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Noninterventional Open-Label Trial Investigating the Efficacy and Safety of Ectoine Containing Nasal Spray in Comparison with Beclomethasone Nasal Spray in Patients with Allergic Rhinitis  [PDF]
Uwe Sonnemann,Marcus M?ller,Andreas Bilstein
Journal of Allergy , 2014, DOI: 10.1155/2014/297203
Abstract: Objectives. The current study aimed to compare the efficacy and safety of a classical anti-inflammatory beclomethasone nasal spray in comparison to a physic-chemical stabilizing ectoine containing nasal spray in the treatment of allergic rhinitis. Design and Methods. This was a noninterventional, open-label, observational trial investigating the effects of beclomethasone or ectoine nasal spray on nasal symptoms and quality of life. Over a period of 14 days, patients were asked to daily document their symptoms. Efficacy and tolerability were assessed by both physicians and patients. Results. Both treatments resulted in a significant decrease of TNSS values. An equivalence test could not confirm the noninferiority of ectoine treatment in comparison with beclomethasone treatment. Although clear symptom reduction was achieved with the ectoine products, the efficacy judgment showed possible advantages for the beclomethasone group. Importantly, tolerability results were comparably good in both groups, and a very low number of adverse events supported this observation. Both treatments resulted in a clear improvement in the quality of life as assessed by a questionnaire answered at the beginning and at the end of the trial. Conclusion. Taken together, it was shown that allergic rhinitis can be safely and successfully treated with beclomethasone and also efficacy and safety were shown for ectoine nasal spray. 1. Introduction Allergic rhinitis is a common disease with estimated 600 million patients suffering from this disease worldwide [1]. According to a large scale investigation, about 20% of the European population suffers from allergic rhinitis [2] and numbers are increasing, particularly in industrial states. Although not being a life-threatening disease, allergic rhinitis has a considerable impact on general well-being and work/school performance, and particularly its impact on comorbidities such as, for example, asthma reflects the need for good treatment options. A number of pharmacological treatments against allergic rhinitis exist, such as antihistamines, leukotriene receptor agonists, mast cell stabilizing agents, and glucocorticosteroids. According to the ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines, intranasal glucocorticosteroids are recommended as pharmacological treatment of allergic rhinitis and should be prescribed preferable to intranasal antihistamines and oral leukotriene receptor agonists [1]. However, many patients have reservations to use corticosteroids, and phobia of their usage can result in bad compliance [3]. This
Treatment of Allergic Rhinitis with Ectoine Containing Nasal Spray and Eye Drops in Comparison with Azelastine Containing Nasal Spray and Eye Drops or with Cromoglycic Acid Containing Nasal Spray  [PDF]
Nina Werkh?user,Andreas Bilstein,Uwe Sonnemann
Journal of Allergy , 2014, DOI: 10.1155/2014/176597
Abstract: Objectives. Allergic rhinitis is a common disease with increasing prevalence and high impact on economic burden and comorbidities. As treatment with pharmacological drugs is not always satisfactory due to side effects and incomplete efficacy, alternative treatment strategies are needed. Ectoine is an osmolyte with membrane stabilizing and inflammation reducing capacities. Nasal spray and eye drops containing ectoine are promising new treatment regimens for allergic rhinitis sufferers. Design and Methods. The current two noninterventional trials evaluated the efficacy and safety of ectoine containing nasal spray and eye drops for treating allergic rhinitis in comparison with either azelastine or cromoglycic acid containing products. Nasal and ocular symptom developments as well as judgment of tolerability and efficacy were assessed both by investigators and patients over a time period of one to two weeks. Results. Both trials confirmed that ectoine containing products reduced nasal and ocular symptoms in allergic rhinitis patients. Results clearly demonstrated good safety profiles of the ectoine products comparable to those of azelastine and even better to those of cromoglycate products. Conclusion. Ectoine containing nasal spray and eye drops are interesting new treatment strategies for sufferers of allergic rhinitis, combining both good efficacy and absence of side effects. 