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Prevalence and diagnosis of chronic obstructive pulmonary disease among smokers at risk. A comparative study of case-finding vs. screening strategies

Early diagnosis of chronic obstructive pulmonary disease (COPD) remains the main intervention to prevent disease progression. However, conflicting results exist on the utility of two different diagnostic strategies that preclude freely recommending one strategy in favor of the other. Spirometry was used to determine the effectiveness of a symptom-based (case-finding) strategy vs. a screening strategy to detect COPD in smokers.

Methods The case-finding strategy was undertaken during the COPD Day campaign in smokers with respiratory symptoms who were willing to submit to lung function testing. Screening was carried out with smokers attending a smoking cessation program. A short standardized questionnaire on respiratory symptoms along with spirometry were carried out and analyzed for both strategies.

Results We evaluated 2781 smokers (mean pack/years 23.38): 1999 from the case-finding strategy and 782 from the smoking cessation program strategy (SCS). Prevalence of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria was 10.1 and 13.3%, respectively (p < 0.01). With the exception of dyspnea (70.6% vs. 72.5%, p = 0.72), prevalence of symptoms such as cough (61.5 vs. 37, p < 0.001), phlegm (60.4 vs. 38.2, p < 0.001) and wheezing (56.7 vs.15.06, p < 0.001) was higher among smokers from the case-finding strategy. Multivariate logistic regression analysis showed that dyspnea [OR = 2.09 (95% CI 1.41–3.1)] was the only common predictor of COPD after jointly and separately analyzing case-finding and screening strategies.

Conclusions For early diagnosis of COPD in a primary care setting, a screening strategy aimed at all smokers may be more useful than a case-finding strategy.

Exploring the impact of screening with low-dose CT on lung cancer mortality in mild to moderate COPD patients: A pilot study

COPD is an independent risk factor for lung cancer, especially in patients with mild to moderate disease. Objective To determine if performing lung cancer screening in GOLD 1 and 2 COPD patients, results in reduced lung cancer mortality.

Methods This study compared patients with mild to moderate COPD from 2 cohorts matched for age, gender, BMI, FEV1%, pack-yrs history and smoking status. The screening group (SG) had an annual low dose computed tomography (LDCT). The control group (CG) was prospectively followed with usual care. Lung cancer incidence and mortality densities were compared between groups.

Results From an initial sample of 410 (SG) and 735 (CG) patients we were able to match 333 patients from each group. At the same follow-up time lung cancer incidence density was 1.79/100 person-years in the SG and 4.14/100 person-years in the CG (p = 0.004). The most frequent histological type was adenocarcinoma in both SG and CG (65% and 46%, respectively), followed by squamous cell carcinoma (25% and 37%, respectively). Eighty percent of lung cancers in the SG (16/20) were diagnosed in stage I, and all of CG cancers (35/35) were in stage III or IV. Mortality incidence density from lung cancer (0.08 vs. 2.48/100 person-years, p < 0.001) was lower in the SG.

Conclusions This pilot study in patients with mild to moderate COPD suggests that screening with LDCT detects lung cancer in early stages, and could decrease lung cancer mortality in that high risk group. Appropriately designed studies should confirm these important findings.

Influence of salmeterol/fluticasone via single versus separate inhalers on exacerbations in severe/very severe COPD

Patients with severe or very severe chronic obstructive pulmonary disease (COPD) frequently suffer repeated exacerbations generating high health care utilization costs. Combined corticosteroid and bronchodilator treatment using a single inhaler might - via improved compliance - reduce exacerbation rates.

Objectives Our aim was to obtain descriptive data on exacerbation rates in patients with severe or very severe COPD (GOLD Stages III and IV as per GOLD 2009 classification) receiving salmeterol xinafoate/fluticasone propionate via a single inhaler (SFC) or via separate inhalers (Sal/FP) in addition to individual existing therapy in order to investigate the potential benefit of a fixed combination device as compared with two separate devices due to potentially improved patients' compliance.

