Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0033774 (pruritus)
 14,546 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

A double-blind, randomized, parallel-group, placebo-controlled study involving 130 patients was conducted at 9 centres in the U.K. to assess the effect of 6 weeks of treatment with azelastine nasal spray (azelastine) and beclomethasone dipropionate nasal spray (BDP) on the symptoms of perennial rhinitis. Efficacy was assessed by patients recording daily the severity of the symptoms of rhinitis on 10-cm visual analogue scales. Analysis of this diary data showed significant reductions in sneezing, blocked nose, running nose, and itching nose during azelastine treatment. Patients on BDP recorded a consistent reduction in rhinitis symptoms, but these reductions were significant only for sneezing on treatment day 7. When rhinitis symptoms were assessed by clinical investigators on a 4-point scale, the scores obtained following treatment with the 2 study medications showed little change from baseline or "active" treatment scores. There was no evidence of a consistent change in nasal airway resistance, measured using anterior rhinomanometry, following treatment with either BDP or azelastine. Azelastine nasal spray and BDP nasal spray were well tolerated by the patients and the relative incidence of adverse events was similar in the azelastine and placebo/azelastine treatment groups, except that taste perversion occurred more frequently during azelastine treatment than during placebo/azelastine treatment. There was no evidence of an increased incidence of somnolence or fatigue in patients who received azelastine nasal spray. Overall, the results of this study indicate that azelastine administered twice daily as an intranasal spray is a safe and efficacious treatment for the symptoms of rhinitis in patients suffering from mild to moderate perennial rhinitis.
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PMID:The effect of intranasal azelastine and beclomethasone on the symptoms and signs of nasal allergy in patients with perennial allergic rhinitis. 790 44

Azelastine is a novel antiallergy medication currently under investigation for the treatment of allergic rhinitis and asthma. Pharmacologic studies in laboratory animals and in vitro model systems indicate that azelastine exerts multiple actions including modulation of airways smooth muscle response, interference with inflammatory processes, and inhibition of allergic reactions. In a previous controlled clinical trial, azelastine nasal solution (ASTELIN N.S.) demonstrated effectiveness in controlling symptoms of seasonal allergic rhinitis (SAR). The objective of this 2-week double-blind, parallel-group study was to further assess the effectiveness of azelastine nasal solution in improving allergic rhinitis symptoms. Two hundred forty-seven patients (> or = 12 years) with symptomatic SAR who satisfied a minimum symptoms score during a 1-week, single-blind, baseline evaluation period were randomized to receive azelastine 2 sprays per nostril bid, azelastine 2 sprays per nostril qd, chlorpheniramine 12 mg bid, or placebo using a double-dummy technique to insure blinding. The primary efficacy variables were changes in Major Symptom Complex (nose blows, sneezes, runny nose/sniffles, itch nose, and watery eyes) and Total Symptom Complex (Major plus itchy eyes/ears/throat/palate, cough, and postnasal drip) severity scores. Patients treated with azelastine nasal solution qd and bid had mean percent improvements in the Total and Major Symptom Complex severity scores that were clinically significant (> or = 50% improvement over placebo) after both weeks, at endpoint, and overall. The improvements for the azelastine bid group were statistically significant (P < or = .05) at all evaluation points. Adverse experiences occurred infrequently, and none was considered serious or potentially limiting to the clinical utility of the nasal solution.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Effectiveness of azelastine nasal solution in seasonal allergic rhinitis. 807 37

The long-term efficacy and tolerability of azelastine (CAS 58581-89-8) nasal spray (0.14 mg/nostril b.i.d.) was investigated in patients suffering from perennial allergic rhinitis. 185 patients entered an initial 6 months' study; 35 of them continued in a follow-up for a further 30 to 60 weeks' treatment. Azelastine both attenuated the severity and reduced the incidence of rhinitis symptoms, with the highest rate of improvement during the first month with some additional improvement during the following months. The most marked effects were on those symptoms which were initially most severe: nasal obstruction, mucosal swelling, rhinorrhoea, sneezing and nasal itching. Signs of rhinitis identified by rhinoscopic examination improved in parallel to symptoms. 84.1% of patients reported 'good' or 'very good' efficacy as did 94.3% during the follow-up. Approximately 96% of patients rated the tolerability of treatment as 'very good' or 'good'. The incidence of adverse events of possibly causal relationship to azelastine treatment was low during the first 6 months. The most frequent events were the experience of application site reactions (e.g. burning) and bitter or unpleasant taste, specific to azelastine. No unwanted effects were reported by patients continuing treatment. In addition, results of nasal biopsies indicate that with the dose used azelastine nasal spray is a safe drug for long-term treatment of perennial allergic rhinitis.
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PMID:Investigation of long-term efficacy and tolerability of azelastine nasal spray in the treatment of perennial allergic rhinitis. 810 60