1. Introduction Allergic rhinitis is a common disease affecting 10–20% of the population [1]. Since it has great impact on patients’ quality of life, school performance, work productivity, and comorbid conditions such as asthma, it is considered as an important health problem. Allergic rhinitis is defined as an allergic reaction (most often IgE-dependent) to offending allergens such as dust mites, insects, animal dander, and pollens. Symptoms include rhinorrhea, nasal obstruction, nasal and nasopharyngeal itching, sneezing, and postnasal drip. Often, allergic rhinitis is accompanied by allergic conjunctivitis with ocular symptoms such as itchy and watery eyes, resulting in the term allergic rhinoconjunctivitis. According to its length of duration, allergic rhinitis is classified into intermittent (symptoms present <4 days a week of <4 weeks) and persistent (symptoms present ≥ 4 days a week and for at least 4 weeks) forms. Symptom severity is used to classify allergic rhinitis into mild or moderate-severe forms. A number of pharmacological treatments of allergic rhinitis exist, such as, for example, oral and topical antihistamines, leukotriene receptor antagonists, intranasal
Meta-Analysis of the Efficacy of Ectoine Nasal Spray in Patients with Allergic Rhinoconjunctivitis  [PDF]
Andrea Eichel,Andreas Bilstein,Nina Werkh?user,Ralph M?sges
Journal of Allergy , 2014, DOI: 10.1155/2014/292545
Abstract: Objectives. The meta-analysis aims to investigate the efficacy of ectoine nasal spray and eye drops in the treatment of allergic rhinitis and rhinoconjunctivitis symptoms. Design and Methods. This meta-analysis is based on yet unpublished data of four studies. Both nasal and eye symptoms were documented in patient diary cards. All scales were transformed into a 4-point scale: 0 = no, 1 = mild, 2 = moderate, and 3 = severe symptoms. Each symptom was analysed individually in a meta-analysis of the area under the curve values as well as in a meta-analysis of pre- and posttreatment comparison. Results. After seven days of treatment with ectoine nasal spray both nasal and ocular symptoms decreased significantly. A strong reduction of symptom severity was shown for the parameters rhinorrhoea (31.76% reduction) and nasal obstruction (29.94% reduction). Furthermore, the meta-analyses of individual symptoms to investigate the strength of effect after seven days of medication intake showed significant improvement for nasal obstruction, rhinorrhoea, nasal itching, sneezing, itching of eyes, and redness of eyes. The improvement of the symptom nasal obstruction was associated with a strong effect 0.53 (±0.26). Conclusions. The ectoine nasal spray and eye drops seem to be equally effective as guideline-recommended medication in the treatment of rhinoconjunctivitis symptoms. 1. Introduction Allergic rhinitis is clinically defined as an inflammation of the nose with characteristic symptoms such as rhinorrhoea, nasal obstruction, sneezing, and/or itching of the nose. The symptomatic disorder of the nasal mucosa and tissue is associated with an IgE-mediated immune response to allergens and is characterised by two phases: an immediate response after allergen exposure (early phase) and a late phase occurring up to 12 hours later, which predominantly causes nasal congestion [1]. If a concurrent respiratory infection is present, a patient’s probability of developing bronchial asthma as comorbidity increases. Likewise, the risk of developing further allergies with more severe symptoms rises over the time of the disease [2]. A variety of causes for rhinitis exist in both children and adults, but 50% of all cases can be ascribed to allergy [3]. Due to its prevalence, impact on quality of life, impairment of work or school performance, reducing effect on productivity, economic burden, and risk of comorbidities, allergic rhinitis is regarded worldwide as a major chronic respiratory disease. Moreover, it can be associated with significant fatigue, mood changes, cognitive
