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Astelin

Astelin is a nasal spray which is used for treating allergy symptoms and symptoms of nasal passage inflammation. Astelin contains azelastine, an antihistamine. It blocks the effects of the chemical histamine in your body. Astelin prevents sneezing, itching, runny nose, and other nasal symptoms of allergies.

Other names for this medication:

Similar Products:
Astepro, Patanase

 

Also known as:  Azelastine.

Description

Astelin belongs to a group of medicines called antihistamines.

Astelin provides relief from bothersome nasal symptoms such as congestion, itchy/runny nose, sneezing and postnasal drip due to seasonal allergens or environmental irritants.

Astelin is steroid-free, does not contain pseudoephedrine, and relieves your symptoms by blocking the effects of histamine - the primary cause of allergy symptoms.

What makes Astelin unique is that it is a steroid-free antihistamine nasal spray that provides symptom relief whether the trigger is an allergen (grass, trees, pollen, mold, etc.), an irritant (cigarette smoke, perfume, cleaning agents, car exhaust, cold air, etc.), or both.

Astelin is also know as Azelastine, Arzep, Rhinolast, Alerdual, Allergodil, Rinalin.

Generic name of Astelin is Azelastine.

Dosage

Follow the directions for using this medicine provided by your doctor. Use Astelin exactly as directed.

Astelin can be used by patients as young as 5 years of age, depending on what type of rhinitis they have been diagnosed with.

For those with seasonal allergic rhinitis, patients from 5 to 11 years of age should administer 1 spray in each nostril twice daily.

Patients 12 years of age and older with seasonal allergic rhinitis should administer 2 sprays of Astelin in each nostril twice daily.

For those with nonallergic vasomotor rhinitis, patients 12 years of age and older should administer 2 sprays of Astelin in each nostril twice daily.

Before using Astelin for the first time, remove the child-resistant screw cap and replace with the pump unit. Prime the delivery system (pump unit) with four sprays or until a fine mist appears. If 3 days or more have elapsed since your last use of the nasal spray, reprime the pump with two sprays or until a fine mist appears.

Overdose

If you overdose Astelin and you don't feel good you should visit your doctor or health care provider immediately.

Storage

Store at a room temperature between 15 and 30 degrees C (59 and 86 degrees F) away from moisture and sunlight. Keep in a tightly closed container. Throw away the after the expiration date. Keep out of the reach of children.

Side effects

The most common side effects associated with Astelin are:

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Side effect occurrence does not only depend on medication you are taking, but also on your overall health and other factors.

Contraindications

Do not take Astelin if you are allergic to Astelin components.

It is not known whether Astelin will harm an unborn baby. Do not use this medicine without your doctor's advice if you are pregnant or breast-feeding.

The medicine has a antihistamine in it. Before you start any new medicine, check the label to see if it has an antihistamine (e.g., diphenhydramine) in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Astelin may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.

Astelin should be used with extreme caution in children younger than 5 years old; safety and effectiveness in these children have not been confirmed.

Do not drink alcohol or use medicines that may cause drowsiness (e.g., sleep aids, muscle relaxers) while you are using Astelin; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Astelin may cause drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Astelin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not stop taking Astelin suddenly.

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To investigate the efficacy and safety of polysaccharide nucleic acid-fraction (BCG-PSN) in the treatment of vasomotor rhinitis.

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The results of this study indicate that the therapeutic use of azelastine eye drops in patients with seasonal allergic conjunctivitis or rhino-conjunctivitis can be recommended.

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• This paper provides for the first time information on potential drug-drug interactions, AZE and FP bioavailability and disposition characteristics of each component administered by the novel nasal spray formulation MP29-02. • The studies employed highly sensitive FP and AZE LC-MS/MS assays and could therefore be conducted with recommended therapeutic doses, thereby circumventing previously recognized draw-backs that required nasal bioavailability studies to be conducted using supra-therapeutic doses. • No significant PK drug-drug interaction between the active components AZE and FP was noted for MP29-02. • AZE bioavailabilty was equivalent when MP29-02 data were compared with MP29-02-AZE-mono and Astelin®. • Increased FP exposure was observed with MP29-02-based products compared with FP-BI. FP serum concentrations were generally very low with all investigational products suggesting no clinically meaningful pharmacodynamic differences in terms of systemic safety.

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We examined the effects of a new antiasthmatic drug, azelastine, on the electromechanical responses of airway smooth muscle to histamine, acetylcholine (ACh), and tetraethylammonium (TEA). Membrane potential and isometric force were simultaneously measured in isolated canine tracheal muscle using intracellular microelectrodes and a microforce transducer. Azelastine, at 1 microM, depressed the histamine-induced contractile force by more than 60 percent. The histamine-induced membrane depolarization was also inhibited, but to a much less extent, compared to the inhibition of contractile force. Similarly, contraction induced by ACh was inhibited by azelastine. In contrast to histamine, ACh elicited electrical oscillations concomitant with the membrane depolarization. Azelastine abolished these oscillations without affecting the depolarization. Azelastine inhibited the Ca2+-dependent slow action potentials (induced by 20 mM TEA) in a concentration-dependent manner; complete inhibition occurred at 30 microM. Such direct inhibitory effects of azelastine on agonist-induced airway muscle contraction may explain its ability to exert bronchodilatation in asthmatic patients. One of its mechanisms of action may involve inhibition of voltage-sensitive Ca2+ influx across the muscle cell membrane; however, additional actions intracellularly are possible.

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Ebastine 10 mg daily is a well tolerated and effective treatment for allergic rhinitis and chronic idiopathic urticaria. At this dosage, it is as effective as the other second-generation antihistamines against which it has been compared. Ebastine 20 mg has similar tolerability to the 10 mg dose, and trends towards greater efficacy with the higher dose have been shown in some studies. Ebastine does not appear to be associated with any significant cardiac adverse events. Ebastine is a useful treatment option for patients with allergic rhinitis or chronic idiopathic urticaria.

