Clinical trial NCT03105999: Observational Study On The Characterization Of 24-Hour Symptoms In Patients With COPD
Official title: Observational Study On The Characterization Of 24-Hour Symptoms In Patients With COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Laboratori Guidotti S.p.A.
Sponsor class: INDUSTRY
First posted: 2017-04-10
Enrollment: 683
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Pulmonary Disease, Chronic Obstructive

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.

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

Primary outcomes:
measure: 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.
timeFrame: At baseline
measure: 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.
timeFrame: 6 and 12 months
Secondary outcomes:
measure: 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
timeFrame: At baseline
measure: 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
timeFrame: 6 and 12 months
measure: Healthcare resources utilization in a cohort of Italian patients with COPD during 12-month observation, globally and by phenotypes
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Acquaviva delle Fonti
country: Italy
facility: Ospedale Ecclesiastico Miulli - Fisiopatologia Respiratoria
state: Bari
city: Chiari
country: Italy
facility: A.O. Mellino Mellini - U.O. Fisiopatologia Respiratoria
state: Brescia
city: Mondragone
country: Italy
facility: Clinica Padre Pio - Medicina
state: Caserta
city: Menaggio
country: Italy
facility: Ospedale Erba Renaldi - Medicina Interna
state: Como
city: Sestri Levante
country: Italy
facility: Ospedale di Sestri Levante - Pneumologia
state: Genova
city: Casatenovo
country: Italy
facility: I.N.R.C.A. Centro per le Broncopneumopatie - Pneumologia Riabilitativa
state: Lecco
city: Abbiategrasso
country: Italy
facility: Ospedale C. Cantù - Pneumologia
state: Milano
city: Monza
country: Italy
facility: Ospedale San Gerardo - Clinica Pneumologica
state: Monza E Brianza
city: Casoria
country: Italy
facility: Ospedale S. Maria della Pietà Camilliani - Pneumologia e Fisiologia Respiratoria
state: Napoli
city: Pollena Trocchia
country: Italy
facility: Ospedale Apicella - U.O.C. Pneumologia
state: Napoli
city: Modica
country: Italy
facility: Ospedale Maggiore - U.O. Medicina
state: Ragusa
city: Orbassano
country: Italy
facility: A.O.U. San Luigi Gonzaga - Malattie Apparato Respiratorio 1
state: Torino
city: Vittorio Veneto
country: Italy
facility: Ospedale Civile - Pneumologia
state: Treviso
city: Dolo
country: Italy
facility: Ospedale di Dolo - U.O.C. Pneumologia
state: Venezia
city: Ancona
country: Italy
facility: Ospedale INRCA - Clinica Medicina Interna e Geriatria
city: Asti
country: Italy
facility: Ospedale Cardinal G.Massaia - Pneumologia
city: Avellino
country: Italy
facility: A.O. San G.Moscati - U.O. Pneumologia
city: Bari
country: Italy
facility: Policlinico Consorziale - U.O. M.A.R.
city: Benevento
country: Italy
facility: A.O. G.Rummo - U.O.C. Pneumologia
city: Bergamo
country: Italy
facility: Humanitas Gavazzeni - Pneumologia
city: Bologna
country: Italy
facility: A.O.U. Policlinico S.Orsola Malpighi - Pneumologia
city: Catanzaro
country: Italy
facility: Policlinico Universitario Mater Domini - U.O.C. Malattie Apparato Respiratorio
city: Firenze
country: Italy
facility: Ospedale Piero Palagi - Fisiopatologia Respiratoria e Riabilitazione Respiratoria
city: Foggia
country: Italy
facility: Ospedale D'Avanzo - MAR 4 Univ.
city: Messina
country: Italy
facility: Ospedale Papardo - Malattie Apparato Respiratorio
city: Milano
country: Italy
facility: A.O. San Carlo Borromeo - Pneumologia
city: Milano
country: Italy
facility: Ospedale Niguarda - Pneumologia
city: Modena
country: Italy
facility: A.O.U. Policlinico - Clinica Malattie Apparato Respiratorio
city: Napoli
country: Italy
facility: A.O.U. Seconda Università Napoli - UOSD Serv.Prevenz.Mal.Broncopolm.
city: Nuoro
country: Italy
facility: Ospedale Zonchello - U.O.C. Pneumologia
city: Palermo
country: Italy
facility: Consiglio Nazionale delle Ricerche - Istituto di Biomedicina ed Immunologia Molecolare
city: Pisa
country: Italy
facility: Fondazione Toscana G. Monasterio - U.O.C. Pneumologia
city: Roma
country: Italy
facility: Ospedale San Filippo Neri - U.O.C. Pneumologia
city: Roma
country: Italy
facility: Ospedale Sandro Pertini - S.C. Pneumologia
city: Roma
country: Italy
facility: Ospedale San Giovanni Addolorata - U.O.C. Malattie Apparato Respiratorio
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea - U.O.C. Pneumologia
city: Salerno
country: Italy
facility: A.O.U. San Giovanni di Dio Ruggi d'Aragona - Pneumologia universitaria
city: Teramo
country: Italy
facility: Ospedale Mazzini - Malattie Apparato Respiratorio
city: Terni
country: Italy
facility: Azienda Unità Sanitaria Locale Umbria n.2 - U.O. Pneumologia Terr.
city: Torino
country: Italy
facility: Ospedale Martini - Pneumologia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.