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

NCT03105999 | Completed

• 1 other identifier: GUID/15/COPD/001
• Study Type: observational
• Target: 683
• Locations: 1 country
• Sites: 40

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Frequency of early-morning, day- and night-time COPD symptoms according to phenotypes in a cohort of Italian patients with stable COPD. Symptoms will be evaluated by means of the Night-Time, Morning and Day-Time symptoms of COPD questionnaire.

  The frequency of early-morning, day and night-time symptoms at enrolment will be assessed based on the questions of the "Night-time, Morning and Day-time Symptoms of COPD questionnaire". It will be calculated within each class of phenotype as the ratio between the number of patients with at least 1 (early-morning, day and night-time) symptom in the week before enrolment and the total number of evaluable patients in the class. Three proportions will be calculated (for early-morning, day and night-time). The frequency of early-morning, day and night-time symptoms severity will be described too: for this reason, the proportion of mild, moderate, severe and very severe early-morning, day- and night-time symptoms in the week before enrollment will be provided. The frequency of specific COPD symptoms (breathlessness, coughing, bringing up phlegm or mucus, wheezing, chest tightness, chest congestion) will be also provided according to phenotypes.

  At baseline

• 12-month frequency and change from baseline of early-morning, day- and night-time COPD symptoms according to phenotypes measured at enrolment. Symptoms will be evaluated by means of the Night-Time, Morning and Day-Time symptoms of COPD questionnaire.

  Phenotypes will be defined as per clinician judgment at enrollment. The proportion of patients changing phenotype during one-year observation provided. Within each class, the frequency of early-morning, day and night-time symptoms at each follow up visit will be calculated as the ratio between the number of patients with at least 1 symptom in the week preceding the follow up visit and the total number of evaluable patients in the class of phenotype with available "Night-time, Morning and Day-time Symptoms of COPD questionnaire" (COPD questionnaire) at follow up visit. For each patient the number of early-morning, day- and night-time symptom at each study visit together with the variation between visits will be calculated separately in the groups of patients according to baseline phenotype. The variation will be calculated as the difference between the number of symptoms at 12- (6-) month follow up and at baseline and between the number of symptoms at 12- and at 6-month follow up.

  6 and 12 months

Secondary Outcomes (3)

• Association between COPD symptoms frequency at enrolment and outcomes: • dyspnea level • disease severity (stages A to D GOLD 2014 criteria) • quality of life • physical activity • quality of sleep • exacerbations • depression and anxiety

  At baseline

• 12-month variation of the following outcomes according to phenotypes measured at enrolment: • dyspnea level • quality of life • physical activity • quality of sleep • frequency and severity of exacerbations • level of depression and anxiety

  6 and 12 months

• Healthcare resources utilization in a cohort of Italian patients with COPD during 12-month observation, globally and by phenotypes

  6 and 12 months

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Pulmonary Disease, Chronic Obstructive

You may qualify if:

• Male and female outpatients aged ≥ 50
• Diagnosis of stable COPD at least 12 months before the enrolment according to the GOLD 2014 criteria (stages A to D)
• Current smokers or ex-smokers with a smoking history of ≥ 10 pack-years (e.g. 10 pack years = 1 pack /day x 10 years, or ½ pack/day x 20 years. An ex-smoker will be defined as a subject who has not smoked for ≥6 months at baseline)
• Patients without any exacerbation at the baseline (enrolment visit) and in the last month prior to the enrolment visit
• Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the questionnaires required by the protocol
• Patients who signed, after explanation, a written informed consent and privacy form, to confirm they understood the purpose of the study, and the procedure required in the study, and that they are willing to participate in the study.

