Abstract
In COPD patients, a distinctive clustering of symptoms in the 3 parts of the day, early morning, day-time and night-time has been observed. These clusters are relevant to shape the health status and to explain the need of care (Kessler R et al. Eur Respir J 2011; 37: 2641; Miravitlles et al. Respir Res 2014, 15:122).
To quantify the intra-day fluctuation of symptoms and to verify whether it: marks selected COPD phenotypes and is stable over time.
Observational prospective cohort multicenter (40 italian sites) study.
600 COPD patients >50 years will be enrolled in STORICO. The multidimensional assessment will cover pattern of symptoms, complete spirometry and DLCO, comorbidity and health status. Based on clinical data, patients will be grouped in clinical phenotypes. Statistical clustering procedures taking into account also respiratory function data will be run. Intra-day symptoms fluctuation will by rated by standardized questionnaires and the relationship between clinical/statistical clusters and symptoms fluctuations assessed. Finally, patients will be reassessed at 6 and 12 months, and the 12 month incidence of selected outcomes (frequency of exacerbations, use of health care resources) within clusters will be computed.
On May 27 enrollees are 97, which conforms to the scheduled recruitment plan. Results are expected to clarify the classificatory and prognostic role of symptoms fluctuations in addition to classical measures of disease status and to compare health status and prognosis of clusters.
Intra-day variations and stability of symptoms over time will likely improve our understanding of phenotypic variability of COPD.
- Copyright ©the authors 2016
