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.
We have investigated the influence of diabetes mellitus including the presence of late complications of the pulmonary system. To check this relationship 31 Type 1 (insulin-dependent) diabetic patients (mean age 30.6 +/- 5.32 years, mean duration of diabetes 12.9 +/- 5.05 years) were admitted into the trial and compared with 18 control subjects. Pulmonary function tests were measured including spirometric parameters, diffusing capacity, specific diffusing capacity and dynamic compliance measured at 20 and 60 breaths per min. No disturbance of the spirometric parameters was observed in the diabetic patients. Diffusing capacity in the diabetic patients with complications was significantly lower than in both the diabetic patients without complications and the control group (81.2 +/- 16.2%, 104 +/- 13.7%, 99.3 +/- 2.8%; p < 0.001, p < 0.005 respectively). Specific diffusing capacity was significantly lower in the diabetic patients than in the control subjects (80.3 +/- 13.1% vs 89.4 +/- 12.9%; p < 0.05). In the group with late complications specific diffusing capacity was lower than in the group without complications (69.7 +/- 9.17%; 87.2 +/- 10.7%, respectively; p < 0.001). Dynamic compliance at 20 breaths per min in diabetic patients was 84.06 +/- 17.08% vs 95.2 +/- 11.59% in the control subjects (p < 0.05). It was particularly low in the group with late complications 80.6 +/- 13.2% and patients with metabolic poor control, 80.3 +/- 12.02% (both p < 0.005 vs the control group). Dynamic compliance at 60 breaths per min was 60.1 +/- 15.0% as compared to 83.2 +/- 13.3% in the control group (p < 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)
Very little is known about the role of adipokines in atopic dermatitis (AD) in children. This study aimed at analyzing the serum levels of resistin, apelin, and visfatin in children with AD in relation to body weight, AD severity, and gender. Serum concentration of adipokines was measured in 27 children with AD and in 46 healthy subjects. Selected biochemical parameters were evaluated and skin prick test was performed. Serum levels of resistin and apelin were significantly higher, whereas serum visfatin concentration was significantly lower in children with AD versus healthy controls, although an increase in resistin levels was exclusively demonstrated in boys. In AD group, a significant increase in apelin levels in girls was documented. There was no relationship between adipokines levels and the degree of allergic sensitization. Receiver operating characteristic curve analysis demonstrated that the serum apelin cutoff value differentiating children with AD from those without was >137.8 pg/mL. Resistin and visfatin cutoff values were >3.8 ng/mL and ≤ 2.13 ng/mL, respectively. Apelin and visfatin can serve as excellent indicators to distinguish children with AD from those without disease.
Exhaled nitric oxide (eNO) concentration measurement may permit the noninvasive estimation of the severity of airways inflammation in respiratory tract diseases. The aim of this study was to evaluate the correlation between eNO concentration and the activity of sarcoidosis, its radiographic staging and lung function abnormalities.eNO concentration was measured using a chemiluminescent analyser in 27 patients with sarcoidosis and 11 control subjects.The mean eNO concentration in patients with sarcoidosis was significantly higher (6.7±0.50 parts per billion (ppb)) than that in the control group (5.17±0.73 ppb). eNO concentration was similar in radiographic stage I, II and III patients (6.53, 7.32 and 6.24 ppb, respectively). No significant difference was found in eNO concentration between the patients with active and inactive disease. Nor did eNO concentration differ between the patients with and without indication for therapy. There was no significant correlation between eNO concentration and forced vital capacity or bronchoalveolar lavage fluid lymphocyte and macrophage counts. There was a weak correlation between eNO concentration and single-breath carbon monoxide diffusing capacity of the lung.Exhaled nitric oxide concentration is elevated in patients with sarcoidosis. This concentration does not depend on the radiographic staging, activity or progression of the disease.
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