Methods This prospective, randomized, open-label, parallel-group, multi-center, exploratory study was conducted in Germany in 2007–2009. Patients were required to have suffered ≥ 2 moderate/severe exacerbations in the preceding year. Results 213 patients (SFC: 108 patients, Sal/FP: 105 patients) from 23 centers were evaluated. Approximately 25% of patients showed COPD Stage IV. On average patients had suffered 2.3 ± 0.6 moderate/severe exacerbations in the preceding year. The annual rate of moderate/severe exacerbations observed in the study was similar in both treatment groups (SFC: 0.86 ± 0.13; Sal/FP: 0.86 ± 0.14; exacerbation rate ratio SFC/Sal/FP: 1.00; p = 0.73; negative binomial model). Compliance was high and comparable in both groups. Besides COPD exacerbations, pneumonia (5.6%) and nasopharyngitis (5.2%) were the most common adverse events.

Conclusion Observed exacerbation rates were lower than those reported at baseline. No substantial difference was observed between administration of salmeterol xinafoate/fluticasone propionate via a single inhaler and separate inhalers. Treatment was safe and well tolerated. ClinicalTrials.gov Identifier: NCT00527826.

Discordance between asthma control clinical, physiological and inflammatory parameters in mild asthma

Discrepancies have been observed between clinical, physiological, and inflammatory asthma control criteria, mostly in asthmatic subjects using regular inhaled corticosteroids (ICS) treatment.

This study compared the prevalence of discrepancies between these 3 control parameters in mild asthmatic subjects not taking ICS. Methods A retrospective analysis of demographic data and results from the Asthma Control Scoring System tool was performed in mild patients with asthma not taking ICS. The % score obtained for the clinical (symptoms), physiological (FEV1), and inflammatory (sputum eosinophil percentage) criteria were compared. Discrepancy was defined as a >20% difference between any 2 scores. Findings Data from 213 subjects with mild asthma were analysed. Discrepancies between clinical and inflammatory scores were observed in 32% of subjects, whereas 31% showed discrepancies between physiological and inflammatory scores, and 20% between clinical and physiological scores. Sub-analysis of the discrepancy groups showed that respectively 88% and 89% of subjects had a higher clinical or physiological score than inflammatory score. Twenty-seven percent of subjects had residual airway inflammation despite adequate clinical control and optimal pulmonary function.

Interpretation There are significant discrepancies between scores of subjective and objective asthma control criteria. Airway inflammation often persists in subjects with good clinical or physiological asthma control scores. The consequences of this persisting airway inflammation in mild patients remain to be further studied.

Dose-dependent anti-inflammatory effect of inhaled mometasone furoate/formoterol in subjects with asthma

A well-controlled study in patients with allergic asthma was warranted to assess dose-dependency between fractional concentration of exhaled nitric oxide (FeNO) and sputum eosinophils to a combination of an inhaled corticosteroid plus a long-acting β 2-agonist. We sought to characterize the dose-dependency of mometasone furoate/formoterol (MF/F) using FeNO and sputum eosinophil percentage as surrogates of airway inflammation in subjects with allergic asthma.

Methods Following a 2-week, open-label run-in, 93 subjects (≥12 y) using only short-acting beta agonist reliever medication as needed, were randomized to twice daily (BID) placebo; MF/F 100/10 μg, 200/10 μg, or 400/10 μg (via pressurized metered-dose inhaler [MDI]); MF-MDI 200 μg; or MF 200 μg via dry powder inhaler (DPI) during a 2-week, double-blind treatment period.

Results All active treatments demonstrated significant percentage reductions from baseline in FeNO compared with placebo at all time points (P ≤ 0.034). At endpoint, mean MF/F treatment group FeNO reductions ranged from −35.3% to −61.4%. Sputum eosinophil percentage reductions from baseline were significant compared with placebo for the MF/F 200/10 μg, MF/F 400/10 μg, and MF-DPI 200 μg groups at endpoint (P ≤ 0.023). Escalating MF/F doses significantly reduced both FeNO (P ≤ 0.001) and sputum eosinophil (P ≤ 0.022) levels in a dose-dependent manner at all time points. All treatments were well tolerated; no serious adverse events were observed.

Conclusion All 3 MF/F doses demonstrated pronounced, clinically meaningful, dose-dependent reductions in FeNO, with reduced sputum eosinophil levels for MF/F 200/10 μg and MF/F 400/10 μg. These findings suggest both inflammatory markers may be useful in assessing corticosteroid responsiveness in asthma patients, and perhaps identifying the same asthma subphenotype. Clinical Trials.gov: NCT00635882.

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