Objective : To determine clinical and economic outcomes following COPD-related hospitalization/emergency department (ED) care in patients receiving COPD maintenance therapy.

Methods : In this retrospective, observational study using administrative claims data, we identified COPD patients age ≥40 years who received maintenance therapy within 30 days of an initial COPD-related hospitalization or ED visit with: (1) fluticasone propionate/salmeterol combination (FSC 250 mcg/50 mcg) as new therapy, or (2) an anticholinergic (AC; tiotropium or ipratropium with or without albuterol). The FSC and AC patients were matched (1:3 ratio) on various baseline characteristics using propensity scores to mitigate selection bias at baseline. The proportion of patients with COPD-related healthcare events, the mean event rates, and the mean costs in the subsequent 12 months were calculated.

Results : The FSC cohort (N = 484) had a significantly lower proportion of rehospitalized patients during follow-up than did the AC cohort (N = 1452), 3.1% versus 4.6% (P = 0.047). The mean number of rehospitalizations was 0.03 in the FSC cohort and 0.07 in the AC cohort (P = 0.001). The proportion of patients with an exacerbation resulting in an ED or physician-outpatient visit and the mean number of such visits did not differ between cohorts. Total annual COPD-related medical costs were lower for FSC than for AC ($2080 versus $2636, P = 0.006), with lower medical and higher pharmacy costs.

Conclusions : Patients receiving FSC as maintenance therapy following an initial COPD-related hospitalization or ED visit experienced better clinical and economic outcomes than patients receiving AC.

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The efficacy and safety of extrafine beclomethasone dipropionate 100 μg/formoterol 6 μg (BDP/F HFA) pressurized metered dose inhaler (pMDI) in patients with moderate-to-severe persistent asthma, has been demonstrated in randomised controlled trials (RCTs).

The aim of this prospective observational study was to assess real-life effectiveness in terms of asthma control in smoking (most of the time excluded from RCTs) and non-smoking asthmatics.

Methods : Adult patients with persistent asthma, in whom treatment with an inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) combination is indicated, were included. Pulmonary function (FEV1%pred or PEF absolute value), Asthma Control Questionnaire (ACQ) and asthma control according to GINA criteria were measured at baseline as well as 2–8 months and >8–14 months after treatment initiation with BDP/F HFA.

Results : Overall, 619 patients were enrolled by 97 investigators. In the effectiveness cohort (N = 568), at baseline, smoking asthmatics (N = 123) had higher ACQ6 (p < 0.0001) and lower asthma control (p = 0.021) than non-smoking asthmatics. Treatment with BDP/F HFA pMDI was associated with significant (p < 0.0001) improvements in pulmonary function (+7.1% in FEV1% pred), ACQ6 (−1.32) and GINA asthma control (improvement of control in 49.8% of patients). Importantly, the same treatment benefits were observed in former or current smokers compared with non-smoking asthmatics. There was a reduction in the dose of ICS from 489 ± 192 μg BDP extrafine equivalents at baseline to 265 ± 125 μg after one year. The drug was well-tolerated.

Conclusion : This prospective cohort study demonstrates the real-life effectiveness and safety of BDP/F HFA in adult asthma patients, including smokers, in normal clinical practice.

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The approach to treating a rare disease is different to that taken for more common diseases. Small patient cohorts alter clinical trial design and limit enrollment, and the picture for rare lung diseases is further complicated by the fact that most are composed of a variety of clinical phenotypes. Since the outcome measures of lung impairment have considerable test-to-test variability, potential new therapies face a substantial challenge.

In this paper we will review the current sources of clinical data for rare lung diseases and the regulatory challenges encountered by their treatment, with particular reference to alpha1-antitrypsin deficiency, lymphangioleiomyomatosis, cystic fibrosis, and pulmonary alveolar proteinosis. Strategies will also be identified for the better utilization of available data from patients with rare lung diseases, recognizing that the development cost of new therapies and the number of patients who will ultimately use them may not be aligned. Also important is improved communication between patients and their organizations, basic researchers, clinicians and their registries, drug developers, regulators such as the European Medicines Agency, and national health services.

At present, licensing and reimbursement requirements are not aligned, either nationally or internationally, and variations also exist in drug availability between countries because of different national licensing and reimbursement rules.

The changes needed to optimize European rare lung disease therapies include a commitment to develop empowered patient communities as advocates for therapy, the development of novel trial designs with new endpoints, and for regulatory bodies to be willing to accept nontraditional models of efficacy for orphan drugs.

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The fraction of nitric oxide in exhaled air (FeNO) is used in asthma diagnosis and management. Smoking reduces FeNO and 20–35% of asthmatics are smoking. However no guidelines exist on the diagnostic value of FeNO in smokers. Therefore we assessed the value of FeNO to diagnose asthma in a population of subjects with asthma-like symptoms and different smoking habits.

Methods : Measurements of FeNO, lung function, bronchial responsiveness and allergy testing were performed in 282 subjects (108 never-, 62 ex- and 112 current smokers) aged 14–44 years, with symptoms suggestive of asthma. These subjects were a subset of subjects reporting respiratory symptoms (n = 686) in a random population sample (n = 10,400).

Results : A diagnosis of asthma was given to 96 of the 282 subjects. Subjects with asthma had higher FeNO levels than subjects with non-specific asthma symptoms in all three smoking strata (p < 0.001), with a percentual increase of FeNO by 76% in never-, 71% in ex- and 60% in current smokers. The area under the ROC-curve was similar in never-, ex- and current smokers (0.72 vs. 0.74 vs. 0.70). The cut-offs were approximately 30% lower for either 90% specificity (22 vs. 31 ppb) or 90% sensitivity (7 vs. 10 ppb) in current vs. never-smokers.

Conclusions : FeNO could differentiate asthmatic subjects from non-asthmatic subjects with asthma-like symptoms equally well in both never- and current smokers within a random population sample. The FeNO cut-off levels needed in order to achieve high sensitivity or specificity were lower in current smokers.

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