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Background: Amongst the common problems facedglobally, Allergic Rhinitis (AR) is very distressing attimes. This is an inflammatory response to either knownor unknown allergen. The symptomatic relief in ARusing topical steroid Fluticasone propionate andantihistaminic Azelastine Hydrochloride in acombination has been studied. Very few studies showingcomparison between these two drugs in a combinationand steroid alone are available in the literature. Aim andObjectives: To study the effectiveness of topicaltreatment using corticosteroid Fluticasone propionateand antihistaminic in a combination versus Fluticasonepropionate alone in patients of AR. Material andMethods: The cases presented with symptoms ofallergic rhinitis were randomized in two groups at startof treatment. All cases of Group I were treated withFluticasone propionate whereas of Group II withFluticasone propionate and Azelastine hydrochloridecombination. In each group, the individual symptomscores were recorded pre-treatment and post-treatmentat the end of four weeks with the help of symptomevaluation scale. Based on these individual symptomscores, the Total Symptom Score (TSS) was calculated.The effectiveness of group specific drugs was evaluatedby comparing individual and TSS. Results: After fourweeks, both TSS and individual symptom score werereduced in either group (p<0.05). Further, Group IIspecific drug was found more effective than Group-I inrelieving symptoms of AR. Conclusion: TSS decreasedby an average of 84.14% in Group-I (i.e. treated withFluticasone propionate) and by 91.16% in Group–II (i.e.treated with Fluticasone propionate and Azelastinehydrochloride I in a combination).
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Introducción: La azelastina es un antihistamínico tópico nasal, exento de los molestos efectos sistémicos, la cual asociada con fluticasona, ha mostrado excelentes resultados en el control de la rinitis alérgica. Objetivo: Evaluar los resultados del tratamiento del spray nasal de azelastina y fluticasona. Diseño: Observacional descriptivo prospectivo. Materiales y métodos: Se evaluaron 76 pacientes de ambos sexos, con edades entre los 12 y 59 años, con diagnóstico de rinitis alérgica en el que se midieron los síntomas: obstrucción, prurito, estornudos y rinorrea. La severidad de los síntomas fue valorada por el propio paciente de 0 a 10 pretratamiento, a la semana, dos, tres y cuatro semanas de iniciado el tratamiento, el cual fue igual para todos los pacientes, con control ambiental y la atomización de 2 puff en cada fosa nasal del spray de azelastina y fluticasona. Se hizo seguimiento de los síntomas nasales y la aparición de efectos colaterales. Resultados: Se observó una diferencia estadísticamente significativa entre el puntaje obtenido previo al tratamiento y en la evaluación posterior desde la primera semana de uso y hasta el momento del seguimiento final a la cuarta semana (p<0,0001 Friedman F). Conclusiones: El spray nasal de azelastina y fluticasona, es muy útil en el control de los síntomas de rinitis alérgica, mostrando además un adecuado perfil de seguridad.
Introduction: Azelastine, is a topical nasal antihistamine free of systemic effects, the quality associated with fluticasone, has been excellent in the control of allergic rhinitis. Objective: To evaluate the results of the treatment of the nasal spray of azelastine and fluticasone. Design: Prospective and descriptive study. Methods: 76 patients of both sexes, aged between 12 and 59 years, with a diagnosis of allergic rhinitis in which the symptoms were measured: obstruction, pruritus, sneezing and rhinorrhea. The severity of each symptom was assessed by the patient from 0 to 10 before and after a week, two, three and four weeks, which was the same for all patients, with environmental control and the atomization of 2 puffs in each nostril of the azelastine and fluticasone spray. A follow-up of nasal symptoms and the appearance of side effects. Results: A statistically significant difference was observed between the score obtained before the treatment and in the subsequent evaluation from the first week until the time of the final follow-up at the fourth week (p <0.0001 Friedman F). Conclusion: The nasal spray of azelastine and fluticasone is very useful in the control of the symptoms of allergic rhinitis.