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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.

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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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We compared the inhibition of the late asthmatic responses by TMK688 with that by other anti-allergic agents in actively sensitized guinea pigs, and examined the relationship between 5-lipoxygenase inhibition and the late asthmatic responses.

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These data suggest that AZ may not provide direct efficacy on the ear symptoms in OME patients with allergic rhinitis, but that there might be a possibility of its indirect efficacy in the patients in part by relieving the allergic rhinitis.

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Use of human acellular dermal matrix (ADM) during prosthetic breast reconstruction has increased. Several ADM products are available produced by differing manufacturing techniques. It is not known if outcomes vary with different products. This study reports the complication prevalence following use of a tutoplast-derived ADM (T-ADM) in prosthetic breast reconstruction. We performed a retrospective chart review of 203 patients (mean follow-up times 12.2 months) who underwent mastectomy and immediate prosthetic breast reconstruction utilizing T-ADM, recording demographic data, surgical indications and complication (infection, seroma, hematoma, wound healing exceeding three weeks and reconstruction failure). During a four-year period, 348 breast reconstructions were performed Complications occurred in 16.4% of reconstructed breasts. Infection occurred in 6.6% of breast reconstructions (3.7% - major infection, requiring intravenous antibiotics and 2.9% minor infection, requiring oral antibiotics only). Seromas occurred in 3.4% and reconstruction failure occurred in 0.6% of breast reconstructions. Analysis suggested that complication prevalence was significantly higher in patients with a BMI >30 (p = 0.03). The complication profile following T-ADM use is this series is comparable to that reported for with other ADM products. T-ADM appears to be a safe and acceptable option for use in ADM-assisted breast reconstruction.

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The chemotherapeutic agent oxaliplatin induces neuropathic pain, a dose-limiting side effect, but the underlying mechanisms are not fully understood. Here, we show the potential involvement of cutaneous mast cells in oxaliplatin-induced mechanical allodynia in mice. A single intraperitoneal injection of oxaliplatin induced mechanical allodynia, which peaked on day 10 after injection. Oxaliplatin-induced mechanical allodynia was almost completely prevented by congenital mast cell deficiency. The numbers of total and degranulated mast cells was significantly increased in the skin after oxaliplatin administration. Repetitive topical application of the mast cell stabilizer azelastine hydrochloride inhibited mechanical allodynia and the degranulation of mast cells without affecting the number of mast cells in oxaliplatin-treated mice. The serine protease inhibitor camostat mesilate and the proteinase-activated receptor 2 (PAR2) antagonist FSLLRY-NH2 significantly inhibited oxaliplatin-induced mechanical allodynia. However, it was not inhibited by the H1 histamine receptor antagonist terfenadine. Single oxaliplatin administration increased the activity of cutaneous serine proteases, which was attenuated by camostat and mast cell deficiency. Depletion of the capsaicin-sensitive primary afferents by neonatal capsaicin treatment almost completely prevented oxaliplatin-induced mechanical allodynia, the increase in the number of mast cells, and the activity of cutaneous serine proteases. These results suggest that serine protease(s) released from mast cells and PAR2 are involved in oxaliplatin-induced mechanical allodynia. Therefore, oxaliplatin may indirectly affect the functions of mast cells through its action on capsaicin-sensitive primary afferents.

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To determine, whether the immediately originated allergic reaction of conjunctivas may be treated with local H1 antihistaminic drugs in a monotherapy (Allergodil gtt, Emadine gtt).

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The KD values measured by frontal analysis were (8.72 ± 0.21) × 10(-7)  M for azelastine, (9.12 ± 0.26) × 10(-7)  M for cyproheptadine, (9.90 ± 0.18) × 10(-7)  M for doxepin, (1.42 ± 0.13) × 10(-6)  M for astemizole, (2.25 ± 0.36) × 10(-6)  M for chlorpheniramine and (3.10 ± 0.27) × 10(-6)  M for diphenhydramine. The results had a positive correlation with those from radioligand binding assay. The ability of displacement order measured on the binding sites occupied by doxepin was doxepin (KD , (2.95 ± 0.21) × 10(-8)  M) > astemizole (KD , (5.03 ± 0.18) × 10(-7)  M) > chlorpheniramine (KD , (1.27 ± 0.16) × 10(-6)  M) > cyproheptadine (KD , (1.61 ± 0.27) × 10(-6)  M), whose order met with the scores by molecular docking study.

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The influence of orally administered azelastine and selected H1-receptor antagonists on aeroallergen-induced acute lung anaphylactic responses in actively sensitized guinea pigs (experimental asthma model) was studied. Azelastine (1 mg/kg, PO, two hours) exerted significant inhibition of the aeroallergen-induced decline in dynamic lung compliance and an elevation in pulmonary airway resistance. Terfenadine, pyrilamine, and diphenhydramine given as oral doses of 1 mg/kg two hours before aeroallergen challenge exerted weak or no inhibition of acute lung anaphylactic responses. In conclusion, the data obtained in this study showed that azelastine administered orally is capable of exerting antiasthmatic effects in both the central and peripheral airways of guinea pigs. This effect may be attributed to its ability to inhibit the formation or secretion of pharmacologic mediators (ie, histamine, LTC4/D4, .O2-) from inflammatory cells.

