Burden of Disease Among Subjects With Eosinophilic Chronic Obstructive Pulmonary Disease (COPD)
25 gennaio 2019 aggiornato da: GlaxoSmithKline
Burden of Disease Among Patients With Eosinophilic COPD in Spain: Multicentre Observational Study
This observational study is designed to more specifically describe the burden of the disease and the use of healthcare resources of subjects with eosinophilic COPD that may be eligible in the future for a biologic treatment.
Subjects who attend a routine follow-up visit and fulfill the inclusion/exclusion criteria defined provide a signed informed consent will be invited by the investigator to participate in this study.
Subjects will be recruited in hospital Pulmonology Services across Spain.
It is planned to include approximately 20 centers.
To select the final participating centers, a feasibility study has been carried out in approximately 50 potential participating centers.
It has been estimated that each investigator will include 18 subjects during the 4-month inclusion period.
Total 354 subjects will be required: 250 subjects with an eosinophil level >=150 cells per microliter and 104 subjects with an eosinophil level <150 cells per microliter.
The study inclusion period will be 4 months (expected to be from November 2017 to March 2018) and the retrospective data collection period will be 12 months prior to the inclusion visit.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Osservativo
Iscrizione (Effettivo)
341
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Barcelona, Spagna, 08036
- GSK Investigational Site
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Madrid, Spagna, 28040
- GSK Investigational Site
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Madrid, Spagna, 28046
- GSK Investigational Site
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Valencia, Spagna, 46017
- GSK Investigational Site
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
40 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Subjects who attend a routine follow-up visit and who fulfill inclusion/exclusion criteria will be invited by the investigator to participate in the study.
The study inclusion period will be four months (from November 2017 to March 2018) and the retrospective data collection period will be 12 months prior to the inclusion visit.
Descrizione
Inclusion Criteria:
- Subjects of both sexes aged >=40 years.
- Subjects with a COPD diagnosis confirmed with a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital capacity <70% recorded at any time in the medical record.
- Subjects with a history of smoking (current or past) >=10 pack-years.
- Subjects who have a qualifying peripheral blood eosinophil test recorded in the 3 months prior to the inclusion visit. If the subject has several eosinophil test recorded in this period, the one closest to the inclusion visit determined in the stable phase should be selected; if it is not available, the record closest to the inclusion visit will be selected, even if it has been determined during an exacerbation. If no records are available, the subject will be invited to perform the test at the inclusion visit.
- Subjects currently exposed to inhaled triple maintenance therapy, defined as at least one overlapping prescription of an ICS with a LABA and with a LAMA in 2 or 3 inhaler devices, without more than 30 days of separation between prescriptions.
- Subjects who have experienced >=2 moderate exacerbations or >=1 severe exacerbation in the 12 months prior to the inclusion visit. Moderate exacerbation is defined as an exacerbation requiring antibiotics and/or oral corticosteroids or requiring an emergency visit <24 hours (without hospitalization). Severe exacerbation is defined as an exacerbation requiring hospitalization.
- Subjects who consent to participate in the study by signing the subjects written informed consent form.
Exclusion Criteria:
- Subjects without a qualifying peripheral blood eosinophil test recorded in the 3 months prior to the inclusion visit and who refuse to perform the test during the inclusion visit.
- Subjects treated with oral corticosteroids continuously during the 12 months prior to the inclusion visit.
- Subjects with a diagnosis of Churg-Strauss disease, hypereosinophilic syndrome, allergic bronchopulmonary aspergillosis or other conditions that result in increased eosinophil levels independently of COPD.
- Subjects with oncologic disease undergoing treatment or with advanced oncologic disease (without possibility of remission), terminal subjects and/or subjects receiving palliative care.
- Cognitively impaired subjects who are not able to understand or complete the informed consent and HRQoL questionnaires.
- Subjects who have participated in an interventional clinical trial during the 12 months prior to the inclusion visit.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Subjects with COPD
Subjects with a COPD diagnosis confirmed with a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital capacity <70% recorded at any time in the medical record who have a qualifying peripheral blood eosinophil test recorded in the 3 months prior to the inclusion visit attend to a routine follow-up visit during the inclusion period, fulfill the inclusion/exclusion criteria and provide informed consent to participate, will be included in this study.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of subjects requiring COPD maintenance treatment and rescue medication
Lasso di tempo: 12 months prior to the inclusion visit
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Subjects currently exposed to inhaled triple maintenance therapy, defined as at least one overlapping prescription of an inhaled corticosteroid (ICS) with a long-acting beta2-agonist (LABA) and with a long-acting muscarinic antagonist (LAMA) in 2 or 3 inhaler devices, without more than 30 days of separation between prescriptions along with rescue medication use will be analyzed.
