deer to lower abundance may enhance coastal resilience if vegetation is allowed to recover unimpeded by foraging and trampling, though a better understanding of the precise nature of deer impacts on dune vegetation is necessary.

Factors Associated With Phantom Odor Perception Among US Adults: Findings From the National Health and Nutrition Examination Survey.

Importance: Phantom odor perception can be a debilitating condition. Factors associated with phantom odor perception have not been reported using population-based epidemiologic data. Objective: To estimate the prevalence of phantom odor perception among US adults 40 years and older and identify factors associated with this condition. Design, Setting, and Participants: In this cross-sectional study with complex sampling design, 7417 adults 40 years and older made up a nationally representative sample from data collected in 2011 through 2014 as part of the National Health and Nutrition Examination Survey. Exposures: Sociodemographic characteristics, cigarette and alcohol use, head injury, persistent dry mouth, smell function, and general health status. Main Outcomes and Measures: Phantom odor perception ascertained as report of unpleasant, bad, or burning odor when no actual odor exists. Results: Of the 7417 participants in the study, 52.8% (3862) were women, the mean (SD) age was 58 (12) years, and the prevalence of phantom odor perception occurred in 534 participants, which was 6.5% of the population (95% CI, 5.7%-7.5%). Phantom odor prevalence varied considerably by age and sex. Women 60 years and older reported phantom odors less commonly (7.5% [n = 935] and 5.5% [n = 937] among women aged 60-69 years and 70 years and older, respectively) than younger women (9.6% [n = 1028] and 10.1% [n = 962] among those aged 40-49 years and 50-59 years, respectively). The prevalence among men varied from 2.5% (n = 846) among men 70 years and older to 5.3% (n = 913) among men 60 to 69 years old. Phantom odor perception was 60% (n = 1602) to 65% (n = 2521) more likely among those with an income-to-poverty ratio of less than 3 compared with those in the highest income-to-poverty ratio group (odds ratio [OR], 1.65; 95% CI, 1.06-2.56; and OR, 1.60; 95% CI, 1.01-2.54 for income-to-poverty ratio <1.5 and 1.5-2.9, respectively). Health conditions associated with phantom odor perception included persistent dry mouth (OR, 3.03; 95% CI, 2.17-4.24) and history of head injury (OR, 1.74; 95% CI, 1.20-2.51). Conclusions and Relevance: An age-related decline in the prevalence of phantom odor perception is observed in women but not in men. Only 11% (n = 64) of people who report phantom odor perception have discussed a taste or smell problem with a clinician. Associations of phantom odor perception with poorer health and persistent dry mouth point to medication use as a potential explanation. Prevention of serious head injuries could have the added benefit of reducing phantom odor perception.

Influence of upper airway abnormalities on the control of severe asthma: a cross-sectional study.

BACKGROUND: A better understanding of severe uncontrolled asthma (UA) in the upper airways is needed. The aims of this study were to assess the prevalence of upper airway abnormalities and their associations with UA. METHODS: An observational study enrolled individuals with severe asthma. Sociodemographic and clinical questionnaires regarding asthma, rhinosinusitis, and laryngopharyngeal reflux (LPR) were administered. Skin-prick tests and fiber optic nasolaryngoscopies were also performed. Descriptive statistical analysis was performed, using a multiple Poisson regression model to obtain adjusted prevalence ratios (PRs) and to identify the clinical profiles associated with the highest and lowest percentages of the dependent variable, lack of asthma control. RESULTS: The sample consisted of 64 participants who were divided into 2 groups according to asthma control. Thus, group I comprised 27 individuals with severe controlled asthma (CA), and group II consisted of 37 individuals with UA. Women represented 87.5% of the study population. The median age was 54 years, and 86% of the sample had rhinosinusitis. Relevant associations were detected between UA and hyposmia (PR = 2.04), hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs) (PR = 1.45), arytenoids hyperemia (PR = 1.45), LPR (PR = 1.37), a positive family history of asthma (PR = 1.35), onset of asthma at age 10 years or older (PR = 0.59), and swelling of the vocal cords (PR = 0.54). CONCLUSION: This study found a very high prevalence of rhinosinusitis in patients with severe asthma as well as associations between UA and hyposmia, hypersensitivity to NSAIDs, arytenoids hyperemia, and LPR. Clinical profiles prone to UA were identified.

