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How should pulmonary nodules be optimally investigated and managed?

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Pulmonary nodules are a common incidental finding on CT and the inexorable rise in the use of CT (10% increase per year in the UK over the last decade) means that the frequency of their detection is likely to increase over coming years. This may be augmented further if CT screening is implemented. Management has previously been influenced by North American guidelines, with the most widely used resource to date being the Fleischner Society guidelines published in 2005. These predominantly focus on the timing of CT scans arranged to survey small pulmonary nodules (≤8mm), and the guideline authors chose not to offer specific recommendations regarding larger nodules.

More recently, the society published specific guidelines for sub-solid nodules, reflecting the different prognosis that this subtype of nodules confers. The American College of Chest Physicians have published two guidelines on pulmonary nodules-the latest was completed in 2012 and published in Chest the following year. However, the investigation and management of pulmonary nodules is a rapidly evolving subject largely driven by evidence from the large CT screening studies. In 2012, The British Thoracic Society (BTS) convened a guideline development group to address the topic of pulmonary nodule investigation and management, with publication of the guideline in July 2015. One third of the 359 references included in the guideline date from 2012 onwards, and many of the differences between the recommendations made and previous guideline recommendations reflect this recent evidence.

This article reviews specific evidence considered in formulating the BTS guidelines, and summarises the main guideline recommendations.

Efficacy and safety of fluticasone furoate/vilanterol or tiotropium in subjects with COPD at cardiovascular risk.

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Fluticasone furoate/vilanterol (FF/VI) is a novel, once-daily, inhaled corticosteroid/long-acting β2-agonist combination approved for the treatment of COPD and asthma. We compared the safety and efficacy of FF/VI and tiotropium (TIO) in subjects with moderate-to-severe COPD with greater risk for comorbid cardiovascular disease (CVD).

METHODS: This randomized, blinded, double-dummy, parallel-group study compared a once-daily morning dose of FF/VI 100/25 mcg delivered via ELLIPTA™ with TIO 18 mcg via HandiHaler(®) for 12 weeks in subjects with diagnosed COPD, forced expiratory volume in 1 second (FEV1) 30%-70% predicted, and CVD or CVD risk. The primary endpoint was change from baseline in 24-hour weighted mean FEV1 on Day 84. Other efficacy endpoints included time to onset of bronchodilation, trough FEV1, other spirometry measures, rescue medication use, symptoms, quality of life (St George's Respiratory Questionnaire-COPD [SGRQ-C]), and health status (COPD Assessment Tests [CAT]) measures. Safety endpoints included cardiovascular monitoring, cortisol excretion, COPD exacerbations, and adverse events, including prespecified drug effects.

RESULTS: Both FF/VI and TIO improved the 24-hour weighted mean FEV1 from baseline after 12 weeks with no significant difference between treatments. Other endpoints favored FF/VI for time to onset of bronchodilation, rescue medication use, dyspnea, SGRQ-C and CAT scores, or favored TIO for change from baseline in forced vital capacity and inspiratory capacity. Pneumonia occurred more frequently in the FF/VI group, and two TIO-treated subjects died following cardiovascular events. Other safety measures were similar between groups, and cardiovascular monitoring did not reveal increased CVD risk.

CONCLUSION: Both FF/VI and TIO were efficacious in improving lung function in subjects with COPD and comorbid CVD or CVD risk factors, with minor differences in efficacy and safety profiles.

The impact of food allergens on airway responsiveness in schoolchildren with asthma: A DBPCFC study.

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BACKGROUND AND OBJECTIVE: Despite the growing evidence of a possible link between asthma and food allergy (FA), so far, the involvement of food in inducing respiratory symptoms has not been fully evaluated. The objective of this study was to evaluate the impact of food allergens on respiratory symptoms and bronchial reactivity (BHR) in schoolchildren with asthma.

METHODS: The initial study group consisted of 362 children with asthma. In the end, 22 children with concomitant FA, and 18 without FA, were selected to participate in the study. Spirometry and Methacholine Inhalation Challenge (MIC) were conducted prior to and after the completion of a double blind placebo control food challenge (DBPCFC).

