Abstract

Both asthma and chronic obstructive pulmonary disease (COPD) are inflammatory chronic respiratory conditions with high rates of morbidity and mortality worldwide. The objectives of this review are to briefly describe the pathophysiology and epidemiology of asthma and COPD, discuss guideline recommendations for uncontrolled disease, and review a new generic option for the treatment of asthma and COPD. Although mild forms of these diseases may be controlled with as-needed pharmacotherapy, uncontrolled or persistent asthma and moderate or severe COPD uncontrolled by bronchodilators with elevated eosinophilia or frequent exacerbations may require intervention with combination therapy with inhaled corticosteroids (ICS) and long-acting beta agonists (LABAs), according to international guidelines. Fixed-dose combinations of ICS/LABA are commonly prescribed for both conditions, with fluticasone propionate (FP) and salmeterol forming a cornerstone of many treatment plans. An oral inhalation powder containing the combination of FP and salmeterol has been available as Advair Diskus® in the United States for almost 20 years, and the first and only substitutable generic version of this product has recently been approved for use: Wixela™ Inhub™. Bioequivalence of Wixela Inhub and Advair Diskus has been established. Furthermore, the Inhub inhaler was shown to be robust and easy to use, suggesting that Wixela Inhub may provide an alternative option to Advair Diskus for patients with asthma or COPD requiring intervention with an ICS/LABA.

Highlights

  • One of the leading causes of morbidity and mortality worldwide is chronic respiratory disease, of which chronic obstructive pulmonary disease (COPD) and asthma are 2 of the most common [1]

  • According to the 2020 Global Initiative for Chronic Obstructive Lung Disease report, COPD is a chronic, preventable condition characterized by “persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gas” [2]

  • The geometric mean ratio and associated upper and lower 90% confidence intervals (CIs) were within the permissible range of 0.80 to 1.25. These results provided evidence that Wixela Inhub and Advair Diskus had local pulmonary therapeutic equivalence of fluticasone propionate (FP)-salmeterol components after inhalation [36]

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Summary

Introduction

One of the leading causes of morbidity and mortality worldwide is chronic respiratory disease, of which chronic obstructive pulmonary disease (COPD) and asthma are 2 of the most common [1]. According to the 2020 Global Initiative for Chronic Obstructive Lung Disease report, COPD is a chronic, preventable condition characterized by “persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gas” [2]. Sputum production, wheezing, and chest tightness In severe cases: fatigue, weight loss, exercise intolerance, and anorexia Airway narrowing caused by chronic inflammation as a response to cigarette smoke or noxious environmental stimuli, parenchymal tissue destruction, and small airway fibrosis; high prevalence of comorbidities. The objective of the present review is to describe unmet clinical needs in asthma and COPD, discuss asthma and COPD guidelines, and review a new generic combination treatment option for these complex conditions, with a focus on clinical aspects of importance to PCPs

Asthma and COPD Pathophysiology
Unmet Clinical Needs in Asthma and COPD
Standards of Care in Asthma and COPD
FP-Salmeterol Combination in Asthma and COPD
Generic FP-Salmeterol Comparison with Branded FP-Salmeterol Combination
Conclusions
Findings
Conflicts of Interest
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