Real-World Study of Single-Inhaler Triple Therapy with Fluticasone Furoate/Umeclidinium/Vilanterol on Asthma Control in the US.

Purpose: Real-world asthma control data among patients initiating fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) are limited. This study assessed rescue medication use and asthma-related exacerbations in patients with asthma before and after initiating single-inhaler FF/UMEC/VI using administrative claims data. Patients and Methods: This retrospective, pre-post cohort study analyzed data from the IQVIA PharMetrics Plus database (September 18, 2016‒March 31, 2020). Patients aged ≥18 years that had ≥1 dispensing of single-inhaler FF/UMEC/VI 100/62.5/25 mcg (first dispensing = index date), ≥12 months of continuous health insurance enrollment prior to (pre-treatment) and following (post-treatment) FF/UMEC/VI initiation and ≥1 diagnosis of asthma during the pre-treatment period or on the index date were included. The primary endpoint was the number of oral corticosteroid (OCS) dispensings per patient per year during pre- and post-treatment periods. Secondary endpoints included asthma-related exacerbation rates and short-acting ß2-agonist (SABA) use. Comparisons between pre- and post-treatment periods were made using risk and rate ratios. Results: Overall, 890 patients with asthma initiating treatment with FF/UMEC/VI were included. The most recently dispensed controller medications prior to FF/UMEC/VI initiation were inhaled corticosteroids/long-acting ß2-agonists (33.5%) and leukotriene modifiers (33.0%). Patients had a 29% reduction in the number of OCS dispensings (rate ratio [95% confidence interval (CI)]: 0.71 [0.65, 0.77], P < 0.001) during post-treatment versus pre-treatment, with a 23% reduction in the proportion of patients with ≥1 OCS dispensing post-treatment (risk ratio [95% CI]: 0.77 [0.73, 0.82], P < 0.001). Significant reductions in rates (rate ratio [95% CI]) of asthma-related exacerbations (0.59 [0.52, 0.67], P < 0.001) and SABA use (0.80 [0.74, 0.86], P < 0.001) were also observed. Conclusion: In this real-world study, patients with asthma had significantly lower OCS use, asthma-related exacerbations, and SABA use following treatment initiation with FF/UMEC/VI compared with their pre-treatment period. These results suggest better asthma control following initiation of FF/UMEC/VI in a routine clinical practice setting.

Optimizing asthma management: Role of long-acting muscarinic antagonists.

Patients with asthma who are suboptimally responsive to inhaled corticosteroids (ICS) and long-acting ß2-agonists (LABAs) are frequently exposed to oral corticosteroids and high-dose ICS, which can lead to significant side effects. Long-acting muscarinic antagonists (LAMAs) have demonstrated efficacy and safety in a subset of these patients. This review summarizes the results of key studies using LAMAs in patients with asthma aged 12 years or older. LAMA as an add-on treatment improved lung function and asthma control in patients with uncontrolled asthma across studies. The efficacy of LAMAs as an add-on to ICS was superior to that of placebo and ICS dose escalation and comparable with that of LABAs. LAMA plus ICS plus LABA provided modest improvements in bronchodilation and increased the time to first severe exacerbation versus ICS plus LABA. Single-inhaler triple therapy was associated with decreased health care resource utilization and improved cost-effectiveness versus multiple inhalers. LAMAs were generally well tolerated; asthma exacerbations, bronchitis, and nasopharyngitis were common adverse events with LAMA in combination with ICS alone or ICS plus LABA. Thus, the overall evidence presented in this review supports the use of add-on LAMA treatment as a reasonable option in patients with asthma uncontrolled with ICS plus LABA or ICS alone.

The Use of Inhaled Corticosteroids for Patients with COPD Who Continue to Smoke Cigarettes: An Evaluation of Current Practice.

The use of inhaled corticosteroids (ICS) in combination with inhaled bronchodilators for patients with chronic obstructive pulmonary disease (COPD) is a common practice in primary care settings. However, ICS-containing therapies may be less effective in patients with COPD compared with asthma, and in individuals with COPD who continue to smoke cigarettes. Preclinical studies suggest that inflammation in COPD is very different from in asthma. Glucocorticoid receptor functioning and other innate anti-inflammatory mechanisms are altered in cells exposed to cigarette smoke. COPD may be relatively insensitive to ICS, especially in individuals who continue to smoke. ICS-containing therapies in patients with asthma who continue to smoke may also be less effective compared with patients who do not smoke. ICS-containing therapies may be inappropriately used in some patients with COPD, and their long-term use is associated with an increased risk for side effects, including pneumonia and bone fractures in some patients. Treatment for patients with COPD should be carefully evaluated, and anti-inflammatory/bronchodilatory strategies should be chosen based on individual patient characteristics and recommendations in current guidelines.

Diagnosis and management of work-related asthma: American College Of Chest Physicians Consensus Statement.

BACKGROUND: A previous American College of Chest Physicians Consensus Statement on asthma in the workplace was published in 1995. The current Consensus Statement updates the previous one based on additional research that has been published since then, including findings relevant to preventive measures and work-exacerbated asthma (WEA). METHODS: A panel of experts, including allergists, pulmonologists, and occupational medicine physicians, was convened to develop this Consensus Document on the diagnosis and management of work-related asthma (WRA), based in part on a systematic review, that was performed by the University of Alberta/Capital Health Evidence-Based Practice and was supplemented by additional published studies to 2007. RESULTS: The Consensus Document defined WRA to include occupational asthma (ie, asthma induced by sensitizer or irritant work exposures) and WEA (ie, preexisting or concurrent asthma worsened by work factors). The Consensus Document focuses on the diagnosis and management of WRA (including diagnostic tests, and work and compensation issues), as well as preventive measures. WRA should be considered in all individuals with new-onset or worsening asthma, and a careful occupational history should be obtained. Diagnostic tests such as serial peak flow recordings, methacholine challenge tests, immunologic tests, and specific inhalation challenge tests (if available), can increase diagnostic certainty. Since the prognosis is better with early diagnosis and appropriate intervention, effective preventive measures for other workers with exposure should be addressed. CONCLUSIONS: The substantial prevalence of WRA supports consideration of the diagnosis in all who present with new-onset or worsening asthma, followed by appropriate investigations and intervention including consideration of other exposed workers.

