Bronchodilator efficacy of 18 µg once-daily tiotropium inhalation via Discair® versus HandiHaler® in adults with chronic obstructive pulmonary disease: randomized, active-controlled, parallel-group, open-label, Phase IV trial.

PURPOSE: To compare the bronchodilator efficacy of 18 µg once-daily tiotropium inhalation administered via Discair® versus HandiHaler® in adults with moderate-to-severe chronic obstructive pulmonary disease (COPD). PATIENTS AND METHODS: Fifty-eight patients with moderate-to-severe COPD were enrolled in this randomized, active-controlled, parallel-group, open-label, Phase IV non-inferiority trial. Patients were randomly assigned to a test group (n=29, inhalation with Discair) or a reference group (n=29, inhalation with HandiHaler). The primary efficacy parameter was the average maximum change in forced expiratory volume in 1 second (FEV1, in L). Change in forced vital capacity (FVC, in L), %FEV1 and %FVC, the standardized area under the response-time curve (AUC) for the absolute change in FEV1 and FVC, time to onset and peak of response, and safety data were also evaluated. RESULTS: The test inhaler was non-inferior to the reference inhaler in terms of maximum change in FEV1 at 24 h (unadjusted change: 0.0017 L [95% confidence interval [CI]: -0.0777, 0.0812]; change adjusted for time to reach maximum change in FEV1 and smoking in pack-years: 0.0116 L [95% CI: -0.0699, 0.0931]), based on a non-inferiority margin of 0.100 L. There were also no significant differences between the two groups in maximum change in FVC value from baseline (0.3417 L vs 0.4438 L, P=0.113), percent change from baseline (22.235 vs 20.783 for FEV1, P=0.662; 16.719 vs 20.337 for FVC, P=0.257), and AUC0-24 h (2.949 vs 2.833 L for FEV1, P=0.891; 2.897 vs 4.729 L for FVC, P=0.178). There were no adverse events, serious adverse events, or deaths. CONCLUSION: Our findings show that the Discair was non-inferior to the HandiHaler. More specifically, these devices had similar clinical efficacy in terms of time-dependent response over 24 h for patients with moderate-to-severe COPD.

Patient and physician delay in the diagnosis and treatment of non-small cell lung cancer in Turkey.

AIM: The early diagnosis and treatment of lung cancer are important for the prognosis of patients with lung cancer. This study was undertaken to investigate patient and doctor delays in the diagnosis and treatment of NSCLC and the factors affecting these delays. MATERIALS AND METHODS: A total of 1016 patients, including 926 (91.1%) males and 90 (8.9%) females with a mean age of 61.5±10.1 years, were enrolled prospectively in this study between May 2010 and May 2011 from 17 sites in various Turkish provinces. RESULTS: The patient delay was found to be 49.9±96.9 days, doctor delay was found to be 87.7±99.6 days, and total delay was found to be 131.3±135.2 days. The referral delay was found to be 61.6±127.2 days, diagnostic delay was found to be 20.4±44.5 days, and treatment delay was found to be 24.4±54.9 days. When the major factors responsible for these delays were examined, patient delay was found to be more frequent in workers, while referral delay was found to be more frequent in patients living in villages (p<0.05). We determined that referral delay, doctor delay, and total delay increased as the number of doctors who were consulted by patients increased (p<0.05). Additionally, we determined that diagnostic and treatment delays were more frequent at the early tumour stages in NSCLC patients (p<0.05). DISCUSSION: The extended length of patient delay underscores the necessity of educating people about lung cancer. To decrease doctor delay, education is a crucial first step. Additionally, to further reduce the diagnostic and treatment delays of chest specialists, multidisciplinary management and algorithms must be used regularly.

Does Repeating CT-Guided Transthoracic Fine Needle Aspiration Increase Diagnostic Yield and Complication Rate? A Single Institution Experience.

BACKGROUND: Transthoracic fine needle aspiration biopsy is a well-established and safe technique for obtaining pulmonary tissue. However, there is very little data about repeating procedure. OBJECTIVES: We aimed to investigate whether repeating CT-guided transthoracic fine needle aspiration (TFNA) increases diagnostic yield and complication rate. PATIENTS AND METHODS: Patients underwent TFNA and the final diagnoses achieved were included in the study. Consequently, 316 TFNA procedures performed in 240 patients were investigated retrospectively. A diagnosis was not reached in the first TFNA in 64 patients, then they underwent repeated TFNA. The factors that affected the diagnostic yield and complication rate were recorded. RESULTS: The final diagnoses of 199 (82.9%) patients were malignant and 41 patients were benign. One hundred seventy six patients underwent the TFNA procedure only once. Sixty-four patients underwent a second procedure, while 12 underwent a third one. The diagnosis rate in the first procedures (diagnosis obtained in 142 out of 240 patients) was 59%. With the repeated procedures, 30 other patients were diagnosed. The diagnosis rate increased to 72% (172 out of 240 patients) (P<0.001). Twenty-nine (9.2%) pneumothoraces in 26 patients were detected in 316 TFNA procedures. In the repeated TFNA group (64 patients) there were seven pneumothoraces (11%) in the first TFNA procedure and six pneumothoraces (9%) in the repeated TFNA procedures (P=0.41). In three patients, pneumothorax was detected in the first and repeated procedures. Pneumothorax was significantly associated with the maximum diameter of the lesion (P=0.003), distance to pleura (P=0.001), contact to the pleura (P=0.0001) and smoking history (pack/year) (P=0.04). CONCLUSION: This study demonstrated that repeating the TFNA procedure in pulmonary lesions improves the diagnostic yield without an increase in the rate of pneumothorax.

Diagnostic and prognostic significance of survivin levels in malignant pleural effusion.

UNLABELLED: We aimed to evaluate the diagnostic and prognostic value of measuring survivin levels, which is an inhibitor of apoptosis in pleural effusions. METHODS: Group I, malignant (MPE) (n = 51); Group II, tuberculosis (TPE) (n = 18); Group III transudative (TE) (n = 9) effusions were enrolled prospectively. We used ELISA to analyze 78 effusions. The value for the differential diagnosis and the correlation between survivin and survival in MPE were analyzed. RESULTS: Survivin level was 41.75 ± 76.20 in MPE, 15.83 ± 10.92 in TPE and 8.33 ± 8.67 in TE. When the patients divided two groups as malignant and non-malignant pleural effusion (non-MPE), survivin level was significantly higher in MPE (41.75 ± 76.20) than in non-MPE (13.33±2.05) (p = 0.012). The cutoff value for survivin levels detected by ROC curve analysis was 7.5 pg/ml, with sensitivity and specificity values of 72%, 44%, respectively. Survivin had no discriminative power in differentiating exudative effusions of MPE from TPE (p = 0.405). There was no correlation between survivin level and age, sex, location, fluid pH, glucose, protein, albumine and ADA level while there was significant moderate correlation with fluid LDH (r = 0.49; p < 0.001). Survivin levels can distinguish patients who had poor prognosis (median survival 75 days, n = 24) and those who had good prognosis (median survival 219 days, n = 27, p = 0.03) in MPE. In conclusion, survivin expression levels detected with ELISA had no discriminative power in differentiating exudative effusions included MPE and TPE. Elevated survivin levels are associated with poor survival in MPE. Our results suggest that survivin may be a potential prognostic marker in MPE.

Predictive role of adenosine deaminase for differential diagnosis of tuberculosis and malignant pleural effusion in Turkey.

Tuberculous pleural effusion (TPE) is a common problem for differential diagnosis from malignant effusion (MPE) in epidemic areas of tuberculosis (TB). Prediction based on adenosine deaminase (ADA) is dependent on age as well as the tuberculosis incidence. The aim of the study was to evaluate cutoff values for ADA with sensitivity and specificity results for the differential diagnosis of MPE and TPE in a population with intermediate incidence of TB. We retrospectively analysed 196 patients with a definitive diagnosis of TPE (n = 114) and MPE (n = 82). The optimal cutoff value of ADA was determined using the receiver operating characteristic (ROC) curve. There was a statistically significant difference according to the levels of pleural fluid ADA between TPE and MPE groups (p < 0.0001). The cutoff value for diagnosing TPE was > 55 U/L, with a sensitivity = 86.8%, specificity = 86.6%, positive predictive value (PPV) = 90%, negative predictive value (NPV) = 82.6% and accuracy = 82.6%. We then combined ADA > 55 U/L and age < 50 and were able to discriminate the TPE group with increased specifity (95.7 %) and PPV (98.8%) results. The model could correctly classify 21 MPE out of 23 and 82 TPE out of 94 patients. A pleural fluid ADA value < 31 U/L suggests that TPE is highly unlikely with a sensitivity = 43.9 %, specificity = 100%, PPV = 100%, NPV = 71.3% and accuracy = 76.6%. It can be concluded that ADA is a very useful parameter for the differential diagnosis of TPE and MPE, specifically in youngers with a higher incidence of tuberculosis.