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TargetCOPD: a pragmatic randomised controlled trial of targeted case finding for COPD versus routine practice in primary care: protocol.

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Many people with clinically significant chronic obstructive pulmonary disease (COPD) remain undiagnosed worldwide. There are a number of small studies which have examined possible methods of case finding through primary care, but no large RCTs that have adequately assessed the most cost-effective approach.

METHODS: In this study, using a cluster randomised controlled trial (RCT) in 56 general practices in the West Midlands, we plan to investigate the effectiveness and cost-effectiveness of a Targeted approach to case finding for COPD compared with routine practice. Using an individual patient RCT nested in the Targeted arm, we plan also to compare the effectiveness and cost-effectiveness of Active case finding using a postal questionnaire (with supplementary opportunistic questionnaires), and Opportunistic-only case finding during routine surgery consultations.

All ever-smoking patients aged 40-79 years, without a current diagnosis of COPD and registered with participating practices will be eligible. Patients in the Targeted arm who report positive respiratory symptoms (chronic cough or phlegm, wheeze or dyspnoea) using a brief questionnaire will be invited for further spirometric assessment to ascertain whether they have COPD or not. Post-bronchodilator spirometry will be conducted to ATS standards using an Easy One spirometer by trained research assistants.The primary outcomes will be new cases of COPD and cost per new case identified, comparing targeted case finding with routine care, and two types of targeted case finding (active versus opportunistic). A multilevel logistic regression model will be used to model the probability of detecting a new case of COPD for each treatment arm, with clustering of patients (by practice and household) accounted for using a multi-level structure.A trial-based analysis will be undertaken using costs and outcomes collected during the trial. Secondary outcomes include the feasibility, efficiency, long-term cost-effectiveness, patient and primary care staff views of each approach.

DISCUSSION: This will be the largest RCT of its kind, and should inform how best to identify undiagnosed patients with COPD in the UK and other similar healthcare systems. Sensitivity analyses will help local policy-makers decide which sub-groups of the population to target first.Trial registration: Current controlled trials ISRCTN14930255.

Indacaterol improves lung hyperinflation and physical activity in patients with moderate chronic obstructive pulmonary disease - a randomized, multicenter, double-blind, placebo-controlled study.

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Indacaterol_ball-and-stick_animationIndacaterol is a long-acting beta-2 agonist for once-daily treatment of COPD. We evaluated the effects of indacaterol 150 mug on lung hyperinflation compared with placebo and open-label tiotropium 18 mug. We measured physical activity during treatment with indacaterol 150 mug and matched placebo.

METHODS: We performed a randomized, three-period, cross-over study (21 days of treatment separated by two wash-out periods of 13 days) with indacaterol 150 mug or matching placebo and tiotropium 18 mug. Lung function was assessed by body plethysmography and spirometry. Physical activity was measured for one week by a multisensory armband at the end of both treatment periods with indacaterol/matched placebo. The primary endpoint was peak inspiratory capacity at the end of each treatment period.

RESULTS: 129 patients (mean age, 61 years; mean post-bronchodilator FEV1, 64%), were randomized and 110 patients completed the study. Peak inspiratory capacity was 0.22 L greater with Indacaterol at day 21 compared to placebo (p < 0.001). Similar results were observed for tiotropium. Both bronchodilators also significantly improved other parameters of lung hyperinflation compared with placebo. All parameters of physical activity were significantly increased during treatment with indacaterol versus placebo.

CONCLUSIONS: Indacaterol 150 mug improved lung hyperinflation in patients with moderate COPD, which was associated with an increase of physical activity.Trial registration: ClinicalTrials.gov registration number: NCT01012765.

Compare the efficacy of inhaled budesonide and systemic methylprednisolone on systemic inflammation of AECOPD.

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Corticosteroids have been shown to improve the outcome of acute exacerbation of chronic obstructive pulmonary diease (AECOPD). However, whether inhaled corticosteroids (IC) alone have have similar effects with systemic corticosteroid (SCS) is still unclear.

OBJECTIVES: To compare the efficacy of inhaled budesonide and systemic methylprednisolone on systemic inflammation of AECOPD.

METHODS: 30 AECOPD patients were randomly divided into two group. Budesonide group (15 cases) were treated with inhaled budesonide (3 mg Bid); methylprednisolone group (15 cases) were treated with systemic methylprednisolone (methylprednisolone acetate injectable suspension 40mg Qd for three days and then methylprednisolone tablets 8mg Bid). Observe symptoms, lung function, blood gas analysis and adverse effects of the patients in two groups. Peripheral blood samples were collected before and after treatment for 1 day, 4 days and 7 days. Interleukin-8 (IL-8) and TNF-α levels were determined by an enzyme linked immunosorbent assay (ELISA). Hs-CRP levels were detected by automatic biochemical analyzer. Western blotting was used to determine histone deacetylase 2 (HDAC2) protein expression.