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In this study the effect of azelastine on the activation (antigen-dependent, Ca(2+)-dependent, Stage I) and release (antigen-independent, Ca(2+)-dependent, Stage II) phases of allergen-induced histamine secretion in rabbit mixed leukocytes (basophils) was investigated. Azelastine (5 microM, 10-min) and diltiazem (5 microM: a Ca2+ antagonist, 10 min) inhibited ragweed extract-induced histamine secretion during the Stage II (release) phase. Theophylline (100 microM), a phosphodiesterase inhibitor, added immediately before antigen challenge, inhibited allergic histamine secretion during the Stage I (activation) phase. The data obtained in this study suggest that diltiazem and azelastine act on the Ca(2+)-dependent and antigen-independent phase (Stage II) of allergic histamine secretion in rabbit basophils.

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The present data do not support the thesis that the increased plasma histamine concentration is causally related to pruritus in hemodialysis patients or that the antiallergic drug, azelastin HCL, alleviates the pruritus of dialysis patients by decreasing plasma histamine levels. The possible role of the increased tissue levels of histamine remains to be studied.

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Relevant articles and references published between 1995 and 2007 regarding the treatment of allergic and vasomotor rhinitis were identified from PubMed, review articles, meta-analyses, and practice guidelines.

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The in vitro interaction of azelastine (a new antiallergic/antiasthmatic drug) with albuterol (a beta 2 bronchodilator), theophylline (a phosphodiesterase inhibitor), disodium cromoglycate (DSCG, a mast cell-stabilizing agent) and prednisolone (a steroid) was studied for effects on allergic histamine release from rat peritoneal mast cells (RPMCs). The RPMCs preincubated with albuterol, theophylline, DSGC (10 min) and prednisolone (2h) caused a 2- to 18-fold decrease in the IC30 for azelastine. Significant potentiation (synergism) was seen only with albuterol (0.01, 0.1 and 1.0 microM, 10 min) and theophylline (1.0 microM, 10 min). The pre-exposure of RPMCs with DSCG (0.1, 1.0 and 10 microM) for a period of 10 min produced a slight leftward shift of azelastine's concentration-effect curve (0.01, 0.1 and 10 microM added immediately before antigen challenge). This effect was not dependent on the concentration of DSCG. These data demonstrated (1) the lack of cross-tachyphylaxis between DSCG and azelastine, and (2) the synergistic interaction between azelastine and albuterol or theophylline.

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This study showed the following: (1) the half dose (0.28 mg/day) and the standard dose (0.56 mg/day) were equally effective in reducing clinical symptoms (p = NS), although the standard dosage required fewer additional puffs during times of peak pollen counts (p < 0.05); (2) both dosages were able to reduce the allergic inflammation (p < 0.05 vs placebo); and (3) on-demand use achieved acceptable clinical control but did not significantly reduce allergic inflammation.

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Due to the interest in azelastine's diverse modes of action, this study investigated its effects on immediate and late-phase cutaneous allergic reactions using visual methods and telethermography.

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The aim of these studies was to investigate the efficacy of MP29-02 (a novel formulation of azelastine and fluticasone propionate [FP]) in patients with moderate-to-severe seasonal allergic rhinitis (SAR) and to compare its efficacy with 2 first-line therapies (ie, intranasal azelastine and intranasal FP) in this population.

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Intranasal corticosteroids (INSs) have been effectively used for >40 years for the treatment of seasonal allergic rhinitis (SAR) and perennial AR (PAR). Following the Montreal Protocol, the initial aerosol formulations using chlorofluorocarbon (CFC) propellants were phased out. For the past 20 years, aqueous solutions have been the only available option for INS treatment. In 2012, the U.S. Food and Drug Administration approved two new nonaqueous aerosol AR treatments that use a hydrofluoroalkane (HFA) propellant. In 2012, the first intranasal aqueous combination product was also approved. This article reviews the clinical profiles of HFA beclomethasone dipropionate (BDP) and HFA ciclesonide (CIC) and the aqueous combination intranasal antihistamine (INA)/INS formulation of azelastine hydrochloride/fluticasone propionate (AZE/FP). The medical literature was searched for clinical trials investigating the use of BDP, CIC, and AZE/FP in SAR and PAR. Clinical trials involving aqueous solutions and CFC propellant or HFA propellant delivery were included. Data from prescribing information and published efficacy and safety data were presented as part of the clinical profile for the reviewed agents. AZE/FP has shown efficacy and safety comparable or greater with the current AR treatment options. Although efficacy comparisons of new HFA formulations have not been investigated in head-to-head clinical trials with aqueous formulations, HFA formulations have shown similar efficacy rates. Furthermore, HFA formulations may have some additional benefits, including a preferable sensory profile for some patients. These new formulations will provide additional options for clinicians and patients to better individualize therapy for control of AR.

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Proinflammatory cytokine and growth factor production, and the expression of intercellular adhesion molecule-1 (ICAM-1) were studied in conjunctival fibroblast cultures challenged with different concentrations of H (from 10(-9) M to 10(-) (4) M). Interleukin (IL)-1, IL-4, IL-6, IL-8, tumor necrosis factor-alfa (TNF-alpha), fibroblast growth factor (FGF), epidermal growth factor (EGF) and transforming growth factor-beta (TGFbeta-1) were measured in supernatants. ICAM-1 expression was evaluated by a fluorescence activated cell sorter (FACS). Inhibitory effects of the H-1 antagonists (antiH): emedastine, levocabastine, and azelastine, and of the antiH-2, cimetidine, on H-stimulated fibroblasts were evaluated by measuring both cytokines in supernatants and the cellular expression of ICAM-1.

