Randomized, placebo-controlled study of cetirizine and loratadine in children with seasonal allergic rhinitis.

Background: Pharmacologic treatment is a mainstay of allergy therapy and many caregivers use over-the-counter antihistamines for the treatment of seasonal allergic rhinitis (SAR) symptoms in children.

Objective: To assess the efficacy and safety of cetirizine 10 mg syrup versus loratadine 10 mg syrup versus placebo syrup in a randomized double-blind study of children, ages 6-11 years, with SAR.

Methods: This randomized, double-blind, parallel-group, placebo-controlled study was conducted at 71 U.

Efficacy of bepotastine besilate ophthalmic solution 1.5% for seasonal allergic conjunctivitis: a randomized, placebo-controlled, natural exposure, clinical trial.

Allergic conjunctivitis (AC) affects an estimated 20% of the population in the Western world, with a large fraction suffering due to seasonal or perennial allergen exposures. Bepotastine besilate ophthalmic solution (BBOS) 1.5%, a dual-acting histamine (H(1)) receptor antagonist and mast cell stabilizer, is indicated for itching associated with AC.

Clinical efficacy of 300IR 5-grass pollen sublingual tablet in a US study: the importance of allergen-specific serum IgE.

Background: Previous trials have demonstrated the efficacy, safety, and optimal dosage of the 5-grass pollen sublingual tablet for adults and children with grass pollen-induced allergic rhinoconjunctivitis.

Objectives: We sought to evaluate the efficacy and safety of 300 index of reactivity (IR) 5-grass pollen sublingual tablet in US adults.

Methods: Adults with grass pollen allergy and Rhinoconjunctivitis Total Symptom Scores of 12 or greater (scale, 0-18) during the previous grass pollen season were randomized in a double-blind, placebo-controlled study to receive 300IR 5-grass pollen sublingual tablet or placebo starting 4 months before and continuing through the pollen season.

Safety of ragweed sublingual allergy immunotherapy tablets in adults with allergic rhinoconjunctivitis.

A sublingually administered allergy immunotherapy tablet (AIT) is under development to treat ragweed (Ambrosia artemisiifolia)-induced allergic rhinoconjunctivitis (ARC). This study investigates the optimal tolerable dose of once daily ragweed pollen AIT.Subjects 18-50 years old with ragweed-induced ARC were enrolled at two U.

Efficacy and safety of triamcinolone acetonide aqueous nasal spray in children aged 2 to 5 years with perennial allergic rhinitis: a randomized, double-blind, placebo-controlled study with an open-label extension.

Background: Intranasal corticosteroids (INSs) are the most effective treatment for allergic rhinitis (AR). However, available INS safety and efficacy data in children younger than 6 years are limited.

Objective: To report the first well-controlled study assessing the safety and efficacy of an INS in children aged 2 to 5 years with perennial AR.

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

Background: Seasonal allergic rhinitis (SAR) is an allergen-induced inflammatory reaction that occurs during periods of high pollen count. Current treatments for SAR include allergen avoidance, systemic antihistamines, and steroidal and nonsteroidal intranasal sprays. Olopatadine is a selective antihistamine and an inhibitor of proinflammatory mediators from human mast cells.

Prevalence and impact of nighttime symptoms in adults and children with asthma: a survey.

Background: The frequency of nighttime asthma symptoms is an important measure of asthma severity. This study was designed to determine the prevalence of daytime and nighttime symptoms in adults and children with asthma and to evaluate the impact of nighttime symptoms on sleep and daytime activities.

Methods: An online survey was conducted among adults (> 18 years) and mothers of children aged 2 to 17 years with asthma.

Pharmacokinetics, safety and tolerability of an oral suspension of fexofenadine for children with allergic rhinitis.

Allergic rhinitis (AR) is a common chronic condition in children and may impact a child's quality of life. Increasing treatment compliance may improve quality of life. An oral suspension of fexofenadine hydrochloride (HCl) has been developed to ease administration to children and may, therefore, improve treatment compliance.

Mometasone furoate monohydrate nasal spray for the treatment of nasal congestion in allergic rhinitis.

Allergic rhinitis (AR) affects an estimated 20-40 million Americans annually. It is a multifaceted condition comprising a range of symptoms, including nasal congestion, arguably the most bothersome symptom. Of the various types of medications available for the treatment of AR, intranasal corticosteroids are considered the most effective.

