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Allergic conjunctivitis is commonly observed eye diseases in Sikkim, India due to the abundance of seasonal pollens, environmental pollutants, and house dust. We evaluated the efficacy of topical 0.03% tacrolimus eye ointment in the management of simple allergic conjunctivitis.
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Allergic eye disease is a term that refers to a number of disease processes that affect about one-fifth of the world's population. Although the more advanced forms of the disease can be sight threatening, the most disabling effects are due to the clinical manifestations, and hence quality of life, with some patients having seasonal exacerbations of their symptoms, whereas others have symptoms that are present throughout the year. Recent increased understanding of the cellular and mediator mechanisms that are involved in the various disease manifestations has greatly facilitated the development of more effective treatment options. Newer topical medications are being used that have multiple actions, such as an antihistaminic effect coupled with mast-cell stabilisation, and which require reduced daily dosing due to their longer duration of action. With greater research into newer therapies and more effective modes of delivery, improved healthcare outcomes with a lower economic burden will be achieved for patients with allergic eye disease.
Topical azelastine progressively improved itching and conjunctival redness in PAC patients compared to placebo and was at least as effective as levocabastine. Rapid relief is consistent with H(1)-receptor antagonist action, while continued improvement up to 6 weeks may be consistent with mechanisms involving other mediators of allergic inflammation.
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A therapeutic response was achieved in 43.8% of patients with a combination of two antihistamines, 68.4% of patients with three antihistamines and 76.9% of patients with high dosage desloratadine. The average reduction in pruritus was 57.5% (two antihistamines), 67.4% (three antihistamines) and 89% (desloratadine). Adverse drug effects were observed rarely.
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The effects of azelastine (0.1%) nasal spray (Rhinolast) on ciliary beat frequency are investigated and compared with those of oxymetazoline hydrochloride (Vicks Sinex), xylometazoline (Otrivine) and ephedrine hydrochloride (0.5%). It is shown that all four formulations exert a ciliotoxic effect. The antihistamine (azelastine) and the two long-acting alpha sympathomimetic decongestants (xylometazoline and oxymetazoline) had comparable effects which were milder than those observed with ephedrine, the less specific alpha and beta sympathomimetic agent. The results suggest that the intranasal application of all four products should be restricted to short-term therapy. Oral antihistamine therapy and not topical therapy should still be the first-line therapy for antihistamine-responsive rhinitis until non-ciliotoxic formulations can be developed.
Allergic rhinitis affects over 20% of the UK population. It can have a significant impact on quality of life and interferes with both attendance and performance at school and at work.1 Intranasal corticosteroids are widely recognised as the most effective symptomatic treatment available, but oral or intranasal new generation antihistamines are usually offered as first-line treatment for intermittent symptoms.1,2 Patients with moderate to severe allergic rhinitis may require a combination of drugs, and many patients only achieve limited control of their symptoms.3 Dymista is described as a novel intranasal formulation combining the antihistamine azelastine hydrochloride with the corticosteroid fluticasone propionate.3 It is licensed for the relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis in adults and adolescents if monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient.4 The manufacturer claims that compared with fluticasone or azelastine alone, Dymista is twice as effective (when placebo effect is excluded) in providing relief from both nasal and ocular symptoms, and leads to greater overall relief from nasal symptoms. It also claims that Dymista controls nasal symptoms up to 6 days faster than fluticasone.5 Here we consider the evidence for Dymista and whether it represents a significant advantage in the management of patients with allergic rhinitis.
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Because the older antihistamines possessed relatively weak antihistaminic action, as well as sedative and anticholinergic effects, they could not be administered in doses high enough to confer relief to atopic patients with asthma. In contrast, the newer nonsedating, more potent H1-receptor antagonists appear to achieve effective histamine blockade in patients with asthma. Terfenadine and astemizole inhibit bronchoconstriction induced by inhaled allergens by 50% in the early asthmatic reaction. High-potency antihistamines also significantly reduce cough and wheeze as compared with placebo in grass pollen-sensitive asthma patients. Significant reductions in symptom severity and bronchodilator use were found with terfenadine, 120 mg twice daily, although these improvements may be confined to younger patients. Some of the newer antihistamines have demonstrated interesting effects on the late-phase allergic response. Azelastine partially inhibits bronchoconstriction in the allergen-induced late reaction of atopic persons with asthma, possibly by suppressing the release of additional inflammatory mediators. In the skin, cetirizine has been found to reduce eosinophil and neutrophil late-phase infiltration and prostaglandin D2 release. These interesting properties now warrant further investigation in clinical studies.
