Allergic rhinits: impact on quality of life of adolescents.

SUMMARY: Adolescence is one of the most rapid phases of human development, in which biological maturity precedes psychosocial maturity. Rhinoconjunctivitis (ARC) is present in around 15 percent of 13-14-year-old children, which indicates a higher prevalence when compared with 6-7-year-old children (8.5 percent). During childhood (0-10 years) prevalence of Allergic Rhinitis (AR) is higher among males compared to females. Quite the reverse, during adolescence (11-17 years) females display higher prevalence of AR compared to males. However, when they reach adulthood (18-79 years), there is no difference in prevalence between genders. AR and ARC have significant physical and mental impacts on the QoL of adolescents and their parents. Apart from de adverse effects of first generation antihistamines, which include sedating effects, AR-ARC leads to school absences and poorer performance due to distraction, fatigue and irritability. The mobile technology facilitates an innovative investigatory approach to better and more precisely characterize allergy symptoms and their association with other allergic diseases. The success of treatment lies in the partnership between adolescents with AR and mobile technology, allowing them to have more information both on the disease and treatment. Adolescence is a special period in which AR is highly prevalent with some sex-dependent differences. There are also peculiarities on how AR affects QoL of adolescent patients.

Mizolastine in the treatment of seasonal allergic rhinoconjunctivitis: a European clinical experience with 5408 patients managed in daily practice (PANEOS SAR Study).

BACKGROUND: Mizolastine, a potent H1 antihistamine with additional antiallergic properties, is marketed for the treatment of allergic rhinoconjunctivitis and urticaria. The objective was to investigate the safety and effectiveness of mizolastine under conditions of daily practice in patients with seasonal allergic rhinoconjunctivitis (SAR). METHODS: In an open multicenter study, mizolastine 10 mg daily was administered for 14 days during the pollen season. Nasal and ocular symptoms, time to onset of symptom relief, and effect of the drug on diurnal alertness were evaluated. Safety was evaluated on the basis of self-reported adverse events (AE). RESULTS: A total of 5408 patients (36+/-14 years of age, females=57%) with a history of SAR for 8+/-9 years were treated for a mean of 17.1+/-5.0 days. SAR symptoms improved in 93% and decreased by at least 50% in 86% of patients; 78% reported improvement after the first drug intake and 51% from the first hour. Sixty-nine percent considered mizolastine more effective than other antihistamines taken previously. The incidence of AE was low (3.8%). CONCLUSION: The high responder rate, the rapid onset of action, and the low incidence of AE observed in this large multicenter study confirm the previously reported beneficial efficacy and safety of mizolastine in the management of SAR.

One-year treatment of chronic urticaria with mizolastine: efficacy and safety. URTOL study group.

AIM: To assess the long-term safety and efficacy of the H1-receptor antagonist mizolastine in the symptomatic treatment of chronic urticaria (CU). BACKGROUND: Mizolastine is a novel second generation antihistamine with additional anti-inflammatory properties which has been shown to be effective in this condition as well as in allergic rhinitis. As the drug is used for chronic treatment, a detailed study of its efficacy and safety over a prolonged period was warranted. METHODS: This open label multicentre trial recruited 211 patients suffering from CU (67% female; mean age 40+/-13 years), with > or = 1 episode/week if untreated. After a 7-day placebo run-in period, patients received mizolastine (10 or 15 mg) for 12 months. Efficacy was assessed by the patient using daily diary cards and overall condition evaluation at study visits. Clinicians also assessed the same parameters at each visit, and gave a global assessment at study termination. Safety was assessed by monitoring adverse events and laboratory parameters. Cardiac safety was monitored every 4 months using 12-lead ECGs, with particular attention to QT intervals. RESULTS: The trial was completed by 127 patients. Mizolastine reduced overall discomfort from the second week of therapy, and reduced itching and the number and size of wheals, as assessed by the patients. The clinician's assessment of the proportion of patients with > 10 wheals decreased from 42% to 28% after 2 months. Clinical assessment also indicated that itch intensity and angioedema were improved by mizolastine, and the improvement was sustained throughout the trial. The investigators estimated that 70% of patients benefited from therapy. There were no drug-related serious adverse events during the study. The cardiac repolarization assessed according to the QTc intervals was not modified during prolonged administration. CONCLUSION: Mizolastine improves CU symptoms, and these improvements are sustained over 12 months with no loss of drug sensitivity. No specific side-effects are associated with its long-term use in the current study.

Humoral and cellular responses to histamine and pollen allergen in a skin chamber model: effect of mizolastine.

BACKGROUND: Mizolastine is a new non-sedative antihistamine and antiallergic drug proven to be effective and safe in the treatment of allergic rhinitis and urticaria. OBJECTIVE: To quantitatively explore the time course of mediator release and cell recruitment during allergen challenge and the effects of mizolastine on the event, using the skin chamber model. METHODS: Twelve pollen-sensitive patients (23+/-6 years) were included in a double-blind crossover study. Patients received 10 mg mizolastine or placebo once daily in the first 4-day period and, after a 3-week washout period, vice-versa in the crossover period. On day 4 of each period, a non-invasive in vivo skin chamber technique was used to determine the alteration of vascular permeability, mast cell mediator release, the release of soluble intercellular adhesion molecule -1(sICAM-1) in skin sites challenged with exogenous histamine or grass pollen allergen extract, over an 8-hour period. RESULTS: Challenge with allergen-induced significant mast cell activation, as indicated by the release of histamine, tryptase and LTC4, in chamber fluids 2 hours after initiation of the allergic reaction and during the following 6 hours. Both exogenous histamine and allergen induced significant vasodilatation, which was sustained during the 8-hour challenge, as indicated by the accumulation of protein in the chamber fluids. Likewise, both histamine and allergen induced the release of significant amounts of ICAM-1 throughout the 8-hour period. Mizolastine significantly inhibited the histamine- and allergen-induced extravasation (after 2 hours, P = .003; after 8 hours, P = .009; after 2 hours, P = .044; after 8 hours, P = .003 respectively) and the histamine- and allergen-induced--ICAM-1 release (after 2 hours, P = .004; after 8 hours, P = .05; after 2 hours, P = .03 respectively). CONCLUSION: Mizolastine strongly inhibited the local response to histamine in this skin chamber model with, of interest, inhibition of the release of the soluble adhesion-molecule ICAM-1.

