NCT03105999: STORICO

Observational Study On The Characterization Of 24-Hour Symptoms In Patients With COPD

Completed Last updated 22 August 2018

What this trial tests

trial in Chronic Obstructive Pulmonary Disease in 683 participants. Completed in 7 June 2018.

Timeline

1 February 2016

Primary endpoint
30 April 2017

7 June 2018

Quick facts

Lead sponsor	Laboratori Guidotti S.p.A.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	683
Start date	1 February 2016
Primary completion	30 April 2017
Estimated completion	7 June 2018
Sites	40 locations across Italy

Conditions studied

• Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →

Sponsor

Laboratori Guidotti S.p.A.

Who can join

50 and older, any sex, with Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. The objective of the STORICO study is to quantify the intra-day fluctuation of symptoms and to verify whether it: marks selected COPD phenotypes and is stable over time. STORICO is an observational prospective cohort multicenter study. 600 COPD patients \>50 years will be enrolled. The multidimensional assessment will cover pattern of symptoms, complete spirometry and DLCO (Diffusing capacity of Lung for Carbon Monoxide ), comorbidity and health status. Based on clinical data, patients will be grouped in clinical phenotypes. 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) will be computed. 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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Circadian rhythm of COPD symptoms in clinically based phenotypes. Results from the STORICO Italian observational study.
   Scichilone N, Antonelli Incalzi R, Blasi F, Schino P, et al · · 2019 · cited 11× · PMID 31500607 · DOI 10.1186/s12890-019-0935-2
2. Characterization of circadian COPD symptoms by phenotype: Methodology of the STORICO observational study.
   Canonica GW, Blasi F, Scichilone N, Simoni L, et al · · 2017 · cited 11× · PMID 28576398 · DOI 10.1016/j.ejim.2017.05.021
3. The COPD multi-dimensional phenotype: A new classification from the STORICO Italian observational study.
   Antonelli Incalzi R, Canonica GW, Scichilone N, Rizzoli S, et al · · 2019 · cited 5× · PMID 31518364 · DOI 10.1371/journal.pone.0221889
4. One-Year Evolution of Symptoms and Health Status of the COPD Multi-Dimensional Phenotypes: Results from the Follow-Up of the STORICO Observational Study.
   Incalzi RA, Blasi F, Scichilone N, Zullo A, et al · · 2021 · cited 3× · PMID 33907389 · DOI 10.2147/copd.s289697
5. The Prescribing Practice for COPD: Relationship to Circadian Rhythm, Disease Severity, and Clinical Phenotype in the STORICO Observational Study.
   Incalzi RA, Blasi F, Canonica GW, Foschino MP, et al · · 2022 · cited 2× · PMID 36219388 · DOI 10.1007/s12325-022-02331-x
6. Clinical Evolution and Quality of Life in Clinically Based COPD Chronic Bronchitic and Emphysematous Phenotypes: Results from the 1-Year Follow-Up of the STORICO Italian Observational Study.
   Blasi F, Antonelli Incalzi R, Canonica GW, Schino P, et al · · 2021 · PMID 34345170 · DOI 10.2147/copd.s310428