Publications by authors named "Lyndon E Mansfield"

Article Synopsis
  • The ARC004 study explored the long-term effects and various dosing regimens of daily oral immunotherapy with Peanut allergen powder (PTAH) in peanut-allergic children and adolescents, following positive results from the PALISADE trial.
  • A total of 358 participants, both those who had continued from the PALISADE trial and new participants, underwent different daily or non-daily dosing strategies, with safety and efficacy being assessed.
  • Results indicated that daily dosing led to higher desensitization rates with sustained safety, and the immune response continued to show signs of improvement in participants over the course of the study.
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Approximately 80% of patients with asthma and chronic obstructive pulmonary disease incorrectly use a metered-dose inhaler and, therefore, fail to obtain full benefit from their inhaler medication. Beclomethasone dipropionate (BDP) hydrofluoroalkane, an inhalation aerosol administered a breath-actuated inhaler (BAI) has been designed to improve ease of use over press-and-breathe metered-dose inhalers by eliminating the need for hand-breath coordination. To present the mechanics of the BAI device, assess the minimum reliable inspiratory flow rate required to trigger an actuation, and evaluate if intended users can safely and effectively use the BDP BAI according to the instructions for use (IFU).

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Background: Peanut allergy, for which there are no approved treatment options, affects patients who are at risk for unpredictable and occasionally life-threatening allergic reactions.

Methods: In a phase 3 trial, we screened participants 4 to 55 years of age with peanut allergy for allergic dose-limiting symptoms at a challenge dose of 100 mg or less of peanut protein (approximately one third of a peanut kernel) in a double-blind, placebo-controlled food challenge. Participants with an allergic response were randomly assigned, in a 3:1 ratio, to receive AR101 (a peanut-derived investigational biologic oral immunotherapy drug) or placebo in an escalating-dose program.

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Introduction: Allergic rhinitis (AR) is a common chronic disorder, affecting 10 -30% of populations. AR has significant morbidity and expense. AR patients treat themselves with over-the-counter medications.

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Background: Peanut allergy creates the risk of life-threatening anaphylaxis that can disrupt psychosocial development and family life. The avoidance management strategy often fails to prevent anaphylaxis and may contribute to social dysfunction. Peanut oral immunotherapy may address these problems, but there are safety concerns regarding implementation in clinical practice.

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Background: Aerosolized intranasal corticosteroid formulations are desirable for many patients with allergic rhinitis (AR), especially children, who wish to avoid the "wet feeling" and "drip down the throat" associated with aqueous formulations. Beclomethasone dipropionate (BDP) hydrofluoroalkane nasal aerosol has been shown to be safe and effective in adolescents and adults with AR.

Objective: To evaluate the efficacy and safety of BDP nasal aerosol in pediatric patients with moderate to severe seasonal AR.

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Oral immunotherapy (OIT) for peanut allergy is ready for clinical allergy practice. Some physicians, particularly at academic centers, believe that OIT is not ready for clinical practice. The shortcomings of the present general recommendations of food avoidance and provision of epinephrine autoinjectors for a select number of patients demand a different approach.

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Background: The inhaled corticosteroid, fluticasone propionate, and the long-acting β(2)-adrenergic agonist, formoterol fumarate, are both highly effective treatments for bronchial asthma. This study (NCT00393952/EudraCT number: 2006-005989-39) compared the efficacy and safety of fluticasone/formoterol combination therapy (flutiform(®); 250/10 μg) administered twice daily (b.i.

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Objective: Spacers and valved holding chambers (VHCs) were developed to facilitate using pressurized metered dose inhaler (pMDI) by patients who could not coordinate the actions required for successful pMDI use. There is little in vivo evidence about how VHC may affect the bronchodilation from combination drugs in pMDI. This study was to determine the effect, if any, of VHC on the bronchodilating actions of the pMDI budesonide/formoterol combination.

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Background: Few clinical trials in asthma have focused on Hispanic populations.

Objective: To compare the efficacy and safety of budesonide/formoterol (BUD/FM) with BUD in an ethnically diverse group of Hispanic participants with asthma previously treated with inhaled corticosteroids (ICS).

Methods: This 12-week, randomized, double-blind, active-controlled study (NCT00419757) was designed to enroll Hispanic participants (self-reported) (≥12 years of age) with moderate to severe asthma requiring medium- to high-dose ICS.

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Objective: To evaluate the efficacy of levocetirizine 5 mg once daily in reducing seasonal allergic rhinitis (SAR) symptoms in US adults.

Research Design And Methods: This multicenter, randomized, double-blind, placebo-controlled, parallel-group study enrolled adults aged 18 to 65 years with SAR symptoms in the spring in the US. After a single-blind placebo run-in period, subjects received levocetirizine 5 mg or placebo once daily over 14 days.

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The combination of long-acting beta-agonist (LABA) bronchodilators with inhaled corticosteroids (ICSs) has been shown to be an extremely effective treatment for asthma. Use of LABA as monotherapy for asthma is associated with increased adverse events including exacerbations and asthma deaths. However, intensive evaluation of the combined LABA-ICS therapy provided no signals of increased risk.

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Allergic rhinitis is a common chronic condition in children. Oral antihistamines are a first-line treatment option in allergic rhinitis and different formulations are available to aid administration to children. The tablet formulation of the second-generation antihistamine fexofenadine has established efficacy and safety in both adults and children.

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Patients with symptomatic allergic rhinitis often complain of daytime drowsiness and impairment in their speed of thinking responses. In this study, we compared subjects with allergic rhinitis treated with intranasal fluticasone propionate or placebo. We measured nasal symptoms, daytime sleepiness, and cognitive performance.

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Allergic rhinitis symptoms, in particular nasal congestion, can have a significant impact on patient quality of life, resulting in reduced productivity and daytime sleepiness. Newer-generation antihistamines are commonly used to treat allergic rhinitis; however, in patients with severe congestion, a combination of a newer-generation antihistamine and a decongestant is particularly beneficial. A new once-daily fexofenadine/pseudoephedrine combination has been developed and recently approved in the US.

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Background: Nasal obstruction is recognized as an important cause of sleep disordered breathing. Congestion of the nasal mucosa and obstruction are common symptoms of allergic rhinitis. Daytime sleepiness is a common finding in symptomatic allergic rhinitis.

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Background: Antihistamines relieve most seasonal allergic rhinitis (SAR) symptoms, with the exception of nasal congestion, which is often the most troublesome symptom for patients. A nonsedating antihistamine that significantly decreases nasal congestion and improves symptoms of seasonal allergic asthma would be a significant advance in therapy.

Objectives: To evaluate the safety and efficacy of desloratadine 5 mg in patients experiencing moderate SAR, nasal congestion, and symptoms of seasonal allergic asthma.

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Background: A 12-month controlled pediatric study of intranasal beclomethasone dipropionate (BDP) reported a 0.9 cm decrease in annual height growth velocity. Since children with allergic rhinitis may be treated for years, this report evaluates long-term height growth effects.

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