Validated allergen exposure chamber is plausible tool for the assessment of house dust mite-triggered allergic rhinitis.

BACKGROUND: Allergen exposure chamber (AEC) is a clinical facility that allows exposure to allergenic airborne particles in controlled environment. Although AECs offer stable levels of airborne allergens, the validation of symptoms and other endpoints induced by allergen challenge is key for their recommendation as a plausible tool for the assessment of patients, especially in clinical research. This study aimed to demonstrate the reproducibility of defined clinical endpoints after AEC house dust mite (HDM) challenge under optimal conditions in patients with allergic rhinitis (AR). METHOD: HDM was distributed at different concentrations. The assessment was subjective by the patients: total nasal symptom score (TNSS), visual analog scale (VAS), and objective by the investigator: acoustic rhinometry, peak nasal inspiratory flow (PNIF), and nasal secretion weight. Safety was assessed clinically and by peak expiratory flow rate (PEFR) and forced expiratory volume in the first second (FEV1 ). RESULTS: Constant environment: temperature, humidity, and carbon dioxide (CO2 ) concentration were maintained during all challenges. The concentration of HDM on average remained stable within the targeted values: 1000, 3000, 5000, 7000 particles (p)/m3 . Most symptoms were observed at concentrations 3000 p/m3 or higher. The symptoms severity and other endpoints results were reproducible. 5000 p/m3 , and challenge duration of 120 min were found optimal. The procedure was safe with no lung function abnormalities due to challenge. CONCLUSION: HDM challenge in ALL-MED AEC offers a safe and reliable method for inducing symptoms in AR patients for the use in controlled clinical studies including allergen immunotherapy.

The burden of allergic rhinitis and allergic rhinoconjunctivitis on adolescents: A literature review.

OBJECTIVE: To evaluate the literature regarding the burden of allergic rhinitis (AR) and allergic rhinoconjunctivitis (ARC) in adolescents (aged 10-19 years). DATA SOURCES: Searches were performed in MEDLINE, Embase, Health Technology Assessment Database, and National Health Service Economic Evaluation Database for studies that evaluated concepts of symptoms, quality of life (QOL), daily activities, sleep, examination performance, school absenteeism and presenteeism, and treatment burden in adolescents with AR or ARC. STUDY SELECTIONS: English-language journal articles indexed in the last 15 years describing noninterventional, population-based studies. Records were assessed by 2 independent reviewers. RESULTS: A total of 27 articles were identified; outcomes evaluated were symptoms (n = 6 studies), QOL (n = 9), daily activities (n = 5), emotional aspects (n = 3), sleep (n = 6), education (n = 7), and treatment burden (n = 2). AR symptoms rated most bothersome were rhinorrhea, nasal congestion, and itchy eyes. QOL was worse in adolescents with AR vs controls regardless of QOL instrument used. Nasal symptoms and nasal obstruction were more likely to be associated with poor QOL in adolescents than in adults or younger children, respectively. Daily functioning and sleep were also negatively affected by AR. In addition, a detrimental effect on absenteeism, school productivity, and academic performance was reported. CONCLUSION: Although AR and ARC are sometimes perceived as trivial conditions, this review indicates that their effect on adolescent life is negative and far-reaching. It is critical that clinicians gain a greater understanding of the unique burden of AR and ARC in adolescents to ensure they receive prompt and appropriate care and treatment to improve clinical and academic outcomes.

Costs of perennial allergic rhinitis and allergic asthma increase with severity and poor disease control.

BACKGROUND: Perennial allergic rhinitis (PAR) represents a global and public health problem, due to its prevalence, morbidity, and impact on the quality of life. PAR is frequently associated with allergic asthma (AA). Costs of PAR with or without AA are poorly documented. OBJECTIVE: Our study aimed to detail medical resource utilization (MRU) and related direct cost for PAR, with or without concomitant AA, in France. METHODS: Using Electronic Health Records (EHRs), we identified in 2010 two cohorts of PAR patients, based on General Practitioners' diagnoses and prescribing data, with and without concomitant AA. For each patient, the EHRs were linked to corresponding claims data with MRU and costs during years 2011 to 2013. Predefined subgroup analyses were performed according to severity of PAR and level of AA control. RESULTS: The median annual cost reimbursed by social security system for a patient with PAR, and no AA was 159€ in 2013. This varied from 111€ to 188€ depending on PAR severity. For patients with PAR and concomitant AA, the median annual cost varied between 266€ and 375€, and drug treatment accounted for 42-55% of the costs, depending on asthma control. CONCLUSION: This study linking diagnoses from EHRs to claims data collected valid information on PAR management, with or without concomitant AA, and on related costs. There was a clear increase in costs with severity of PAR and control of AA.