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Ketotifen inhibits development of airway hyperreactivity in guinea-pigs exposed to PAF, (+/-)isoprenaline, immune complexes or endotoxin. Ketotifen is not a competitive histamine(H1) antagonist, so that it cannot be concluded that there is mandatory involvement of histamine in the development or expression of these forms of airway hyperreactivity. This conclusion has been reinforced by determining the efficacy of other histamine(H1) antagonists as inhibitors of PAF-induced airway hyperreactivity. When compounds were administered intravenously, at a dosage (1 mg/kg) which fully abolished responses to intravenous histamine, the observed rank order for inhibition of PAF-induced hyperreactivity was: ketotifen greater than cetirizine greater than acrivastine greater than KB-2413 greater than oxatomide greater than azelastine greater than terfenadine = astemizole = clemastine = mepyramine = loratadine = saline. Terfenadine may lack inhibitory activity because of a capacity to induce airway hyperreactivity in the guinea-pig. It can be concluded that inhibition of the development of airway hyperreactivity is not a characteristic of histamine(H1) antagonists.

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Mast cells play an important role in allergic inflammation by releasing vasoactive molecules, proteases and cytokines. Corticotropin-releasing hormone (CRH) and its structural analogue urocortin (Ucn) were shown to trigger skin mast cell activation and vascular permeability. We investigated the effect of acute stress on rat skin vascular permeability and CRH secretion, as well as the effect of intradermal CRH, and that of two histamine-1 receptor antagonists, azelastine and olopatadine, on vascular permeability.

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The effect of azelastine, a new on the down-regulation of beta-receptor agonist was investigated. Male Hartley guinea pigs received injections of saline or terbutaline (T.) and/or azelastine (A.) for successive 7 days. The radioligand binding assays for beta-adrenoceptors in the lung membranes of the guinea pigs were performed. The results showed the differences of numbers of maximal binding sites (Bmax) among four groups were significant. The Bmax of beta-adrenoceptor in T. group was less than that in control group (P less than 0.02). The Bmax in A. group was more than that in control group (P less than 0.05). The Bmax in T. plus A. was more than that in T. group, and there was no significant difference between Bmax in T. group and in T. plus A. group (P greater than 0.1). The differences of affinity (Kd) of beta-adrenoceptor among four groups were not significant. Azelastine increased the density of beta-adrenoceptors and partially prevented the down-regulation of beta-adrenoceptor caused by terbutaline.

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The effects of azelastine hydrochloride on cell proliferation and collagen synthesis in cultured human skin fibroblasts were studied. Azelastine inhibited cell proliferation during proliferating cell phases. Azelastine was found to inhibit collagen synthesis without altering cell proliferation during quiescent phases. It did not alter the ratio of type I to III collagen synthesis. Northern blot analysis of collagen chain mRNAs revealed that the levels of alpha1 (I), alpha1 (III) and alpha1 (VI) mRNAs were reduced by azelastine treatment, whereas the level of alpha2 (VI), alpha3 (VI) mRNAs were not significantly changed. These results suggest that azelastine modulates collagen synthesis at a pretranslational level. Azelastine inhibited collagen synthesis in fibroblasts from scleroderma patients to the same extent as in normal skin fibroblasts. This drug may be useful in the treatment of fibrotic diseases.

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The antiallergic and antiasthmatic drug, azelastine, interacts strongly with calmodulin (but not bovine serum albumin) as determined by an indirect assay; it also moderately inhibited the Ca2+-calmodulin-dependent enzyme bovine brain phosphodiesterase. Ketotifen was less active than azelastine in both assays of calmodulin reactivity and both drugs were less active than the recognized calmodulin inhibitor, W-7. Neither azelastine nor ketotifen had any inhibitory effect on the Ca2+- and phospholipid-dependent protein kinase C. A number of other commonly employed antiallergic and antiasthmatic drugs were essentially inactive in the calmodulin assays and had no or marginal inhibitory effect on protein kinase C.

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To clarify the mechanisms of O2- formation by polymorphonuclear leukocytes (PMNs), the effects of clinically employed drugs on PMNs were investigated by measuring changes in membrane potential and rates of O2- production. These variables were effectively diminished with antihistaminic agents, adrenergic beta-antagonists, and antiarrhythmic drugs when guinea pig peritoneal PMNs were stimulated by either phorbol myristate acetate (PMA) or n-formyl-methionyl-leucyl-phenylalanine (FMLP). The order of potency of the inhibitory effects of these chemicals on the PMA-induced O2- formation was as follows: azelastine (IC50 = 4.1 microM) less than clemastine less than dl-propranolol less than chlorpheniramine maleate less than dichlorisoproterenol less than quinidine less than diphenhydramine less than indomethacin (IC50 greater than 400 microM). Similar phenomena were observed when FMLP was employed instead of PMA, but the FMLP-stimulated O2- production was effectively inhibited by indomethacin. Changes in membrane potential, using the cyanin dye method, also indicated that most of these drugs cancelled functional changes of plasma membrane of PMNs. From these observations, it was demonstrated that changes in membrane potential by the stimuli were essential for the initiation of O2- generation from plasma membrane of PMNs, although the initiation mechanisms were not identical for the two stimuli.

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Pranlukast is a well tolerated and effective preventative treatment in adult and paediatric patients with persistent asthma of all severities. In some patients, pranlukast may be beneficial when added to low-dose inhaled corticosteroids; it may also be a viable alternative to increasing inhaled corticosteroid dosages. The efficacy of pranlukast relative to placebo has been confirmed; its efficacy relative to other therapy awaits further investigation. Nonetheless, pranlukast is a useful therapeutic option (with as-required short-acting beta(2)-agonists), either as preventative monotherapy for the treatment of mild persistent asthma or in conjunction with inhaled corticosteroids in the management of moderate or severe persistent asthma.

