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Tiotropium discontinuation in patients with early-stage COPD: a prospective observational cohort study.

ABSTRACT: Background:Tiotropium improves lung function and ameliorates the annual decline in forced expiratory volume in 1?s (FEV1) after bronchodilator use in patients with mild to moderate chronic obstructive pulmonary disease (COPD). However, whether these benefits persist in patients with early-stage COPD after tiotropium discontinuation is unknown. Methods:In this prospective cohort observational follow-up study, patients who had completed the Tiotropium in Early-Stage COPD (Tie-COPD) trial were followed for a maximum of 3?years, continuing or discontinuing treatment according to their willingness. The outcomes measured were spirometry parameters, COPD exacerbations, COPD Assessment Test (CAT) scores, Clinical COPD Questionnaire (CCQ) scores, modified Medical Research Council (mMRC) scores and the use of respiratory medications. Results:Out of 376 patients, 262 (126 in the post-placebo group and 136 in the post-tiotropium group) completed the maximum 3-year follow-up after the study medication was withdrawn. After discontinuation, the decrease in FEV1 and forced vital capacity (FVC) did not differ significantly between the two groups, and neither did their annual decline. In addition, the frequency of acute COPD exacerbations and the mMRC scores were similar between the two groups after medication withdrawal. Both the mean CAT and CCQ scores were significantly lower in the post-tiotropium group than in the post-placebo group (p<0.05 for all comparisons) at the 1-year follow-up after withdrawal, but they were not different at the next follow-up. Conclusion:Withdrawal of tiotropium treatment in early-stage COPD resulted in difference reduction of both FEV1 and FVC, indicating that treatment should be continued.

SUBMITTER: Li C

PROVIDER: S-EPMC6378343 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Tiotropium discontinuation in patients with early-stage COPD: a prospective observational cohort study.

Li Chenglong C Zhou Yumin Y Liu Sha S Zheng Mengning M Zheng Jinzhen J Peng Huanhuan H Deng Zhishan Z Zhong Nanshan N Ran Pixin P

ERJ open research 20190218 1

<h4>Background</h4>Tiotropium improves lung function and ameliorates the annual decline in forced expiratory volume in 1 s (FEV<sub>1</sub>) after bronchodilator use in patients with mild to moderate chronic obstructive pulmonary disease (COPD). However, whether these benefits persist in patients with early-stage COPD after tiotropium discontinuation is unknown.<h4>Methods</h4>In this prospective cohort observational follow-up study, patients who had completed the Tiotropium in Early-Stage COPD ...[more]

PMID: 30792986

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Project description:BackgroundThe number of resuscitated cardiac arrest patients suffering from anoxic-ischemic encephalopathy is considerable. However, outcome prediction parameters such as somatosensory evoked potentials need revision because they are based on data predating the implementation of mild therapeutical hypothermia and because data from our own laboratory suggest that they may fail to predict prognosis accurately. The present research project "Hypoxia and Outcome Prediction in Early-Stage Coma" is an ongoing observational prospective cohort study that aims to improve outcome prediction in anoxic coma by limiting the effects of falsely pessimistic predictions at the intensive care unit.MethodsOur outcome analysis is based on functional and behavioural definitions. This implies the analysis of the positive predictive value of prognostic markers yielding either positive or negative results. We also analyse the effect of covariates adjusted for age and sex such as sociodemographic variables, prognostic variables and treatment factors on functional and behavioural outcomes, with mixed effects regression models (i.e. fixed and random effects). We expect to enrol 172 patients based on the result of previous research. The null hypothesis is that there is a probability of <10 % that a positive outcome will be observed despite the presence of any of the predictors of a poor/negative outcome. We test the null hypothesis against a one-sided alternative using a Simon's two-stage design to determine whether it is warranted to recruit the full number of patients suggested by a power analysis. The second stage has a design with a Type I error rate of 0.05 and 80 % power if the true response rate is 25 %.DiscussionWe aim to make a significant contribution to the revision and improvement of current outcome prediction methods in anoxic-ischemic encephalopathy patients. As a result, neurocritical care specialists worldwide will have considerably more accurate methods for prognosticating the outcome of anoxic-ischemic encephalopathy following cardiac arrest. This will facilitate the provision of treatment tailored to individual patients and the attainment of an optimal quality of life. It will also inform the decision to withdraw treatment with a level of accuracy never seen before in the field.Trial registrationClinicalTrials.gov NCT02231060 (registered 29 August 2014).

Project description:Main risk factor for the development of chronic obstructive pulmonary disease (COPD) is smoking, although only less than 1/3 of smokers develop clinically manifest COPD. COPD's progressive nature with high disability and mortality makes it plausible to detect it as early as possible thus allowing for an early intervention. The only tool for an early diagnosis that could be used on the global scale is spirometry, even though symptoms and deprivation of health related quality of life (HRQoL) precede relevant spirometric changes. Existing HRQoL questionnaires are too complicated or not developed for an early detection of COPD. The aim of our study was to develop a new simple HRQoL tool that will allow (alone or in combination with other markers) early detection of patients with COPD.A multicenter prospective cohort study recruiting 500 subjects at risk for COPD (smokers/ex-smokers ?20 pack-years, 40-65 years, both sexes, with no prior diagnosis of COPD) will be carried out in two phases: (1) cross-sectional - development and validation of a new questionnaire; and (2) prospective - follow-up of a cohort of patients at risk for COPD. Subjects were recruited by 25 GPs and assessed for COPD by dedicated pulmonologists in 7 hospital centers using a predefined protocol: HRQoL, history, physical, blood sampling, exhaled breath temperature (EBT), lung function, 6-min walk test (6MWT). Patients without COPD and those in GOLD stage 1 at initial assessment will be reassessed for disease progression by the same pulmonologist after 2 and 5 years.This is one of the first cohort studies attempting to establish the incidence of COPD in the pre-symptomatic stage before significant end organ damage. We intend to assess the validity, predictability and discriminative power ('healthy' smokers vs. pre-symptomatic phase in newly developed COPD) of newly developed HRQoL tool alone or in combination with other markers; EBT, lung function, 6MWT, genomics, transcriptomics, proteomics). We expect that the results of this study can improve our understanding of the development of COPD, identify some new underlying pathophysiological pathways, and offer to sensitive smokers/ex-smokers new preventive and early intervention measures thus improving the management of COPD.Clinicaltrial.gov NCT01550679 retrospectively registered February 28, 2012.

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Tiotropium discontinuation in patients with early-stage COPD: a prospective observational cohort study.

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Tiotropium discontinuation in patients with early-stage COPD: a prospective observational cohort study.

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