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

2018年8月21日更新者：Laboratori Guidotti S.p.A.

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.

研究概览

地位

完全的

条件

慢性阻塞性肺疾病

详细说明

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.

研究类型

观察性的

注册 (实际的)

683

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

意大利
- - Ancona、意大利、60127
    - Ospedale INRCA - Clinica Medicina Interna e Geriatria
  - Asti、意大利、14100
    - Ospedale Cardinal G.Massaia - Pneumologia
  - Avellino、意大利、83100
    - A.O. San G.Moscati - U.O. Pneumologia
  - Bari、意大利、70124
    - Policlinico Consorziale - U.O. M.A.R.
  - Benevento、意大利、82100
    - A.O. G.Rummo - U.O.C. Pneumologia
  - Bergamo、意大利、24125
    - Humanitas Gavazzeni - Pneumologia
  - Bologna、意大利、40185
    - A.O.U. Policlinico S.Orsola Malpighi - Pneumologia
  - Catanzaro、意大利、88100
    - Policlinico Universitario Mater Domini - U.O.C. Malattie Apparato Respiratorio
  - Firenze、意大利、50125
    - Ospedale Piero Palagi - Fisiopatologia Respiratoria e Riabilitazione Respiratoria
  - Foggia、意大利、71122
    - Ospedale D'Avanzo - MAR 4 Univ.
  - Messina、意大利、98158
    - Ospedale Papardo - Malattie Apparato Respiratorio
  - Milano、意大利、20153
    - A.O. San Carlo Borromeo - Pneumologia
  - Milano、意大利、20162
    - Ospedale Niguarda - Pneumologia
  - Modena、意大利、41124
    - A.O.U. Policlinico - Clinica Malattie Apparato Respiratorio
  - Napoli、意大利、80138
    - A.O.U. Seconda Università Napoli - UOSD Serv.Prevenz.Mal.Broncopolm.
  - Nuoro、意大利
    - Ospedale Zonchello - U.O.C. Pneumologia
  - Palermo、意大利、90146
    - Consiglio Nazionale delle Ricerche - Istituto di Biomedicina ed Immunologia Molecolare
  - Pisa、意大利、56124
    - Fondazione Toscana G. Monasterio - U.O.C. Pneumologia
  - Roma、意大利、00135
    - Ospedale San Filippo Neri - U.O.C. Pneumologia
  - Roma、意大利、00157
    - Ospedale Sandro Pertini - S.C. Pneumologia
  - Roma、意大利、00184
    - Ospedale San Giovanni Addolorata - U.O.C. Malattie Apparato Respiratorio
  - Roma、意大利、00189
    - Azienda Ospedaliera Sant'Andrea - U.O.C. Pneumologia
  - Salerno、意大利、84131
    - A.O.U. San Giovanni di Dio Ruggi d'Aragona - Pneumologia universitaria
  - Teramo、意大利、64100
    - Ospedale Mazzini - Malattie Apparato Respiratorio
  - Terni、意大利、05100
    - Azienda Unità Sanitaria Locale Umbria n.2 - U.O. Pneumologia Terr.
  - Torino、意大利、10141
    - Ospedale Martini - Pneumologia
- Bari
  - Acquaviva delle Fonti、Bari、意大利、70021
    - Ospedale Ecclesiastico Miulli - Fisiopatologia Respiratoria
- Brescia
  - Chiari、Brescia、意大利、25032
    - A.O. Mellino Mellini - U.O. Fisiopatologia Respiratoria
- Caserta
  - Mondragone、Caserta、意大利、81034
    - Clinica Padre Pio - Medicina
- Como
  - Menaggio、Como、意大利、22017
    - Ospedale Erba Renaldi - Medicina Interna
- Genova
  - Sestri Levante、Genova、意大利、16039
    - Ospedale di Sestri Levante - Pneumologia
- Lecco
  - Casatenovo、Lecco、意大利、23880
    - I.N.R.C.A. Centro per le Broncopneumopatie - Pneumologia Riabilitativa
- Milano
  - Abbiategrasso、Milano、意大利、20081
    - Ospedale C. Cantù - Pneumologia
- Monza E Brianza
  - Monza、Monza E Brianza、意大利、20900
    - Ospedale San Gerardo - Clinica Pneumologica
- Napoli
  - Casoria、Napoli、意大利、80026
    - Ospedale S. Maria della Pietà Camilliani - Pneumologia e Fisiologia Respiratoria
  - Pollena Trocchia、Napoli、意大利、80040
    - Ospedale Apicella - U.O.C. Pneumologia
- Ragusa
  - Modica、Ragusa、意大利、97015
    - Ospedale Maggiore - U.O. Medicina
- Torino
  - Orbassano、Torino、意大利、10043
    - A.O.U. San Luigi Gonzaga - Malattie Apparato Respiratorio 1
- Treviso
  - Vittorio Veneto、Treviso、意大利、31029
    - Ospedale Civile - Pneumologia
- Venezia
  - Dolo、Venezia、意大利
    - Ospedale di Dolo - U.O.C. Pneumologia