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Original azelastine nasal spray and the reformulated spray produced comparable improvements in the TNSS at both dosages. There was a dose-related difference in TNSS comparing the 1- and 2-spray dosages. The percentage changes from baseline in the TNSS in the 2-sprays/nostril dosage groups were 27.9% (p<0.001) with the reformulated nasal spray, 23.5% (p<0.01) with the original formulation, and 15.4% with placebo. The incidence of bitter taste was 7% with the reformulated spray and 8% with the original at the 2-sprays/nostril dosage.

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We performed a systematic review of randomized, controlled trials to determine whether intranasal corticosteroids offered an advantage over topical antihistamines in the treatment of allergic rhinitis.

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We performed a meta-analysis of classes of products (second-generation H1-antihistamines, nasal corticosteroids and grass pollen SLIT tablet formulations) and single products (the azelastine-fluticasone combination MP29-02, and the leukotriene receptor antagonist montelukast) for the treatment of seasonal allergic rhinitis in adults, adolescents and/or children. We searched the literature for large (n >100 in the smallest treatment arm) double-blind, placebo-controlled randomized clinical trials. For each drug or drug class, we performed a meta-analysis of the effect on symptom scores. For each selected trial, we calculated the relative clinical impact (according to a previously published method) on the basis of the reported post-treatment or season-long nasal or total symptom scores: 100 × (scorePlacebo - scoreActive)/scorePlacebo.

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Application of azelastine reduces the degree of acute radiation dermatitis without affecting the antitumoral effect of radiation therapy.

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Olopatadine, at 0.1% and 0.2% concentrations, was effective in suppressing allergen-induced nasal symptoms. At 0.2%, olopatadine provided evidence suggestive of inhibition of mast cell degranulation.

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Evaluation of the number of microflora revealed increased bacterial reproduction after treatment, but this difference was not statistically significant. The use of azelastine nasal spray decreased the buy astelin reproduction of three potentially pathogenic bacteria; however, it did not affect the reproduction of other potentially pathogenic bacteria.

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The effect of the treatment of allergic rhinitis buy astelin with azelastine on physiological indicators of aerobic performance such as VO2 max and ventilatory threshold (VT) were evaluated. The clinical efficacy of azelastine was also established.

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Both direct health care costs and indirect costs significantly impact the health care system due to delays in diagnosis, lack of treatment, ineffective treatment, poor medication adherence, and associated comorbidities. Many patients who have AR turn to over-the-counter medications for relief but often find themselves dissatisfied with the results. Determining the correct diagnosis, followed by initiation of the most-effective treatment(s), is essential to provide patients with better symptomatic management and quality of life. Although there are many options, currently available combination therapies, e.g., azelastine with fluticasone and intranasal Aldactone 50 Mg Weight Loss corticosteroids with nasal decongestants, offer distinct advantages for the management of complex rhinitis phenotypes. Further research is required to investigate the pathomechanisms and biomarkers for mixed rhinitis and nonallergic vasomotor rhinitis subtypes that will lead to novel targeted therapies for these conditions.

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Sixty-three patients who received inductive concomitant chemoradiotherapy with cobalt 60 (60Co, approximately 30 Gy), peplomycin (PLM, approximately 38 mg), and 5-fluorouracil (5-FU, approximately 3,500 mg) were included in this study. From the start of therapy to the disappearance of oral erosion, 37 patients received daily doses of Azelastine (2 mg) + vitamin C (500 mg) + vitamin E (200) + glutathione (200 mg) (azelastine group), whereas the other 26 patients received Zyrtec 12 Hour Dosage the same regimen without azelastine (control group). The severity of oral mucositis in both groups was evaluated periodically.

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The in vitro interaction of azelastine (a new antiallergic/antiasthmatic drug) with albuterol (a beta 2 bronchodilator), theophylline (a phosphodiesterase inhibitor), disodium cromoglycate (DSCG, a mast cell-stabilizing agent) and prednisolone (a steroid) was studied for effects on allergic histamine release from rat peritoneal mast cells (RPMCs). The RPMCs preincubated with albuterol, theophylline, DSGC (10 min) and prednisolone (2h) caused a 2- to 18-fold decrease in the IC30 for azelastine. Significant potentiation (synergism) was seen only with albuterol (0.01, 0.1 and 1.0 microM, 10 min) and theophylline (1.0 microM, 10 min). The pre-exposure of RPMCs with DSCG (0.1, 1.0 and 10 microM) for a period of 10 min produced a slight leftward shift of azelastine's concentration-effect curve (0.01, 0.1 and 10 microM added immediately before antigen challenge). This effect was not dependent on the concentration of DSCG. These data demonstrated (1) the lack of Aldactone 25mg Reviews cross-tachyphylaxis between DSCG and azelastine, and (2) the synergistic interaction between azelastine and albuterol or theophylline.

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Azelastine, a phthalazinone derivative, is a new potent, long acting, orally active Levaquin 500 Mg Qd anti-allergic compound with particularly strong H1-histamine receptor antagonistic effects which has been proven to possess in vitro and in vivo a number of anti-inflammatory properties. The aim of the present study was to investigate whether azelastine would be able to prevent and/or reverse the seasonal increase in non-specific bronchial responsiveness to methacholine in pollen allergic patients. Twelve atopic patients (5 males, mean age 31 years), skin positive exclusively to grass and/or Parietaria pollen extract, with rhinitis and mild asthma occurring in the spring for at least two years previously, were studied. After a 2 week run-in period, oral azelastine, 4 mg twice daily, or placebo, was given for 2 weeks from the start of the pollen season, according to a randomized, double-blind design. After 2 weeks, the treatments were crossed over. During both the run-in and study periods, patients recorded rhinitis and asthma symptoms, additional antihistamine and bronchodilator drugs taken and peak expiratory flow measurements. A methacholine inhalation test was carried out on four occasions in each patient: before the run-in period, before the start of the treatment, and at the end of the two 2 week treatment periods. Azelastine significantly reduced rhinitis symptoms and the need for antihistamine drugs, whereas asthmatic symptoms, use of bronchodilator drugs, peak flow recordings and bronchial responsiveness to methacholine were unaffected by the treatment. Compliance level and adverse side-effects were not significantly different between active treatment and placebo. In the final subjective evaluation of the two treatments, eight out of 12 patients preferred azelastine.(ABSTRACT TRUNCATED AT 250 WORDS)