Evaluation of Fluticasone (Flixonase) Nasal Spray Versus Beclomethasone (Beconase) Nasal Spray in the Treatment of Allergic Rhinitis
Reza Farid,Farhad Farid,Javad Ghaffari,Farahzad Jabbari
Iranian Journal Of Allergy, Asthma and Immunology , 2003,
Abstract: Although response to intranasal steroid therapy has been reported in pa tients with allergic rhinitis, efficacy of some nasal steroids is noteworthy.This study was undertaken to evaluate the efficacy of a two-week course of Fluticasone (Flixonase) nasal spray vs. Beclomethasone (beconase) nasal spray in patients with symptoms of allergic rhinitis referred to our clinic. This study reviewed sixty randomized studies with symptoms of allergic rhinitis which sup ported common aeroallergens with skin prick test. Patients received a total daily dose of nasal spray of Fluticasone (Flixonase) 100 meg bid (N=30) compared with patients with allergic rhinitis who received a total daily dose of Beclomethasone (Beconase) 50mcg 2 puffs bid (N=30). Patients were visited before and after therapy, and efficacy of Flixonase. and Beconase was evaluated by the change in nasal symptoms including: nasal discharge, nasal obstruction, nasal itching, and sneezing. After two weeks of treatment nasal symptoms of blockage, discharge, sneezing and itching were significantly better in the group treated with Fluticasone nasal spray (65%, 82%, 67%, 79% respectively (/?<0.001) but after treatment with beconase nasal spray lower benefits in the nasal symptoms includes: 50%, 71%, 51%, 57% respectively. After two weeks of treatment no deleterious changes consequent to therapy were observed in nasal symptoms.100 meg bid Flixonase (Fluticasone) intranasal spray is more effective than 50 meg 2 puffs bid Beconase (Beclomethasone) intranasal spray. Like asthma, allergic rhinitis is an inflammatory disease and should be managed with anti-in flammatory medication.
Fluticasone furoate nasal spray in the treatment of allergic rhinitis
Pedro Giavina-Bianchi,Rosana Agondi,Rafael Stelmach,Alberto Cukier
Therapeutics and Clinical Risk Management , 2008,
Abstract: Pedro Giavina-Bianchi1, Rosana Agondi1, Rafael Stelmach2, Alberto Cukier2, Jorge Kalil11Division of Clinical Immunology and Allergy, University of S o Paulo, S o Paulo, Brazil; 2Pulmonary Division, University of S o Paulo, S o Paulo, BrazilAbstract: Allergic rhinitis (AR) is a prevalent disease with great morbidity and significant societal and economic burden. Intranasal corticosteroids are recommended as first-line therapy for patients with moderate-to-severe disease, especially when nasal congestion is a major component of symptoms. To compare the efficacy and safety profile of different available intranasal corticosteroids for the treatment of AR, it is important to understand their different structures and pharmacokinetic and pharmacodynamic properties. Knowledge of these drugs has increased tremendously over the last decade. Studies have elucidated mechanisms of action, pharmacologic properties, and the clinical impact of these drugs in allergic respiratory diseases. Although the existing intranasal corticosteroids are already highly efficient, the introduction of further improved formulations with a better efficacy/safety profile is always desired. Fluticasone furoate nasal spray is a new topical corticosteroid, with enhanced-affinity and a unique side-actuated delivery device. As it has high topical potency and low potential for systemic effects, it is a good candidate for rhinitis treatment.Keywords: fluticasone furoate, corticosteroids, rhinitis, efficacy, safety, ARIA
Psychometric validation of the experience with allergic rhinitis nasal spray questionnaire
Crawford B, Stanford RH, Wong AY, Dalal AA, Bayliss MS
Patient Related Outcome Measures , 2011, DOI: http://dx.doi.org/10.2147/PROM.S19371
