Safety of a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate in children: A randomized clinical trial.

Background: The safety of a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP) has been established in adults and adolescents with allergic rhinitis but not in children <12 years old.

Objective: To evaluate the safety and tolerability of an intranasal formulation of AZE and FP in children ages 4-11 years with allergic rhinitis.

Methods: The study was a randomized, 3-month, parallel-group, open-label design.

Safety of house dust mite sublingual immunotherapy standardized quality tablet in children allergic to house dust mites.

Background: Sublingual immunotherapy (SLIT) tablets could be an important alternative to subcutaneous immunotherapy for house dust mite (HDM) allergy in children.

Objective: To characterize the safety, tolerability, and duration of local adverse events (AEs) of an HDM SLIT tablet (MK-8237; Merck, ALK Abellò, and Torii) in North American children 12 to 17 years old with HDM allergic rhinitis with and without conjunctivitis and with or without asthma.

Methods: In this phase 1, multicenter, double-blinded, randomized trial (NCT01678807), children received placebo, HDM SLIT tablet 6 standardized quality (SQ) HDM, or 12 SQ-HDM once daily for 28 days.

Intranasal triamcinolone and growth velocity.

Background: Inadequate designs and conflicting results from previous studies prompted the US Food and Drug Administration to publish guidelines for the design of clinical trials evaluating the effects of orally inhaled and intranasal corticosteroids on the growth of children. This study conformed to these guidelines to evaluate the effect of triamcinolone acetonide aqueous nasal spray (TAA-AQ) on the growth of children with perennial allergic rhinitis (PAR).

Methods: This randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluated the effect of once-daily TAA-AQ (110 μg) on the growth velocity (GV) of children aged 3-9 years with PAR by using stadiometry at baseline (4-6 months), during treatment (12 months), and at follow-up (2 months).

A phase 3 trial assessing the efficacy and safety of grass allergy immunotherapy tablet in subjects with grass pollen-induced allergic rhinitis with or without conjunctivitis, with or without asthma.

Background: Design and execution of immunotherapy trials for seasonal allergies may be complicated by numerous factors including variable allergy testing methods, pollen levels, and timing and intensity of other seasonal allergens. We evaluated grass allergy immunotherapy tablet (AIT) treatment in North American adults with grass pollen-induced allergic rhinitis with or without conjunctivitis (AR/C), with/without asthma.

Methods: Subjects age 18-65 with clinical history of grass pollen-induced AR/C, with/without asthma were randomized 1:1 to once-daily 2800 BAU Timothy grass AIT (oral lyophilisate, Phleum pratense, 75,000 SQ-T, containing approximately 15 μg of Phl p 5) or placebo.

Randomized controlled trial of ragweed allergy immunotherapy tablet efficacy and safety in North American adults.

Background: Ragweed is an important cause of allergic rhinitis with or without conjunctivitis (AR/C) in North America and elsewhere. Allergen immunotherapy enabling safe patient self-administration is considered an unmet clinical need. Allergy immunotherapy tablet (AIT) treatment has shown promising efficacy and safety for grass allergy but has not been assessed for ragweed allergy.

Linear growth and bone maturation are unaffected by 1 year of therapy with inhaled flunisolide hydrofluoroalkane in prepubescent children with mild persistent asthma: a randomized, double-blind, placebo-controlled trial.

Background: Inhaled corticosteroids (ICS) are the preferred long-term therapy for subjects with persistent asthma. However, concerns remain about potential effects of long-term ICS use on growth in children.

Objective: To determine the effect of 1 year of inhalation therapy with flunisolide hydrofluoroalkane (HFA) on growth velocity and bone maturation in children with mild persistent asthma.

Latex allergy.

Allergy to natural rubber latex is an important clinical condition that occurred after the institution of universal precautions to protect healthcare workers. A rapid increase and production of both examination and surgical gloves resulted in an epidemic of allergy to latex protein. Healthcare workers in both the medical and dental environments, as well as specific groups of individuals including those with spina bifida, myelodysplasia, and food allergies (banana, kiwi, avocado, and others), were at increased risk of sensitization.