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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 Buy Propecia Generic Online 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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Capsaicin, a prototypic transient receptor potential vanilloid 1 (TRPV1) agonist, has been shown to be more clinically effective in the treatment of nonallergic rhinitis (NAR) compared with other rhinitis subtypes. Azelastine has also been found to be clinically effective in the treatment of NAR but its mechanism(s) of action is still poorly elucidated. This study was designed to determine, using in vitro cell lines, whether topical therapies Singulair 10 Mg Uses including azelastine have activity on TRPV1 ion channels similar to capsaicin.

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Recently, mast cell stabilizers, so called antiallergic drugs, that also have blocking effects on receptors for chemical mediators (CM) have been developed. The present study investigated the effects of a new antiallergic drug, epinastine (3-amino-9,13b-dihydro-1H-dibenz[c,f]imidazol [1,5-a]azepine hydrochloride, WAL 810 CL; CAS 80012-43-7) on the in vivo bronchoconstriction (BC) induced by several CM as compared with those of other antiallergic drugs such as ketotifen, azelastine and oxatomide. Male Hartley guinea pigs were used. The BC was measured with a modified Konzett-Rössler method and expressed as a change in ventilation overflow (VO) under anesthesia. Antiallergic drugs were given orally 1 h before i.v. administration of CM. I.v. administrations of histamine (His), U-46619 (thromboxane A2 mimetic), leukotriene D4 (LTD4), prostaglandin D2 (PGD2), substance P (SP), neurokinin A (NKA), bradykinin (BK) and endothelin-1 (ET-1) increased VO in a dose dependent manner. The potency was as follows; ET-1 greater than LTD4 greater than NKA much greater than U-46619 greater than SP greater than His greater than BK much greater than PGD2. All the antiallergic drugs used markedly inhibited the His-induced BC. Epinastine, ketotifen and azelastine also significantly inhibited the BK-induced BC; epinastine had the strongest anti-BK effect among them. On the other hand, the four antiallergic drugs did not inhibit the BC induced by the Evista Reviews other CM except for His and BK. Based on the above results, it is suggested that epinastine possesses anti-His and BK effects, and therefore could be promising as a new antiallergic drug without sedative effect.

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In this 14-day, randomized, double-blind, placebo-controlled study, patients with moderate-to-severe SAR were randomized Luvox Pill to azelastine 0.15% (n = 251) or placebo (n = 255), both at a dosage of 2 sprays/nostril once daily. The primary efficacy variable was change from baseline in the 12-hour reflective Total Nasal Symptom Score (TNSS). Key secondary variables were change from baseline in 24-hour instantaneous TNSS, to establish the dosing interval, and change from baseline in the Total Ocular Symptom Score (TOSS).

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Sixty-three patients (29 male, 29 female; 34 in the age range of 6 to 65 years) with allergic conjunctivitis were enrolled in this study. The patients were randomly assigned to receive topical azelastine 0.02% (n = 31) or topical MMC (0.2 mg/10 mL) (n = 31) four times daily for 3 months. Follow-up examinations were done at 2 weeks to examine side effects of the medications and again at 4 weeks to assess the outcome of treatment. The eyes were examined for relief of symptoms, cure of signs, and the appearance of side effects with use of these drugs.

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Three hundred seven patients were randomized to treatment, and 299 completed 2 weeks of study treatment. The age of the population ranged from 12 to 74 years (mean, 35 years), 62.9% were female, and 69.6% were white. Over 2 weeks of treatment, both groups had significant improvements in the TNSS compared with baseline (P < 0.001). The overall change in TNSS was significantly greater with azelastine nasal spray compared with cetirizine (29.3% vs 23.0% improvement, respectively; P = 0.015). In terms of onset of action, azelastine nasal spray significantly improved the instantaneous TNSS compared with cetirizine at 60 and 240 minutes after the initial dose (both, P = 0.040). Scores on each domain of the RQLQ were significantly improved in both groups compared with baseline (P < 0.001); the overall RQLQ score was significantly improved with azelastine nasal spray compared with cetirizine (P = 0.049). Both treatments were well tolerated.

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Patients allergic to birch pollen (n = 11) and control subjects not allergic to birch pollen (n = 5) were included in a randomized, double-blind, placebo-controlled, 3-way crossover study outside the pollen season. Each subject was treated with azelastine nasal spray 0.14 mg per nostril twice daily, cetirizine tablets 10 mg every day, or placebo for 1 week using a double-dummy design. At the end of each treatment period, nasal allergen challenges were performed, and the number of sneezes were counted. In addition, nasal lavage fluid was collected, and the levels of mast-cell mediators (histamine and tryptase) were measured.

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As a chronic disease, allergic rhinitis (AR) requires regular use of allergy medications for the effective management of symptoms. It is therefore imperative that AR treatments not only provide adequate symptom control but are also well tolerated.

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It seems that all reported topical antihistamines and mast cell stabilisers reduce symptoms and signs of seasonal allergic conjunctivitis when compared with placebo in the short term. However, there is no long-term data on their efficacy. Direct comparisons of different antihistamines and mast cell stabilisers need to be interpreted with caution. Overall, topical antihistamines and mast cell stabilisers appear to be safe and well tolerated. We observed a large variability in outcomes reported. Poor quality of reporting challenged the synthesis of evidence.

