Azelastine Hydrochloride Nasal Spray Research Articles

Comparative Analysis of Treatment of Allergic Rhinitis Utilizing Azelastine and Fluticasone

The present study was conducted to evaluate the efficacy of topical therapy in patients with allergic rhinitis by fluticasone propionate as well as corticosteroid propionate in conjunction with fluticasone propionate alone. The study aims to evaluate the efficacy of topical treatment on people with Allergic Rhinits (AR). The medicines propionate fluticasone and antihistamine corticosteroids and propionate fluticasone alone were administered to patients with allergic rhinitis. AR was tested. A comparison of the effectiveness of topical treatment with Azelastine of fluticasone propionate and Fluticasone to suppress Allergic Rhinitis symptoms was assessed. Significant disruptions in the quality of living, health as well as function are linked with potentially severe allergic rhinitis. The most prevalent form of recurrent rhinitis is allergic rhinitis, impacting between 10 and 20% of the world population. Statistics show that there is an exponential increase in this condition. The common signs of human rhinorrhea, sneezing, coughing, respiratory inflammation, vomiting and weeping of skin, palatal scratching and ear coughing are considerably higher(* P=.001). The average symptom value (84,14 per cent) was significantly minimised during the test by Fluticasone propionate nasal spray. The intensity of complication decreased substantially by the administration of fluticasone propionate + azelastine hydrochloride nasal spray often functions (91.16 per cent). A mixture of Fluticasone propionate and Azelastine hydrochloride is better than Fluticasone propionate nasal spray to relieve the reactions of Allergic Rhinitis.

Clinical observation of nasal spray allergen blocker combined with antihistamines in treatment of allergic rhinitis children

Objective:To investigate the clinical effect and safety of nasal spray allergen blocker combined with antihistamines in children with allergic rhinitis. Method:Eighty-four children with mild-severe allergic rhinitis were randomly divided into observation group（42 cases） and control group（42 cases）. Children in control group were treated with azelastine hydrochloride nasal spray, while children in observation group added with nasal spray allergen blocker on the basis of control group. Both groups were treated for 4 weeks. The changes of symptoms and signs integral in both groups were compared and analyzed after 1, 2 and 4 weeks treatment. And Clinical efficacy and adverse reactions between two groups were compared after treatment. Result:Among 4 weeks treatment, the symptoms and signs integral of the two groups showed a significant decreasing trend（P<0.01）. The reduction in the observation group was greater than that in the control group, there were statistical differences in the variation trends of symptoms and signs integral between the two groups（P<0.01, P<0.05）. And there were significant differences in symptoms and signs integral between the two groups（P<0.05）. The total effective rate of observation group（90.5%） was significantly higher than that of control group（64.3%）（P<0.05）. There was no statistically significant difference in the incidence of adverse reactions between the two groups（9.5%vs 4.8%, P>0.05）. Conclusion:The effect of nasal spray allergen blocker combined with antihistamines on allergic rhinitis children is remarkable. They can alleviate the symptoms and signs of allergic rhinitis with rapidity and safety.

Azelastine hydrochloride nasal spray and its combination with fluticasone propionate in the management of allergic rhinitis - A comparative study

Background: Allergic rhinitis (AR) is a global health problem affecting 500 million of population. H1-antihistamines are the first-line therapy although intranasal corticosteroids are the gold standard treatment in patients with more severe symptoms. Aims and Objectives: The aim of the study was to evaluate the efficacy and safety of azelastine hydrochloride nasal spray and its combination with fluticasone propionate nasal spray in the management of AR. Materials and Methods: A total of 70 patients clinically diagnosed as AR were randomized into two groups, Group A received azelastine hydrochloride nasal spray alone and Group B received a combination of azelastine hydrochloride with fluticasone propionate nasal spray for 2-weeks. Efficacy was assessed by mean change in the total symptom score (TSS) which was the sum of total nasal symptom score (TNSS) and total ocular symptom score (TOSS) at the end of 2 weeks from baseline. Results: Both groups showed statistically significant (P < 0.0001) improvements in the symptoms at the end of 2 weeks of treatment. In Group A, the baseline TNSS, TOSS, and TSS was 9.88 ± 0.99, 5.8 ± 1.32, and 15.68 ± 1.98, respectively, which was reduced to 5.78 ± 2.35, 1.60 ± 1.19, and 5.78 ± 2.35. In Group B, TNSS, TOSS, and TSS were reduced from 9.97 ± 0.92 to 2.71 ± 1.36, 6.08 ± 1.37 to 1.04 ± 0.87, and 16 ± 1.86 to 3.22 ± 1.64, respectively. There was a greater reduction in symptom score in Group B than Group A which was statistically significant (P < 0.0001). Conclusion: Combination of azelastine hydrochloride with fluticasone propionate nasal spray offers an advantage over the treatment with azelastine hydrochloride alone in regard to symptomatic improvement in AR.