Correlates of household smoking bans in low-income families of children with and without asthma.

Exposure to secondhand smoke (SHS) harms all children's health, especially children with asthma. Yet, children with asthma are as likely to live with smokers as healthy children. Household smoking bans are being advocated to reduce children's harm from SHS. To measure the effect of household smoking bans on child SHS exposure and to examine correlates of strict smoking bans in a low-income, diverse sample, 91 children with asthma were matched to 91 healthy children. All had at least one smoker living in their homes. Nicotine dosimeters, child cotinine assays, and maternal reports quantified child SHS exposures. Maternal reports of household smoking rules, behaviors, and beliefs, and other family characteristics were also gathered. The presence of a strict household smoking ban vastly reduced children's SHS exposures and was associated with fewer cigarettes smoked by the mother and by other family members, the belief that SHS was a personal health risk, having children with asthma, and living in a single-family home. Many children are exposed to high levels of SHS at home. Strict household smoking bans greatly decrease, but do not eliminate children's SHS exposure. Even in disadvantaged families, mutable factors were associated with strict smoking bans. Increased dissemination and use of established public health strategies are needed to reduce children's SHS exposures.

Asthma overview.

This article presents our current understanding of the biological heterogeneity of asthma and reviews some of the key features of the latest proposed recommendations of the National Asthma Education and Prevention Program Guidelines. The diagnosis of asthma is based on such clinical features as variable airflow obstruction that is partially if not fully reversible and airway hyperresponsiveness that predisposes to episodic bronchospasm following exposure to a variety of triggers. The underlying inflammation and airway biology of asthma is heterogeneous and is part of the explanation for the variable response to therapy. New biologics that help to characterize patients according to their underlying biology will aid in making better choices for treatment. New asthma guidelines emphasize the importance of regular monitoring.

Current perspectives on management of co-morbid depression in COPD.

Individuals with COPD have a higher prevalence of co-morbid depression than either the general population or patients with other chronic illnesses. The best estimates report a prevalence of approximately 40% in COPD patients, compared to 15% in the general population. Depression in COPD patients leads to a lower quality of life, greater objective impairment in function, and decreased adherence to therapeutic interventions. While many depressed COPD patients have been treated empirically with antidepressants--subjecting them to antidepressant side effects, toxicities, and costs--there is a surprising lack of evidence supporting or directing that treatment. We review the current literature regarding the management of depression in COPD, suggest strategies for management, and future research needs.

Beryllium sensitization progresses to chronic beryllium disease: a longitudinal study of disease risk.

The blood beryllium lymphocyte proliferation test is used in medical surveillance to identify both beryllium sensitization and chronic beryllium disease. Approximately 50% of individuals with beryllium sensitization have chronic beryllium disease at the time of their initial clinical evaluation; however, the rate of progression from beryllium sensitization to chronic beryllium disease is unknown. We monitored a cohort of beryllium-sensitized patients at 2-year intervals, using bronchoalveolar lavage and repeated transbronchial lung biopsies to determine progression to chronic beryllium disease as evidenced by granulomatous inflammation in lung tissue. Fifty-five individuals with beryllium sensitization were monitored with a range of 2 to 5 clinical evaluations. Disease developed in 17 sensitized individuals (31%) within an average follow-up period of 3.8 years (range, 1.0-9.5 years). Thirty-eight of the 55 (69%) remained beryllium sensitized without disease after an average follow-up time of 4.8 years (range, 1.7-11.6 years). Progressors were more likely to have worked as machinists. We found no difference in average age, sex, race or ethnicity, smoking status, or beryllium exposure time between those who progressed to chronic beryllium disease and those who remained sensitized without disease. We conclude that beryllium sensitization is an adverse health effect in beryllium-exposed workers and merits medical follow-up.

Use of fluticasone in acute symptomatic pulmonary sarcoidosis.

BACKGROUND: Inhaled corticosteroids have been used with variable success in sarcoidosis. The role of the inhaled corticosteroid fluticasone in symptomatic pulmonary patients was studied. METHODS: Twenty-two patients at five institutions who had been given an initial dose of oral corticosteroids within the prior four weeks were enrolled in a randomized double blind trial of inhaled fluticasone. An algorithm for the dosage of prednisone including rules for reducing dose was developed and applied at all centers. RESULTS: Of the 21 patients seen for more than one visit, 10 received fluticasone and 11 placebo. There was no significant difference in the improvement of vital capacity or average daily dose of prednisone for the fluticasone versus placebo. Eight of ten patients taking fluticasone had improvement in cough, while only 6 of 11 patients on placebo had improved cough despite taking oral corticosteroids (p = 0.36, N.S.). The algorithm for decreasing corticosteroid dosage was exactly applied in over 80% of patient visits and oral corticosteroids were used throughout most of the year of treatment. Patients registered higher complaints regarding increased appetite and polyuria when on ten mg or more prednisone a day. There was no clinical difference in the rate of toxicity for the fluticasone versus placebo group. CONCLUSION: A standard approach to tapering oral corticosteroids was followed in over 80% of patient visits. Oral corticosteroids were associated with significant complaints, while inhaled corticosteroids were well tolerated.