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Research findings and various published studies point to interleukin 4 (IL-4) and CD23 antigen as instrumental in allergic reactions of allergy patients because these two substances are part of the main triggering mechanisms in cells producing IgE antibodies. In this study it was investigated whether the control of IL-4 and CD23 levels result in a decrease of the severity of allergic reactions. It is well known that azelastine hydrochloride (AZ, CAS 79307-93-0) suppresses symptoms of nasal allergy. The antiallergic activity of this drug includes the suppression of IgE antibody production, antigen-antibody reactions, liberation of mediators and mediator antagonism. One report states that the cytokines IL-2, IL-3, and IL-4 were suppressed by AZ in cultured cells. There have been no reports regarding cytokines in clinical treatment using AZ. Therefore, the effects of AZ treatment on IL-4, soluble CD23, and RAST (radioallergosorbent test) levels in the sera of allergic rhinitis patients were studied. The results show that the levels of IL-4 and soluble CD23 were significantly reduced by the administration of AZ over a 4-week period, especially in patients with "excellent" or "good" efficacy of therapy.

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The human airway epithelium lines the respiratory tract from the nasal mucosa to the bronchioles. Electrolyte transport by these epithelia is crucial in maintaining the appropriate volume and salt composition of the airway surface fluid. When this epithelium becomes functionally impaired, the airways are more prone to respiratory infections. We studied the effect of six common topical agents that are commonly used to treat rhinorrhea and nasal inflammation on the transepithelial resistance, sodium, and chloride transport of primary cultures of human airway epithelia grown at the air-liquid interface. The pharmaceuticals fluticasone propionate, cromolyn sodium, ipratropium bromide, azelastine, oxymetazoline, and normal saline were used and the electrical function of the epithelia was studied in Ussing chambers. Azelastin and ipratropium bromide-treated epithelia were found to have a significant decrease in transepithelial resistance. Both normal saline and fluticasone propionate resulted in significant increases in amiloride-sensitive short circuit currents that reflect sodium transport. Finally, normal saline resulted in a significant increase in bumetanide-sensitive short circuit current that reflects chloride transport across the epithelia. The data presented may explain a mechanism by which some topical pharmaceuticals help reduce rhinorrhea, and may point to some unwanted side effects of some pharmaceuticals on the electrolyte transport of the airway epithelia. In summary, several of the common topical nasal agents alter the electrolyte transport of the nasal airway epithelia. The in vivo significance of these findings is to be determined.

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This article will review four new medications for the treatment of asthma. Extensive studies have been undertaken with these medications to demonstrate their efficacy. All these agents, in use in other countries, are presently in different stages of review by the Food and Drug Administration. This review will give physicians an understanding of these medications, so when they are approved in the United States, the clinician will have an idea of their proper place in treatment of the asthmatic patient.

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The aim of the study was to investigate the effect of azelastine on the immediate and late-phase skin reactions using both planimetric evaluation of weal and erythema and a telethermographic technique.

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Following treatment, the reductions in mean combined and individual nasal symptom scores from baseline values were significantly greater in the budesonide group compared with the placebo group (P < .0001 for all variables except runny nose P = .01). In patients treated with budesonide, there were also significantly larger reductions from baseline values in combined nasal symptom scores (P < .01) and in scores for all individual nasal symptoms (P < or = .05) compared with those treated with azelastine. The reductions from baseline in both combined and individual nasal symptom scores did not differ between azelastine and placebo. The study medications were well tolerated, producing no unexpected or serious treatment-related adverse events.

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Thymus- and activation-regulated chemokine (TARC) and macrophage-derived chemokine (MDC) are accepted to be important molecules in the development and maintenance of allergic diseases. Although several types of histamine H(1) receptor antagonist (antihistamine) have been developed and used for the treatment of allergic diseases, the influence of antihistamines on TARC and MDC production is not well understood.

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The interference of azelastine with pleurisy induced by antigen was investigated in actively sensitized rats. The antigenic challenge (ovalbumin, 12 micrograms/cavity) caused early plasma leakage, which peaked within 4 h, accompanied by intense neutrophil infiltration. Pleural exudate decayed 24 h after antigen provocation, when a long-lasting increase in the number of resident eosinophils was observed. Oral pretreatment with azelastine (1-10 mg/kg) dose dependently inhibited the vasopermeation (ED50 = 4.2 mg/kg) and reduced the pleural exudate (ED50 = 6.8 mg/kg) induced by the antigen. In contrast, azelastine (10 mg/kg) failed to modify the neutrophil influx observed at 4 h and the eosinophil accumulation detected at 24 h. Azelastine was also effective against rat pleurisy induced by either platelet-activating factor (PAF-acether), histamine or serotonin. It reduced exudation and the increase in the number of mononuclear cells, neutrophils and eosinophils observed 6 h after PAF-acether. Nevertheless, antagonism of PAF-acether may not be relevant to the inhibition observed in the present model of allergic pleurisy, as the inhibition was refractory to three distinct PAF-acether receptor antagonists. In contrast, like azelastine, the histamine H1 receptor antagonist meclizine and the dual histamine and serotonin receptor antagonist cyproheptadine blocked antigen-induced exudation and failed to interfere with cell influx. We conclude that the anti-exudatory activity of oral azelastine on antigen-induced pleurisy is consistent with it exerting direct effects against vasoactive amines, but is not related to an effect against leucocyte infiltration nor to its ability to inhibit PAF-acether.

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Azelastine nasal spray may be useful in decreasing adenoid pad size and the severity of symptoms related to adenoidal hypertrophy. Hippokratia 2014; 18 (4): 340-345.

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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.