Eficacia y seguridad del furoato de fluticasona (spray nasal) para el tratamiento de pacientes adultos con rinitis alérgica perenne que no responden a los antihistamínicos orales / Efficacy and safety of fluticasone furoate (nasal spray) for the treatment of adult patients with perennial allergic rhinitis who do not respond to oral antihistamines

INTRODUCCIÓN: El presente dictamen expone la evaluación de la eficacia y seguridad del medicamento furoato de fluticasona para el tratamiento de pacientes adultos con rinitis alérgica perenne que no responden a antihistamínicos orales. La rinitis alérgica (RA) representa un desorden inflamatorio de la mucosa nasal que se inicia con una respuesta inmune mediada por anticuerpos IgE contra alérgenos inhalados. La RA perenne se caracteriza por la manifestación de síntomas durante todo el año, generalmente debido a alérgenos encontrados en ambientes cerrados o intradomiciliaros, incluyendo el moho, los ácaros del polvo en el hogar y la caspa de los animales. Los síntomas de la RA perenne incluyen la congestión nasal, los estornudos, la rinorrea y el prurito, siendo la congestión nasal a menudo el síntoma más predominante. Aunque la mayoría de pacientes con RA perenne responden adecuadamente a los antihistamínicos orales (AOs), tratamiento farmacológico de primera línea para la RA, aproximadamente el 20% de ellos continúan manifestando síntomas moderados o severos comprometiendo su calidad de vida de manera significativa, afectando el sueño, las actividades diarias o cotidianas, el trabajo habitual o las atividades escolares. TECNOLOGÍA SANITARIA DE INTERÉS: El furoato de fluticasona (FF) es un medicamento que se usa para tratar los síntomas de la rinitis alérgica, es un corticosteroide sintético trifluorado que actúa fijándose a los receptores de diversos tipos de células del sistema inmune reduciendo así la actividad de sistema inmunológico. De este modo se produce una reducción en la liberación de sustancias implicadas en el proceso inflamatorio, como la histamina, y en consecuencia el alivio de los síntomas de la alergia. METODOLOGÍA: En la presente evaluación de tecnología sanitaria se llevó a cabo una búsqueda sistemática de la literatura con respecto a la eficacia y seguridad del FF en spray nasal, comparado a los AOs, en el tratamiento de pacientes adultos con rinitis alérgica perenne que no responden a AOs. No obstante, dado que no se encontraron ensayos clínicos que respondieran de manera directa a la pregunta PICO de la presente evaluación, se decidió incluir ensayos clínicos que pudieran brindar evidencia indirecta en relación a la pregunta PICO de interés, esto es, ensayos clínicos en donde se haya evaluado la eficacia y seguridad del FF en spray nasal, comparado al placebo, en el tratamiento de pacientes adultos con RA perenne previamente tratados. Adicionalmente, el IETSI realizó un meta-análisis con los ensayos clínicos identificados, el cual se describe en el presente documento. RESULTADOS: Se realizó una búsqueda de la literatura con respecto a la eficacia y seguridad de furoato de fluticasona (FF) (spray nasal), en comparación a los AOs, para el tratamiento de pacientes adultos con rinitis alérgica perenne que no responden a antihistamínicos orales. Debido a que no se encontraron ensayos clínicos que respondieran directamente a la pregunta PICO de la presente evaluación de tecnología, se incluyeron ensayos clínicos que evaluaron la eficacia y seguridad del FF, en comparación al placebo, en pacientes adultos con RA perene previamente tratados (evidencia indirecta). Así, la evidencia científica disponible a agosto de 2017 que ayuda a responder la pregunta PICO de interés incluye, una guía de práctica clínica (Seidman et al. 2015) ; y seis ensayos clínicos aleatorizados (ECAs) de fase III o IV (Nathan et al. 2008; Vasar et al. 2008; Given et al. 2010; Rosenblut et al. 2007; Laforce et al. 2013; Patel et al. 2008), con los cuales el IETSI realizó un meta-análisis. En la guía de práctica clínica de Seidman, para el manejo de la rinitis alérgica se recomienda el uso de los corticoesteroides intranasales (CIN) para el tratamiento de pacientes con RA