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Chronic Obstructive Pulmonary DiseaseSTORICONCT03105999

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

An observational study of Chronic Obstructive Pulmonary Disease, run by Laboratori Guidotti S.p.A. at 40 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
How many people
683 participants
Where
40 sitesItaly
Study dates
1 Feb 2016to 7 Jun 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients with Pulmonary Disease, Chronic Obstructive

Who may be able to join

  • 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.

Who cannot join

  • 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
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  • Diagnosis of asthma, sleep apnea syndrome or other chronic respiratory disease different from COPD
  • Death
  • Inclusion in a clinical trial

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

Italy40 sites

  • Ospedale C. Cantù - Pneumologia

    Abbiategrasso, Milano, 20081

  • Ospedale Ecclesiastico Miulli - Fisiopatologia Respiratoria

    Acquaviva delle Fonti, Bari, 70021

  • Ospedale INRCA - Clinica Medicina Interna e Geriatria

    Ancona, 60127

  • Ospedale Cardinal G.Massaia - Pneumologia

    Asti, 14100

  • A.O. San G.Moscati - U.O. Pneumologia

    Avellino, 83100

  • Policlinico Consorziale - U.O. M.A.R.

    Bari, 70124

  • A.O. G.Rummo - U.O.C. Pneumologia

    Benevento, 82100

  • Humanitas Gavazzeni - Pneumologia

    Bergamo, 24125

  • A.O.U. Policlinico S.Orsola Malpighi - Pneumologia

    Bologna, 40185

  • I.N.R.C.A. Centro per le Broncopneumopatie - Pneumologia Riabilitativa

    Casatenovo, Lecco, 23880

  • Ospedale S. Maria della Pietà Camilliani - Pneumologia e Fisiologia Respiratoria

    Casoria, Napoli, 80026

  • Policlinico Universitario Mater Domini - U.O.C. Malattie Apparato Respiratorio

    Catanzaro, 88100

  • A.O. Mellino Mellini - U.O. Fisiopatologia Respiratoria

    Chiari, Brescia, 25032

  • Ospedale di Dolo - U.O.C. Pneumologia

    Dolo, Venezia

  • Ospedale Piero Palagi - Fisiopatologia Respiratoria e Riabilitazione Respiratoria

    Florence, 50125

  • Ospedale D'Avanzo - MAR 4 Univ.

    Foggia, 71122

  • Ospedale Erba Renaldi - Medicina Interna

    Menaggio, Como, 22017

  • Ospedale Papardo - Malattie Apparato Respiratorio

    Messina, 98158

  • A.O. San Carlo Borromeo - Pneumologia

    Milan, 20153

  • Ospedale Niguarda - Pneumologia

    Milan, 20162

  • A.O.U. Policlinico - Clinica Malattie Apparato Respiratorio

    Modena, 41124

  • Ospedale Maggiore - U.O. Medicina

    Modica, Ragusa, 97015

  • Clinica Padre Pio - Medicina

    Mondragone, Caserta, 81034

  • Ospedale San Gerardo - Clinica Pneumologica

    Monza, Monza E Brianza, 20900

  • A.O.U. Seconda Università Napoli - UOSD Serv.Prevenz.Mal.Broncopolm.

    Naples, 80138

  • Ospedale Zonchello - U.O.C. Pneumologia

    Nuoro

  • A.O.U. San Luigi Gonzaga - Malattie Apparato Respiratorio 1

    Orbassano, Torino, 10043

  • Consiglio Nazionale delle Ricerche - Istituto di Biomedicina ed Immunologia Molecolare

    Palermo, 90146

  • Fondazione Toscana G. Monasterio - U.O.C. Pneumologia

    Pisa, 56124

  • Ospedale Apicella - U.O.C. Pneumologia

    Pollena Trocchia, Napoli, 80040

  • Ospedale San Filippo Neri - U.O.C. Pneumologia

    Roma, 00135

  • Ospedale Sandro Pertini - S.C. Pneumologia

    Roma, 00157

  • Ospedale San Giovanni Addolorata - U.O.C. Malattie Apparato Respiratorio

    Roma, 00184

  • Azienda Ospedaliera Sant'Andrea - U.O.C. Pneumologia

    Roma, 00189

  • A.O.U. San Giovanni di Dio Ruggi d'Aragona - Pneumologia universitaria

    Salerno, 84131

  • Ospedale di Sestri Levante - Pneumologia

    Sestri Levante, Genova, 16039

  • Ospedale Mazzini - Malattie Apparato Respiratorio

    Teramo, 64100

  • Azienda Unità Sanitaria Locale Umbria n.2 - U.O. Pneumologia Terr.