The study was designed to compare the effectiveness and safety of two dosages of azelastine nasal spray (2 sprays per nostril once daily and twice daily) with that of placebo in the treatment of patients with symptomatic seasonal allergic rhinitis.
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The efficacy of MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate in an advanced delivery system) has been well established in controlled clinical trials. This study was designed to assess the use of MP29-02 and its effectiveness in routine clinical practice. This was a German multicenter, prospective, noninterventional study, including 1781 allergic rhinitis (AR) patients. Eligible patients (i.e., acute AR symptoms and visual analog scale [VAS] score >50 mm) were included, assigned MP29-02 at baseline, and reassessed after ∼14 days. Patients assessed symptom control using a VAS from 0 (not at all bothersome) to 100 mm (very bothersome) in the morning before MP29-02 use, on days 0, 1, 3, and 7 and after ∼ 14 days. Patients' perceived levels of disease control were assessed on day 3. The Youden index determined patient-reported VAS score cutoffs on day 3 for "well controlled" and "partly controlled." MP29-02 reduced the VAS score from 75.4 mm (SD = 17.2) at baseline to 21.3 mm (SD = 18.3) by the last visit, a shift of 54.1 mm (SD = 24.6). One in every two patients felt their symptoms were well controlled at day 3. This perception of well-controlled symptoms at day 3 corresponded to an optimal VAS cutoff of 36 mm. On average, patients treated with MP29-02 crossed this well-controlled VAS cutoff by last visit. Similar results were found in adolescents, adults, and older adults, in those with perennial AR (PAR), seasonal AR (SAR), or PAR + SAR and in those with more and less severe disease. MP29-02 provides effective and rapid symptom control across all age groups in a real-life setting with responder rates higher than those observed in controlled clinical trials, supporting MP29-02's position as the drug of choice for the treatment for AR.
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Twelve asymptomatic subjects (4 female, 8 male), being allergic to grass pollen proved by positive anamnesis, positive Prick-test and positive nasal provocation test, were challenged under controlled conditions with purified airborne grass pollen of Dactylis glomerata in the Vienna Challenge Chamber (VCC), located at the Universitätsklinik für Hals-Nasen-Ohrenheilkunde, Allgemeines Krankenhaus (AKH), der Stadt Wien, Vienna (Austria) by means of a double-blind, randomised, cross-over design, with 2 weeks wash-out periods between. Efficacy and safety of 2 concentrations of dimethindene (dimethindene maleate; DMM, CAS 3614-69-5, Fenistil resp. Foristal) 0.025% DMM, 0.1% DMM) were tested vs placebo as negative control and vs 0.1% azelastine as positive control, as topical nasal sprays. The tested nasal sprays were applied as single doses in the morning (2 puffs = 0.28 ml of the respective solution) to each nostril 15 min before the start of the 4 h lasting provocation procedure in the VCC, thus representing a total daily dose of 0.14 mg resp. 0.56 mg DMM and 0.56 mg azelastine, respectively. Compared to placebo, the objective variables nasal flow (150 Pa., measured by active anterior rhinomanometry) and nasal secretion (g), showed similar onset of antiobstructive and antisecretory effects in the nose after 0.1% DMM and 0.1% azelastine, respectively. The same applied for the subjective nasal symptom complex and for nasal symptom scores, evaluated by Visual Analog Scale (VAS): Time curves showed statistically significant and clinically relevant superiority of 0.1% DMM and 0.1% azelastine vs placebo, during the 4 h lasting provocation period. 0.025% DMM was not significantly different from placebo. No systemic adverse events were reported after the 4 tested preparations. Only a total of 3 subjects reported very slight local irritations (1 subject after placebo, 1 subject after 0.025% DMM and 1 subject after 0.1% azelastine). However, after 0.1% DMM no local adverse events were reported. It is concluded from this study that 0.1% DMM as nasal spray, is an efficient and safe galenical formulation for nasal spray application for patients suffering from seasonal allergic rhinitis (SAR).