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To assess the efficacy and onset of action of azelastine nasal spray and desloratadine tablets in patients with allergen-induced seasonal allergic rhinitis (SAR).

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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.

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Efficacy and tolerance of azelastine (A 5610; CAS 58581-89-8), a new antiallergic compound with a unique structure, were investigated over up to one year of treatment in 225 male and female out-patients (age mean +/- s = 48 +/- 13 years) suffering from chronified intrinsic asthma. The trial was conducted by 24 German and Austrian consulting physicians of pneumology. Plasma levels indicated sufficient compliance in almost 90% of the patients. Tablets containing 4.4 mg azelastine HCl were administered b.i.d. in addition to the pre-existing antiasthmatic medication. Only other antiallergic agents were excluded. Adverse events, vital parameters and laboratory tests on safety were tightly assessed. Eighteen patients dropped out because of adverse events, 78 reported adverse experiences under therapy, normally mild and "vegetative" symptoms. No indicative findings regarding blood pressure, heart rate and laboratory tests were seen. The most frequent observations were taste disorders, asthenia and weight gain. No serious side effects at all were reported. The results on efficacy obtained from this non-controlled study may be predicative due to a baseline validation by an initial single blind placebo controlled run-in phase. Statistically significant improvements were seen for FEV1 and for the physicians' and the patients' rating on efficacy. To a lesser extent peak flow and airway resistance were improved, too. Thus, azelastine was safely tolerated over one year and might be effective in intrinsic asthma.

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When hesperidin isolated from pericarpium of Citrus unshiu (family Rutaceae) was incubated with human intestinal microflora, its main metabolite was hesperetin, which was a main metabolite in urine of orally hesperidin-administered rats. The antiallergic activity of hesperidin and its metabolite hesperetin were investigated. Hesperidin did not inhibit the histamine release from RBL-2H3 cells induced by IgE. However, its metabolite hesperetin potently inhibited the histamine release from RBL-2H3 cells induced by IgE and the PCA reaction. The inhibitory activity of hesperetin was found to be comparable with azelastine, a commercially available antiallergic drug, and to potently inhibit prostaglandin E2 production in lipopolysaccharide-stimulated RAW 264.7 cells. Hesperetin weakly inhibits cyclooxygenase 2 enzyme activities. These results suggest that hesperidin may be a prodrug, which is metabolized to hesperetin by intestinal bacteria.

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The combination of intranasal antihistamines and intranasal corticosteroids results in superior relief of seasonal allergic rhinitis (SAR) symptoms compared with monotherapy. This study was designed to evaluate the safety and efficacy of olopatadine hydrochloride nasal spray, 0.6% (OLO), administered in combination with fluticasone nasal spray, 50 micrograms (FNS), relative to azelastine nasal spray, 0.1% (AZE), administered in combination with FNS in the treatment of SAR. This was a multicenter, double-blind, randomized, parallel-group comparison of OLO + FNS versus AZE + FNS administered for 14 days to patients > or =12 years of age with histories of SAR. Efficacy assessments recorded by patients in a daily diary included nasal symptom scores. Safety was evaluated based on adverse events (AEs). Pretreatment values for reflective total nasal symptoms scores (rTNSS) were similar for both treatment groups. The mean (SD) 2-week average rTNSS was 4.28 (2.63) for OLO + FNS and 4.15 (2.63) for AZE + FNS; these scores were not statistically different between treatment groups. No significant differences (p > 0.05) between OLO + FNS and AZE + FNS were observed for the average 2-week percent changes from baseline in rTNSS or in the individual nasal symptoms (nasal congestion, rhinorrhea, itchy nose, and sneezing). Compared with baseline, both groups had statistically significant improvement in rTNSS (p < 0.05). No serious AEs were reported in either group during the study period. Overall, 19 AEs were reported in the OLO + FNS group and 29 AEs were reported in the AZE + FNS group. OLO, when administered adjunctively with FNS, is effective, safe, and well-tolerated in patients with SAR.

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A new AR drug class has recently been introduced (i.e. RO1AD58). Currently MP-AzeFlu is the only treatment option within this drug class. It can be estimated that combination treatments like MP-AzeFlu will become the mainstay of PAR and PER therapy since use will result in better compliance, improved efficacy over INS and a faster response together with good levels of tolerability. The challenge is to find other equally, or more effective, combination treatments, as has been the therapeutic standard in bronchial asthma for decades. The potential of biologics, as well as TLR-agonists and other new treatment options needs to be further evaluated.

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TMK688 appears to be a novel anti-allergic drug having inhibitory effects on both the bronchoconstriction and the infiltration of inflammatory cells during late asthmatic responses.

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Patients aged at least 12 (United States) or 16 years (Europe) with allergic rhinitis or nonallergic vasomotor rhinitis.

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A total of 1225 health professionals enrolled 7864 patients into the study. Completed physician and patient questionnaires were returned by 1081 health professionals and 5073 patients, 4364 of whom used azelastine nasal spray as their only rhinitis medication during the 2-week study period. The patients were predominantly caucasian (82.6%) and female (61.1%), with a mean age of 50 years. The majority had a diagnosis of mixed rhinitis (51.5%), followed by seasonal allergic rhinitis (32.3%), and nonallergic (vasomotor) rhinitis (16.2%). After 2 weeks of treatment, the percentage of patients reporting some control or complete control of individual symptoms ranged from 78% for postnasal drip in patients with nonallergic vasomotor rhinitis to 90% for sneezing in patients with seasonal allergic rhinitis. More than 85% of patients who reported difficulty sleeping or impairment of daytime activities due to rhinitis symptoms had improvement in these parameters. Azelastine nasal spray was well tolerated, the discontinuation rate due to adverse events was 2.3%.