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

NCT ID: NCT03105999

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 683 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2018-06-07

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.

Detailed Description

Primary objective - cross-sectional phase 1. To describe the frequency of early-morning, day- and night-time COPD symptoms according to phenotypes in a cohort of Italian patients with stable COPD (GOLD 2014 criteria). Symptoms will be evaluated by means of the Night-Time, Morning and Day-Time symptoms of COPD questionnaire. Primary objective - longitudinal phase 1. To describe the 12-month frequency and evolution 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. Secondary objectives - cross sectional phase 1. To evaluate the association between early-morning, day- and night-time symptoms frequency at enrolment and the following outcomes: • dyspnea level • disease severity, as defined by the GOLD 2014 criteria (stages A to D) • quality of life • physical activity • quality of sleep • frequency and severity of exacerbations • level of depression and anxiety Secondary objectives - longitudinal phase 1. To describe the 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 2. To describe the healthcare resources utilization in a cohort of Italian patients with COPD during 12-month observation, globally and by phenotypes. STUDY DESIGN: Italian observational cohort multicentre study in patients with stable COPD PLANNED NUMBER OF SUBJECTS: 600 patients STUDY PROCEDURE The study plan foresees: -Enrolment visit [Baseline visit (V1)] -A control visit at 6 months since Baseline at the investigational site (V2) -A final visit at 12 months since Baseline at the investigational site (V3) The clinical staff at the investigational sites will collect retrospectively all the necessary information about the medical history of the patient to confirm his-her eligibility. Patients confirmed with a diagnosis of stable COPD will be evaluated at enrolment visit and, if eligible, they will be asked to provide a written and signed privacy and informed consent form. The diagnosis of stable COPD should be compliant with 2014 GOLD criteria (stages A to D). At enrolment visit, patients will be asked to complete questionnaires for early-morning, day- and night-time symptoms, level of dyspnea, quality of life, physical activity, anxiety and depression levels, sleep quality, as well as to provide data on lifestyle, such as smoking. The investigator will be requested to complete study case report forms (CRFs) recording specified baseline information (demography data, medical history and comorbidities, COPD phenotype, ongoing treatments for COPD). Finally patients will perform a spirometry (baseline, lung volumes, bronchodilation test and CO diffusion) according to routine clinical practice. No additional mandated interventions on top of routinely performed physician visits, examinations or treatments will be required. Except the completion of the questionnaires, there are no other study-prescribed procedures. Any procedure ordered by the physician during this study will be one that is appropriate to the routine clinical care delivered to the COPD patients at the discretion of the physician. After 6 and 12 months, the same information as in the enrolment visits will be collected, excluding demographic data, to ascertain any changes in the outcomes of interest, including any exacerbations and medical healthcare resources utilization in the period between the visits. At follow up visits, patients will undergo the same procedures (spirometry) performed at the enrolment visit. For the entire period of observation, data regarding Adverse Event/Serious Adverse Event will be collected.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Male and female outpatients aged ≥ 50

2. Diagnosis of stable COPD at least 12 months before the enrolment according to the GOLD 2014 criteria (stages A to D)

3. 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)

4. Patients without any exacerbation at the baseline (enrolment visit) and in the last month prior to the enrolment visit

5. Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the questionnaires required by the protocol

6. 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.

Exclusion Criteria

1. Patients participating in a clinical trial at enrolment

2. 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)

3. 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)

4. Patients under long-term oxygen therapy

Study exit criteria:

1. Withdraw of informed consent to participate in the study

2. Diagnosis of asthma, sleep apnea syndrome or other chronic respiratory disease different from COPD

3. Death

4. Inclusion in a clinical trial

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratori Guidotti S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ospedale Ecclesiastico Miulli - Fisiopatologia Respiratoria

Acquaviva delle Fonti, Bari, Italy

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

Chiari, Brescia, Italy

Clinica Padre Pio - Medicina

Mondragone, Caserta, Italy

Ospedale Erba Renaldi - Medicina Interna

Menaggio, Como, Italy

Ospedale di Sestri Levante - Pneumologia

Sestri Levante, Genova, Italy

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

Casatenovo, Lecco, Italy

Ospedale C. Cantù - Pneumologia

Abbiategrasso, Milano, Italy

Ospedale San Gerardo - Clinica Pneumologica

Monza, Monza E Brianza, Italy

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

Casoria, Napoli, Italy

Ospedale Apicella - U.O.C. Pneumologia

Pollena Trocchia, Napoli, Italy

Ospedale Maggiore - U.O. Medicina

Modica, Ragusa, Italy

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

Orbassano, Torino, Italy

Ospedale Civile - Pneumologia

Vittorio Veneto, Treviso, Italy

Ospedale di Dolo - U.O.C. Pneumologia

Dolo, Venezia, Italy

Ospedale INRCA - Clinica Medicina Interna e Geriatria

Ancona, , Italy

Ospedale Cardinal G.Massaia - Pneumologia

Asti, , Italy

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

Avellino, , Italy

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

Bari, , Italy

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

Benevento, , Italy

Humanitas Gavazzeni - Pneumologia

Bergamo, , Italy

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

Bologna, , Italy

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

Catanzaro, , Italy

Ospedale Piero Palagi - Fisiopatologia Respiratoria e Riabilitazione Respiratoria

Florence, , Italy

Ospedale D'Avanzo - MAR 4 Univ.

Foggia, , Italy

Ospedale Papardo - Malattie Apparato Respiratorio

Messina, , Italy

A.O. San Carlo Borromeo - Pneumologia

Milan, , Italy

Ospedale Niguarda - Pneumologia

Milan, , Italy

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

Modena, , Italy

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

Napoli, , Italy

Ospedale Zonchello - U.O.C. Pneumologia

Nuoro, , Italy

Consiglio Nazionale delle Ricerche - Istituto di Biomedicina ed Immunologia Molecolare

Palermo, , Italy

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

Pisa, , Italy

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

Roma, , Italy

Ospedale Sandro Pertini - S.C. Pneumologia

Roma, , Italy

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

Roma, , Italy

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

Roma, , Italy

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

Salerno, , Italy

Ospedale Mazzini - Malattie Apparato Respiratorio

Teramo, , Italy

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

Terni, , Italy

Ospedale Martini - Pneumologia

Torino, , Italy

Countries

Italy

References

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Reference Type: DERIVED

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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.

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Related Links

http://www.goldcopd.org

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

Other Identifiers

GUID/15/COPD/001

Identifier Type: -

Identifier Source: org_study_id