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12 months prior to the inclusion visit
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Number of subjects with moderate and severe exacerbations
Lasso di tempo: 12 months prior to the inclusion visit
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Subjects who have experienced >=2 moderate exacerbations or >=1 severe exacerbation in the 12 months prior to the inclusion visit.
Moderate exacerbation is defined as an exacerbation requiring antibiotics and/or oral corticosteroids or requiring an emergency visit <24 hours (without hospitalization).
Severe exacerbation is defined as an exacerbation requiring hospitalization.
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12 months prior to the inclusion visit
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Number of subjects with COPD-related scheduled and unscheduled primary and secondary care visits
Lasso di tempo: 12 months prior to the inclusion visit
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Subjects with COPD-related scheduled and unscheduled primary and secondary care visits will be analyzed.
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12 months prior to the inclusion visit
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Number of subjects with COPD-related emergency visits to primary care and hospital
Lasso di tempo: 12 months prior to the inclusion visit
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Subjects with COPD-related emergency visits to primary care and hospital will be analyzed.
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12 months prior to the inclusion visit
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Number of subjects with COPD-related hospitalizations
Lasso di tempo: 12 months prior to the inclusion visit
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Subjects with COPD-related hospitalizations will be analyzed.
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12 months prior to the inclusion visit
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Number of days of hospitalizations
Lasso di tempo: 12 months prior to the inclusion visit
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The number of days of hospitalization for subjects will be analyzed.
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12 months prior to the inclusion visit
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Number of subjects with COPD-related complementary tests
Lasso di tempo: 12 months prior to the inclusion visit
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Subjects with COPD-related complementary tests will be analyzed.
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12 months prior to the inclusion visit
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Number of subjects with COPD-related days-off work
Lasso di tempo: 12 months prior to the inclusion visit
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Subjects with COPD-related days-off work will be analyzed.
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12 months prior to the inclusion visit
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Subjects age as a measure of sociodemographic characteristics
Lasso di tempo: 4 months (inclusion period)
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Age will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in the study.
A threshold of >=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis.
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4 months (inclusion period)
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Number of subjects with different gender
Lasso di tempo: 4 months (inclusion period)
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Gender will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in the study.
A threshold of >=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis.
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4 months (inclusion period)
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Number of subjects with different sociodemographic variables
Lasso di tempo: 4 months (inclusion period)
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Subjects with different educational level, employment status, monthly net income will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in the study A threshold of >=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis.
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4 months (inclusion period)
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Number of subjects with abnormal clinical variables
Lasso di tempo: 4 months (inclusion period)
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Clinical variables comprising weight, height, body mass index (self-calculated), smoking history, Charlson comorbidity index, diagnosis of asthma will be assessed for abnormalities.
A threshold of >=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis.
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4 months (inclusion period)
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Number of subjects with abnormal COPD related variables
Lasso di tempo: 12 months prior to the inclusion visit
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COPD variables comprising COPD diagnosis date, pulmonary function with bronchodilator test, modified Medical Research Council (mMRC) dyspnea scale, clinical phenotypes according to Spanish COPD Clinical Guidelines (GesEPOC) criteria will be assessed for abnormalities.
A threshold of >=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis.
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12 months prior to the inclusion visit
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Number of subjects with abnormal blood cell count
Lasso di tempo: 12 months prior to the inclusion visit
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Peripheral blood eosinophil count, peripheral blood neutrophil count, peripheral blood leukocyte count, fibrinogen and red cell distribution width will be assessed for abnormalities.
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12 months prior to the inclusion visit
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COPD Assessment Test (CAT) score as a measure of Health Related Quality of Life (HRQoL)
Lasso di tempo: 4 months (inclusion period)
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The CAT questionnaire is a COPD-specific questionnaire that measures the impact of the disease on HRQoL and allows symptoms to be described.
It consists of 8 items, which yield a score range from 0 to 40, 0 representing the lowest impact on HRQoL and 40 the maximum impact.
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4 months (inclusion period)
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EuroQOL five dimensions five level (EQ-5D-5L) score as a measure of HRQoL
Lasso di tempo: 4 months (inclusion period)
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The EQ-5D-5L is a preference-based generic HRQoL questionnaire, consisting on five health dimensions (mobility, personal care, daily activities, pain/discomfort and anxiety/depression), divided in five levels of severity (no problems, slight problems, moderate problems, severe problems and extreme problems).
It included also a visual analogue scale (VAS) in which respondents are asked to evaluate their overall health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
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4 months (inclusion period)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
5 dicembre 2017
Completamento primario (Effettivo)
31 ottobre 2018
Completamento dello studio (Effettivo)
10 dicembre 2018
Date di iscrizione allo studio
Primo inviato
12 febbraio 2018
Primo inviato che soddisfa i criteri di controllo qualità
12 febbraio 2018
Primo Inserito (Effettivo)
19 febbraio 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
29 gennaio 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 gennaio 2019
Ultimo verificato
1 gennaio 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 206555
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .