- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03425760
A Cross-sectional Study of COPD and Symptom Variability in MEA Countries (COPVAR)
This non-interventional study aims at assessing stable GOLD C and D COPD patient's perception of daily and weekly symptoms variability and their impact on daily activities.
It will also explore the current practice in management of stable GOLD C and D COPD patients.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
- Primary objective: To assess perception of daily and weekly variability of symptoms in stable GOLD C and D COPD patients and their impact on daily life activities
Secondary objectives:
- To describe the current treatment practice for the management of GOLD C and D COPD in MEA countries and their adherence to the GOLD 2015 guidelines
- To compare patients' perception of symptoms variability and their impact on activities between Gold categories C and D
- To identify demographic, behavioral and clinical factors associated with symptoms variability.
Tipo di studio
Iscrizione (Effettivo)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
Patients eligible for inclusion have to fulfill all of the following criteria:
- Stable GOLD C or D COPD patient under maintenance treatment, over 45 years, who provided signed informed consent;
- COPD diagnosis documented by spirometry performed in the past 12 months with an FEV1/FVC < 0.7 and an FEV1 < 50% predicted.
Exclusion Criteria:
Patients are not eligible for inclusion if they meet one of the following criteria:
- Patient with an ongoing COPD exacerbation*;
- Patient who has experienced an exacerbation* in the previous 3 months;
- History of asthma, allergic rhinitis, lung cancer or any other significant respiratory disease, such as tuberculosis, lung fibrosis or sarcoidosis;
- Inability to understand the study related questions;
- Mentally disabled patient or unable to read and write;
- Pregnant.
- Current participation in a clinical trial;
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Perception of symptoms variability in Chronic obstructive pulmonary disease(COPD) patients
Lasso di tempo: 1 Year
|
Mean score of Morning Activities and Symptoms Questionnaires (MASQ).
MASQ is a patient-reported outcome instrument developed to measure morning activities and morning symptoms.
The MASQ consist of two parts that captures instant symptoms through the Global Chest Symptoms Questionnaire (GCSQ), and morning activities through the Capacity of Daily Living during the morning (CDLM) questionnaire.
Each item is rated on a 5 point Likert scale, from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions.
Score Range a score ranging from 0 (so difficult that the activity could not be carried out by the patient on their own) to 5 (activity was not at all difficult to carry out).
|
1 Year
|
Impact of symptom variability on daily life activities of Chronic obstructive pulmonary disease(COPD) Patients
Lasso di tempo: 1 Year
|
Percentage of patients whose daily activities are affected as captured in the Chronic obstructive pulmonary disease(COPD) Assessment Test(CAT).
CAT IS a questionnaire that assesses the impact of COPD (cough, sputum, dyspnoea, chest tightens) on health status.
There are eight questions with a scale of 1 to 5. Range of CAT scores from 0-40.
Higher scores denote a more severe impact of COPD on a patient's life.
The difference between stable and exacerbation patients was five units.
No target score represents the best achievable outcome.
|
1 Year
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Current treatment practice for the management of COPD in Middle East Africa countries and their adherence to The Global Initiative for Chronic Obstructive Lung Disease(GOLD 2015) guidelines
Lasso di tempo: 1 Year
|
Patients whose treatment is adherent with The Global Initiative for Chronic Obstructive Lung Disease(GOLD) 2015 in Percentage
|
1 Year
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- D2287R00105
Informazioni su farmaci e dispositivi, documenti di studio
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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 .