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Perspective
The Risks and Benefits of Indacaterol — The FDA's Review
In July 2011, the Food and Drug Administration (FDA) approved Arcapta Neohaler (indacaterol maleate powder), a long-acting beta-agonist (LABA), at a dose of 75 μg once daily as a bronchodilator for patients with chronic obstructive pulmonary disease (COPD). Since the European Medicines Agency (EMA)…
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Original Article
Daily or Intermittent Budesonide in Preschool Children with Recurrent Wheezing
Recurrent wheezing episodes in preschool-age children are usually triggered by respiratory tract infections,, which often progress to severe exacerbations requiring systemic glucocorticoids and frequent use of health care services. In children under the age of 5 years who had at least four wheezing…
Review Article
Mechanisms of Disease: Filaggrin Mutations Associated with Skin and Allergic Diseases
Mutations in the filaggrin gene (FLG) are among the most common and profound single-gene defects identified to date in the causation and modification of disease. FLG encodes an important epidermal protein abundantly expressed in the outer layers of the epidermis. Approximately 10% of persons of…
Original Article
Genomewide Association between GLCCI1 and Response to Glucocorticoid Therapy in Asthma
Asthma is a complex genetic syndrome that affects 300 million persons worldwide. The response to treatment is also genetically complex and is characterized by high intraindividual repeatability and high interindividual variability, with up to 40% of patients with asthma having no response to…
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Editorial
A Step toward Personalized Asthma Treatment
Inhaled glucocorticoids are used every day by millions of patients with asthma. As with all asthma-controller treatments, there is marked patient-to-patient variability in the therapeutic response; about one in three patients with asthma who use inhaled glucocorticoids may not benefit from this…
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Editorial
Asthma Phenotypes and Interleukin-13 — Moving Closer to Personalized Medicine
Asthma is a chronic inflammatory disease of the airways manifested by reversible airflow obstruction and airway hyperresponsiveness. One of the challenges of treating patients with asthma is the known heterogeneity of the disease and differential responses to standard treatments.– For example, in…
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Original Article
Lebrikizumab Treatment in Adults with Asthma
Asthma is a complex disease with marked heterogeneity in the clinical course and in the response to treatment.– Variability in the type of airway inflammation may underlie this heterogeneity.– Despite treatment with inhaled glucocorticoids, many patients continue to have uncontrolled asthma…
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- CME
Original Article
Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma
Placebo effects (i.e. benefits resulting from simulated treatment or the experience of receiving care) are reported to improve signs and symptoms of many diseases in clinical trials and in clinical practice. On this basis, the accepted standards for clinical-trial design specify that the effects of…
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- CME
Editorial
Meaningful Placebos — Controlling the Uncontrollable
In this issue of the Journal, Wechsler et al. report data from a study that compared four interventions involving patients with asthma (ClinicalTrials.gov number, NCT01143688). They found that three of the interventions — active albuterol, sham albuterol, and sham acupuncture — were all equally…
Perspective
Assessing the Safety of Adding LABAs to Inhaled Corticosteroids for Treating Asthma
Long-acting beta-agonists (LABAs) — drugs that provide bronchodilation for 12 hours or longer by stimulating the β2-adrenergic receptor — have been associated with serious adverse asthma outcomes such as asthma-related hospitalization, need for intubation, and even death in some patients. In…
Original Article
Effect of Bronchoconstriction on Airway Remodeling in Asthma
Asthma is a common chronic respiratory condition characterized clinically by an excessive tendency toward reversible airway narrowing. This may arise in response to everyday environmental exposure and is worsened both by intercurrent infection and, in sensitized persons, by allergen exposure. In…
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Editorial
Physical Forces and Airway Remodeling in Asthma
Asthma is a disease of the airways characterized by variable airflow obstruction, bronchial hyperresponsiveness, and airway inflammation. Asthma is also accompanied by changes to the structure and composition of the airway walls, collectively termed airway remodeling. Cardinal features of airway…
Perspective
Statistics in Medicine: Pragmatic Trials — Guides to Better Patient Care?
Although randomized clinical trials provide essential, high-quality evidence about the benefits and harms of medical interventions, many such trials have limited relevance to clinical practice. The investigations are often framed in ways that fail to address patients' and clinicians' actual…
Original Article
Leukotriene Antagonists as First-Line or Add-on Asthma-Controller Therapy
Results of double-blind, randomized, controlled trials provide, appropriately, the bedrock of evidence in determining the efficacy of therapeutic interventions. Proof of efficacy in the trial setting of optimized adherence and follow-up for selective patient populations does not, however, guarantee…
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In this pragmatic trial, patients with asthma who required first-line controller therapy or were already using an inhaled glucocorticoid and needed additional therapy received a leukotriene-receptor antagonist (LTRA) or an inhaled glucocorticoid as first-line treatment or an LTRA or a long-acting beta2-agonist as an add-on.
Editorial
Asthma Treatment Guidelines Meet the Real World
Asthma is a common reason for seeking medical care; it is the most frequent medical handicap among children. Because it is so common, most patients with asthma are treated by generalists and family physicians. Guidelines for treating asthma are built on results from randomized, tightly controlled…
Original Article
Randomized Trial of Omalizumab (Anti-IgE) for Asthma in Inner-City Children
Studies of inner-city children, adolescents, and young adults with asthma show that symptom control is improved and exacerbations are decreased when there is either a reduction in household exposure to allergens or aggressive implementation of guidelines-based therapy. Nonetheless, achieving…
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Perspective
Collaborative Clinical Trials
Ongoing improvement in health care requires, among other things, the introduction of new therapies that have been evaluated in clinical trials. Unfortunately, the clinical trial environment is facing a crisis, produced by burgeoning costs, burdensome regulatory requirements, and other factors that…
Editorial
Barnyard Microbes and Childhood Asthma
It is easy to imagine why children who are raised on farms might grow up healthy: there is plenty of fresh air, exercise, and exposure to sunlight. In fact, studies from Europe, North America, and Australasia provide convincing evidence that allergic diseases and asthma are less likely to develop…
Original Article
Exposure to Environmental Microorganisms and Childhood Asthma
Environmental exposure to microorganisms has repeatedly been found to be inversely related to the manifestation of atopic diseases such as asthma and hay fever. This observation has been made in various contexts, including the studies conducted in the Republic of Karelia (Russia) and North Karelia (…
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Editorial
Anticholinergics for Patients with Asthma?
Current guidelines for treating patients with asthma whose symptoms are not controlled by a low dose of an inhaled glucocorticoid alone recommend either doubling the glucocorticoid dose or adding a long-acting beta-agonist (LABA). However, inhaled glucocorticoids have a relatively flat…