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Humans , Rhinitis, Allergic, Perennial , Fluticasone , Glucocorticoids , Histamine AntagonistsABSTRACT
OBJECTIVE:To observe the effectiveness and safety of azelastine combined with fluticasone in the treatment of allergic rhinitis(AR). METHODS:A total of 135 AR patients were selected from 3 hospitals during Jan. 2015-Jul. 2016, and divided into azelastine group,fluticasone group and drug combination group according to random number table,with 45 cases in each group. On the basis of decongestant Oxymetazoline hydrochloride spray,azelastine group was given Azelastine hydrochloride nasal spray,1 spray each nostril,morning and night;fluticasone group was given Fluticasone propionate nasal spray,1 spray each nostril,morning and night;drug combination was given Azelastine hydrochloride nasal spray combined with Fluticasone propionate nasal spray,with the same usage and dose. Three groups were treated for consecutive 30 d. Total nasal symptom score (TNSS) and total ocular symptom score (TOSS) decline indexes,nasal minimal cross-sectional area (NMCA),total nasal resistance(TNR)and the occurrence of ADR were compared among 3 groups. RESULTS:Some pa-tients were withdrawal from the trial;finally,127 patients were included in full analysis set,and 130 patients were included in safety set. After treatment,TNSS decline index of drug combination group was significantly higher than azelastine group and fluticasone group,with statistical significance(P0.05). Before treatment, 3 groups suffered from nasal ventilation disorder to different extents,but there was no statistical significance in TNR or NMCA among 3 groups(P>0.05). After treatment,NMCA and TNR at 75,150 Pa of 3 groups were significantly lower than before,and TNR of drug combination group was significantly lower than azelastine group and fluticasone group,with statisti-cal significance(P0.05). There was no statistical significance in the incidence of ADR among 3 groups(P>0.05). CONCLUSIONS:Both azelastine and fluticasone can effec-tively relieve nasal symptom as well as improve nasal ventilation disorder in AR patients;therapeutic efficacy of drug combi-nation is better than single drug,and it doesn't increase the incidence of ADR.
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Objective To observe the clinical efficacy of needle-knife therapy in treating allergic rhinitis. Method Sixty allergic rhinitis patients were randomized into a treatment group and a control group, 30 cases in each group. The treatment group was intervened by needle-knife therapy; the control group was given Azelastine hydrochloride nasal spray plus oral administration of Desloratadine, both twice a day. The intervention lasted for 4 weeks in both groups. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and symptoms scores were observed before and after the treatment, and the clinical efficacies were compared between the two groups. Result The markedly effective rate was 90.0% in the treatment group versus 66.7% in the control group, and the between-group difference was statistically significant (P<0.05). The RQLQ and symptoms scores were significantly changed after the intervention in both groups (P<0.05). After the treatment, the RQLQ and symptoms scores in the treatment group were significantly different from those in the control group (P<0.05). Conclusion Needle-knife therapy is safe and effective in treating allergic rhinitis.
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OBJECTIVE To observe clinical efficacy of azelastine hydrochloride nasal spray plus budesonide nasal spray on persistent allergic rhinitiss(AR). METHODS 120 patients with persistent AR were devided randomly into group A(n=40), group B(n=40) and group C(n=40). Group A were treated with azelastine hydrochloride nasal spray and budesonide nasal spray, group B received only azelastine hydrochloride nasal spray and group C received budesonide nasal spray only, the treatment process were 4 weeks. Clinical efficacy were compared among 3 groups 4 weeks later. RESULTS 1. VAS scores: VAS scores of nasal symptoms in group A were lower than those both in group B and in group C after 4 weeks, the difference were statistically significant(P<0.05); 2. RQLQ scores: RQLQ scores in 3 groups were all significantly improved after 4 weeks, the RQLQ scores of sleep, nonnose/eye symptoms, nasal symptoms and emotions in group A were improved more significantly than those in group B and in group C, the difference were statistically significant(P<0.05); 3. Clinical efficacy: the significant effective rate and the total effective rate were 50.00% and 93.33% in group A, but were 30.00% and 75.00% in group B and 27.50% and 77.50% in group C, the differences between group A and group B or group A and group C were statistically significant(P <0.05). CONCLUSION Azelastine hydrochloride nasal spray plus budesonide nasal spray can rapidly relieve nasal symptoms and improve the life quality of the patients with persistent AR.