Abstract: ychometric validation of the experience with allergic rhinitis nasal spray questionnaire Original Research (1962) Total Article Views Authors: Crawford B, Stanford RH, Wong AY, Dalal AA, Bayliss MS Published Date June 2011 Volume 2011:2 Pages 127 - 133 DOI: http://dx.doi.org/10.2147/PROM.S19371 Bruce Crawford1, Richard H Stanford2, Audrey Y Wong3, Anand A Dalal2, Martha S Bayliss1 1Mapi Values, Boston, MA, USA; 2GlaxoSmithKline, Research Triangle Park, NC, USA; 3BioMedical Insights, San Francisco, CA, USA Background: Patient experience and preference are critical factors influencing compliance in patients with allergic rhinitis (AR) receiving intranasal corticosteroids. The Experience with Allergic Rhinitis Nasal Spray Questionnaire (EARNS-Q) was developed to measure subject experiences with and preferences for nasal sprays. Objective: To describe the psychometric validation of the EARNS-Q modules. Methods: An observational study was conducted with subjects aged 18–65 years with physician-diagnosed vasomotor, seasonal, and/or perennial allergic rhinitis who were using a prescription nasal spray. Subjects completed the experience module of the EARNS-Q and the Treatment Satisfaction Questionnaire with Medication (TSQM) at baseline and after 2 weeks. Further validation analyses were conducted in a 3-week, randomized, single-blind, crossover, multicenter clinical study in which subjects ≥18 years of age with documented seasonal AR received flunisolide and beclomethasone and completed the EARNS-Q experience module on days 1 and 8, the EARNS-Q preference module on day 22, and the TSQM on days 8 and 22. Results: The observational and clinical studies were completed by 121 and 89 subjects, respectively. Both modules demonstrated acceptable reliability (α = 0.72 experience module; α = 0.93 preference module global scores) and validity (intraclass correlation coefficient or ICC 0.64 to 0.82 test–retest validity). Correlations among the experience and preference modules were moderate (r = 0.39 to 0.79) and within internal consistency reliability estimates, indicating measurement of distinct constructs. Conclusion: The EARNS-Q is a patient-reported outcomes measure that enables reliable and valid measurement of subject experience with, and preference for, prescription intranasal corticosteroid sprays for allergic rhinitis.
Psychometric validation of the experience with allergic rhinitis nasal spray questionnaire  [cached]
Crawford B,Stanford RH,Wong AY,Dalal AA
Patient Related Outcome Measures , 2011,
Abstract: Bruce Crawford1, Richard H Stanford2, Audrey Y Wong3, Anand A Dalal2, Martha S Bayliss11Mapi Values, Boston, MA, USA; 2GlaxoSmithKline, Research Triangle Park, NC, USA; 3BioMedical Insights, San Francisco, CA, USABackground: Patient experience and preference are critical factors influencing compliance in patients with allergic rhinitis (AR) receiving intranasal corticosteroids. The Experience with Allergic Rhinitis Nasal Spray Questionnaire (EARNS-Q) was developed to measure subject experiences with and preferences for nasal sprays.Objective: To describe the psychometric validation of the EARNS-Q modules.Methods: An observational study was conducted with subjects aged 18–65 years with physician-diagnosed vasomotor, seasonal, and/or perennial allergic rhinitis who were using a prescription nasal spray. Subjects completed the experience module of the EARNS-Q and the Treatment Satisfaction Questionnaire with Medication (TSQM) at baseline and after 2 weeks. Further validation analyses were conducted in a 3-week, randomized, single-blind, crossover, multicenter clinical study in which subjects ≥18 years of age with documented seasonal AR received flunisolide and beclomethasone and completed the EARNS-Q experience module on days 1 and 8, the EARNS-Q preference module on day 22, and the TSQM on days 8 and 22.Results: The observational and clinical studies were completed by 121 and 89 subjects, respectively. Both modules demonstrated acceptable reliability (α = 0.72 experience module; α = 0.93 preference module global scores) and validity (intraclass correlation coefficient or ICC 0.64 to 0.82 test–retest validity). Correlations among the experience and preference modules were moderate (r = 0.39 to 0.79) and within internal consistency reliability estimates, indicating measurement of distinct constructs.Conclusion: The EARNS-Q is a patient-reported outcomes measure that enables reliable and valid measurement of subject experience with, and preference for, prescription intranasal corticosteroid sprays for allergic rhinitis.Keywords: EARNS-Q, allergic rhinitis, compliance, intranasal corticosteroid, patient preference, psychometric validation