que no responden a los AOs; no obstante, no se menciona el uso específico del fluroato de fluticasona, pues, según lo mencionado en la guía, en la actualidad, los estudios no han mostrado diferencias entre los CIN en términos de eficacia. Específicamente para el FF, esta recomendación se basó en la opinión de expertos y en la evidencia proveniente de la revisión sistemática (RS) de Rodrigo et al. CONCLUSIONES: En la presente eevaluación de ttecnología ssanitaria se incluyó la evidencia publicada hasta agosto 2017 con respecto a la eficacia y seguridad del FF en spray nasal, comparado a los AOs, en el tratamiento de pacientes adultos con rinitis alérgica perenne que no responden a AOs. No obstante, dado que no se encontraron ensayos clínicos que respondieran de manera directa a la pregunta PICO de la presente evaluación, se decidió incluir ensayos clínicos que pudieran brindar evidencia indirecta en relación a la pregunta PICO de interés, esto es, ensayos clínicos en donde se haya evaluado la eficacia y seguridad del FF en spray nasal, comparado al placebo, en el tratamiento de pacientes adultos con RA perenne previamente tratados. Adicionalmente, el IETSI realizó un meta-análisis con los ensayos clínicos identificados, el cual se describe en el presente documento. Así, la evidencia identificada en el presente Ddictamen incluye una guía de práctica clínica (Seidman et al. 2015) ; y seis ensayos clínicos de fase III o IV (Nathan et al. 2008; Vasar et al. 2008; Given et al. 2010; Rosenblut et al. 2007; Laforce et al. 2013; Patel et al. 2008) , con los cuales el IETSI realizó un meta-análisis. En la guía de práctica clínica de Seidman para el manejo de la rinitis alérgica se recomienda el uso de los corticoesteroides intranasales (CIN) para el tratamiento de pacientes con RA que no responden a los AOs; no obstante, no se menciona el uso específico del fluroato de fluticasona, pues, según lo mencionado en la guía, a la actualidad, los estudios no han mostrado diferencias entre los CIN en términos de eficacia. Específicamente para el FF, esta recomendación se basó en la opinión de expertos y en la evidencia proveniente de la revisión sistemática (RS) de Rodrigo et al, La RS de Rodrigo et al., publicada en el 2010, fue la única RS identificada que incluyó una análisis del efecto del FF en spray nasal en pacientes con RA perenne. No obstante, dado que esta RS combinó resultados de estudios que no cumplían com nuestros criterios de elegibilidad (i.e., pacientes adultos y ensayos clínicos de fase III o IV), esta fue utilizada como fuente de estudios primarios que sí cumplieran con estos criterios, como lo fueron los estudios de Nathan et al. (Nathan et al. 2008) , Vasar et al. (Vasar et al. 2008) , Given et al. (Given et al. 2010) , Patel et al. (Patel et al. 2008) y Rosenblut et al. (Rosenblut et al. 2007) . Adicionalmente a estos cinco estúdios seleccionados, se encontró un ensayo clínico publicado en el 2014 (Laforce et al. 2013), identificándose de este modo un total de seis 6 ECAs como fuente de evidencia indirecta que fueron incluidos en el meta-análisis realizado por el IETSI. Debido a que, en la actualidad, no se cuenta con un valor establecido de la mínima diferencia clínicamente importante (MDCI) para los desenlaces de eficacia de relevância en la RA perenne, en nuestro meta-análisis se optó por considerar como clinicamente importante a una diferencia media estandarizada (DME) menor o igual a -0.8 de acuerdo a la metodología validada de Cohen (Cohen 1988) , la cual considera a este valor como un tamaño de efecto grande. Adicionalmente, se utilizaron los valores de MDCI establecidos por la Agencia para la Investigación y la Calidad del Cuidado de la Salud (AHRQ, por su sigla en inglés) de los Estados Unidos para evaluar la magnitude de los efectos del tratamiento en lo que concierne a la RA estacional en base a la opinión de sus expertos y la evidencia disponible. El Instituto de Evaluación de Tecnologías en Salud e Investigación - IETSI no aprueba el uso del furoato de fluticasona para el tratamiento de pacientes adultos con rinitis alérgica perenne que no responden a los antihistamínicos orales.