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OBJECTIVE:To optimize Azelastine hydrochloride (AH) thermosensitive in-situ gel nasal drops formulation. METHODS:Using poloxamer 407(P407)and poloxamer 188(P188)as excipients,AH thermosensitive in-situ gel was prepared by cold solution method. The formulation was optimized by central composite design-response surface methodology using the amount of P407 and P188(g/100 ml)as factors and phase-transition temperature as index. Binomial expression was fitted,and pre-dicted and measured values were compared. RESULTS:The correlation coefficient R2 fitted by binomial expression was equal to 0.986 5. The optimal formulation was as follows as P407 for 20.414 4%,P188 for 5.035 4%,measured value of(30.81±0.02)℃, predicted values of 31 ℃,deviation of 0.61%. CONCLUSIONS:AH thermosensitive in-situ gel nasal drops formulation is opti-mized by central composite design-response surface methodology.
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Objective To explore the effect of azelastine hydrochloride nasal spray combined with desloratadine to inflammatory factors, cell function and IgE of patients with allergic rhinitis.Methods 92 cases of allergic rhinitis patients treated in the first affiliated hospital of wenzhou medical college hospital from June 2014 to December 2015 were divided into experimental group(n=46) and control group(n=46) according to the random number table method.The control group was given oral loratadine tablets, one piece per time, one time per day, while the experimental group was given azelastine hydrochloride nasal spray on the basis of the control group,each nostril one spray, one time in the morning and night.The clinical efficacy of two groups of patients would be observed after 4 weeks,ELISA would be used to detect serum levels of IFN-γ, IL-4, IL-8 and IgE level, and IFN-γ/IL-4 was the value of Thl/Th2,flow cytometry instrument was used to the determination of T cell subgroup CD4 +,CD8 + cells.Results 4 weeks after treatment,stuffy nose, nasal itching, runny nose, sneezing and nasal cavity change points are lower than before the treatment in both the two groups.Experimental group obviously lower than the control group, the difference was statistically significant ( P <0.05 ).The total effective rate of treatment group is higher than the control group,the difference was statistically significant(χ2 =4.389,P=0.036).The serum level of IFN-γis higher than before treatment in both the two groups.IL-4, IL-8 inflammatory factor levels were lower than before treatment,the experimental group was better than control group,the difference was statistically significant(P<0.05).CD4 +,CD8 +of T cells and Thl/Th2 values are higher than before the treatment in both the two groups,the experimental group was higher than control group, the difference was statistically significant ( P<0.05 ).Serum IgE levels were lower than before the treatment in both the two groups,the experimental group was lower than control group,the difference was statistically significant (P<0.05).Conclusion The therapy of azelastine hydrochloride nasal spray combined with desloratadine can improve the clinical effect of the treatment of allergic rhinitis,reduce inflammation,strengthen the body's immune function, improve thelevel of serum IgE.
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Aims: Stability indicating densitometry-TLC assay was established and validated for determination of azelastine hydrochloride (AZT) and emedastine difumarate (ETD) in the presence of their acid and oxidative degradants. Methodology: Forced degradation was performed using 30% H2O2 and 5 M HCl. The method was based on thin-layer chromatographic separation of the two drugs from their degradants, using methanol- 10% ammonia (9.5:0.5, v/v) as developing system, followed by densitometric measurements of the intact drug spots at 292 and 283 nm, for azelastine hydrochloride and emedastine difumarate respectively. Results: The linear range was 0.5 - 10.0 μg/spot, with mean recoveries of 100.09 ± 0.53% and 100.36 ± 0.40% for azelastine hydrochloride and emedastine difumarate respectively. Conclusion: The proposed method was successfully applied for the routine quality control analysis of both drugs in laboratory prepared mixtures and commercially available preparations. The degradation products were identified by IR and MS and the pathways were illustrated. The method was validated according to ICH.