You may not qualify if:

• Patients participating in a clinical trial at enrolment
• Patients who had changed active, dosage or frequency of administration of the maintenance therapy of COPD treatment regimen in the last 3 months prior to the enrolment visit (baseline)
• Patients with a previous diagnosis of asthma, sleep apnea syndrome or other chronic respiratory disease different from COPD or other relevant medical conditions (on clinician's opinion) that will reduce the life expectancy of less than 3 years (Charlson index not including COPD \>3)
• Patients under long-term oxygen therapy
• Study exit criteria:
• Withdraw of informed consent to participate in the study
• Diagnosis of asthma, sleep apnea syndrome or other chronic respiratory disease different from COPD
• Death

Sponsors & Collaborators

• Laboratori Guidotti S.p.A.: lead

Study Sites (40)

Ospedale Ecclesiastico Miulli - Fisiopatologia Respiratoria

Acquaviva delle Fonti, Bari, 70021, Italy

Location

A.O. Mellino Mellini - U.O. Fisiopatologia Respiratoria

Chiari, Brescia, 25032, Italy

Location

Clinica Padre Pio - Medicina

Mondragone, Caserta, 81034, Italy

Location

Ospedale Erba Renaldi - Medicina Interna

Menaggio, Como, 22017, Italy

Location

Ospedale di Sestri Levante - Pneumologia

Sestri Levante, Genova, 16039, Italy

Location

I.N.R.C.A. Centro per le Broncopneumopatie - Pneumologia Riabilitativa

Casatenovo, Lecco, 23880, Italy

Location

Ospedale C. Cantù - Pneumologia

Abbiategrasso, Milano, 20081, Italy

Location

Ospedale San Gerardo - Clinica Pneumologica

Monza, Monza E Brianza, 20900, Italy

Location

Ospedale S. Maria della Pietà Camilliani - Pneumologia e Fisiologia Respiratoria

Casoria, Napoli, 80026, Italy

Location

Ospedale Apicella - U.O.C. Pneumologia

Pollena Trocchia, Napoli, 80040, Italy

Location

Ospedale Maggiore - U.O. Medicina

Modica, Ragusa, 97015, Italy

Location

A.O.U. San Luigi Gonzaga - Malattie Apparato Respiratorio 1

Orbassano, Torino, 10043, Italy

Location

Ospedale Civile - Pneumologia

Vittorio Veneto, Treviso, 31029, Italy

Location

Ospedale di Dolo - U.O.C. Pneumologia

Dolo, Venezia, Italy

Location

Ospedale INRCA - Clinica Medicina Interna e Geriatria

Ancona, 60127, Italy

Location

Ospedale Cardinal G.Massaia - Pneumologia

Asti, 14100, Italy

Location

A.O. San G.Moscati - U.O. Pneumologia

Avellino, 83100, Italy

Location

Policlinico Consorziale - U.O. M.A.R.

Bari, 70124, Italy

Location

A.O. G.Rummo - U.O.C. Pneumologia

Benevento, 82100, Italy

Location

Humanitas Gavazzeni - Pneumologia

Bergamo, 24125, Italy

Location

A.O.U. Policlinico S.Orsola Malpighi - Pneumologia

Bologna, 40185, Italy

Location

Policlinico Universitario Mater Domini - U.O.C. Malattie Apparato Respiratorio

Catanzaro, 88100, Italy

Location

Ospedale Piero Palagi - Fisiopatologia Respiratoria e Riabilitazione Respiratoria

Florence, 50125, Italy

Location

Ospedale D'Avanzo - MAR 4 Univ.

Foggia, 71122, Italy

Location

Ospedale Papardo - Malattie Apparato Respiratorio

Messina, 98158, Italy

Location

A.O. San Carlo Borromeo - Pneumologia

Milan, 20153, Italy

Location

Ospedale Niguarda - Pneumologia

Milan, 20162, Italy

Location

A.O.U. Policlinico - Clinica Malattie Apparato Respiratorio

Modena, 41124, Italy

Location

A.O.U. Seconda Università Napoli - UOSD Serv.Prevenz.Mal.Broncopolm.