Montelukast in the treatment of allergic rhinitis: an evidence-based review.

Cysteinyl-leukotrienes (CysLTs) are endogenous mediators of inflammation and play an important role in allergic airway disease by stimulating bronchoconstriction, mucus production, mucosal oedema and inflammation, airway infiltration by eosinophils, and dendritic cell maturation that prepares for future allergic response. Montelukast inhibits these actions by blocking type 1 CysLT receptors found on immunocytes, smooth muscle and endothelium in the respiratory mucosa. Initially developed as a treatment for asthma, montelukast has more recently found use in the treatment of allergic rhinitis (AR).

Judicious antibiotic use and intranasal corticosteroids in acute rhinosinusitis.

Most patients with symptoms of acute rhinosinusitis are treated with antibiotics. However, many cases of rhinosinusitis are secondary to viral infections and unlikely to benefit from antibiotic therapy. Inappropriate use of antibiotics in patients with acute nonbacterial rhinosinusitis contributes to the increase in bacterial antibiotic resistance.

Inhaled mometasone furoate reduces oral prednisone usage and improves lung function in severe persistent asthma.

Objective: The reduction of oral prednisone use by mometasone furoate (MF) delivered by HFA-227 metered dose inhaler (MDI) was examined in oral corticosteroid (OCS)-dependent patients with severe persistent asthma.

Methods: A 3-month, double-blind, placebo-controlled clinical trial (n=123), followed by a 9-month open-label phase (n=120). The study was conducted at 26 medical centers in the United States.

Efficacy and safety of desloratadine/pseudoephedrine tablet, 2.5/120 mg two times a day, versus individual components in the treatment of patients with seasonal allergic rhinitis.

Although antihistamines are highly effective in alleviating many symptoms associated with seasonal allergic rhinitis (SAR), relief from nasal congestion is variable. The efficacy of desloratadine, an effective antihistamine, in combination with pseudoephedrine, a potent nasal decongestant, was evaluated to determine whether combination therapy was more effective than individual component therapy in reducing nasal congestion, as well as other SAR symptoms. This multicenter, randomized, double-blind, three-arm study included 650 patients with SAR.

Mometasone furoate improves congestion in patients with moderate-to-severe seasonal allergic rhinitis.

Background: A recent survey estimated that 85% of patients with allergic rhinitis experience nasal congestion. This symptom considerably impacts quality of life.

Objective: To evaluate the effectiveness of mometasone furoate nasal spray (MFNS) in subjects with seasonal allergic rhinitis (SAR) experiencing moderate-to-severe nasal congestion.

Pharmacokinetics of topical calcineurin inhibitors in adult atopic dermatitis: a randomized, investigator-blind comparison.

Objective: We sought to compare pharmacokinetics of pimecrolimus cream 1% and tacrolimus ointment 0.1% in adults with extensive, moderate to severe atopic dermatitis. Secondary end points included efficacy and safety.

Effectiveness of azelastine nasal spray compared with oral cetirizine in patients with seasonal allergic rhinitis.

Background: Azelastine nasal spray and oral cetirizine are selective histamine H(1)-receptor antagonists that are approved in the United States for the treatment of seasonal allergic rhinitis (SAR).

Objective: The objective of the present study was to compare the efficacy and tolerability of azelastine nasal spray administered at the recommended dosage of 2 sprays per nostril twice daily with those of cetirizine in the treatment of moderate to severe SAR.

Methods: This multicenter, randomized, double-blind, parallel-group, 2-week comparative study was conducted during the 2004 fall allergy season in patients with moderate to severe SAR.

The effect of montelukast on rhinitis symptoms in patients with asthma and seasonal allergic rhinitis.

Objective: The objective of this study was to evaluate montelukast 10 mg daily as treatment for allergic rhinitis in patients with symptomatic allergic rhinitis and active asthma during the allergy season.

Methods: This was a multicenter study of 831 patients (ages 15 years-85 years) with seasonal allergen sensitivity, active symptoms of seasonal allergic rhinitis, and active asthma. Following a single-blind, placebo run-in period of 3 days-5 days, patients were randomized to oral montelukast 10 mg (n = 415) or placebo (n = 416) daily during the 2-week, double-blind, active-treatment period.