[Socio-economic impact of allergic rhinitis and perspectives of appropriate therapy]. / Sozioökonomische Auswirkungen der allergischen Rhinitis und Perspektiven einer adäquaten Therapie.

Allergic rhinitis is a very common disease that causes high economic costs. Furthermore inadequate treatment can lead to bronchial asthma. Against this background, drugs for the treatment of allergic rhinitis should be evaluated from a comprehensive medical-economic perspective. The new combination of an antihistamine and a corticosteroid, introduced in the market in 2013, emerges as useful pharmaceutical alternative, both with regard to the medical outcome parameters as well as cost-effectiveness.

Decision-making analysis for allergen immunotherapy versus nasal steroids in the treatment of nasal steroid-responsive allergic rhinitis.

BACKGROUND: The purpose of the study was to determine the age at which initiation of specific subcutaneous immunotherapy (SCIT) becomes more cost-effective than continued lifetime intranasal steroid (NS) therapy in the treatment of allergic rhinitis, with the use of a decision analysis model. METHODS: A Markov decision analysis model was created for this study. Economic analyses were performed to identify "break-even" points in the treatment of allergic rhinitis with the use of SCIT and NS. Efficacy rates for therapy and cost data were collected from the published literature. Models in which there was only incomplete improvement while receiving SCIT were also evaluated for economic break-even points. The primary perspective of the study was societal. RESULTS: Multiple break-even point curves were obtained corresponding to various clinical scenarios. For patients with seasonal allergic rhinitis requiring NS (i.e., fluticasone) 6 months per year, the age at which initiation of SCIT provides long-term direct cost advantage is less than 41 years. For patients with perennial rhinitis symptoms requiring year-round NS, the cut-off age for SCIT cost-effectiveness increases to 60 years. Hypothetical subjects who require continued NS treatment (50% reduction of previous dosage) while receiving SCIT also display break-even points, whereby it is economically advantageous to consider allergy referral and SCIT, dependent on the cost of the NS prescribed. CONCLUSION: The age at which SCIT provides economic advantages over NS in the treatment of allergic rhinitis depends on multiple clinical factors. Decision analysis models can assist the physician in accounting for these factors and customize patient counseling with regard to treatment options.

Intranasal corticosteroids: the role of patient preference and satisfaction.

Allergic rhinitis (AR) is a disease with a significant global burden, associated with many comorbidities and quality-of-life issues. Overwhelming evidence shows that intranasal corticosteroids are the most effective treatment for AR to control the disease, decrease comorbidities, and decrease costs. Poor adherence is a major barrier to achieving control of AR. This article addresses patient preferences and satisfaction regarding intranasal corticosteroids and factors leading to better adherence. We review and summarize the published literature. Factors affecting patient preference and, ultimately, adherence include a variety of sensory components such as odor, taste, comfort of delivery, delivery devices (aerosol versus aqueous) and patient cost. The intensity of adverse sensory attributes is negatively correlated with patient preference and the likelihood of adherence. Selection of an intranasal steroid (INS) with patient preference and satisfaction in mind can influence patient outcomes and cost. Providers need to assess each patient to determine which inhaled INS will lead to the best adherence, thereby improving outcomes in our patients and ultimately reducing the overall global burden of this disease.

Allergic rhinoconjunctivitis in the Australian population: burden of disease and attitudes to intranasal corticosteroid treatment.

BACKGROUND: Allergic rhinoconjunctivitis (AR/C) is a global health problem causing significant morbidity and has a major impact on quality of life (QOL) and health expenditure. Despite the widespread prevalence, the overall health impact of AR/C may be underappreciated. The results of a survey designed to capture the burden of allergic rhinitis within the Asia-Pacific region have been published recently. Of particular note when evaluating treatment in this region was the fact that despite the value of intranasal corticosteroid (INCS) use, only a small percentage of patients used them. Whether this same trend is present within the population of Australian sufferers is unknown. This study examines the burden of AR/C and explores use of, and attitudes, to INCS sprays in the Australian population. METHODS: Three hundred three completed interviews from adults and children who had physician-diagnosed AR/C and who were symptomatic or had received treatment in the previous 12 months were analyzed for QOL measures and attitudes to INCS use. RESULTS: Most patients surveyed had received their diagnosis from a general practitioner (GP), and in most cases, a GP provided the majority of ongoing medical care. Only 8% of respondents had consulted a relevant specialist. Diagnostic tests had not been performed in 55% of respondents. The major symptoms causing most distress were nasal congestion and ocular symptoms. The burden of AR/C was considerable; 42% described significant work or school interference because of symptoms, one-third reporting moderate-to-extreme interference with sleep. Despite the significant impact on QOL reported by this sample, 17% had never used INCS and 27% had not used them in the previous 12 months. Respondents' knowledge about INCSs was poor. CONCLUSION: AR/C is a common disease associated with significant morbidity and impairment of QOL. Improvement in diagnosis, management, and patient education is needed.

