Respiratory care
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Corticosteroids have numerous applications in treating inflammation and diseases of immune function based on their significant anti-inflammatory and immunosuppressive effects. Corticosteroids modulate immune function through various effects in the nucleus of numerous cells. When used in pharmacologic doses to suppress allergic responses or inflammation, these agents can cause numerous adverse effects associated with an excess of glucocorticoid activity. ⋯ Inhaled corticosteroids are potent synthetic agents that exert their actions locally in the airways but can cause systemic effects based on several factors that influence systemic bioavailability. Inhaled corticosteroids are the cornerstone of asthma therapy and important options for COPD in patients who experience frequent exacerbations. By the nasal route, they are the most effective therapy for treating moderate-to-severe allergic rhinitis.
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Drug delivery by inhalation is the principal strategy to treat obstructive lung diseases, which affect about 15% of the population in the United States. Aerosol delivery devices have evolved over more than 60 years from the basic pressurized metered-dose inhaler and nebulizer to numerous types of inhalers and devices, including valved holder chambers, dry powder inhalers, soft mist inhalers, as well as smart inhalers and nebulizers. ⋯ Aerosol science is evolving, with methods of measurement that include radio-scintigraphy and magnetic resonance imaging, to provide a better understanding of aerosol delivery and effects. Understanding the science and clinical application of aerosol drug delivery can substantially aid clinicians in optimizing these therapies for their patients.
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This review addresses drug development intended to support United States clearance for asthma and COPD by explaining basic regulatory terms and broadly discussing the regulatory pathways to clearance. Some of the key clinical regulatory challenges that are faced by drugs for asthma and COPD are explained and clarified, both overall and by class of drug, citing relevant examples that emphasize key lessons. Generic drug development of inhaled drugs is also addressed. The purpose of this review is to provide the reader with a greater understanding and appreciation of asthma and COPD drug development from the regulatory perspective.
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Guideline-based management of asthma was developed as a means of standardizing asthma therapies and of improving outcomes. The National Asthma Education and Prevention Program and the Global Initiative for Asthma guidelines provide recommendations to care providers about the routine management of asthma. ⋯ We are increasingly recognizing that asthma is a heterogenous disease with a diverse underlying pathophysiology, and therefore, it is imperative for care providers to begin to understand asthma phenotypes and endotypes, and the implications of these classifications on management, especially of severe refractory asthma. This article serves as a review of guideline-based therapy for asthma and includes updates on alternative therapies, new approaches that use previously recognized therapies, and special populations with asthma.
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Asthma exacerbation is defined as a progressive increase in symptoms of shortness of breath, cough, or wheezing sufficient to require a change in therapy. After ruling out diagnoses that mimic an asthma exacerbation, therapy should be initiated. Short-acting β2 agonists and short-acting muscarinic antagonists are effective as bronchodilators for asthma in the acute setting. ⋯ The evidence favors the use of intravenous magnesium sulfate in selected cases, particularly in severe exacerbations. Methylxanthines have a minimum role as therapy for asthma exacerbations but may be considered in refractory cases of status asthmaticus with careful monitoring of toxicity. Current guidelines recommend the use of helium-oxygen mixtures in patients who do not respond to standard therapies or those with severe disease.