The efficacy and safety of a new antiallergic drug, intranasal azelastine (CAS 58581-89-8), in the treatment of seasonal allergic rhinitis was investigated in a 16 patient double-blind comparison with placebo and another 36 patient open comparison with budesonide (CAS 51333-22-3). Efficacy was assessed in terms of 13 signs and symptoms of allergic rhinitis and tolerability on the basis of spontaneously reported adverse events. In the first study, compared to placebo a one week's treatment with azelastine resulted in substantial relief of sneezing (p = 0.009), nasal itching (p = 0.009), swelling of the nasal mucosa (p = 0.067) and rhinorrhoea (p = 0.262) in patients having the above symptoms at baseline of at least moderate to severe intensity. According to the judgement of the supervising physician, 7/8 azelastine-treated patients but none receiving placebo responded well to therapy (p = 0.001). In the second study a two weeks' treatment with intranasal azelastine was found not to differ significantly from budesonide 67% of patients showed improvement in principal signs of rhinitis after one week's therapy irrespective of treatment. Nasal symptoms, including nasal obstruction, were most markedly improved by both treatments. Azelastine, but not budesonide, also relieved ocular symptoms associated with rhinitis. Adverse events did not occur more frequently under azelastine than under placebo treatment and were often of uncertain relationship to treatment.
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PMID:Efficacy and tolerability of azelastine nasal spray in patients with allergic rhinitis compared to placebo and budesonide. 810 85

We compared the efficacy and tolerance of Azelastine nasal spray (0.14 mg in each nostril twice a day) versus Ebastine tablets (10 mg) as a single night dose in a Phase IV open, randomized, parallel-group clinical trial lasting 14 days, conducted with 63 patients diagnosed of seasonal allergic rhinitis. The symptoms assessed before and after the treatment period were: sneezing, nasal pruritus, rhinorrhea, nasal obstruction, conjunctival erythema, eye pruritus, eye watering, photophobia, pharyngeal pruritus and cough. Each symptom was rated by the patients according to a 4-point scale: absent: 0, mild: 1, moderate: 2, and severe: 3. The score required to be included in the study was 8 or above. In addition, the resistance of nasal fossae was assessed, before and after the treatment, by active anterior rhinomanometry, as well as the appearance of adverse events. Both drugs were equally effective both in the control of symptoms and in decreasing the airway resistance and no statistically significant differences were observed in the variables tested in both groups. We concluded that Azelastine nasal spray is a treatment as effective as Ebastine in the relief of symptoms of seasonal allergic rhinitis, with an excellent tolerance and minimum adverse effects.
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PMID:Investigation on the efficacy and tolerance of azelastine (HCL) nasal spray versus ebastine tablets in patients with seasonal allergic rhinitis. 852 67

This double-blind, randomised, placebo-controlled study was carried out to assess the efficacy and safety of 0.025% and 0.05% azelastine eye drops twice daily administered for 14 days to patients with seasonal allergic conjunctivitis or rhinoconjunctivitis. A total of 278 patients were recruited and 226 patients were evaluable for per protocol analysis. The target parameter was the response rate. Four eye symptoms, including the main symptom (itching) were recorded by patients in diaries and eight symptoms were assessed by physicians before and after seven and 14 days of treatment. Severity of symptoms was measured on a four-point scale. The response rates for itching (improvement of at least one score point within the first three days) according to patient assessment were 43% for placebo, 52% for 0.025% and 56% for 0.05% azelastine (NS). However, a more objective assessment of the three main eye symptoms by physicians showed a concentration-dependent improvement in response rate compared with placebo (a decrease of > or = 3 points from a baseline total score of > or = 6), which reached statistical significance for 0.05% azelastine on Day 7 (p < 0.002). In the evaluable patient population, the scores of the three main eye symptoms as well as of all eight recorded eye symptoms, as assessed by the physician, were significantly (p < 0.05) lower in the 0.05% azelastine eye drops group in comparison with the placebo group at Day 7. Inefficacy was the cause of withdrawal in five and three patients on 0.025% and 0.05% azelastine, respectively, and in six patients on placebo. Adverse drug effects, mainly a mild, transient irritation and a bitter or unpleasant taste, were reported by 14% (0.025%), 20% (0.05%) and 15% (placebo) of the patients. No serious side-effects occurred. Azelastine eye drops are effective and well tolerated at a concentration of 0.05% for the treatment of seasonal allergic conjunctivitis.
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PMID:Double-blind, randomised, placebo-controlled study of two concentrations of azelastine eye drops in seasonal allergic conjunctivitis or rhinoconjunctivitis. 952 90