Efficacy and safety of timothy grass allergy immunotherapy tablets in North American children and adolescents.

Background: Allergy immunotherapy tablet (AIT) treatment might be a safe and convenient form of specific immunotherapy but it has not been investigated in North American children and adolescents.

Objective: We sought to investigate the efficacy and safety of timothy grass AIT treatment in North American children/adolescents with grass pollen-induced allergic rhinoconjunctivitis (ARC) with or without asthma.

Methods: Three hundred forty-five subjects (5-17 years old) were randomized to once-daily grass AIT treatment (2,800 bioequivalent allergen units, 75,000 standardized quality tablet, approximately 15 μg of Phl p 5) or placebo approximately 16 weeks before the 2009 grass pollen season (GPS).

Efficacy and safety of levocetirizine in improving symptoms and health-related quality of life in US adults with seasonal allergic rhinitis: a randomized, placebo-controlled study.

Background: Levocetirizine, a second-generation antihistamine for symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria, has not been previously studied in US patients.

Objective: To assess the efficacy and safety of levocetirizine in improving symptoms and health-related quality of life in US adults with seasonal allergic rhinitis (SAR).

Methods: This multicenter, double-blind trial randomized adults with SAR, sensitized to at least 1 grass allergen, to receive levocetirizine, 5 mg, or placebo once daily in the evening for 2 weeks.

Pollinex Quattro Tree: allergy vaccine.

An overview of short-term specific immunotherapy (ST-SIT) highlighting Pollinex Quattro (PQ) Tree is presented. The product development of this novel allergy vaccine using modifying agent glutaraldehyde, adjuvant monophosphoryl lipid and L-tyrosine have heralded a superior ST-SIT. Since 1999 when PQ was founded in Germany, various research trials assessing both the standardization and clinical studies have been done.

Successful treatment of previously uncontrolled adult asthma with budesonide inhalation suspension: five-year case histories.

Objective: To determine whether nebulized budesonide inhalation suspension (BIS) is effective in treating adults with asthma that has been uncontrolled by inhaled therapies.

Case Summaries: Three adults with severe persistent asthma were switched to BIS after poor outcomes with other controller medications, including inhaled corticosteroids (ICSs). BIS dosages were initiated with 1 mg twice daily.

Aspirin challenge and desensitization for aspirin-exacerbated respiratory disease: a practice paper.

Aspirin desensitization is indicated for patients who have aspirin-exacerbated respiratory disease and whose asthma and/or rhinosinusitis is suboptimally controlled with inhaled corticosteroids and leukotriene-modifying drugs. In this practice paper, the general requirements for aspirin desensitization are presented, the locations where desensitizations can be safely performed are outlined, prechallenge patient preparation is discussed, an oral aspirin challenge protocol is presented, treatment of adverse reactions is reviewed, and maintenance of aspirin desensitization is discussed.

Triamcinolone acetonide aqueous nasal spray and fluticasone propionate are equally effective for relief of nasal symptoms in patients with seasonal allergic rhinitis.

Objective: We compared 220 microg daily intranasal aqueous triamcinolone acetonide (TAA AQ) with 200 microg daily fluticasone propionate (FP) for relief of seasonal allergic rhinitis symptoms. Study design and setting Randomized, parallel-group, investigator-blind study included patients with symptomatic seasonal allergic rhinitis. After a baseline period, TAA AQ or FP was taken for about 21 days.

Relief of cough and nasal symptoms associated with allergic rhinitis by mometasone furoate nasal spray.

Background: Cough commonly occurs as a symptom of seasonal allergic rhinitis (SAR), an inflammatory condition of the nasal mucous membranes that results in rhinorrhea, nasal stuffiness/congestion, nasal itching, and sneezing. Mometasone furoate nasal spray (MFNS, Nasonex, Schering, Kenilworth, NJ), an anti-inflammatory nasal corticosteroid, has been shown to be safe and effective in reducing the nasal inflammation of SAR.