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年及以上 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients with Pulmonary Disease, Chronic Obstructive

描述

Inclusion Criteria:

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.

Exclusion Criteria:

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
Inclusion in a clinical trial

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
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. 大体时间：At baseline	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. 大体时间：6 and 12 months	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

次要结果测量

结果测量	措施说明	大体时间
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 大体时间：At baseline	The association at enrolment will be evaluated by calculating the frequency of symptoms in the groups of patients according to disease severity (A, B, C, D in GOLD 2014 guideline). Frequency of symptoms will be provided according to number of exacerbations in the year before baseline (0-1 vs ≥2) and to severity of exacerbations in the year before. Chi-squared tests (or Fisher exact tests if appropriate) will be provided too. The descriptive statistics of dyspnea level (mMRC score), quality of life (SGRQ symptoms, activity and impacts on daily life scores and total score), physical activity (IPAQ walking, moderate-intensity, vigorous-intensity activity and total scores), quality of sleep (CASIS total score), level of depression and anxiety (HADS anxiety, depression and total score) at enrollment in patients with vs without at least one symptom will be provided; the association between symptoms and outcomes will be evaluated by means of student T-test.	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 大体时间：6 and 12 months	At each follow up visit the following outcomes will be described and the variation (i.e. the difference) between each follow-up visit and since enrolment visit will be calculated by patient: dyspnea level (mMRC score), quality of life (SGRQ symptoms, activity and impacts on daily life scores and total score), physical activity (IPAQ walking, moderate-intensity, vigorous-intensity activity and total scores), quality of sleep (CASIS total score), level of depression and anxiety (HADS anxiety, depression and total score), number of exacerbations and of severe exacerbations. Such differences will be summarized by means of descriptive statistics globally and stratified by phenotype assessed at enrollment.	6 and 12 months
Healthcare resources utilization in a cohort of Italian patients with COPD during 12-month observation, globally and by phenotypes 大体时间：6 and 12 months	The healthcare resources consumption will take into consideration the following events related both to management of COPD and to COPD exacerbations: inpatients and outpatients hospitalization, accesses to emergency department, GP and outpatient visits, laboratory tests, spirometry, pharmacological (LABA, LAMA, SABA, SAMA, etc.) and non-pharmacological therapies (rehabilitation) occurred/administered during study period. Medications for adverse events will be considered too. The annual direct healthcare resource consumption will be provided by means of descriptive statistics of the variables mentioned above. Analyses will be performed on the whole sample and stratified by phenotype.	6 and 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Laboratori Guidotti S.p.A.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

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

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年2月1日

初级完成 (实际的)

2017年4月30日

研究完成 (实际的)

2018年6月7日

研究注册日期

首次提交

2017年3月28日

首先提交符合 QC 标准的

2017年4月3日

首次发布 (实际的)

2017年4月10日

研究记录更新

最后更新发布 (实际的)

2018年8月22日

上次提交的符合 QC 标准的更新

2018年8月21日

最后验证

2018年8月1日