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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.

調査の概要

状態

完了

条件

慢性閉塞性肺疾患

詳細な説明

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.

研究の種類

観察的

入学 (実際)

683

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

50年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

なし

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Patients with Pulmonary Disease, Chronic Obstructive

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
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. 時間枠：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. 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
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 時間枠：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 時間枠：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 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Laboratori Guidotti S.p.A.

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

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

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2016年2月1日

一次修了 (実際)

2017年4月30日

研究の完了 (実際)

2018年6月7日

試験登録日

最初に提出

2017年3月28日

QC基準を満たした最初の提出物

2017年4月3日

最初の投稿 (実際)

2017年4月10日

学習記録の更新

投稿された最後の更新 (実際)

2018年8月22日

QC基準を満たした最後の更新が送信されました

2018年8月21日

最終確認日

2018年8月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

GUID/15/COPD/001

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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