Clinical application of seven-item Eustachian Tube Dysfunction Questionnaire

Objective: To investigate the clinical value of the seven-item Eustachian Tube Dysfunction Questionnaire(ETDQ-7) in evaluating Eustachian tube dysfunction before and after treatment.Method: A retrospective analysis of 50 patients with Eustachian tube dysfunction diagnosed. All the patients were given chymotrypsin 4 000 IU and dexamethasone injection 5 mg by blowing through the Eustachian tube under nasal endoscopic guidance once daily for 3-6 consecutive days. At the same time, azelastine hydrochloride nasal spray and budesonide nasal spray were applied, 2 sprays each time, 2 times a day; oral Olongma drops, 3 ml each time, 3 times a day. ETDQ-7 was completed before and after treatment, and the results of ear endoscopy, pure tone audiometry, acoustic impedance test, and Eustachian tube function test were analyzed comprehensively. Result: The ETDQ-7 score(15.6±7.1) after treatment was significantly higher than that before treatment(23.1±6.5) points (P<0.05), and the difference was statistically significant. After treatment, all patients felt that aural fullness, tinnitus or discomfort, hearing loss and other symptoms were relieved. The tympanic membrane was observed to be better than before treatment. The tympanic effusion and tympanic membrane invagination were improved, which was in line with the change of ETDQ-7 score. Conclusion: ETDQ-7 has a good clinical value in the evaluation of Eustachian tube dysfunction before and after treatment. It is a reproducible and effective method for evaluating Eustachian tube dysfunction(ETD).

The effectiveness of intranasal corticosteroids and antihistamines combination - mometasone furoate and azelastine hydrochloride nasal spray in adults with seasonal allergic rhinitis (The results of clinical trial)

Background. Intranasal corticosteroids and antihistamines are the basis of pharmacotherapy of allergic rhinitis (AR). The aim of this study was to evaluate the efficacy, safety and tolerability of Momat Rhino Advance (fixed combination of azelastine hydrochloride 140 mcg + mometasone furoate 50 mcg) intranasal spray in seasonal rhinitis patients. Materials and methods. Momat Rhino Advance was administered within 14 days in adults with seasonal AR in comparison with the original azelastine hydrochloride and mometasone furoate, used in combination with each other from separate devices against nasal (TNSS) and non-nasal (TNNSS) rhinitis symptoms. In total, 220 patients 18-65 years old with moderate/severe seasonal AR, were randomized in an open, parallel-group, multicenter clinical trial conducted in 16 centers in the Russian Federation during the period from April to September 2014. Results and conclusion. As a result of the study a marked decreasing of nasal symptoms using scale TNSS (in 89,6% relatively to the initial visit, p

Shadbindu Taila Nasya in Allergic Rhinitis: a Controlled Clinical Trial to Compare its Efficacy with Topical Azelastine hydrochloride Nasal Spray

Shadbindu Taila Nasya in Allergic Rhinitis: a Controlled Clinical Trial to Compare its Efficacy with Topical Azelastine hydrochloride Nasal Spray

A clinical pharmacokinetic study comparing two azelastine hydrochloride nasal formulations in a single-dose design

Azelastine hydrochloride is a potent second-generation antihistamine, available in Europe and the USA as a nasal spray formulation for the treatment of allergic rhinitis symptoms. GlaxoSmithKline (GSK) Consumer Healthcare has developed a new nasal formulation of azelastine hydrochloride. The present study was aimed at comparing the clinical pharmacokinetic profiles and assessing the bioequivalence of the new formulation of azelastine hydrochloride with a marketed reference nasal spray product. This was a randomized, two-way crossover, two-stage, single-dose pharmacokinetic study with 2 weeks washout between the two treatment periods. A dosage of 0.28 mg of the test and reference products was administered as a single dose to healthy volunteers according to the crossover design. Twenty-three subjects (15 subjects from stage 1 and 8 subjects from stage 2) were enrolled in the study. Adjusted mean values for AUC0-t were 1,526.8 h pg/mL for the test drug and 1,441.5 h pg/mL for the reference drug; for C max the values were 61.59 pg/mL for the test drug and 58.21 pg/mL for the reference drug. The 94.12 % CI of geometric mean ratios (test/reference) were 0.99-1.13 and 0.95-1.18 for AUC0-t and C max. This met the predefined criteria for bioequivalence between test and reference drugs. Secondary pharmacokinetic parameters for azelastine and for the metabolite desmethyl azelastine, AUC(0-∞) and t max, were numerically similar between the two study treatments. Both test and reference azelastine hydrochloride formulations were well tolerated at single dose. This study demonstrated the bioequivalence between the new azelastine hydrochloride nasal spray formulation and the marketed reference Allergodil(®) after single-dose administration.

