Randomized trial to assess the efficacy and safety of beclomethasone dipropionate breath-actuated inhaler in patients with asthma.

Background: Breath-actuated inhalers (BAI) eliminate the need for the hand-breath coordination required with standard metered-dose inhalers (MDI).

Objective: To evaluate the efficacy and safety of beclomethasone dipropionate (BDP) administered via BAI.

Methods: This 6-week, phase III, double-blind study included patients aged ≥12 years with persistent asthma.

Advancing Alternative Analysis: Integration of Decision Science.

Background: Decision analysis-a systematic approach to solving complex problems-offers tools and frameworks to support decision making that are increasingly being applied to environmental challenges. Alternatives analysis is a method used in regulation and product design to identify, compare, and evaluate the safety and viability of potential substitutes for hazardous chemicals.

Objectives: We assessed whether decision science may assist the alternatives analysis decision maker in comparing alternatives across a range of metrics.

Novel albuterol multidose dry powder inhaler in patients with exercise-induced bronchoconstriction: A single-dose, double-blind, randomized, 2-way crossover study.

Background: A novel, inhalation-driven, multidose dry powder inhaler (MDPI) was developed that eliminates the need to coordinate device actuation with inhalation as is required with conventional metered-dose inhalers.

Objective: To evaluate albuterol MDPI efficacy and safety in patients with exercise-induced bronchoconstriction (EIB).

Methods: This single-dose, double-blind, 2-way crossover study randomized adolescents and adults with EIB (≥20% fall from pre-exercise challenge FEV(1)) to treatment sequences of albuterol MDPI (180 μg [2 inhalations of 90 μg each])/placebo MDPI (n = 19) or the reverse sequence (n = 19).

Recommendations for the pharmacologic management of allergic rhinitis.

Allergic rhinitis (AR) affects at least 60 million people in the United States each year, resulting in a major impact on patient quality of life, productivity, and direct and indirect costs. As new therapies, data, and literature emerge in the management of AR, there is a need to communicate and disseminate important information to health care professionals to advance the practice of medicine and lessen the disease burden from AR. Treatment recommendations for AR have not been updated since the 2012 Food and Drug Administration approval of nonaqueous intranasal aerosol agents using hydrofluoroalkane propellants and the first aqueous intranasal combination product.

The history and progression of treatments for allergic rhinitis.

This article intends to place new treatments in the context of allergic rhinitis (AR) treatment history. The medical literature was searched for significant advances and changes in AR treatment. Historical data on AR treatment options and management were selected.

Exercise-induced bronchospasm, asthma control, and obesity.

Exercise-induced bronchospasm (EIB) commonly affects patients with asthma. However, the relationship between EIB and asthma control remains unclear. Exercise limitation due to asthma might lead to reduced physical activity, but little information is available regarding obesity and EIB in asthma.

The CHOICE survey: high rates of persistent and uncontrolled asthma in the United States.

Background: Surveys have consistently shown that many patients with asthma do not have their disease well controlled.

Objectives: The CHOICE (Comprehensive Survey of Healthcare Professionals and Asthma Patients Offering Insight on Current Treatment Gaps and Emerging Device Options) survey was designed to evaluate the current status of inhalation devices used in asthma treatment, but questions also were included about asthma severity and control.

Methods: A total of 1,000 patients with asthma were interviewed about their use of inhalation devices and asthma-related burden, medication use, and hospital/emergency care.

Exercise-induced bronchospasm: a case study in a nonasthmatic patient.

Purpose: To provide an overview of the clinical presentation, diagnosis, and management of exercise-induced bronchospasm (EIB) without underlying asthma.

Data Sources: Case presentation and review of the EIB Landmark Survey.

Conclusions: EIB is a common and well-described occurrence in patients with asthma, as well as in patients with no overt respiratory condition.

Impact of exercise-related respiratory symptoms in adults with asthma: Exercise-Induced Bronchospasm Landmark National Survey.

An estimated 5-20% of the general population and up to 90% of people with asthma experience exercise-induced bronchospasm (EIB). The EIB Landmark Survey is the first comprehensive study on exercise-related respiratory symptoms in the United States. Two surveys were conducted: the first surveyed adults (≥18 years) in the general public and the second surveyed adults with asthma or taking medications for asthma in the prior year.

Exercise-induced bronchospasm in children with asthma in the United States: results from the Exercise-Induced Bronchospasm Landmark Survey.

Despite the availability of effective therapies, uncontrolled asthma remains a common problem. Previous large surveys suggest that exercise-related respiratory symptoms may be a significant element of uncontrolled asthma. The Exercise-Induced Bronchospasm (EIB) Landmark Survey is the first comprehensive, national survey evaluating EIB awareness and impact among the general public, asthma patients, and health care providers.

Exercise-induced bronchospasm: implications for patients with or without asthma in primary care practice.

Exercise-induced bronchospasm (EIB) can represent a substantial barrier to physical activity. We present the cases of two patients with EIB, one with asthma, and one without asthma, who were evaluated at our primary care practice. The first case was a 44-year-old man with a history of seasonal allergic rhinitis but no asthma, who reported difficulty breathing when playing tennis.

