Respiratory care
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Historical treatments for asthma and COPD have primarily focused on addressing the underlying inflammation and bronchoconstriction that result in air flow obstruction symptoms, including shortness of breath, cough, chest tightness, and mucus production. However, in the past several years, new research into the underlying pathophysiology of asthma and COPD has led to novel targeted therapies that address the underlying pathways that cause these obstructive disorders. ⋯ Targets for asthma and COPD include immunoglobulin E, interleukin 5, interleukin 4/interleukin 13, thymic stromal lymphopoietin, interleukin 17, tyrosine kinases, and others. The new biologics are generally safe and well tolerated, and are bringing promise and hope of personalized therapy to patients with severe asthma.
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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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Obstructive lung diseases, including asthma and COPD, are characterized by air-flow limitation. Bronchodilator therapy can often decrease symptoms of air-flow obstruction by relaxing airway smooth muscle (bronchodilation), decreasing dyspnea, and improving quality of life. In this review, we discuss the pharmacology of the β agonist and anticholinergic bronchodilators and their use, particularly in asthma and COPD. Expanding knowledge of receptor subtypes and G-protein signaling, agonist and antagonist specificity, and drug delivery have led to the introduction of safer medications with fewer off-target effects, medications with longer duration of action that may improve adherence, and more effective and efficient aerosol delivery devices.
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Long-term oxygen therapy (LTOT) at home has been demonstrated to improve survival in patients with COPD and severe resting hypoxemia. Support for LTOT is based on 2 landmark trials published nearly 4 decades ago. These results form the basis for reimbursement and prescription of LTOT to this day. ⋯ New technology for automated control of LTOT shows promise but is hampered by regulatory processes and cost pressures. Recent changes in government reimbursement for home oxygen therapy also present challenges. This paper will review the current evidence regarding LTOT in COPD and the impact on mortality and functional outcomes as well as reviewing technological challenges.
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Alpha-1 antitrypsin deficiency is a genetic disease that first highlighted the importance of protease balance in normal lung homeostasis. Proteases such as neutrophil elastase are important in many pulmonary diseases. However, the first commercially licensed anti-protease therapy was used for emphysema in alpha-1 antitrypsin deficiency. ⋯ Because neutrophilic inflammation is the hallmark of usual COPD, anti-protease therapy also has been explored in this disease. Further trials with different dosing schema, inhaled therapy, and in different disease states are all ongoing. These studies would be facilitated by having COPD outcomes that are independent of measurement of air flow and achievable in smaller populations over a short period of time.