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A prospective observational study was designed consisting of 41 patients with refractory simple allergic conjunctivitis, whose condition responded very poorly to conventional anti-allergic eye drops (azelastine, olopatadine, chlorpheniramine maleate, sodium chromoglycate). Simple allergic conjunctivitis cases were diagnosed and followed up evaluating both subjective and objective findings (itching, photophobia, tearing, chemosis, conjunctival congestion, tarsal papilla, and eyelid edema). Existing ocular treatment was discontinued at enrolment and 0.03% tacrolimus ointment was applied into the conjunctival sac of the affected eyes twice daily for 4 weeks followed by a 2 weeks washout period. Patients were followed up at the end of 1(st) week, 4(th) week, and at 7(th) week (2 weeks washout period).
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Each of the 80 randomized patients completed the trial. Mean itching and conjunctival redness scores at visit 3 (onset) were significantly lower (P: < 0.001) in the AZE-treated eyes than in the placebo-treated eyes. At visit 4 (duration), mean itching and conjunctival redness scores (P: = 0.003) for the 8-hour group and mean itching scores (P: = 0.001) for the 10-hour group were significantly lower in the AZE-treated eyes than in the placebo-treated eyes. Significant differences in mean tearing and chemosis severity scores were also seen at visit 3 (onset) and visit 4 (duration) in the AZE-treated eyes when compared with the placebo-treated eyes. Treatment with AZE was well tolerated.
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Olopatadine, an effective topical ocular human conjunctival mast cell stabilizer/antihistaminic antiallergic drug, was evaluated and compared to selected classical antihistamines for their interaction with model and natural membranes to ascertain potential functional consequences of such interactions.
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Allergic rhinitis (AR) is the most common chronic condition in children and is estimated to affect up to 40% of all children. It is usually diagnosed by the age of 6 years. The major impact in children is due to co-morbidity of sinusitis, otitis media with effusion, and bronchial asthma. AR also has profound effects on school absenteeism, performance and quality of life. Pharmacotherapy for AR should be based on the severity and duration of signs and symptoms. For mild, intermittent symptoms lasting a few hours to a few days, an oral second-generation antihistamine should be used on an as-needed basis. This is preferable to a less expensive first-generation antihistamine because of the effect of the latter on sedation and cognition. Four second-generation antihistamines are currently available for children under 12 years of age: cetirizine, loratadine, fexofenadine and azelastine nasal spray; each has been found to be well tolerated and effective. There are no clearcut advantages to distinguish these antihistamines, although for children under 5 years of age, only cetirizine and loratadine are approved. Other agents include pseudoephedrine, an oral vasoconstrictor, for nasal congestion, and the anticholinergic nasal spray ipratropium bromide for rhinorrhoea. Sodium cromoglycate, a mast cell stabiliser nasal spray, may also be useful in this population. For patients with more persistent, severe symptoms, intranasal corticosteroids are indicated, although one might consider azelastine nasal spray, which has anti- inflammatory activity in addition to its antihistamine effect. With the exception of fluticasone propionate for children aged 4 years and older, and mometasone furoate for those aged 3 years and older, the other intranasal corticosteroids including beclomethasone dipropionate, triamcinolone, flunisolide and budesonide are approved for children aged 6 years and older. All are effective, so a major consideration would be cost and safety. For short term therapy of 1 to 2 months, the first-generation intranasal corticosteroids (beclomethasone dipropionate, triamcinolone, budesonide and flunisolide) could be used, and mometasone furoate and fluticasone propionate could be considered for longer-term treatment. Although somewhat more costly, these second-generation drugs have lower bioavailability and thus would have a better safety profile. In patients not responding to the above programme or who require continuous medication, identification of specific triggers by an allergist can allow for specific avoidance measures and/or immunotherapy to decrease the allergic component and increase the effectiveness of the pharmacological regimen.