Computational fluid dynamics: a suitable assessment tool for demonstrating the antiobstructive effect of drugs in the therapy of allergic rhinitis.

This systematic review aims first to summarize the previous areas of application of computational fluid dynamics (CFD) and then to demonstrate that CFD is also a suitable instrument for generating three-dimensional images that depict drug effects on nasal mucosa. Special emphasis is placed on the three-dimensional visualization of the antiobstructive effect of nasal steroids and antihistamines in the treatment of allergic rhinitis. In the beginning, CFD technology was only used to demonstrate physiological and pathophysiological airflow conditions in the nose and to aid in preoperative planning and postoperative monitoring of surgical outcome in the field of rhinosurgery. The first studies using CFD examined nasal respiratory physiology, important functions of the nose, such as conditioning and warming of inspired air, and the influence of pathophysiological changes on nasal breathing. Also, postoperative outcome of surgical procedures could be "predicted" using the nasal airflow model. Later studies focused on the three-dimensional visualization of the effect of nasal sprays in healthy subjects and postoperative patients. A completely new approach, however, was the use of CFD in the area of allergic rhinitis and the treatment of its cardinal symptom of nasal obstruction. In two clinical trials, a suitable patient with a positive history of allergic rhinitis was enrolled during a symptom-free period after the pollen season. The patient developed typical allergic rhinitis symptoms after provocation with birch pollen. The 3-D visualization showed that the antiallergic treatment successfully counteracted the effects of nasal allergen provocation on nasal airflow. These observations were attributed to the antiobstructive effect of a nasal steroid (mometasone furoate) and a systemic antihistamine (levocetirizine), respectively. CFD therefore constitutes a non-invasive, precise, reliable and objective examination procedure for generating three-dimensional images that depict the effects of drugs used in the treatment of allergic rhinitis.

Evidence-based review and assessment of botulinum neurotoxin for the treatment of secretory disorders.

Botulinum neurotoxin (BoNT) can be injected to achieve therapeutic benefit across a large range of clinical conditions. To assess the efficacy and safety of BoNT injections for the treatment of certain hypersecretory disorders, including hyperhidrosis, sialorrhea, and chronic rhinorrhea, an expert panel reviewed evidence from the published literature. Data sources included English-language studies identified via MEDLINE, EMBASE, CINAHL, Current Contents, and the Cochrane Central Register of Controlled Trials. Evidence tables generated in the 2008 Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology (AAN) review of the use of BoNT for autonomic disorders were also reviewed and updated. The panel evaluated evidence at several levels, supporting BoNT as a class, the serotypes BoNT-A and BoNT-B, as well as the four individual commercially available formulations: abobotulinumtoxinA (A/Abo), onabotulinumtoxinA (A/Ona), incobotulinumtoxinA (A/Inco), and rimabotulinumtoxinB (B/Rima). The panel ultimately made recommendations for each therapeutic indication, based upon the strength of clinical evidence and following the AAN classification scale. For the treatment of axillary hyperhidrosis in a total of 923 patients, the evidence supported a Level A recommendation for BoNT-A, with a Level B recommendation for A/Abo and A/Ona and a Level U recommendation (insufficient data) for A/Inco and B/Rima. Five trials in 82 patients supported the use of BoNT in palmar hyperhidrosis, with a Level B recommendation for BoNT-A and a Level C recommendation for BoNT-B; individual formulations received a Level U rating due to insufficient data. BoNT (and all individual formulations) received a Level U recommendation for the treatment of gustatory sweating. Support for use of BoNT in sialorrhea was derived from eight trials in a total of 222 adults and children. Evidence supported a Level B recommendation for A/Abo, A/Ona, and B/Rima and a Level U recommendation for A/Inco. Evidence supported a Level B recommendation for A/Ona for the treatment of allergic rhinitis, based on two Class II studies in 73 patients. A lack of published studies for A/Abo, A/Inco, or B/Rima supported a Level U recommendation for those formulations. Further clarity on the optimal mode of administration and additional studies using other BoNT formulations are needed to fill current evidence gaps.