RESULTS: The food-induced asthmatic reactions were observed in nine (2.5%) out of all 362 children with asthma. Mean FEV1 prior to and after allergen or placebo challenge did not differ between the groups studied. Increase of BHR after DBPCFC was seen in 17 (4.7%) children with asthma. The mean PC20 value in children with FA was 1.41 ± 1.12 mg/ml prior to the allergen challenge and 0.86 ± 0.71 mg/ml (P = 0.002) after the test, whereas these values were 1.93 ± 1.68 mg/ml and 2.02 ± 1.75 mg/ml, respectively, in children without FA (P > 0.05). Significant differences were noted after the allergen provocation in children with FA as compared to children without FA (P = 0.007).

CONCLUSIONS: Although food allergens are a rare trigger of food-induced asthmatic reactions in schoolchildren with asthma, they could enhance BHR, despite a lack of evident clinical respiratory signs and decreased in FEV1 values after food challenge. Pediatr Pulmonol. © 2016 Wiley Periodicals, Inc.

The natural history of severe asthma and influences of early risk factors: a population-based cohort study.

BACKGROUND: Severe asthma is associated with disproportionately high morbidity, but little is known about its natural history and how risk factors at first year of diagnosis modify its subsequent development.

METHODS: Using administrative health data, we retrospectively followed patients 14-55 years of age with newly diagnosed severe asthma in British Columbia, Canada. Based on intensity of resource use (drug therapy) and occurrence of exacerbations, each patient-year was classified into mild, moderate, or severe asthma. We estimated the probability of transition between severity levels or to death over the study period using a four-state Markov model, and used this to assess the 10-year trajectory of severe asthma and the influence of baseline risk factors.

RESULTS: We followed 13 467 patients. Ten years after incident severe asthma, 83% had transitioned to a less severe level (mild: 43%, moderate: 40%). Low socioeconomic status, high comorbidity burden, and high adherence (proportion of days covered (PDC) by asthma controller therapy) in the first year were independently associated with, respectively, 10%, 24% and 35% more time in severe asthma over the next 10 years. Sex was not associated with the clinical course.

CONCLUSIONS: Most patients with incident severe asthma used fewer resources over time, indicating a long-term transition to milder asthma. Potentially modifiable risk factors for poor prognosis of severe asthma include low socioeconomic status and high comorbidity burden. The association between PDC and future asthma severity is likely due to residual confounding by disease severity.

Aberrant small airways function relates to asthma severity in young children.

BACKGROUND: Frequency dependence of resistance (R5-20) assessed by impulse oscillometry (IOS) is suggested to be a measure of small airways. Small airways involvement during induced bronchoconstriction has been shown to reflect severity of asthma in adults.

OBJECTIVE: Our aim was to evaluate if methacholine (Mch) induced changes in R5-20 are associated with the severity of exercise induced bronchoconstriction (EIB) in young children.

METHODS: A total of 109 children aged 3-8 years were studied, 95 with obstructive symptoms and 14 in good health, to assess small airways function during a Mch challenge. R5-20 and other IOS resistance and reactance parameters were measured at baseline and after the Mch challenge. In a standardized exercise test, the children were grouped according to the severity of EIB expressed as the percentage increase in resistance at 5 Hz (ΔR5) after exercise, indicating either no EIB (ΔR5 < 40%, n = 84), moderate EIB (ΔR5 40-80%, n = 13) and severe EIB (ΔR5 > 80%, n = 12).

RESULTS: The baseline R5-20 was not associated with the severity of EIB, but during Mch induced bronchoconstriction the change in R5-20 was significantly higher in children with severe EIB (2.61 fold increase) than in children with moderate EIB (1.48) or no EIB (1.74, p = 0.036). No significant associations were found in changes of other IOS parameters. The children with severe EIB also used more short-acting beta-agonists during the past two months than the other two groups (p < 0.001).

CONCLUSION: Frequency dependence of resistance (R5-20) measured by IOS during the Mch induced bronchoconstriction and more frequent use of beta-agonists are associated with severe EIB in young children.

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