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Objective:To provide scientific basis for the clinical diagnosis and treatment of allergic rhinitis by observation of curative effect of treatment to allergic rhinitis by azelastine hydrochloride nasal spray combined with desloratadine .Methods: One hundred and twenty-nine patients with allergic rhinitis were randomly divided into two groups: an experimental group and a control group.The control group was treated by azelastine hydrochloride nasal spray .The experimental group was treated by azelastine hydrochloride nasal spray and desloratadine 5 mg per night.One period of treatment for each group is 4 weeks.Results:the cure rate of the experimental group was 93.85%and 81.25%in control group, with a great difference between them (P0.05).Conclusion:azelastine hydro-chloride nasal spray combined with desloratadine can treat patients with allergic rhinitis effectively and safely .It can increase the total effective rate and improve present ’s symptoms.It has great value in clinical application .
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Objective To observe the effect of bronchial asthma combined with allergic rhinitis by azelastine hydrochloride nasal spray.Methods Eighty-seven cases of bronchial asthma combined with allergic rhinitis patients were divided into treatment group(45 cases)and control group (42 cases) by random number table method,both groups were given the treatment of bronchial asthma according to the guidelines for regulating,treatment group on the basis was combined with azelastine hydrochloride 1 spray per side,2times per day,for 3 months.Observe two groups of asthma symptoms within 3 months control situation,the number of antibiotics and hospitalization for acute exacerbation.Results Treatment group total effective rate,asthma control test score,number of antibiotics and due to the number of exacerbations hospitalization were superior to control group [93.33％(42/45) vs.76.19％(32/42),(23.80 ± 2.15)scores vs.(22.05 ±3.16) scores,13.3％ (6/45) vs.35.7％ (15/42),11.1％ (5/45) vs.33.3％ (14/42)] (P ＜ 0.05 or ＜ 0.01).Conclusion Combined by azelastine hydrochloride nasal spray may make a good control,reduce the use of antibiotics for acute attack and times of hospitalization,worthy of clinical application.
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Several antihistaminics possess antibacterial activity against a broad spectrum of bacteria. However, the exact mechanism of such activity was unclear. Hence, the aim of this study is to investigate their mechanism of antibacterial activity especially their effect upon the permeability of the bacterial cytoplasmic membrane. The effects of azelastine, cetirizine, cyproheptadine and diphenhydramine were studied using Gram-positive and Gram-negative multiresistant clinical isolates. Leakage of 260 and 280 nm UV-absorbing materials was detected upon treatment with the tested antihistaminics; indicative of membrane alteration. Using an artificial membrane model, cholesterol-free negatively-charged unilamellar liposomes, confirmed the effect of antihistaminics upon the membrane permeability both by showing an apparent membrane damage as observed microscopically and by detection of leakage of preloaded dye from the liposomes colorimatrically. Moreover, examination of the ultrastructure of cells treated with azelastine and cetirizine under the transmission electron microscope substantiated the detected abnormalities in the cell wall and membrane. Furthermore, the effect of pretreating certain isolates for both short and long periods with selected antihistaminics was followed by the viable count technique. Increased vulnerability towards further exposure to azelastine was observed in cells pretreated with azelastine for 2 days and those pretreated with azelastine or cetrizine for 30 days.
