- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
- 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.
Type d'étude
Inscription (Réel)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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;
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Perception of symptoms variability in Chronic obstructive pulmonary disease(COPD) patients
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
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
Délai: 1 Year
|
Patients whose treatment is adherent with The Global Initiative for Chronic Obstructive Lung Disease(GOLD) 2015 in Percentage
|
1 Year
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- D2287R00105
Informations sur les médicaments et les dispositifs, documents d'étude
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