A Multicenter Randomized Double-Blind 2-Week Comparison Study of Azelastine Nasal Spray 0.1% versus Levocabastine Nasal Spray 0.05% in Patients with Moderate-to-Severe Allergic Rhinitis

Objective: To compare the onset of action, efficacy, and safety of azelastine and levocabastine in the treatment of allergic rhinitis. Subjects and Methods: In a multicenter, randomized, double-blind, parallel-group trial, 244 patients with moderate-to-severe allergic rhinitis were randomized to receive either azelastine hydrochloride nasal spray (ANS) 0.1% or levocabastine hydrochloride nasal spray (LNS) 0.05% for 14 consecutive days. A visual analog scale was used to record total nasal symptom score (TNSS) changes. Indexes for further assessment included onset of action, total effective rate, and evaluation of therapeutic effect. Results: Statistically significant changes from baseline in TNSS were seen in both the LNS group and the ANS group. No significant differences were seen between the two groups in terms of evaluation of therapeutic effect, total effective rate, and onset of action, except for a higher symptom relief rate in the LNS group than in the ANS group within 30 min of administering the first dose. Adverse reactions were mild to moderate, with an incidence of 0.9% for LNS and 2.5% for ANS. Conclusion: Both ANS and LNS were effective and safe in the treatment of moderate-to-severe persistent allergic rhinitis. Moreover, LNS reached a higher symptom relief rate within 30 min of administering the first dose.

Two-week comparison study of olopatadine hydrochloride nasal spray 0.6% versus azelastine hydrochloride nasal spray 0.1% in patients with vasomotor rhinitis

Olopatadine hydrochloride nasal spray 0.6% (OLO) and azelastine nasal spray 137 micrograms (AZE) are effective in treating allergic rhinitis and AZE is indicated for nonallergic vasomotor rhinitis (VMR). This study evaluates the relative safety and efficacy of OLO and AZE in patients with VMR. This randomized, double-blind, parallel-group, multicenter study compared OLO (an investigational use) with AZE over 14 days in patients (n = 129) ≥12 years of age with chronic VMR. Efficacy included the severity of nasal symptom scores. Safety included adverse events (AEs) and nasal examinations. Patient perceptions of treatment satisfaction and changes in allergy condition were determined using the Treatment Satisfaction Questionnaire for Medication and Patient Global Assessment scores. In the OLO and AZE groups, reflective scores for individual nasal symptoms (nasal congestion, rhinorrhea, postnasal drip, and sneezing) and total nasal VMR symptom scores decreased significantly from baseline to day 14 (p < 0.05). No significant between-group differences were observed (p > 0.05). No serious AEs were reported in either group. Overall, 22 and 20 AEs were reported in the OLO and AZE groups, respectively. The most common AE was taste disturbance, reported by three (5.3%) and six (10.3%) patients in the OLO and AZE groups, respectively. Patients in both groups reported similar treatment satisfaction scores and a majority of patients in both groups perceived an overall improvement in their rhinitis condition. OLO has a similar efficacy and safety profile to AZE for the management of VMR in patients ≥12 years of age.

Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device

A proof-of-concept study suggested that combination therapy with commercial azelastine hydrochloride nasal spray and fluticasone propionate nasal spray significantly improved nasal symptoms of seasonal allergic rhinitis compared with either agent alone. To compare an azelastine-fluticasone combination nasal spray administered in a single-delivery device with a commercially available azelastine nasal spray and fluticasone nasal spray. This 14-day, multicenter, randomized, double-blind study was conducted during the Texas mountain cedar season. After a 5-day placebo lead-in, 610 patients with moderate-to-severe nasal symptoms were randomized to treatment with (1) azelastine nasal spray, (2) fluticasone nasal spray, (3) combination azelastine and fluticasone nasal spray, or (4) placebo nasal spray. All treatments were given as 1 spray per nostril twice daily. The primary efficacy variable was the change from baseline in the total nasal symptom score (TNSS), consisting of nasal congestion, runny nose, itchy nose, and sneezing. All 3 active groups were statistically superior (P <or= .02) to placebo, and the combination was statistically superior (P <or= .003) to either agent alone. The TNSS improved by 28.4% with combination azelastine-fluticasone, 20.4% with fluticasone, 16.4% with azelastine, and 11.2% with placebo. All 3 treatments were well tolerated. The combination azelastine-fluticasone nasal spray provided statistically significant improvement in the TNSS and additive clinical benefit compared with either agent alone in patients with moderate-to-severe seasonal allergic rhinitis. clinicaltrials.gov Identifier: NCT00660517.