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Humans , Cell Membrane , Cell Membrane Permeability , Cell Wall , Cytoplasm , Drug Resistance, Microbial , Histamine H1 Antagonists , Unilamellar Liposomes/analysis , Unilamellar Liposomes/pharmacology , Methods , MethodsABSTRACT
<b>Objective: </b>To investigate frequency of adverse drug reactions (ADR) on HIGURD ®<br>, a switch OTC product of azelastine hydrochloride, in a three-year post-marketing surveillance study.<br><b>Methods: </b>We conducted two surveys in this study a solicited survey with a questionnaire and a survey of spontaneous ADR reports.<br><b>Results: </b>A total of 183 cases with 293 ADRs were reported in the solicited survey on 3,453 consumers and a total of 29 cases with 37 ADRs were reported from spontaneous sources. No serious ADRs were reported. Most frequently reported ADRs were somnolence, thirst, malaise, and dysgeusia, all of which are common on azelastine hydrochloride. This study indicated that HIGURD ®<br>is well tolerated.<br><b>Conclusion: </b>This study suggested that efficacy and safety of HIGURD ®<br>depend on how much consumers understand the contents of “Precautions for Use” section of package insert. It is considered to be effective for safety assurance in an early post-marketing phase that pharmacists inform consumers about appropriate use of HIGURD ®<br>and ask for the occurrence of ADRs.
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Background & Objectives: Vasomotor rhinitis (VMR) is a chronic non-allergic rhinitis without the increased Ig E level and eosinophilia. Azelastine hydrochloride is a second generation anti-histamine medication with anti-inflammatory properties that inhibits the synthesis of inflammatory materials. There are reports that azelastine hydrochloride can be effective in the treatment of VMR. Therefore, this study examined the clinical efficacy of intranasal azelastine hydrochloride spray in comparison with placebo for the treatment of VMR. MATERIALS AND METHOD: This study was a prospective double blind randomized test. The subjects consisted of 84 VMR patients. Among them, 54 patients were treated with intranasal azelastine hydrochloride for 4 weeks and 30 patients with intranasal normal saline. Following the treatment, an analysis of the symptom score was performed in order to compare the treatment effects between the study group and the control group. RESULTS: In the study group, the symptom score was significantly improved in the areas of sneezing (1.38 to 0.72), rhinorrhea (1.57 to 0.76), nasal obstruction (1.76 to 1.01) and postnasal drip (1.43 to 0.65). In the control group, however, the symptom score was significantly improved in a single area of rhinorrhea (1.73 to 0.65). Patients in the study group, thus, displayed greater improvements in the areas of sneezing, rhinorrhea, nasal obasturction and postnasal drip comparative to the control group. Consequently, the study group patients were more satisfied with their quality of life than those of the control group. CONCLUSION: Azelastine chloride is a useful medicine for the treatment of VMR, especially in controlling sneezing, rhinorrhea, nasal obstruction and postnasal drip.
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Humans , Eosinophilia , Nasal Obstruction , Prospective Studies , Quality of Life , Rhinitis , Rhinitis, Vasomotor , SneezingABSTRACT
AIM: To evaluate the antihistamine effects of domestic azelastine hydrochloride. METHODS: Histamine increased skin vascular permeability and induced shock model in guinea pigs. In isolated guinea pig ileal rings, the contraction of smooth muscle induced by histamine was determined. RESULTS: Pretreament with azelastine hydrochloride( 0.05, 0.15,and 0.45 mg?kg -1,ig) significantly inhibited the increase in skin vascular permeability induced by histamine in a dose-dependent manner in guinea pigs. Pretreament with azelastine hydrochloride( 0.05, 0.1,and 0.2 mg?kg -1,ig)produced a significant improvement of shock, as shown by a decrease in reactivity degree, mortality and a prolongation of latency. In isolated guinea pig ileal rings, azelastine hydrochloride (10 -8,3?10 -8,10 -7,3? 10 -7 mol?L -1)significantly inhibited contraction of smooth muscle induced by histamine in a concentration-dependent manner and caused a parallel right shift of the dose-effect curve of histamine (pA 2= 8.55). CONCLUSION: Domestic azelastine hydrochloride shows significant the antihistamine effects.
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AIM: To probe the effect of azelastine hydrochloride on experimental asthma and its mechanism. METHODS: Experimental asthma models of guinea pigs induced by histamine and acetylcholine in vivo as well as guinea pig tracheal spirals in vitro were used in this experiment. RESULTS: Azelastine hydrochloride inhibited asthma induced by histamine and acetylcholine in guinea pigs in a dose dependent manner, prolonged the incubation period of histamine and acetylcholine induced asthma (P