Napoli, 80138, Italy

Location

Ospedale Zonchello - U.O.C. Pneumologia

Nuoro, Italy

Location

Consiglio Nazionale delle Ricerche - Istituto di Biomedicina ed Immunologia Molecolare

Palermo, 90146, Italy

Location

Fondazione Toscana G. Monasterio - U.O.C. Pneumologia

Pisa, 56124, Italy

Location

Ospedale San Filippo Neri - U.O.C. Pneumologia

Roma, 00135, Italy

Location

Ospedale Sandro Pertini - S.C. Pneumologia

Roma, 00157, Italy

Location

Ospedale San Giovanni Addolorata - U.O.C. Malattie Apparato Respiratorio

Roma, 00184, Italy

Location

Azienda Ospedaliera Sant'Andrea - U.O.C. Pneumologia

Roma, 00189, Italy

Location

A.O.U. San Giovanni di Dio Ruggi d'Aragona - Pneumologia universitaria

Salerno, 84131, Italy

Location

Ospedale Mazzini - Malattie Apparato Respiratorio

Teramo, 64100, Italy

Location

Azienda Unità Sanitaria Locale Umbria n.2 - U.O. Pneumologia Terr.

Terni, 05100, Italy

Location

Ospedale Martini - Pneumologia

Torino, 10141, Italy

Location

Related Publications (7)

• Kessler R, Partridge MR, Miravitlles M, Cazzola M, Vogelmeier C, Leynaud D, Ostinelli J. Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J. 2011 Feb;37(2):264-72. doi: 10.1183/09031936.00051110. Epub 2010 Nov 29.

  PMID: 21115606 BACKGROUND

• Miravitlles M, Worth H, Soler Cataluna JJ, Price D, De Benedetto F, Roche N, Godtfredsen NS, van der Molen T, Lofdahl CG, Padulles L, Ribera A. Observational study to characterise 24-hour COPD symptoms and their relationship with patient-reported outcomes: results from the ASSESS study. Respir Res. 2014 Oct 21;15(1):122. doi: 10.1186/s12931-014-0122-1.

  PMID: 25331383 BACKGROUND

• Incalzi RA, Blasi F, Canonica GW, Foschino MP, Prediletto R, Simoni L, Ori A, Giovannetti C, Barsanti S, Scichilone N. The Prescribing Practice for COPD: Relationship to Circadian Rhythm, Disease Severity, and Clinical Phenotype in the STORICO Observational Study. Adv Ther. 2022 Dec;39(12):5582-5589. doi: 10.1007/s12325-022-02331-x. Epub 2022 Oct 11.

  PMID: 36219388 DERIVED

• Blasi F, Antonelli Incalzi R, Canonica GW, Schino P, Cuttitta G, Zullo A, Ori A, Scichilone N; STORICO study group. 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. Int J Chron Obstruct Pulmon Dis. 2021 Jul 21;16:2133-2148. doi: 10.2147/COPD.S310428. eCollection 2021.

  PMID: 34345170 DERIVED

• Antonelli Incalzi R, Canonica GW, Scichilone N, Rizzoli S, Simoni L, Blasi F; STORICO study group. The COPD multi-dimensional phenotype: A new classification from the STORICO Italian observational study. PLoS One. 2019 Sep 13;14(9):e0221889. doi: 10.1371/journal.pone.0221889. eCollection 2019.

  PMID: 31518364 DERIVED

• Scichilone N, Antonelli Incalzi R, Blasi F, Schino P, Cuttitta G, Zullo A, Ori A, Canonica GW; STORICO study group. Circadian rhythm of COPD symptoms in clinically based phenotypes. Results from the STORICO Italian observational study. BMC Pulm Med. 2019 Sep 9;19(1):171. doi: 10.1186/s12890-019-0935-2.

  PMID: 31500607 DERIVED

• Canonica GW, Blasi F, Scichilone N, Simoni L, Zullo A, Giovannetti C, Briguglio C, Barsanti S, Antonelli Incalzi R; STORICO study group. Characterization of circadian COPD symptoms by phenotype: Methodology of the STORICO observational study. Eur J Intern Med. 2017 Sep;43:62-68. doi: 10.1016/j.ejim.2017.05.021. Epub 2017 May 31.

  PMID: 28576398 DERIVED

Related Links

• 1 Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 10, 2017
• Study Start: February 1, 2016
• Primary Completion: April 30, 2017
• Study Completion: June 7, 2018
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

IT (40)