Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

21 sierpnia 2018 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

683

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

50 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie dotyczy

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Patients with Pulmonary Disease, Chronic Obstructive

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
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.
Ramy czasowe: 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.
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Laboratori Guidotti S.p.A.

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 lutego 2016

Zakończenie podstawowe (Rzeczywisty)

30 kwietnia 2017

Ukończenie studiów (Rzeczywisty)

7 czerwca 2018

Daty rejestracji na studia

Pierwszy przesłany

28 marca 2017

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 kwietnia 2017

Pierwszy wysłany (Rzeczywisty)

10 kwietnia 2017

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 sierpnia 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 sierpnia 2018

Ostatnia weryfikacja

1 sierpnia 2018

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • GUID/15/COPD/001

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Przewlekła obturacyjna choroba płuc

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Qatar

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj