Background The INBUILD trial investigated the efficacy and safety of nintedanib versus placebo in patients with progressive fibrosing interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis (IPF). We aimed to establish the effects of nintedanib in subgroups based on ILD diagnosis. Methods The INBUILD trial was a randomised, double-blind, placebo-controlled, parallel group trial done at 153 sites in 15 countries. Participants had an investigator-diagnosed fibrosing ILD other than IPF, with chest imaging features of fibrosis of more than 10% extent on high resolution CT (HRCT), forced vital capacity (FVC) of 45% or more predicted, and diffusing capacity of the lung for carbon monoxide (DLco) of at least 30% and less than 80% predicted. Participants fulfilled protocol-defined criteria for ILD progression in the 24 months before screening, despite management considered appropriate in clinical practice for the individual ILD. Participants were randomly assigned 1:1 by means of a pseudorandom number generator to receive nintedanib 150 mg twice daily or placebo for at least 52 weeks. Participants, investigators, and other personnel involved in the trial and analysis were masked to treatment assignment until after database lock. In this subgroup analysis, we assessed the rate of decline in FVC (mL/year) over 52 weeks in patients who received at least one dose of nintedanib or placebo in five prespecified subgroups based on the ILD diagnoses documented by the investigators: hypersensitivity pneumonitis, autoimmune ILDs, idiopathic non-specific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. The trial has been completed and is registered with ClinicalTrials.gov, number NCT02999178.
Spiral volumetric computed tomography (CT) with single breath-hold technique was compared with conventional sequential CT in 39 patients. The spiral CT protocol consisted of a 10 mm/sec table feed during a 24-second breath hold at 145 mA, with reconstruction of images at 10-mm intervals; one (n = 21) or two (n = 18) sequences were necessary to screen the complete lung. Conventional CT was performed with a 1-second scan time, 145 mA, and contiguous 10-mm-thick sections. In the 39 patients studied with each technique, no lung nodule was detected in three, two had a single nodule, and 29 had multiple nodules. Two patients with normal findings at chest radiography and three with a solitary pulmonary nodule at conventional CT had multiple nodules at spiral CT. Mean number of nodules per patient was significantly higher with spiral versus conventional CT (18 +/- 4.5 vs 12.6 +/- 3.2 [mean +/- standard error of the mean], P = .01) as were the number of nodules less than 5 mm in diameter per patient (12.7 +/- 3.7 vs 8.4 +/- 2.3, P < .05) and 5-10 mm in diameter (2.9 +/- 0.9 vs 2.4 +/- 0.8, P < .05). Respiratory motion artifacts were never observed with spiral CT although they were present on four conventional CT scans.
In primary spontaneous pneumothorax (PSP) requiring intervention, removal of air from the pleural space can be achieved by manual needle aspiration or by pleural drainage after insertion of a chest tube. This study aimed to evaluate the efficacy and safety of a serial-steps approach with a single system (small-calibre catheter/Heimlich valve) in a homogeneous population of patients with a first episode of PSP.All patients had an 8.5 F distally multiperforated polyurethane pigtail catheter inserted via the anterior route, at the bedside without any guidance, using the Seldinger technique. A one-way Heimlich valve was connected to the catheter, allowing the air to flow spontaneously outwards for 24-48 h. Thereafter, if the lung failed to re-expand wall suction was applied. Patients with an air leak persisting for .4 days were referred for surgery. Primary end-points were success rates at 24 h and 1 week, and 1 yr recurrence-free survival.In total, 41 consecutive patients entered the study. They were typically thin, young, smoking males. No procedure-related complications were observed. The need for pain relief medication was minimal. Within the first 24 h, most of the patients were able to walk around and half of them were able to take a shower with their catheter in place. The 24-h and 1-week success rates were 61 and 85%, respectively, and the actuarial 1-yr recurrence rate was 24%. Four patients underwent surgical pleurodesis because of a persistent air leak. The length of stay when excluding the four surgical cases was 2.3¡1.3 days.When 24-h and 1-week success rates and recurrence at 12 months were taken as end-points, the method described here is as effective as simple manual needle aspiration or a conventional chest tube thoracotomy. These results support further studies assessing this ''one system, serialsteps approach'' in an outpatient management algorithm.
Exposure to coal-mine dust leads to coal workers' pneumoconiosis (CWP), characterized by the development of a perifocal and progressive fibrotic reaction. In order to confirm their in vivo participation in the pathogenesis of CWP, the expression of tumor necrosis factor (TNF) and interleukin-6 (IL-6) was evaluated in bronchoalveolar lavage (BAL) specimens collected from 12 patients with simple pneumoconiosis (SP) and six with progressive massive fibrosis (PMF), and in pulmonary tissue from one patient with SP and three with PMF. Expression of TNF and IL-6 was assessed using both in situ hybridization and immunohistochemistry. The number of positive cells found in BALF was significantly higher for patients with PMF (TNF = 55 +/- 6%; IL-6 = 46 +/- 12.8%) than for those with SP (TNF = 34 +/- 11.6%; IL-6 = 26 +/- 10.2%) or normal controls (TNF = 15 +/- 5.5%; IL-6 = 13.3 +/- 6%), and was correlated with cytokine concentrations in supernatants from alveolar macrophages (AM). In lung biopsies, the expression of messenger ribonucleic acid (mRNA) for TNF was associated with the presence of coal dust and was limited to lung macrophages; mRNA for IL-6 was detected in mononuclear phagocytes but also in other types of cells such as endothelial cells. Monokine synthesis was confirmed by immunohistochemistry. These data confirm that TNF and IL-6 production is increased in the lungs of pneumoconiotic patients. Moreover TNF and IL-6 expression was associated with the presence of coalmine dust particles, suggesting a direct role of mineral particles in the cytokine production and development of pneumoconiotic lesions in CWP.
To describe the clinical and economic burden of severe asthma in France over 12 months. Methods: Data were retrieved from the observational, prospective "Cohorte Obstruction Bronchique et Asthme" (COBRA) cohort, which has enrolled nearly 1000 asthma patients since 2007 from throughout France. Patients undergoing treatment with GINA step-4 or 5 medications uninterruptedly for 12 months (thus defining "severe asthma") were identified and their clinical data used to describe the clinical burden of asthma (exacerbations, symptoms outside exacerbations, and level of asthma control). Patients' utilization of healthcare resources was described and used to estimate the direct medical costs incurred to treat severe asthma. Results: 155 patients were included in the present study. Over the 12-month period of interest, 128 (83%) patients experienced at least one asthma exacerbation, 22 (14%) patients were hospitalized for asthma, 133 (86%) patients experienced continuous symptoms outside exacerbations, and 77 (50%) patients experienced important limitations in daily life activities. The median number of asthma-related drugs used was 4. The mean estimated annual asthma-related cost was 8,222 euros (standard deviation, SD = 11,886), including 7,229 euros (SD = 11,703) for controller medications. Conclusion: Symptoms outside exacerbation periods are highly prevalent in severe asthma patients, for whom the main driver of medical costs is controller medication.
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