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

2018년 8월 21일 업데이트: 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.

연구 개요

상태

완전한

정황

만성 폐쇄성 폐질환

상세 설명

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.

연구 유형

관찰

등록 (실제)

683

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

50년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

해당 없음

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Patients with Pulmonary Disease, Chronic Obstructive

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
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. 기간: 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. 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
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 기간: 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 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Laboratori Guidotti S.p.A.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2016년 2월 1일

기본 완료 (실제)

2017년 4월 30일

연구 완료 (실제)

2018년 6월 7일

연구 등록 날짜

최초 제출

2017년 3월 28일

QC 기준을 충족하는 최초 제출

2017년 4월 3일

처음 게시됨 (실제)

2017년 4월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 8월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 8월 21일

마지막으로 확인됨

2018년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

GUID/15/COPD/001

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .