The Asthma Controller Step-down Yardstick.

Asthma guidelines recommend a control-based approach to disease management in which the assessment of impairment and risk is linked to step-based therapy. Using this model, controller treatment is adjusted-upward or downward-according to a patient's level of asthma control over time. Strategies for stepping up controller therapy are well described, and the adult and pediatric Asthma Yardsticks provide operational recommendations based on patient profiles. Strategies for stepping down controller treatment are less clear, although stepping down to the minimum effective therapy is important and should be considered when a patient's asthma has been well controlled for an adequate period as defined by risk and impairment. This Yardstick presents recommendations for when and how to step down asthma controller therapy according to guideline-defined control levels. The objective is to provide clinicians who treat patients with asthma with a practical and clinically relevant framework for implementing a step-down in controller therapy.

The pediatric asthma yardstick: Practical recommendations for a sustained step-up in asthma therapy for children with inadequately controlled asthma.

Current asthma guidelines recommend a control-based approach to management involving assessment of impairment and risk followed by implementation of treatment strategies individualized according to the patient's needs and preferences. However, for children with asthma, achieving control can be elusive. Although tools are available to help children (and families) track and manage day-to-day symptoms, when and how to implement a longer-term step-up in care is less clear. Furthermore, treatment is challenged by the 3 age groups of childhood-adolescence (12-18 years old), school age (6-11 years old), and young children (≤5 years old)-and what works for 1 age group might not be the best approach for another. The Pediatric Asthma Yardstick provides an in-depth assessment of when and how to step-up therapy for the child with not well or poorly controlled asthma. Development of this tool follows others in the Yardstick series, presenting patient profiles and step-up strategies based on current guidance documents, but modified according to newer data and the authors' combined clinical experience. The objective is to provide clinicians who treat children with asthma practical and clinically relevant recommendations for each step-up and each intervention, with the intent of helping practitioners better treat their pediatric patients with asthma, particularly those who do not always respond to recommended therapies.

Asthma Yardstick: Practical recommendations for a sustained step-up in asthma therapy for poorly controlled asthma.

Current asthma guidelines recommend a control-based approach to management that involves assessment of impairment and risk followed by implementation of treatment strategies individualized according to the patient's needs and preferences. The fact that many patients still experience severe symptoms that negatively affect quality of life suggests that asthma control remains an objective to be achieved. Tools are available to help patients (and families) manage the day-to-day and short-term variability in asthma symptoms; however, when and how to implement a sustained step-up in therapy is less clear. The Asthma Yardstick is a comprehensive update on how to conduct a sustained step-up in asthma therapy for the patient with not well-controlled or poorly controlled asthma. Patient profiles and step-up strategies are based on current guidelines, newer data, and the authors' combined clinical experience and are intended to provide a practical and clinically meaningful guide toward the goal of well-controlled asthma for every patient. The development of this tool comes in response to the continued need to proactively address the sustained loss of asthma control at all levels of severity.

Omalizumab and asthma control in patients with moderate-to-severe allergic asthma: a 6-year pragmatic data review.

Controlled clinical trials have shown the recombinant humanized monoclonal anti-IgE antibody omalizumab to improve asthma control and reduce symptom exacerbations in patients with moderate-to-severe allergic asthma who remain clinically unstable despite optimal medical therapy. An objective retrospective review compared clinical experience with the data reported in the controlled studies. Data tracking for 167 patients progressively enrolled between 2003 and 2010 treated with omalizumab included symptoms, forced expiratory volume at 1 second (FEV(1)), systemic steroid bursts, and need for short-acting bronchodilator rescue measured at the start of therapy; 3, 6, and 12 months after starting treatment, and yearly thereafter. Exacerbations were compared for the 12 months before and the 12 months after starting treatment in a subgroup of patients. Asthma control improved with omalizumab over time (up to 6 years) as indicated by fewer symptoms and less need for rescue medication (p < 0.001 for both). FEV(1) remained stable. The number of patients reporting asthma exacerbations requiring urgent care decreased by 49% during the first 12 months of treatment (p ≤ 0.01), and significant reductions in exacerbations were also evident when measured by hospitalizations or systemic corticosteroid bursts (p < 0.001 for both). This is the first long-term pragmatic review of omalizumab. Our clinical experience (up to 6 years in some patients) supports the results of earlier controlled studies, confirming the usefulness of adding omalizumab to the long-term management of patients with difficult-to-treat disease who suffer from persistent symptoms despite optimal therapy with medications.

Is there a role for aerosol nasal sprays in the treatment of allergic rhinitis: a white paper.

This White Paper presents the Consensus Statements derived from a Special Issues Board (SIB) held in Chicago, IL, in October 2010. The SIB was convened to address the question of whether there is a need for both aerosol and aqueous intranasal steroids (INSs) in the treatment of allergic rhinitis (AR). The faculty reviewed the published record of efficacy and safety of aerosol and aqueous INSs, as well as patient and physician satisfaction and preferences for currently available INSs, and burden of disease. Agreement on unmet needs also included the practice experience of the faculty and their colleagues. The body of evidence indicates that INSs are equally effective and well tolerated for most patients. However, differences exist among current aqueous formulations as well as between these products and their aerosol antecedents, based on the properties of the nasal spray. Aerosol formulations, although no longer available, may be preferred for some patients with specific pathophysiology and may be preferred by some patients based on sensory perception. There are good reasons to expand the currently available options of INSs by having both aerosol and aqueous formulations.

Comprehensive review of olopatadine: the molecule and its clinical entities.

Olopatadine is a tricyclic compound with antihistaminic, mast cell-stabilizing, and anti-inflammatory properties. In the United States olopatadine is approved as a b.i.d. ophthalmic solution, Patanol (Alcon Laboratories, Inc., Fort Worth, TX) to treat all signs and symptoms of allergic conjunctivitis and as a q.d. formulation, Pataday (Alcon Laboratories, Inc.), to treat itching associated with allergic conjunctivitis. A nasal spray, Patanase (Alcon Laboratories, Inc.), was approved in 2008 for treatment of the symptoms of seasonal allergic rhinitis. The available data on olopatadine was assessed with regard to future uses through a comprehensive literature review and a Roundtable Discussion held at the 2009 meeting of the American Academy of Allergy Asthma and Immunology. The unique mechanisms of action of olopatadine still under study include mast cell stabilization, potent H(1)-anthistaminic activity, and anti-inflammatory effects. Data support consideration of nasal olopatadine for as-needed use for episodic symptoms of allergic rhinitis, for treatment of nonallergic rhinitis, and for use in combination with topical steroids for patients with moderate-to-severe allergy symptoms.

Guaifenesin in rhinitis.

Mucus in the airways is a complex mixture of water, lipids, glycoproteins, sugars, and electrolytes that serves as a lubricant for the epithelium. The efficient flow of respiratory mucus is a first level of immune defense that requires an appropriate viscosity and elasticity for optimal barrier and ciliary functions. Thickening and drying of airway mucus by respiratory tract infections, allergies, and drugs can impair evacuation. Tenacious, bothersome mucus is an annoying and frequent symptom of rhinitis that is difficult to manage. Common remedies include adequate hydration through fluid intake and nasal washes. The use of mucoactive agents is controversial due to limited data and equivocal efficacy in available studies. Nonetheless, some patients benefit. This review examines the use of guaifenesin (glyceryl guaiacolate) on bothersome nasal mucus associated with rhinitis, including the available published data and clinical experience.

Bacterial interference in upper respiratory tract infections: a systematic review.

BACKGROUND: Published definitions of bacterial interference (BI) differ, some focusing on changes in the normal flora and others on changes in subsequent infection. A need for consensus was identified at a roundtable discussion of BI in upper respiratory tract infections (URTI). We conducted a systematic review of the available data to justify a consensus definition of BI specific to URTI as "a dynamic, antagonistic interaction between at least 2 organisms that affects the life cycle of each, changes the microenvironment, and alters the organisms' colonization, invasiveness, and ability to affect the health of the host." METHODS: Continued communication among the faculty postroundtable was used to identify and refine the search criteria to (1) in vitro and in vivo studies assessing bacterial URTI, (2) BI evaluated by response to treatment of URTI with antimicrobial agents, and (3) bacterial function in relation to interactions between normal (nonpathogenic) and pathological flora. The criteria were applied to systematic searches of MEDLINE (1950 onward), EMBASE (1974 onward), and the Cochrane Library (2007). RESULTS: Twenty-nine studies met the inclusion criteria, most focused on children with recurrent infections. Qualitative analysis supports the consensus definition. Interfering organisms affected the life cycle of test pathogens and inhibited their colonization, invasiveness, and health outcomes. Data were insufficient for statistical analysis. CONCLUSION: Interactions between interfering organisms and potential pathogens isolated from the same host can alter response to infection and treatment. More studies are needed, particularly in adults, to understand the role of interfering organisms, the influence of antibiotics, and the potential for recolonization posttreatment.

Section 4. What the guidelines have missed: a general discussion of the faculty: highlights of the asthma summit 2009: beyond the guidelines.

The sessions during the 2 days of the Asthma Summit focused largely on some specific aspects of the current European and U.S. guidelines for managing asthma. By way of summary, the faculty addressed the question of what they thought the guidelines missed, starting with consideration of those aspects of their own practice management that they believed are not clearly discussed in current guidelines.

Evaluating approved medications to treat allergic rhinitis in the United States: an evidence-based review of efficacy for nasal symptoms by class.

OBJECTIVE: To evaluate how well the medications currently approved in the United States for allergic rhinitis (AR) treat nasal symptoms when examined according to Food and Drug Administration-indicated uses and dosages. DATA SOURCES: MEDLINE (1966 onward), EMBASE (1974 onward), and the Cochrane Library (2007) were systematically searched according to the following criteria defined at a roundtable meeting of the authors: randomized controlled trial, at least a 2-week duration, and approved indication and dosage in the United States. STUDY SELECTION: Data from studies that met the inclusion criteria were extracted into evidence tables, which were reviewed twice by the full panel of authors. Individual panel members also were asked to comment on abstracts, articles, and summary tables based on their known expertise. The entire faculty approved the selection of studies included in this review. RESULTS: Fifty-four randomized, placebo-controlled studies involving more than 14,000 adults and 1,580 children with AR met the criteria for review: 38 studies of seasonal allergic rhinitis (SAR; n = 11,980 adults and 946 children) and 12 studies of perennial allergic rhinitis (PAR; n = 3,800 adults and 366 children). The median percentage changes from baseline for total nasal symptom score for SAR were as follows: nasal antihistamines, -22.2%; oral antihistamines, -23.5%; intranasal steroids (INSs), -40.7%; and placebo, -15.0%. For PAR, the changes were as follows: oral antihistamines, -51.4%; INSs, -37.3%; and placebo, -24.8%. Data for mediator antagonists were limited. CONCLUSIONS: The data, although limited, confirm that INSs produce the greatest improvements in nasal symptoms in patients with SAR. In addition, INSs are effective for PAR, but the data were of variable quality, and oral antihistamines may be equally effective for some patients. The reporting of published data should be standardized to permit better comparisons in future studies.

Consensus Review and Definition of Nonallergic Rhinitis With a Focus on Vasomotor Rhinitis, Proposed to Be Known henceforth as Nonallergic Rhinopathy: Introduction to Part 2.

"Nonallergic vasomotor rhinitis" (also referred to as nonallergic rhinitis and/or idiopathic rhinitis) is a term that has been used to describe a common nasal condition of unclear pathophysiology. Clinical options for patients are limited by a lack of straight-forward diagnostic criteria and poorly defined and heterogeneous populations in clinical trials. A roundtable conference convened in December 2008 addressed these challenges. Part 1 of the proceedings of that meeting provided a consensus definition of "nonallergic rhinopathy," proposed to replace the former terms above based on the clinical characteristics of the disease, which were described in individual papers. Part 2 of the proceedings uses the revised definition for a consensus discussion on appropriate criteria for enrolling subjects in future clinical studies of the efficacy of potential treatments for this disease.

Consensus Review and Definition of Nonallergic Rhinitis With a Focus on Vasomotor Rhinitis, Proposed to be Known henceforth as Nonallergic Rhinopathy Part 1. Introduction.

"Nonallergic vasomotor rhinitis" (also referred to as nonallergic rhinitis and/or idiopathic rhinitis) is a term that has been used to describe a common nasal condition of unclear pathophysiology. Clinical options for patients are limited by a lack of straightforward diagnostic criteria and poorly defined and heterogeneous populations in clinical trials. A roundtable conference convened in December 2008 addressed these challenges. The outcomes were (1) a revised clinical definition and (2) appropriate inclusion and exclusion criteria (based on the revised definition) to be used for the enrollment of subjects in future clinical studies.

Consensus Definition of Nonallergic Rhinopathy, Previously Referred to as Vasomotor Rhinitis, Nonallergic Rhinitis, and/or Idiopathic Rhinitis.

"Nonallergic vasomotor rhinitis" (also referred to as nonallergic rhinitis and/or idiopathic rhinitis) is a term that has been used to describe a common nasal condition of unclear pathophysiology. The lack of straightforward diagnostic criteria is limiting; research for better treatment options requires the definition of homogeneous populations characterized by well-defined inclusion and exclusion criteria. Following considerable discussion and counterpoints at a roundtable conference convened in December 2008, we proposed to change the terminology to reference this condition as "nonallergic rhinopathy." Nonallergic rhinopathy is a chronic nasal condition with symptoms that may be perennial, persistent, intermittent, or seasonal and/or elicited by recognized triggers. There is a well-recognized set of clinical exposures that lead to the symptoms, predominantly congestion and rhinorrhea. The clinical characteristics as outlined provide well-defined inclusion and exclusion criteria that should permit precise identification of patients for participation in clinical trials.

Consensus Description of Inclusion and Exclusion Criteria for Clinical Studies of Nonallergic Rhinopathy (NAR), Previously Referred to as Vasomotor Rhinitis (VMR), Nonallergic Rhinitis, and/or Idiopathic Rhinitis.

"Nonallergic rhinopathy" was defined by consensus at a Roundtable conference in December 2008 as "a chronic nasal condition with symptoms that may be perennial, persistent, intermittent or seasonal and/or elicited by recognized triggers." The definition includes a well-recognized set of clinical exposures that lead to the symptoms, predominantly congestion, rhinorrhea, and postnasal drip. These clinical characteristics help to identify patients for participation in clinical trials examining the efficacy of treatments for this important disease. The next step is to establish inclusion and exclusion criteria that will provide a framework for the clinical trials. Agreement on study criteria was obtained at the consensus conference by discussion, counterpoint, and compromise.