Chronic Obstructive Pulmonary Disease Clinical Trial
— STORICOOfficial title:
Observational Study On The Characterization Of 24-Hour Symptoms In Patients With COPD
Verified date | August 2018 |
Source | Laboratori Guidotti S.p.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 683 |
Est. completion date | June 7, 2018 |
Est. primary completion date | April 30, 2017 |
Accepts healthy volunteers | |
Gender | All |
Age group | 50 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale C. Cantù - Pneumologia | Abbiategrasso | Milano |
Italy | Ospedale Ecclesiastico Miulli - Fisiopatologia Respiratoria | Acquaviva delle Fonti | Bari |
Italy | Ospedale INRCA - Clinica Medicina Interna e Geriatria | Ancona | |
Italy | Ospedale Cardinal G.Massaia - Pneumologia | Asti | |
Italy | A.O. San G.Moscati - U.O. Pneumologia | Avellino | |
Italy | Policlinico Consorziale - U.O. M.A.R. | Bari | |
Italy | A.O. G.Rummo - U.O.C. Pneumologia | Benevento | |
Italy | Humanitas Gavazzeni - Pneumologia | Bergamo | |
Italy | A.O.U. Policlinico S.Orsola Malpighi - Pneumologia | Bologna | |
Italy | I.N.R.C.A. Centro per le Broncopneumopatie - Pneumologia Riabilitativa | Casatenovo | Lecco |
Italy | Ospedale S. Maria della Pietà Camilliani - Pneumologia e Fisiologia Respiratoria | Casoria | Napoli |
Italy | Policlinico Universitario Mater Domini - U.O.C. Malattie Apparato Respiratorio | Catanzaro | |
Italy | A.O. Mellino Mellini - U.O. Fisiopatologia Respiratoria | Chiari | Brescia |
Italy | Ospedale di Dolo - U.O.C. Pneumologia | Dolo | Venezia |
Italy | Ospedale Piero Palagi - Fisiopatologia Respiratoria e Riabilitazione Respiratoria | Firenze | |
Italy | Ospedale D'Avanzo - MAR 4 Univ. | Foggia | |
Italy | Ospedale Erba Renaldi - Medicina Interna | Menaggio | Como |
Italy | Ospedale Papardo - Malattie Apparato Respiratorio | Messina | |
Italy | A.O. San Carlo Borromeo - Pneumologia | Milano | |
Italy | Ospedale Niguarda - Pneumologia | Milano | |
Italy | A.O.U. Policlinico - Clinica Malattie Apparato Respiratorio | Modena | |
Italy | Ospedale Maggiore - U.O. Medicina | Modica | Ragusa |
Italy | Clinica Padre Pio - Medicina | Mondragone | Caserta |
Italy | Ospedale San Gerardo - Clinica Pneumologica | Monza | Monza E Brianza |
Italy | A.O.U. Seconda Università Napoli - UOSD Serv.Prevenz.Mal.Broncopolm. | Napoli | |
Italy | Ospedale Zonchello - U.O.C. Pneumologia | Nuoro | |
Italy | A.O.U. San Luigi Gonzaga - Malattie Apparato Respiratorio 1 | Orbassano | Torino |
Italy | Consiglio Nazionale delle Ricerche - Istituto di Biomedicina ed Immunologia Molecolare | Palermo | |
Italy | Fondazione Toscana G. Monasterio - U.O.C. Pneumologia | Pisa | |
Italy | Ospedale Apicella - U.O.C. Pneumologia | Pollena Trocchia | Napoli |
Italy | Azienda Ospedaliera Sant'Andrea - U.O.C. Pneumologia | Roma | |
Italy | Ospedale San Filippo Neri - U.O.C. Pneumologia | Roma | |
Italy | Ospedale San Giovanni Addolorata - U.O.C. Malattie Apparato Respiratorio | Roma | |
Italy | Ospedale Sandro Pertini - S.C. Pneumologia | Roma | |
Italy | A.O.U. San Giovanni di Dio Ruggi d'Aragona - Pneumologia universitaria | Salerno | |
Italy | Ospedale di Sestri Levante - Pneumologia | Sestri Levante | Genova |
Italy | Ospedale Mazzini - Malattie Apparato Respiratorio | Teramo | |
Italy | Azienda Unità Sanitaria Locale Umbria n.2 - U.O. Pneumologia Terr. | Terni | |
Italy | Ospedale Martini - Pneumologia | Torino | |
Italy | Ospedale Civile - Pneumologia | Vittorio Veneto | Treviso |
Lead Sponsor | Collaborator |
---|---|
Laboratori Guidotti S.p.A. |
Italy,
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. — View Citation
Miravitlles M, Worth H, Soler Cataluña JJ, Price D, De Benedetto F, Roche N, Godtfredsen NS, van der Molen T, Löfdahl CG, Padullés 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;15:122. doi: 10.1186/s12931-014-0122-1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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 | |
Primary | 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. | 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 | |
Secondary | 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 | 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 | |
Secondary | 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 | 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 | |
Secondary | Healthcare resources utilization in a cohort of Italian patients with COPD during 12-month observation, globally and by phenotypes | 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 |
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