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.
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' selfreported 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.
Exacerbations of chronic obstructive pulmonary disease (COPD) impair health-related quality of life (HRQoL). It is unknown whether exacerbations requiring hospitalisation have an impact on HRQoL. 611 ambulatory COPD patients were prospectively identified. The average age (SD) was 65.5 (8.6), FEV(1) (SD) was 52% (14%) of the predicted value. All patients completed the Saint George's Respiratory Questionnaire (SGRQ) and the Medical Outcomes Study Short Form (SF-36) questionnaire at the beginning of the study. After five years of follow-up, the 391 survivors again completed these HRQoL instruments. No changes in HRQoL were observed among patients not hospitalised for COPD exacerbations. Those hospitalised during follow-up experienced significant declines in HRQoL. The largest changes were observed among patients with >or=3 hospitalisations, with a 13.6 unit increase in the total SGRQ and a 10.5 unit decrease in the physical component summary scale of the SF-36. Similar changes were observed among patients with FEV(1)>or=50% at baseline. In the multivariate analysis, after adjustment by FEV(1%), age, comorbidities, and HRQoL in the respective HRQoL domain at baseline, hospitalisations were an independent predictor of the change in HRQoL. Hospitalisations for exacerbations of COPD have an independent and negative impact on the evolution of HRQoL, regardless of COPD severity.
Patients with COPD with a low level of PA or who reduced their PA over time were more likely to experience a significant increase in the rate of hospitalization for eCOPD. Changes to a higher level of PA or maintaining a moderate or high level of PA over time, with a low intensity activity such as walking for at least 3-6 km/day, could reduce the rate of hospitalizations for eCOPD.
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