Effects of olopatadine hydrochloride nasal spray 0.6% in the treatment of seasonal allergie rhinitis: A phase III, multicenter, randomized, double-blind, active- and placebo-controlled study in adolescents and adults

Background: Seasonal allergic rhinitis (SAR) is an allergen-induced inflammatory reaction that occurs during periods of high pollen count. Current treatments for SAR include allergen avoidance, systemic antihistamines, and steroidal and nonsteroidal intranasal sprays. Olopatadine is a selective antihistamine and an inhibitor of proinflammatory mediators from human mast cells. An intranasal formulation of olopatadine has been developed for the treatment of SAR. Objective: The aim of this study was to compare the efficacy and tolerability of olopatadine hydrochloride nasal spray 0.6% (OLO) relative to azelastine hydrochloride nasal spray 0.1% (AZE) and an inactive vehicle in the treatment of SAR. Methods: This Phase III, multicenter, randomized, double-blind, active- and placebo-controlled, parallel-group study was conducted at 21 centers across the United States. Eligible patients were aged ≥12 years and had a history of SAR and verified allergy to a prevalent local allergen. After a run-in period during which inactive vehicle was administered, patients were randomly assigned to OLO, AZE (active control), or inactive vehicle (identical to OLO; placebo control), 2 sprays in each nostril BID for 16 days. The timing of enrollment was correlated with the start of the allergy season at each site. Symptoms were recorded twice daily in an electronic diary. Efficacy assessments included changes in mean daily reflective total nasal symptom scores (TNSS). Tolerability was evaluated based on adverse events (AEs) and nasal, physical, and cardiovascular parameters. Results: A total of 544 patients were randomized. The mean age was 36 years (range, 12–77 years); men and boys represented 32.2% of the population; and the patients were predominantly white (75.4%). The mean reductions from baseline in reflective TNSS were 26.8%, 29.9%, and 18.4% with OLO, AZE, and inactive vehicle, respectively ( P = 0.003 OLO vs inactive vehicle; 95% CI, −2.5% to 8.7% OLO vs AZE [non-inferiority]). The most commonly reported treatment-related AE in the OLO and AZE groups was bitter taste (12.2% [22/180] and 19.7% [37/188], respectively). The prevalence and intensity of bitter taste were significantly lower with OLO than with AZE ( P = 0.05 and P = 0.005, respectively). In the group that received inactive vehicle, the prevalence of bitter taste was 1.7% (3/176). The prevalences of other treatment-related AEs, including epistaxis and nasal discomfort, were ≤3.7% in each group and did not differ significantly between groups. Conclusions: In this small study in patients aged ≥12 years with SAR, the percentage reduction from baseline in TNSS was significantly greater with OLO (2 sprays in each nostril BID) compared with vehicle and not significantly different from that with AZE. OLO and AZE were similarly well tolerated, with the exception of prevalence and intensity of bitter taste, which were significantly lower with OLO.

Pharmacokinetic characteristics and safety and tolerability of a reformulated azelastine hydrochloride nasal spray in patients with chronic rhinitis

Background: Intranasal azelastine hydrochloride (Astelin®, Meda Pharmaceuticals, Somerset, NJ, USA) is a first-line treatment for allergic and non-allergic vasomotor rhinitis with well-established therapeutic efficacy and safety. A new formulation of azelastine nasal spray (Astepro®, Meda Pharmaceuticals, Somerset, NJ, USA), with a sorbitol-based vehicle and sucralose as a taste-masking agent, was developed to reduce the bitter taste of azelastine experienced by some patients. Objective: Two studies were conducted to evaluate the safety, tolerability and pharmacokinetic parameters of this new formulation compared with the original azelastine nasal spray. Methods: In a pharmacokinetic study, 18 healthy volunteers received either a single dose of the new formulation or the original formulation and pharmacokinetic parameters were determined. In a 1-year safety study, patients with chronic rhinitis were randomized to the new formulation (n = 430) or the original formulation (n = 432) to assess tolerability and the potential for adverse effects on the nasal mucosa. Results/conclusions: The new formulation was safe and well tolerated with long-term use and had a comparable pharmacokinetic profile to the original formulation. The overall incidence of treatment-emergent adverse events with the new formulation (48.4%) and the original formulation (49.1%) was similar, with no evidence of increased nasal irritation, nasal septal perforation, severe epistaxis or ulceration with either formulation during the 1-year study.