Olfactory cocainization is not an effective long-term treatment for phantosmia.

Phantosmia, the perception of an odor when there are no odorants in the environment, can be a very debilitating symptom. In the 1960s, Zilstorff reported olfactory distortions could be treated by the topical application of a cocaine solution to the olfactory epithelium. In evaluating this treatment, we observed no long-term benefit using cocaine on 6 patients with phantosmia. Based on our observations, the patient's olfactory ability was not a determining factor in the initiation or quality of their phantosmia. Following topical cocainization, we observed a remarkable delay of hours to days in the return of olfactory ability, and when cocaine was applied to only 1 nostril, there was a decreased olfactory ability on the noncocainized side. These results may suggest the possibility that phantosmia is related to a central processing problem.

Distorted olfactory perception: a systematic review.

The sense of smell provides people with valuable input from the chemical environment around them. The human sense of smell generally fails in three ways; one is an intensity reduction and the other two are the quality of changes. Smell disorders can be classified into central or peripheral depending on their origin. Central causes can be related to an area of hyper-functioning brain cells generating this odor perception, thus olfactory distortions have also been observed with epilepsy and migraine. In this paper, we present a review of the current clinical understanding of olfactory distortions and discuss how they can be evaluated and therapies to treat this debilitating condition.

Smell and taste disorders.

Olfaction and taste promote satisfaction and protection in daily life. The astute facial plastic surgeon recognizes the importance of a baseline smell test to document the patients' olfactory status before surgery. After surgery, the surgeon must be alert to the possible mechanisms of hyposmia and anosmia and the pertinent treatment strategies. The surgeon must also understand the importance of counseling the patient and family regarding the cause of the dysfunction and the proper treatments. This article updates the facial plastic surgeon on the importance of smell and taste and associated disorders with a current review of the literature.

Gastric bypass does not influence olfactory function in obese patients.

Morbidly obese individuals have altered sense of taste and smell. Gastric bypass (GBP) alters taste but olfactory function has not been evaluated. Changes in these senses may influence dietary preferences following GBP. Our aim was to evaluate the effect of abdominal operation, specifically GBP, and weight loss on olfactory function. Fifty-five persons undergoing GBP and cholecystectomy and 40 persons undergoing cholecystectomy (CC) alone were administered the Cross Cultural Smell Identification Test (CC-SIT) preoperatively and 2 and 6 weeks postoperatively. Patients undergoing GBP underwent further tests at 3, 6, 9, and 12 months. Body mass index (BMI) was also assessed. Mean BMI was significantly greater preoperatively in the GBP group (50.6 ± 8.0 vs. 30.6 ± 7.3 kg/m(2), p < 0.05). Significantly more GBP patients had abnormal CC-SIT results preoperatively (12.7% vs. 5.0%). There were no significant differences in percentage of abnormal tests at 2 and 6 weeks within groups but remained lower in CC patients (2 weeks, GBP 6.2% vs. CC 5.7%; 6 weeks, GBP 9.8% vs. CC 3.2%, p < .05). BMI decreased in the GBP group at 12 months (50.6 ± 8.0 preoperatively to 31.9 ± 6.9 p < 0.05). Absolute olfactory dysfunction (AOD) was present at each interval up to 12 months after GBP. Only 22% of patients with AOD remained obese. GBP does not appear to influence olfactory function. AOD present in morbidly obese persons is not affected by weight loss. These findings support that olfactory dysfunction may be a contributing factor to the development of obesity.