Medical costs and adherence in patients receiving aqueous versus pressurized aerosol formulations of intranasal corticosteroids.

Intranasal corticosteroid (INS) formulations have different sensory attributes that influence patient preferences, and thereby possibly adherence and health outcomes. This study compares health care use and costs and medication adherence in matched cohorts of patients with allergic rhinitis (AR) using a chlorofluorocarbon-propelled pressurized metered-dose inhaler (pMDI) or aqueous intranasal corticosteroid (A-INS). Florida Medicaid retrospective claims analysis was performed of enrollees aged ≥12 years with at least 1 year of continuous enrollment before their initial AR diagnosis, 1 year for continuous enrollment before their index INS claim, and 18 months of continuous enrollment after their index INS claim during which they received either pMDI or A-INS. pMDI and A-INS patients were matched 1:2 using propensity scores. Nonparametric analyses compared outcomes between matched cohorts at 6, 12, and 18 months of follow-up. A total of 585 patients were matched (pMDI = 195, A-INS = 390). pMDI patients were more adherent to INS, as reflected in their higher median medication possession ratio (53.2% versus 32.7%; p < 0.0001) and fewer median days between fills (73 days versus 111 days; p = 0.0003). Significantly lower median per patient pharmacy fills (34.0 versus 50.5; p < 0.05) and costs ($1282 versus $2178; p < 0.01) were observed among pMDI patients versus A-INS patients 18 months after INS initiation and were maintained when analyses excluded INS fills. Adherence to INS and health care utilization and costs following INS initiation for AR differed by type of formulation received. Our findings suggest patient preferences for INS sensory attributes can drive adherence and affect disease control, and ultimately impact health care costs.

Suicide and prescription rates of intranasal corticosteroids and nonsedating antihistamines for allergic rhinitis: an ecological study.

OBJECTIVE: To estimate the relationship between antiallergy drug prescription rates and suicide across the United States and over time. The relationship between allergy, allergens, and suicidal behavior and suggestions of a possible immune mediation led us to hypothesize that intranasal corticosteroids, known to reduce local airway production of T-helper cell type 2 cytokines, may be associated with reduced risk of suicide relative to antihistamines, which only secondarily affect cytokine production. METHOD: The authors evaluated the relationship of suicide rates at the county level in the United States (N = 120,076 suicides) with prescriptions for intranasal corticosteroids and nonsedating antihistamines, in interaction with antidepressant prescriptions and other socioeconomic variables, for the period from 1999 to 2002. Suicide rate data were derived from state vital record systems based on local death certificate registries, and county-level allergy and antidepressant prescription data were obtained from IMS Health Incorporated (Plymouth Meeting, Pennsylvania). RESULTS: The prescription volume of intranasal corticosteroids was associated with a lower suicide risk (P = .0004), while that of antihistamines was associated with a modestly greater suicide risk (P = .0001). Adjustment for antidepressant prescriptions did not affect these relationships. CONCLUSIONS: This is the first study, to our knowledge, to find a possible association between completed suicide and medications for allergic rhinitis and also the first report of an association of intranasal corticosteroid use with a lower suicide rate. This association should be considered preliminary and deserving of further investigation.

Outcomes and cost comparison of three therapeutic approaches to allergic rhinitis.

BACKGROUND: Allergic rhinitis (AR) is a global health problem because of its increasing impact on economics, society, and the individual's quality of life. This study compares the outcomes and cost of three intranasal therapeutic approaches to the treatment of AR. METHODS: This was a retrospective cohort study using propensity scores to achieve balanced cohorts. The study population included patients ≥16 years of age with at least one intranasal prescription claim, without concurrent nasal polyps or sinusitis. Health care use and costs, airway infections, pharmacy costs, and indicators of unsatisfactory treatment (i.e., treatment augmentation or switching) were evaluated in the 1-year follow-up period using a claims database. RESULTS: Data from 141,190 patients in intranasal antihistamines (INA) therapy, intranasal steroids (INS) therapy, and intranasal combination therapy (ICT) cohorts were analyzed. The INA cohort showed the lowest rate of change in treatment (switching or augmentation). Switching rates were lowest in the INS therapy cohort, whereas augmentation was lowest in the INA cohort. AR- and asthma-related medication costs were significantly lower in the INA cohort. No differences were observed in airway infections and overall health care costs. Concurrent chronic obstructive pulmonary disorder and asthma were the strongest predictors of health care cost and respiratory infection in the follow-up period. CONCLUSION: A change in treatment was noted in ∼⅓ of the entire study population. None of the treatments had a remarkable effect on health care costs or the occurrence of airway infections. The INA treatment cohort had lower AR- and asthma-related medication costs.