Montelukast for treating fall allergic rhinitis: effect of pollen exposure in 3 studies.

Background: Montelukast, a potent leukotriene receptor antagonist, is an effective therapy for symptoms of seasonal allergic rhinitis, a disease governed by patients' individual sensitivity and exposure to relevant allergens.

Objective: To evaluate the relationship of montelukast treatment effect vs pollen exposure in studies conducted during 3 consecutive fall allergy seasons.

Method: A combined analysis of these multicenter, randomized, double-blind, parallel-group studies was performed; 1 of the 3 studies is presented for the first time in this article.

A review of montelukast in the treatment of asthma and allergic rhinitis.

Montelukast sodium (Singulair, Merck) is a selective and orally-active leukotriene-receptor antagonist (LTRA) that inhibits the cysteinyl leukotriene 1 (CysLT1) receptor. Montelukast is an effective and well-tolerated preventative treatment for asthma and allergic rhinitis in adults and children. The upper and lower airway show similar inflammatory responses to allergen challenge.

The asthma and allergic rhinitis link.

During the past 10 years, our understanding of asthma and allergic rhinitis (AR) has evolved. The historic perspective of these allergen-induced disorders as distinct and separate entities is being displaced by current thinking that they are described better as a continuum of inflammation involving one common airway. Therefore, traditional therapies originally indicated for AR and asthma are being reassessed to explore their potential value in both upper- and lower-airway diseases.

A randomized trial of etanercept as monotherapy for psoriasis.

Objective: To determine safety and efficacy of monotherapy with etanercept.

Design: Randomized, double-blind, placebo-controlled, multicenter study.

Setting: Outpatient, ambulatory; private practice and university dermatology research centers.

Tolerability of retreatment with omalizumab, a recombinant humanized monoclonal anti-IgE antibody, during a second ragweed pollen season in patients with seasonal allergic rhinitis.

Two randomized, placebo-controlled, double-blind studies have shown clinical benefit with omalizumab (Xolair), a recombinant humanized monoclonal anti-immunoglobulin E (IgE) antibody, at a dose of 300 mg every 3 or 4 weeks in patients with seasonal allergic rhinitis. The present open-label, 12-week study was designed to assess the safety and tolerability of retreatment with omalizumab in 287 patients previously treated with this agent in one of the latter studies. Omalizumab, 300 mg, was administered subcutaneously every 4 weeks (three injections) to patients with IgE levels < or = 150 IU/mL (n = 182) and every 3 weeks (four injections) to patients with IgE levels > 150 IU/mL (n = 105) at screening before retreatment.

Lack of effect of fluticasone propionate aqueous nasal spray on the hypothalamic-pituitary-adrenal axis in 2- and 3-year-old patients.

Objective: Fluticasone propionate aqueous nasal spray (FP) at the highest recommended doses does not affect hypothalamic-pituitary-adrenal (HPA) axis function in adults or older children, but its potential effects in children younger than 4 years have not been previously studied. This randomized, double-blind, placebo-controlled study evaluated the effects of FP on HPA axis function measured by 12-hour urinary-free cortisol levels in children 2 to 3 years of age.

Methods: Patients ages 2 to 3 years with symptoms of allergic rhinitis were administered FP 200 microg/day (FP200 QD) or vehicle placebo for 6 weeks.

A common pathway: asthma and allergic rhinitis.

Historically, the structural and functional differences within the respiratory tract have been the basis for separating the airway into upper and lower entities. For centuries, researchers suggested similar mechanisms in asthma and rhinitis. The implications of such a connection are significant in that asthma and allergic rhinitis (AR) are associated with a high prevalence in adults and children, substantial health care costs, and, often, serious negative effects on quality of life.

Efficacy and safety of beclomethasone dipropionate extrafine aerosol in childhood asthma: a 12-week, randomized, double-blind, placebo-controlled study.

Background: Beclomethasone dipropionate (BDP) has been formulated as an extrafine aerosol (hydrofluoroalkane-134a [HFA]-BDP) [QVAR; 3M Pharmaceuticals; St Paul, MN], which gives improved lung deposition compared with chlorofluorocarbon (CFC)-BDP. The clinical efficacy of HFA-BDP has been established in adult asthma at a required dose below that of CFC-BDP, but has not been evaluated in children.

Objective: To examine the efficacy and safety of HFA-BDP in childhood asthma.