Efficacy and safety of mizolastine 10 mg in a placebo-controlled comparison with loratadine in chronic idiopathic urticaria: results of the MILOR Study.

BACKGROUND: Mizolastine is a novel histamine H1-antagonist registered in Europe for the management of allergic rhinitis and urticaria. OBJECTIVES: To compare the clinical efficacy and safety of mizolastine with loratadine and placebo in patients with chronic idiopathic urticaria (CIU). METHODS: A multicentre, double-blind, parallel group study was designed in which 247 patients with CIU were randomised after a 1-week placebo run-in period to 10 mg daily mizolastine (n = 88), 10 mg daily loratadine (n = 79), or placebo (n = 80) for a 4-week treatment period. RESULTS: Mizolastine and loratadine both relieved symptoms of CIU. After 2 weeks' treatment, the severity of pruritus (visual analogue score (VAS) assessed by patients) decreased significantly in both the mizolastine and loratadine groups compared with placebo (mizolastine: -36.7 mm, P = 0.0001; loratadine: -29.8, P = 0.0071; placebo: -16.3); this improvement with both active treatments was maintained throughout the treatment period, the difference being significant only for the mizolastine group (P = 0.0090). Both active treatments were also associated with reduced weekly episodes of urticaria compared with placebo, which was significant after 2 weeks' treatment (mizolastine: 7.9 episodes, P = 0.0061; loratadine: 8.3, P = 0.0221; placebo: 13.3). Angioedema was improved to a clinically significant extent with mizolastine, and loratadine compared with placebo in those patients who had this symptom before treatment. Overall tolerability of both treatments was similar to placebo, and there were no clinically relevant effects on cardiac repolarisation with either mizolastine or loratadine. CONCLUSION: Mizolastine (10 mg daily) is confirmed as an effective and well tolerated agent, comparable to loratadine and superior to placebo, for the management of CIU. Mizolastine acted as rapidly as loratadine in improving urticarial symptoms from the first day of treatment.

Mizolastine is effective and well tolerated in long-term treatment of perennial allergic rhinoconjunctivitis. Riperex Study Group.

The aim of this study was to determine the long-term efficacy and safety of mizolastine, a new second-generation antihistamine with European approval, in the treatment of perennial allergic rhinoconjunctivitis. In this study, 141 patients were treated with once-daily mizolastine 10 mg or 15 mg in a 5-month open-label extension of a 1-month double-blind, placebo-controlled trial, which assessed once-daily mizolastine 10 mg. Mizolastine significantly reduced the nasal subscore (sneezing, rhinorrhoea, itch; end-baseline +/- SD, -2.5 +/- 6.3), nasal obstruction (-1.2 +/- 2.6) and rhinoscopy scores (-1.3 +/- 2.6), and improved ocular and total nasal scores after 6 months' treatment. Improvement was maintained for the duration of the study with no loss of drug efficacy. Adverse effects were mild with no specific effects associated with prolonged use. These results clearly demonstrate that mizolastine is effective and well tolerated in the long-term treatment of perennial allergic rhinoconjunctivitis. The significant clinical improvement in nasal blockade may reflect mizolastine's histamine/5-lipoxygenase dual inhibition.

Rapid and sustained efficacy of mizolastine 10 mg once daily in seasonal allergic rhinitis.

This 28-day, double-blind, randomized study in 256 patients compared the efficacy and safety of mizolastine 10 mg daily with placebo in patients with seasonal allergic rhinoconjunctivitis. All four nasal symptoms (itch, rhinorrhoea, sneezing, obstruction) and three ocular symptoms (itch, tears, redness) were rated by investigators using both a 0-3 and a 0-9 rating scale. Compared with the placebo group total, nasal and ocular scores were all significantly lower in the mizolastine-treated patients at day 14 of the study (P = 0.0002-0.0009, using the 0-9 scale) and relief was maintained throughout the 4-week study duration. Patient diary total scores showed that mizolastine was effective from the first day of treatment. The 0-9 scale appears to be more sensitive than the 0-3 scale for rating symptoms of seasonal allergic rhinitis.

Systemic allergic reactions to corticosteroids.

Allergic anaphylactic (type I) reactions to corticosteroid medications are uncommon; however, a number of well-documented cases have been reported. We present a review of the literature, and report on two patients who suffered anaphylaxis after injections of corticosteroids. The first patient, a registered nurse, was finally found to be sensitive to all corticosteroid preparations containing carboxymethylcellulose, as well as the pure carboxymethylcellulose. The second patient had positive skin tests to hydrocortisone, hydrocortisone sodium succinate, methylprednisolone sodium succinate, and suxamethonium. Both patients were tested on two occasions; four normal subjects were tested in parallel, and did not elicit any positive skin reaction. In patients with systemic severe reactions to injectable corticosteroids, we recommend careful and comprehensive skin testing with most available corticosteroids, as well as the components of the injectables.