A new instrument for the assessment of patient-defined benefit in the treatment of allergic rhinitis.

BACKGROUND: Allergic rhinitis (AR) is a common disease that affects health-related quality of life (HRQoL). Current and future health policy demands the assessment of patient-relevant treatment benefit for evaluation of treatments. METHODS: We developed, validated and tested a standardized instrument for the assessment of patient-relevant needs and benefits in AR. In an open survey of patients with AR, 100 need and benefit items were generated. The items were condensed to a 25-item list by an expert panel. On this list, patient rates the personal importance of 25 treatment needs on a scale ranging from 'not at all' to 'very' before treatment (Patient Needs Questionnaire, PNQ). At the end of the treatment, patient rates the extent, to which these needs were achieved by treatment from 'did not help at all' to 'helped a lot' (Patient Benefit Questionnaire). The patient benefit index (PBI) is computed to provide a global weighted benefit parameter. This disease-specific instrument was validated in n = 104 patients with AR. RESULTS: The PBI-AR showed good acceptability and feasibility in clinical routine. Reduction in nose and eye symptoms was rated most important. The PBI amounted to 2.2 (PBI ranges from 0 = 'no benefit' to 4 = 'maximum benefit'). Reliability of the PNQ was high (Cronbach's alpha = 0.9).The PBI was significantly correlated with relevant external validation criteria, such as patient satisfaction (R = 0.54) and HRQoL (R = 0.26). CONCLUSION: The PBI-AR is a feasible, reliable and valid instrument for the standardized assessment of patient-relevant benefits in the treatment of AR.

Allergic rhinitis: Direct and indirect costs.

Allergic rhinitis is one of the most common conditions affecting both children and adults. Along with the burden of the disease and decrease in quality of life associated with allergic rhinitis, there are high costs related to the disorder. Costs due to allergic rhinitis can be divided into two categories: direct costs that are related to monies spent on the course of managing the disease and indirect costs that are due to missing work and decreased productivity due to the illness. There are also the costs associated with the comorbidities of allergic rhinitis, such as sinusitis and asthma, which are classified as "hidden" direct costs. Management of allergic rhinitis involves allergen avoidance, proper pharmacologic therapies, and allergen immunotherapy. These treatments add to the direct cost of the condition and need to be evaluated to determine their cost-effectiveness in the control of the patient's nasal allergies. This article reviews the latest data on cost issues in allergic rhinitis and information of cost-effectiveness of treatments for this condition.

Specific recommendations for PROs and HRQoL assessment in allergic rhinitis and/or asthma: a GA(2)LEN taskforce position paper.

The GA(2)LEN taskforce on Patient-Reported Outcomes (PROs) and Health-Related Quality of Life (HRQoL) published in 2009 a position paper concerning PROS and HRQoL assessment in clinical trials on allergy. Because of the specificity of this topic in asthma and rhinitis, specific recommendations are needed. The aim of this position paper is to define PROs and their meaning in asthma and rhinitis research, explore the available tools to provide criteria for a proper choice, identify patient-related factor which could influence PROs assessment, define specific recommendations for assessment, analysis and results spreading, underline the unexplored areas and unmet needs. PROs assessment is gaining increasing importance, and it must be performed with a rigorous methodological procedure and using validated tools. This approach enables to better understand patient-related factors influencing clinical trials and real-life management outcomes, identify patients subgroups that can benefit from specific treatment and management plan and tailor treatment to address PROs (not only physician-defined targets) to improve asthma and rhinitis management.

Clinical assessment of levocetirizine and budesonide in treatment of persistent allergic rhinitis regarding to symptom severity.