The Childhood Asthma Control Test: retrospective determination and clinical validation of a cut point to identify children with very poorly controlled asthma.

Background: The Childhood Asthma Control Test (C-ACT) has demonstrated validity in classifying children aged 4 to 11 years as having either "well-controlled" or "not well-controlled" asthma. However, new asthma management guidelines distinguish 3 levels of asthma control.

Objective: We sought to determine a second cut point on the C-ACT to identify children with "very poorly controlled" asthma.

Adding montelukast to fluticasone propionate/salmeterol for control of asthma and seasonal allergic rhinitis.

Limited information exists comparing fluticasone propionate/salmeterol combination (FSC) versus montelukast (MON) in patients with coexistent asthma and allergic rhinitis. The purpose of this study was to compare the addition of MON to patients receiving FSC on asthma control while experiencing asthma and allergy symptoms. Additionally, the effect of fluticasone propionate aqueous nasal spray (FPANS) and MON were assessed in allergic rhinitis control.

Deterioration in asthma control when subjects receiving fluticasone propionate/salmeterol 100/50 mcg Diskus are "stepped-down".

In this study, 647 subjects stable on fluticasone propionate/salmeterol Diskus 100/50 mcg BID (FSC) were randomized to continue FSC 100/50 mcg BID or "step down" to either fluticasone propionate (FP) 100 mcg BID, salmeterol (SAL) 50 mcg BID, or montelukast (MON) 10 mg once daily for 16 weeks. Overall asthma control significantly improved in the FSC group; whereas, "stepping down" to FP, SAL, or MON resulted in deterioration in asthma control, as determined by decreased measures of lung function and clinical features. This study provides support that treatment of both inflammation and smooth muscle dysfunction may be necessary to achieve and maintain asthma control in patients uncontrolled on ICS.

Ciclesonide improves health-related quality of life in adults and adolescents with mild-to-moderate persistent asthma.

Health-related quality of life (HRQOL) provides information on patients' everyday physical, emotional, and social difficulties that traditional measurements of asthma severity (pulmonary function assessments and asthma symptom scores) may not reflect. Our objective is to evaluate the effect of ciclesonide (CIC) on HRQOL in a combined analysis of two identical, 12-week, multicenter, double-blind, parallel-group, placebo-controlled trials. Patients (N=1015) with mild-to-moderate asthma (aged >or=12 years; forced expiratory volume in 1 s 60-85% predicted at randomization after administration of single-blind placebo during baseline [5-28 days]) were randomized to receive placebo or CIC 80, 160, or 320 microg (ex-actuator) once daily.

Development and cross-sectional validation of the Childhood Asthma Control Test.

Background: For children younger than 12 years old with asthma, there are several quality-of-life instruments, clinical diaries, and questionnaires assessing symptoms; however, a validated tool for assessing asthma control is currently lacking.

Objective: To develop and validate the Childhood Asthma Control Test (C-ACT), a self-administered tool for identifying children aged 4-11 years whose asthma is inadequately controlled.

Methods: A 21-item questionnaire was administered to 343 patients with asthma and their caregivers, randomly assigning 75% (n = 257) for development and cross-sectional validation of the tool and 25% (n = 86) to a confirmatory sample.

Women with asthma: a review of potential variables and preferred medical management.

Objectives: To summarize the potential variables that contribute to the increased risk of asthma in women, outline therapeutic strategies that address these variables, and review current treatment recommendations for both pregnant and nonpregnant women with asthma.

Data Sources: Literature searches (MEDLINE and cross-references) were performed using the keywords asthma and women in combination with the terms compliance, depression, emergency department, hormones, menstruation, mortality, National Asthma Education and Prevention Program, osteoporosis, pregnancy, prevalence, smoking, and treatment. Searches were limited to human studies with data published before 2005.

Comparative efficacy and safety of low-dose fluticasone propionate and montelukast in children with persistent asthma.

Objective: To evaluate efficacy, safety, health outcomes, and cost-effectiveness of fluticasone propionate (FP) versus montelukast (MON) in 342 children (6 to 12 years of age) with persistent asthma.

Study Design: Randomized, double-blind, 12-week study of treatment with FP inhalation powder 50 mug twice daily or MON chewable 5 mg once daily for 12 weeks.

Results: Compared with MON, FP significantly increased mean percent change from baseline FEV1 (forced expiratory volume in 1 second) (P=.

Tolerability of short-term, high-dose formoterol in healthy volunteers and patients with asthma.

Background: Formoterol is a long-acting (>or=12 hours) beta(2)-receptor agonist with a rapid onset of action (1-3 minutes). It is approved in the United States, delivered via a single-dose dry-powder inhaler (DPI), for use in combination with anti-inflammatory therapy for the maintenance treatment of asthma and for the prevention of exercise-induced bronchospasm. Potential exposure of patients to higher doses than are currently approved is an important consideration in assessing the safety profile of formoterol.