MEASUREMENTS AND MAIN RESULTS: Symptoms, pulmonary function and blood gas analysis were significantly improved after treatment in the two groups (P<0.05) and no significant differences between the two groups (P> 0.05). There were no significant differences of IL-8, TNF-α and hs-CRP levels in the two groups (P> 0.05). Besides, the levels of HDAC2 protein expression before treatment were significantly lower comparing to that after treatment for 4 and 7 days. Incidence of adverse events (heart rate, blood pressure, glycemic, sleep condition, gastrointestinal symptoms) in budesonide group was lower than methylprednisolone group (P <0.05).

CONCLUSIONS: Inhaled budesonide and systemic methylprednisolone have the same effects on systemic inflammation of AECOPD. Inhaled corticosteroid alone could instead systemic corticosteroid in AECOPD treatment.

Biologic therapy in asthma: entering the new age of personalized medicine.

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Biologic therapy in asthma: entering the new age of personalized medicine.

J Asthma. 2014 Sep;51(7):669-76

Authors: Fajt ML, Wenzel SE

Abstract
OBJECTIVE: Asthma is a common chronic disease with various phenotypes and therapeutic responses. Unlike other diseases, current anti-inflammatory treatment with corticosteroids does not include any reference to biological measures which may vary among different asthma phenotypes. Morbidity from uncontrolled asthma suggests a need for specific targeted treatment approaches such as biologic medications. In half of asthmatics, chronic airway inflammation may be driven by T helper (Th)-2 cells, which release pro-inflammatory cytokines, such as interleukin (IL)-4, IL-5 and IL-13, contributing to eosinophil inflammation and IgE production. Earlier studies of cytokine-targeted biologic therapy on non-phenotyped asthma patients were generally not clinically effective.
METHODS: Literature published from 1958-2013 was identified through PubMed using the search terms which included asthma and therapy. A total of 32 studies were reviewed covering both pediatric and adult asthmatics and included double-blind randomized placebo-controlled trials testing efficacy of biologic agents to treat asthma.
RESULTS: More recent approaches to personalized medicine with expression profiling studies, genetic analysis and clinical biomarkers of Th2 inflammation have allowed identification of asthma phenotypes including a Th2 "high" phenotype. Studies targeting IgE, IL-5, IL-13 and the IL4 receptor alpha chain have shown some efficacy in phenotyped patients. For those without evidence of Th2 inflammation, no specific therapies have been identified.
CONCLUSIONS: In recent years, the identification of Type-2 cytokine "high" asthma in numerous studies has predicted the clinical response to the Th2 associated therapies. It is not yet clear whether all Type 2 high asthma will respond similarly to IL-4, 5 and 13 approaches.

PMID: 24712500 [PubMed - indexed for MEDLINE]

Carinal resection and reconstruction in thoracic malignancies.

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Carinal resection and reconstruction in thoracic malignancies.

J Surg Oncol. 2014 Sep;110(3):239-44

Authors: Shin S, Park JS, Shim YM, Kim HJ, Kim J

Abstract
BACKGROUND AND OBJECTIVES: The purpose of this study was to present clinical outcomes of malignant tumors involving the carina after surgery in order to establish the management guidelines.
METHODS: Between 1996 and 2011, 30 patients underwent carinal resection and reconstruction for malignancy involving carina. We retrospectively analyzed their medical records. There were 22 cases of common type of NSCLC (squamous cell carcinoma/adenocarcinoma/large cell neuroendocrine carcinoma) and eight cases of carcinomas of salivary gland type (adenoid cystic carcinoma/mucoepidermoid carcinoma).
RESULTS: Seventeen right sleeve pneumonectomies, two left sleeve pneumonectomies, nine carinal sleeve right upper lobectomies, and two airway resections and reconstructions without lung resection were performed. There were no in-hospital mortalities. Eleven postoperative morbidities occurred including three cases of acute respiratory distress syndrome following pneumonectomy. Late complications occurred in eight patients including three cases of anastomotic stenosis. During follow-up, 12 mortalities occurred, including 6 cancer-related mortalities. The 5-year overall survival rate (OS) and disease-free survival rate (DFS) were 66.3% and 52.9%, respectively.
CONCLUSIONS: Malignant tumors involving the carina can be controlled with carinal surgery with acceptable mortality and morbidity. Patients with thoracic malignancy involving the carina should be considered as surgical candidate based on disease extent and functional status.

PMID: 24888321 [PubMed - indexed for MEDLINE]

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