OBJECTIVE: To compare effectiveness of levocetirizine and budesonide in treatment of persistent allergic rhinitis (PER) in patients with high and low total symptom scores (TSS). MATERIAL AND METHOD: Randomized, parallel-group study. Patients with PER were randomized to receive levocetirizine 5 mg (n = 50) or budesonide 256 microg (n = 50) daily for 4 week and were followed-up for another 4 weeks post-treatment. TSS combining itching, sneezing, rhinorrhea, daytime and nighttime nasal congestion was recorded daily during and after treatment for an entire period of 8 weeks. Efficacy variables included area under curves depicting reduction and increase in TSSs over time relative to baselines and time to response and symptom relapses. RESULTS: Symptoms were categorized as high and low using a median TSS of 8 as cutoff. Levocetirizine was as effective in control of high and low symptoms except for time to achieve maximum effect (2 days versus 1 week, respectively, p = 0.002) but was more effective in preventing relapses of high symptoms (p = 0.001). Budesonide was more effective against high than low symptoms (p < 0.001) but showed no difference in preventing relapses. Typical response rate of levocetirizine and budesonide were demonstrated in treatment of high symptoms. Levocetirizine achieved its full effectiveness in 2 days while budesonide required 2 weeks. Budesonide at full effect (after 2 weeks) was superior to levocetirizine (p = 0.004) but comparable for the entire treatment of 4 weeks (p =.059) and was inferior to in preventing relapses (p = 0.001). No such difference could be observed between these drugs in control of low symptoms. CONCLUSION: The effectiveness of the drug treatment in the present study is dependent of symptom severity. Levocetirizine bases on its rate of response and relapse was superior to budesonide in treatment of the high symptom group and is comparable in the low symptom group.

Continuous versus on-demand pharmacotherapy of allergic rhinitis: evidence and practice.

This review aims to compare continuous with on-demand pharmacotherapy of allergic rhinitis by focusing on pharmacodynamic, pharmacokinetic, safety, effectiveness, cost and cost-effectiveness considerations. A working party of experts reviewed and discussed the literature and guidelines, and conducted a qualitative analysis of the Summary of Product Characteristics of specific medicines. With respect to medicines, the working party limited itself to antihistamines, nasal corticosteroids and leukotriene antagonists. Based on a review of the evidence from a multidisciplinary perspective, this article makes pharmacotherapeutic recommendations that are easy, functional and applicable to daily practice in primary care. The pharmacotherapeutic evidence for continuous versus on-demand treatment of allergic rhinitis was limited. Clearly, for corticosteroids, their mechanism of action in allergic rhinitis of reducing allergic inflammation requires continuous therapy at least for the duration of symptoms. For H(1)-antihistamines, some trials suggest that continuous treatment is preferable but more studies are needed to confirm this conclusion. For both H(1)-antihistamines and nasal corticosteroids safety data indicate that continuous treatment may be given without fears of adverse consequences, although a distinction can be made between the first and the second generation antihistamines. With regard to the cost and cost-effectiveness implications of continuous therapy versus on-demand therapy, more studies are necessary before definitive conclusions may be made.

Nasal steroid perspective: knowledge and attitudes.

Intranasal corticosteroids (INCSs) seem to be the best medication available to control and eliminate symptoms of allergic rhinitis. However, the amounts of nasal steroids prescribed and used were not directly proportional to the number of allergic rhinitis cases in Turkey. Herein, we aimed to clarify the unexpectedly low prescription and use of INCSs in Turkey by checking the outlook of patients' and physicians' perspectives. The patients' perspective on oral and nasal steroids was evaluated with a custom-designed questionnaire drawn up specifically for this preliminary study. The physicians' perspective on prescribing nasal steroids was evaluated with the data obtained from the IMS Health Turkey reports. The findings we obtained in this survey by analyzing data from the self-administered questionnaires showed that among these young people, oral and nasal steroids were on the whole well-known drugs. Hence, even though steroids in general are well-known drugs, the young people we surveyed mainly remained uninformed about their safety. The incidence of using nasal steroids if prescribed is higher than the one with oral steroids; that may be due to the lack of knowledge about nasal steroids. The analysis of the IMS Health Turkey data for nasal steroid prescriptions between 2005 and 2008 shows that the market share has increased steadily. The role of INCSs in the treatment of allergic rhinitis is increasingly being recognized as an appropriate and effective treatment option. However, patients' and parents' concerns over the safety of INCS therapy have frequently resulted in their being positioned as a second-line treatment choice. Physicians need to be aware that patients may have a significant information gap. Instructing the family and caregivers about the correct use of INCS therapy is an important part of treatment.