In search of an improved treatment of pruritic dermatoses, we have studied azelastine, a novel H1-receptor antagonist, during a 2-week treatment period, using a double-blind, placebo-controlled design. The potent H1-antagonist cetirizine was used for comparison. Symptoms were recorded daily by the patients on a diary card, using a 4-point scale. The same parameters and adverse events were evaluated at weekly intervals, and global improvement was evaluated at the end of treatment. In all 230 evaluable patients with moderate to severe itching, azelastine caused an overall significant improvement in comparison to placebo (P = 0.02), with significance also for pruritus (P = 0.01 after 1 week and P = 0.02 after 2 weeks). Both drugs reduced itching more effectively in urticaria than in atopic eczema. Azelastine was superior to cetirizine in reducing pruritus, whereas cetirizine caused a more marked reduction of whealing. Both drugs rarely caused fatigue and dry mouth, but taste perversion occurred only in azelastine-treated patients (9.7%) and headaches only with cetirizine (10.4%). Therefore, the two H1-blockers exert differential effects on pruritus verses whealing and a distinctive adverse events pattern. The data also underline the low efficacy of antihistamines in atopic eczema, compared to urticaria.
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PMID:Differential effects of new-generation H1-receptor antagonists in pruritic dermatoses. 953 17

The efficacy and tolerability of azelastine (CAS 58581-89-8) eye drops at three different doses (0.025%, 0.05% and 0.1%) were investigated in a double-blind, randomized, placebo-controlled, crossover study in 24 subjects with a history of allergic conjunctivitis/rhinoconjunctivitis, who were challenged, out of season, by airbone allergen in the "Vienna Challenge Chamber" (VCC). Subjects received a single dose of azelastine eye drops 60 min before the start of a 4 h challenge in the VCC. Additional local challenge, mimicking a gust of wind, was administered 15 min before the end of the session. Each of the 4 study days was separated by a 2 week washout period. Azelastine eye drops showed a dose-dependent inhibition of the development of itching of the eyes. The effect was most pronounced 15 min after the additional local challenge. A maximal effect was achieved at a dose of 0.05%. Similar effects were observed on lacrimation. Azelastine eye drops also dose-dependently inhibited the degree of conjunctival redness, measured by digital imaging, and tended to reduce the low incidence of chemosis observed. Ranking of the results of all symptoms for each treatment group confirmed the optimal effect at a dose of 0.05%. Azelastine eye drops had no effect on nasal and bronchial symptoms or on measurements of airways function (FEV1). No adverse effects of the treatments were reported. The data support the use of 0.05% azelastine eye drops in the treatment of allergic conjunctivitis/rhinoconjunctivitis.
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PMID:Dose-dependent protection by azelastine eye drops against pollen-induced allergic conjunctivitis. A double-blind, placebo-controlled study. 960 80

We have evaluated the efficacy of azelastine, a new long acting antihistamine, in the topic treatment of seasonal allergic rhinitis to Parietaria officinalis. Forty five patients have been considered, 20 males and 25 females, mean age 28.5 years, suffering from seasonal rhinitis to Parietaria officinalis for at least 4 years. Azelastine was administered twice a day for 4 weeks in the pollen season. On a daily diary-card, patients had to record the severity of the symptoms considered: runny nose, sneeze, itching nose, nasal obstruction, following an arbitrary score from 0 to 3. At the end of the study, patients obtained a significant improvement of the symptoms considered without the addition of any other topical or systemic therapy. No side effects have been reported. Therefore azelastine is an effective drug in the treatment of seasonal allergic rhinitis to Parietaria officinalis.
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PMID:[Efficacy of topical azelastine in the treatment of allergic rhinitis caused by Parietaria officinalis]. 961 9

In a randomised, multicentre study, the effect of azelastine eye drops (n = 51 patients) was compared in a double-blind manner with placebo eye drops (n = 30 patients) and in an open manner with levocabastine eye drops (n = 32 patients) during a 14-day treatment period involving 113 children (aged 4 to 12 years) suffering from seasonal allergic conjunctivitis/rhinoconjunctivitis. The primary variable was the response rate defined as the number of patients showing an improvement after three days of treatment of at least three score points, from a minimum baseline score of six, in the main ocular symptoms of itching, conjunctival redness and lacrimation (each assessed on a four-point scale). Patients discontinuing due to inefficacy were regarded as non-responders. The mean response rate in the azelastine eye drops group (74%) was significantly higher (p < 0.01) than that in the placebo group (39%) and comparable with that in the levocabastine group. The response rates assessed by the patients in their diaries were very similar. Significant differences (p < 0.01) for azelastine compared with placebo were observed on days 3 and 14 in the mean sum scores for the three main symptoms and for a total of eight eye symptoms. The overall assessment of efficacy confirmed the superiority of both active treatments compared with placebo. Adverse drug reactions were reported in 23% of placebo-, 35% of azelastine- and 38% of levocabastine-treated patients. These were mainly local irritant effects. Overall tolerability was assessed as very good or good in 80%, 84% and 91% of placebo-, azelastine- and levocabastine-treated patients, respectively. Azelastine eye drops are effective and well-tolerated in children with seasonal allergic conjunctivitis.
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PMID:Azelastine eye drops in the treatment of seasonal allergic conjunctivitis or rhinoconjunctivitis in young children. 978 82


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