    Terni, 05100

  • Ospedale Martini - Pneumologia

    Torino, 10141

  • Ospedale Civile - Pneumologia

    Vittorio Veneto, Treviso, 31029

Other trials in Italy

About this study

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.

Read the detailed description

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.

Medical subject headings
Pulmonary Disease, Chronic Obstructive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline

  2. 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.

    Measured: 6 and 12 months

Secondary outcomes (3)

  1. 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.

    Measured: At baseline

  2. 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.

    Measured: 6 and 12 months

  3. 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.

    Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2017
  2. Study start1 Feb 2016
  3. Primary completion30 Apr 2017
  4. Study completion7 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
683 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03105999
Sponsor's protocol ID
GUID/15/COPD/001
Acronym
STORICO
Status last verified
Aug 2018
First submitted
28 Mar 2017
Last updated
22 Aug 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 21115606

  • Miravitlles M, Worth H, Soler Cataluna JJ, Price D, De Benedetto F, Roche N, Godtfredsen NS, van der Molen T, Lofdahl CG, Padulles 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(1):122. doi: 10.1186/s12931-014-0122-1.

    PubMed 25331383

  • Incalzi RA, Blasi F, Canonica GW, Foschino MP, Prediletto R, Simoni L, Ori A, Giovannetti C, Barsanti S, Scichilone N. The Prescribing Practice for COPD: Relationship to Circadian Rhythm, Disease Severity, and Clinical Phenotype in the STORICO Observational Study. Adv Ther. 2022 Dec;39(12):5582-5589. doi: 10.1007/s12325-022-02331-x. Epub 2022 Oct 11.

    PubMed 36219388

  • Blasi F, Antonelli Incalzi R, Canonica GW, Schino P, Cuttitta G, Zullo A, Ori A, Scichilone N; STORICO study group. Clinical Evolution and Quality of Life in Clinically Based COPD Chronic Bronchitic and Emphysematous Phenotypes: Results from the 1-Year Follow-Up of the STORICO Italian Observational Study. Int J Chron Obstruct Pulmon Dis. 2021 Jul 21;16:2133-2148. doi: 10.2147/COPD.S310428. eCollection 2021.

    PubMed 34345170

  • Antonelli Incalzi R, Canonica GW, Scichilone N, Rizzoli S, Simoni L, Blasi F; STORICO study group. The COPD multi-dimensional phenotype: A new classification from the STORICO Italian observational study. PLoS One. 2019 Sep 13;14(9):e0221889. doi: 10.1371/journal.pone.0221889. eCollection 2019.

    PubMed 31518364

  • Scichilone N, Antonelli Incalzi R, Blasi F, Schino P, Cuttitta G, Zullo A, Ori A, Canonica GW; STORICO study group. Circadian rhythm of COPD symptoms in clinically based phenotypes. Results from the STORICO Italian observational study. BMC Pulm Med. 2019 Sep 9;19(1):171. doi: 10.1186/s12890-019-0935-2.

    PubMed 31500607

  • Canonica GW, Blasi F, Scichilone N, Simoni L, Zullo A, Giovannetti C, Briguglio C, Barsanti S, Antonelli Incalzi R; STORICO study group. Characterization of circadian COPD symptoms by phenotype: Methodology of the STORICO observational study. Eur J Intern Med. 2017 Sep;43:62-68. doi: 10.1016/j.ejim.2017.05.021. Epub 2017 May 31.

    PubMed 28576398

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Obstructive Pulmonary Disease, run by Laboratori Guidotti S.p.A. at 40 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03105999, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.

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