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Screening for Chronic Obstructive Pulmonary Disease: Validity and Reliability of a Portable Device in Non-Specialized Healthcare Settings.

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INTRODUCTION AND OBJECTIVES: The underdiagnosis of chronic obstructive pulmonary disease (COPD) could be improved through screening using portable devices simpler than conventional spirometers in specific healthcare settings to reach a higher percentage of the at-risk population. This study was designed to assess the validity and reliability of the COPD-6 portable device to screen for COPD in non-specialized healthcare settings.

METHODS: Prospective cohort study to validate a diagnostic test. Three cohorts were recruited: primary care (PC), emergency services (ES) and community pharmacies (CPh).

STUDY POPULATION: individuals with risk factors for COPD (>40 years, smoking >10 pack-years, with respiratory symptoms). The values measured using the COPD-6 were FEV1, FEV6 and the FEV1/FEV6 ratio. Subsequently, participants underwent conventional spirometry at hospital, using a post-bronchodilator FEV1/FVC value <0.7 as the gold standard criterion for the COPD diagnosis.

RESULTS: 437 participants were included, 362 were valid for the analysis. COPD was diagnosed in 114 patients (31.5%). The area under the ROC curve for the COPD-6 for COPD screening was 0.8.The best cut-off point for the FEV1/FEV6 ratio was 0.8 (sensitivity, 92.1%) using spirometry with the bronchodilator test as the gold standard. There were practically no differences in the COPD-6 performancein the different settings and also regarding age, gender and smoking status.

CONCLUSIONS: The COPD-6 device is a valid tool for COPD screening in non-specialized healthcare settings. In this context, the best cut-off point for the FEV1/FEV6 ratio is 0.8.

Radial Endobronchial Ultrasound (EBUS) Guided Suction Catheter-Biopsy in Histological Diagnosis of Peripheral Pulmonary Lesions.

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EBUS guided trans-bronchial biopsy became routine in diagnosis of peripheral pulmonary lesions (PPL). Suction catheter-biopsy is a technique for obtaining a tissue sample from peripheral lung parenchyma. Aim of this study was to evaluate diagnostic efficiency, feasibility and safety of EBUS guided suction catheter-biopsy (SCB) in comparison to trans-bronchial biopsy (TBB) in diagnosis of PPL. The main intention was to demonstrate non-inferiority of the technique over trans-bronchial biopsy, especially when used under navigation of the EBUS.

METHODS: Radial EBUS probe (UM-3R, Olympus Co, Japan.) without guiding sheath was used to navigate suction catheter and TBB forceps to the PPL. The catheter was connected to the collection canister via vacuum pump. The SCB specimens were fixed with 10% buffered formalin.

RESULTS: There were 168 patients enrolled in this study; 69.9% males and 30.1% females. Main lesion diameter was 4.1±1.9 cm. Majority of patients, 131(77.9%) were diagnosed with lung cancer. Per-biopsy calculated sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for EBUS-SCB were 92.4%, 100%, 100% and 67.7%, respectively. Corresponding values for EBUS-TBB were 92.3%, 100%, 100% and 69.7%. Only the size of the lesion significantly influenced (p=0.005) diagnostic performance. Complications occurred in 2 patients; one pneumothorax and one excessive bleeding.

CONCLUSION: EBUS guided SCB is efficient, feasible and safe in diagnosis of peripheral lung cancer. The technique is complementary to trans-bronchial biopsy.

Challenges and successes using nanomedicines for aerosol delivery to the airways.

Numerous diseases affect the respiratory tract and the aerosol administration has been widely considered as an adapted and non-invasive method for local delivery.This pathway induces a lung concentration and thus also limits, systemic side effects. However, aerosol delivery of active pharmaceutical ingredients represents a real challenge, due to numerous obstacles such as the specific respiratory movement, the presence of mucus or surfactant, mucociliary clearance.

Nanomedicines, such as liposomes, micelles or nanoparticles, offer the possibility to increase bioavailability and favor intracellular penetration of specific drugs into lung tissue. This review focuses on the description of aerosol formulations and cellular barriers including design, characteristics and progressive adaptation to airways anatomy. Then, aerosolized formulations currently clinically approved, or in clinical trial are summarized according to the encapsulated drug.