Objective: To examine the effectiveness of MFNS in relieving SAR-associated cough, in addition to nasal symptoms.

Safety of budesonide inhalation suspension (Pulmicort Respules) after up to 52 weeks of treatment in infants and young children with persistent asthma.

Three open-label extension trials evaluated the safety of budesonide inhalation suspension (BIS; Pulmicort Respules) in 670 children (8 months-9 years of age) with mild-to-severe persistent asthma. Patients were randomized to receive either BIS or conventional asthma therapy (CAT) for 52 weeks. The percentage of patients who discontinued because of clinical adverse events was low and similar among the CAT (0.

A risk-benefit assessment of intranasal triamcinolone acetonide in allergic rhinitis.

The efficacy of intranasal triamcinolone acetonide in seasonal and allergic rhinitis has been evaluated in clinical trials and has been compared with antihistamines and other intranasal corticosteroids. Intranasal corticosteroids are either as equally effective as or more effective than comparative drugs. Intranasal corticosteroids are particularly useful as they decrease membrane permeability and inhibit both early and late phase reactions to allergens.

Role of antileukotriene agents in asthma therapy.

Leukotrienes are proinflammatory mediators with special significance in asthma. Released by numerous cell types, particularly after exposure to allergens, leukotrienes cause a potent contraction of bronchial smooth muscle, resulting in reduced airway caliber. Further, they cause plasma to leak from the vessels, resulting in edema, and enhance the secretion of mucus--both events that increase airway obstruction.

The safety and efficacy of nebulized levalbuterol compared with racemic albuterol and placebo in the treatment of asthma in pediatric patients.

Background: Limited dose-response information is available for nebulized beta2 -agonists, especially in young children.

Objective: The purpose of this study was to determine the safety and efficacy of increasing doses of nebulized levalbuterol (Xopenex; the pure R-isomer of racemic albuterol) and racemic albuterol compared with placebo in the treatment of asthma in pediatric patients.

Methods: In this randomized, double-blind, crossover study, children (aged 3 to 11 years) with asthma (resting FEV1 50% to 80% of predicted normal [Polgar's] values) were treated with either levalbuterol, racemic albuterol, or placebo.

Comparison of intranasal triamcinolone acetonide with oral loratadine in the treatment of seasonal ragweed-induced allergic rhinitis.

A double-blind, randomized, multicenter, parallel-group controlled study compared the efficacy and safety of intranasal triamcinolone acetonide (220 micrograms/day) and oral loratadine (10 mg/day) in patients with at least two seasons of ragweed-induced seasonal allergic rhinitis. A 28-day screening period, including a 5-day baseline period, preceded a 4-week treatment period. Reduction in rhinitis symptom scores was evident in both groups as early as day 1, with no significant between-group differences during week 1.

Comparative efficacy and safety of a once-daily loratadine-pseudoephedrine combination versus its components alone and placebo in the management of seasonal allergic rhinitis.

Background: The treatment of symptoms of seasonal allergic rhinitis often requires the use of a decongestant to improve nasal congestion, along with an antihistamine to adequately control other nasal, as well as nonnasal symptoms.

Methods: In this double-blind, placebo-controlled, multicenter study, 874 patients with moderate to severe symptoms of seasonal allergic rhinitis were treated with one of the following: SCH 434 QD (a combination of 10 mg of loratadine in the coating and 240 mg of pseudoephedrine sulfate in an extended-release core) once daily, 10 mg of loratadine once daily, 120 mg of pseudoephedrine sulfate every 12 hours, or placebo for 2 weeks.

Results: SCH 434 QD was consistently superior to placebo in controlling the symptoms of seasonal allergic rhinitis.

Comparison of a new sustained-release theophylline preparation, TheoBeads, with Theo-Dur tablets in children with asthma.

A new, slow-release theophylline formulation for children, TheoBeads, which has the potential for once-daily dosing, has become available. We report the results of a study of pediatric patients whose medication was changed from Theo-Dur tablets b.i.