The aim of this study was to evaluate whether changes in regular physical activity (PA) affect health-related quality of life (HRQoL) among patients with chronic obstructive pulmonary disease (COPD).611 patients (mean age 67.2±8.4 yrs; forced expiratory volume in 1 s 49.7±14.6) completed the St George's Respiratory Questionnaire (SGRQ), the Chronic Respiratory Questionnaire (CRQ) and the Medical Outcomes Short Form (SF-36) questionnaire. PA, defined as patients' self-reported regular walking times, was classified as low, moderate and high. After 5 yrs, 391 survivors completed these instruments again.After adjustment for relevant confounders, patients who reported low PA at baseline and who increased their PA over the study period improved their SGRQ and CRQ scores by 15.9 and 8.7 points, respectively. Patients who moved from moderate to high PA improved their SGRQ scores by 18.4 and their CRQ scores by 14.8. Slightly smaller increases were observed for patients who maintained a high level of PA throughout the study period. Maintaining a low level of PA or decreasing PA over the study period was associated with a significant HRQoL decline.Among COPD patients, a reduction in time spent engaging in PA or maintaining a low level may impair HRQoL, whereas an increase in PA can improve HRQoL parameters.
1 September 2019 in The Lancet Respiratory Medicine
A hallmark of idiopathic pulmonary fibrosis is the excess accumulation of extracellular matrix in the lungs. Degradation of extracellular matrix generates free-circulating protein fragments called neoepitopes. The aim of the INMARK trial was to investigate changes in neoepitopes as predictors of disease progression in patients with idiopathic pulmonary fibrosis and the effect of nintedanib on these biomarkers. In this randomised, double-blind, placebo-controlled trial, patients with a diagnosis of idiopathic pulmonary fibrosis within the past 3 years and forced vital capacity (FVC) of 80% predicted or higher were eligible to participate. Patients were recruited from hospitals, private practices, clinical research units, and academic medical centres. Patients were randomly assigned (1:2) with the use of a pseudo-random number generator to receive oral nintedanib 150 mg twice a day or placebo for 12 weeks in a double-blind fashion, followed by open-label nintedanib for 40 weeks. The primary endpoint was the rate of change in C-reactive protein (CRP) degraded by matrix metalloproteinases 1 and 8 (CRPM) from baseline to week 12 in the intention-to-treat population. The trial has been completed and is registered with ClinicalTrials.gov, number NCT02788474, and with the European Clinical Trials Database, number 2015-003148-38. Between June 27, 2016, and May 15, 2017, 347 patients were randomly assigned to the nintedanib group (n=116) or to the placebo group (n=231). One patient from the placebo group was not treated owing to a randomisation error. At baseline, mean FVC was 97·5% (SD 13·5) predicted. In the double-blind period, 116 patients received nintedanib and 230 patients received placebo. The rate of change in CRPM from baseline to week 12 was -2·57 × 10-3 ng/mL/month in the nintedanib group and -1·90 × 10-3 ng/mL/month in the placebo group (between-group difference -0·66 × 10-3 ng/mL/month [95% CI -6·21 × 10-3 to 4·88 × 10-3]; p=0·8146). The adjusted rate of change in FVC over 12 weeks was 5·9 mL in the nintedanib group and -70·2 mL in the placebo group (difference 76·1 mL/12 weeks [31·7 to 120·4]). In patients who received placebo for 12 weeks followed by open-label nintedanib, rising concentrations of CRPM over 12 weeks were associated with disease progression (absolute decline in FVC ≥10% predicted or death) over 52 weeks. In the double-blind period, serious adverse events were reported in eight (7%) patients given nintedanib and 18 (8%) patients given placebo. Grade 3 diarrhoea was reported in two (2%) patients in the nintedanib group and two (1%) patients in the placebo group. No patients had grade 4 diarrhoea. In patients with idiopathic pulmonary fibrosis and preserved lung function, treatment with nintedanib versus placebo for 12 weeks did not affect the rate of change in CRPM but was associated with a reduced rate of decline in FVC. These results suggest that change in CRPM is not a marker of response to nintedanib in patients with idiopathic pulmonary fibrosis. Boehringer Ingelheim.
The aim of this study was to develop and validate a new method: a classification and regression tree (CART) based on easily accessible measures to predict mortality in patients with stable chronic obstructive pulmonary disease (COPD).This was a prospective study of two independent prospective cohorts: a derivation cohort with 611 recruited patients and a validation cohort with 348 patients, all followed for 5 yrs. CART analysis was used to predict 5-yr mortality risk using the following covariates from the derivation cohort: age, % predicted forced expiratory volume in 1 s (FEV1), dyspnoea, physical activity, general health and number of hospital admissions for COPD exacerbations in the previous 2 yrs.Age (≥75 or 75 yrs of age with higher levels of dyspnoea and FEV1<50% pred. Patients with the lowest risk of 5-yr mortality (0.04) were 35% pred and one or no recent hospitalisations for COPD exacerbations.A simple decision tree that uses variables commonly gathered by physicians can provide a quick assessment of the severity of the disease, as measured by the risk of 5-yr mortality.