In a final section, promising aerosol formulations in pre-clinical studies are detailed.

Safety and efficacy of tiotropium in patients switching from HandiHaler to Respimat in the TIOSPIR trial.

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OBJECTIVES: This post hoc analysis of TIOtropium Safety and Performance In Respimat (TIOSPIR) evaluated safety and exacerbation efficacy in patients with stable (≥2 months) use of tiotropium HandiHaler 18 µg (HH18) prior to study entry, to evaluate whether there was a difference in risk for patients who switched from HH18 to tiotropium Respimat 2.5 µg (R2.5) or 5 µg (R5).

SETTING: TIOSPIR (n=17 135) was an international, Phase IIIb/IV, randomised, double-blind, parallel-group, event-driven trial.
PARTICIPANTS: Patients from TIOSPIR with chronic obstructive pulmonary disease (COPD) and postbronchodilator ratio of forced expiratory volume in 1 s to forced vital capacity ≤0.70, receiving HH18 before study entry, were analysed (n=2784).
INTERVENTIONS: Patients were randomised to once-daily tiotropium R2.5 (n=914), R5 (n=918) or HH18 (n=952) for 2-3 years.
PRIMARY AND SECONDARY OUTCOME MEASURES:
PRIMARY OUTCOMES: time to death (safety) and time to first COPD exacerbation (efficacy).
SECONDARY OUTCOMES: number of exacerbations and time to first major adverse cardiovascular event (MACE).

RESULTS: Baseline characteristics were similar in all groups. Respimat had a similar mortality risk versus HH18 (vital status follow-up, HR; 95% CI R2.5: 0.87; 0.64 to 1.17; R5: 0.79; 0.58 to 1.07) with no significant differences in the risk and rates of exacerbations and severe exacerbations across treatment groups. Risk of MACE and fatal MACE was similar for Respimat versus HH18 (HR; 95% CI MACE R2.5: 0.73; 0.47 to 1.15; R5: 0.69; 0.44 to 1.08; fatal MACE R2.5: 0.57; 0.27 to 1.19; R5: 0.67; 0.33 to 1.34). Overall risk of a fatal event (on treatment) was lower for R5 versus HH18 (HR; 95% CI R2.5: 0.78; 0.55 to 1.09; R5: 0.62; 0.43 to 0.89).

CONCLUSIONS: This analysis indicates that it is safe to switch patients from tiotropium HandiHaler to tiotropium Respimat, and that the efficacy is maintained over the switch.

Pulse Oximetry Overestimates Oxygen Saturation in COPD.

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BACKGROUND: Measurement of oxygen saturation with a handheld pulse oximeter is widely practiced as a surrogate to invasive arterial blood gas analysis. Oxygen saturation is an important parameter in cases of COPD, but there are insufficient data on the role of pulse oximetry in patients with COPD, moreso in diseases across its spectrum, such as chronic bronchitis and emphysema. We assessed the performance of pulse oximetry in acute respiratory failure of patients with COPD.

METHODS: This was a cross-sectional, observational study. We studied 50 subjects with COPD admitted to the Government General Hospital, a 1,000-bed tertiary referral center in Guntur, India, from June 2013 to July 2013. Simultaneous reading of SpO2 by a handheld pulse oximeter and SaO2 by an automated arterial blood gas analyzer were taken.

RESULTS: Pulse oximetry was sufficiently sensitive (84.60%) to hypoxemia in respiratory failure to be used in clinical situations. The mean difference (bias) between SaO2 and SpO2 was -3.98 (95% CI -4.68 to 3.28). There was less sensitivity (82% vs 85%) and positive predictive value (69% vs 85%) of the pulse oximeter to respiratory failure in subjects with chronic bronchitis versus emphysema.
CONCLUSIONS: Pulse oximetry performed poorly in comparison with the invasive arterial blood gas analysis. The variability of the readings was greater in the subjects with chronic bronchitis than in those with emphysema.

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