Combination therapy with azelastine hydrochloride nasal spray and fluticasone propionate nasal spray in the treatment of patients with seasonal allergic rhinitis

To our knowledge, there are no published studies that evaluated the efficacy of azelastine hydrochloride nasal spray in combination with an intranasal corticosteroid, although anecdotal reports of the use of these agents in combination are common. To determine if greater efficacy could be achieved with the intranasal antihistamine azelastine and the intranasal corticosteroid fluticasone propionate used concurrently compared with the efficacy of each agent alone. This randomized, 2-week, multicenter, double-blind trial was conducted during the Texas mountain cedar season. After a 5-day placebo lead-in period, 151 patients with moderate to severe nasal symptoms were randomized to treatment with the following: (1) azelastine nasal spray, 2 sprays per nostril twice daily; (2) fluticasone nasal spray, 2 sprays per nostril once daily; or (3) azelastine nasal spray, 2 sprays per nostril twice daily, plus fluticasone nasal spray, 2 sprays per nostril once daily. The primary efficacy variable was the change from baseline in the total nasal symptom score (TNSS), consisting of sneezing, itchy nose, runny nose, and nasal congestion. All 3 groups had statistically significant (P < .001) improvements from their baseline TNSS after 2 weeks of treatment. The TNSS improved 27.1% with fluticasone nasal spray, 24.8% with azelastine nasal spray, and 37.9% with the 2 agents in combination (P < .05 vs either agent alone). All 3 treatments were well tolerated. The significant improvement in the TNSS with combination therapy relative to the individual agents alone is in contrast to previously published studies that found no advantage with an oral antihistamine and an intranasal corticosteroid in combination. Azelastine nasal spray and fluticasone nasal spray in combination may provide a substantial therapeutic benefit for patients with seasonal allergic rhinitis compared with therapy with either agent alone.

Efficacy and safety of azelastine nasal spray at a dose of 1 spray per nostril twice daily

Azelastine hydrochloride nasal spray is available worldwide for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis. One spray per nostril twice daily is the most commonly recommended dose. To determine the efficacy and safety of azelastine nasal spray, 1 spray per nostril twice daily, in patients with SAR. In 2 studies conducted in the United States we assessed 554 patients with moderate-to-severe SAR who were still symptomatic after a 1-week placebo lead-in period. Patients were randomized to 2 weeks of double-blind treatment with azelastine nasal spray, 1 spray per nostril twice daily, or placebo nasal spray. The primary efficacy variable was change from baseline in total nasal symptom score, consisting of sneezing, itchy nose, runny nose, and nasal congestion. Mean differences in total nasal symptom score between the azelastine and placebo groups were significant in both studies: 2.69 vs 1.31 (P = .01) in study 1 and 3.68 vs 2.50 (P = .02) in study 2. Bitter taste was reported by 8.3% of patients treated with 1 spray per nostril twice daily compared with the labeled incidence of 19.7% with 2 sprays per nostril twice daily. Somnolence was reported by 1 patient (0.4%) using the 1-spray regimen compared with the labeled incidence of 11.5% using the 2-spray regimen. Azelastine nasal spray at a dose of 1 spray per nostril twice daily is effective and has improved tolerability compared with 2 sprays per nostril twice daily in patients with SAR.

Onset of Action of Azelastine Nasal Spray Compared with Mometasone Nasal Spray and Placebo in Subjects with Seasonal Allergic Rhinitis Evaluated in an Environmental Exposure Chamber

The objective of this study was to determine the onset of action of azelastine hydrochloride nasal spray compared with placebo and an intranasal steroid, mometasone furoate, in subjects with seasonal allergic rhinitis (SAR). Subjects with a history of SAR and symptomatic while exposed to ragweed pollen in an environmental exposure chamber (EEC) were randomized to azelastine nasal spray (n=150), mometasone nasal spray (n=150), or placebo (n=150) and recorded total nasal symptom scores (TNSS), consisting of sneezing, nasal pruritus, rhinorrhea, and congestion, during an 8-hour study period. Azelastine nasal spray showed a statistically significant improvement in the TNSS at 15 minutes compared with placebo. The effect was durable at each time point during the 8-hour study. Azelastine nasal spray also was significantly more effective than mometasone at each time point. Azelastine nasal spray has a rapid (15 minute) onset of action. Azelastine nasal spray was superior to both placebo and imometasone nasal spray in reducing nasal symptoms of SAR occurring within 8 hours after an allergen challenge.