Fluticasone furoate nasal spray: Profile of an enhanced-affinity corticosteroid in treatment of seasonal allergic rhinitis  [cached]
Robert Anolik
Journal of Asthma and Allergy , 2010,
Abstract: Robert AnolikAllergy and Asthma Specialists, PC, Blue Bell, Pennsylvania, USAAbstract: Of the classes of pharmacotherapy for seasonal allergic rhinitis, intranasal corticosteroids are the preferred treatment and are recommended in practice guidelines as first-line pharmacotherapy for rhinitis with prominent nasal congestion. The enhanced-affinity intranasal corticosteroid fluticasone furoate nasal spray (GW685698X), is one of the newest additions to the armamentarium for allergic rhinitis. This review summarizes the preclinical and clinical data on fluticasone furoate nasal spray and discusses its place in pharmacotherapy for seasonal allergic rhinitis. Important attributes of fluticasone furoate in seasonal allergic rhinitis include low systemic bioavailability (<0.5%), onset of symptom relief as early as eight hours after initiation of treatment, 24-hour symptom relief with once-daily dosing, comprehensive coverage of both nasal and ocular symptoms, safety and tolerability with daily use, and availability in a side-actuated device that makes medication delivery simple and consistent. With these attributes, fluticasone furoate nasal spray has the potential to enhance patient satisfaction and compliance and reduce the need for polypharmacy in the management of seasonal allergic rhinitis.Keywords: seasonal allergic rhinitis, allergy, corticosteroid, fluticasone furoate
Fluticasone furoate nasal spray: Profile of an enhanced-affinity corticosteroid in treatment of seasonal allergic rhinitis
Robert Anolik
Journal of Asthma and Allergy , 2010, DOI: http://dx.doi.org/10.2147/JAA.S10839
Abstract: ticasone furoate nasal spray: Profile of an enhanced-affinity corticosteroid in treatment of seasonal allergic rhinitis Review (3748) Total Article Views Authors: Robert Anolik Published Date August 2010 Volume 2010:3 Pages 87 - 99 DOI: http://dx.doi.org/10.2147/JAA.S10839 Robert Anolik Allergy and Asthma Specialists, PC, Blue Bell, Pennsylvania, USA Abstract: Of the classes of pharmacotherapy for seasonal allergic rhinitis, intranasal corticosteroids are the preferred treatment and are recommended in practice guidelines as first-line pharmacotherapy for rhinitis with prominent nasal congestion. The enhanced-affinity intranasal corticosteroid fluticasone furoate nasal spray (GW685698X), is one of the newest additions to the armamentarium for allergic rhinitis. This review summarizes the preclinical and clinical data on fluticasone furoate nasal spray and discusses its place in pharmacotherapy for seasonal allergic rhinitis. Important attributes of fluticasone furoate in seasonal allergic rhinitis include low systemic bioavailability (<0.5%), onset of symptom relief as early as eight hours after initiation of treatment, 24-hour symptom relief with once-daily dosing, comprehensive coverage of both nasal and ocular symptoms, safety and tolerability with daily use, and availability in a side-actuated device that makes medication delivery simple and consistent. With these attributes, fluticasone furoate nasal spray has the potential to enhance patient satisfaction and compliance and reduce the need for polypharmacy in the management of seasonal allergic rhinitis.
POSSIBILITY OF PHARMACOMODULATION OF THE HYPERSENSITIVE RHINITIS JOINED WITH THE NASAL POLYPOSIS
Dejan Ursulovi?,Ljiljana Jano?evi?,Slobodanka Jano?evi?
Acta Medica Medianae , 2001,
Abstract: The research goai is to examine the effects of the local corticosteroidapplication to the number of eosinophils in the nasal secretion of the patients withhypersensitive rhinitis joined with the nasal polyposis. The study comprises 13patients with hypersensitive rhinitis joined with the nasal polyposis; 9 of them madeup the experimental group. The local corticosteroid (bechomethasone dipropionatein water spray) was given at 12 hours in individual doses of 200 micrograms to theexperimental group patients in six weeks. During the treatment it was confirmed thatthere was a highly important reduction of the number of eosinophils of the nasalsecretion in the experimental group patients.
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