Essais cliniques sur Maladie pulmonaire obstructive chronique MPOC - Registre des essais cliniques

Aperçu de l'étude

Statut

Complété

Les conditions

Maladie pulmonaire obstructive chronique MPOC

Description détaillée

This is a multi-centre, prospective, observational study. This study aims to observe the general situation in clinical practice, and the evolution and outcome of current usual care of COPD in China.This is an observational study. It will be carried out under routine clinical practice and the treatment will be determined by patients' treating physicians. Information about exposure to treatments as part of routine care will be collected (dose, frequency and duration).

A multi-stage, stratified and cluster sampling method will be used to select a nationally representative sample from the tertiary and secondary hospitals with respiratory department in six geographic regions around China as the study sites. Approximately 5000 patients with COPD will be enrolled from 50 selected study sites in order to recruit a nationally representative study population and followed up for one year.

Type d'étude

Observationnel

Inscription (Réel)

5020

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Chine
- - Beijing, Chine, 100029
    - Research Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Enfant
Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

Approximately 5000 patients with COPD will be enrolled from 50 tertiary and secondary hospitals in six geographic regions around China in order to recruit a nationally representative study population from 2017 Q2 to 2018 Q2.

La description

Inclusion Criteria:

Outpatients, more than 40 years old
Clinically diagnosed as COPD (the patients are clinically diagnosed as COPD based on chronic cough, sputum, wheeze and a history of exposure to harmful factors, and confirmed by spirometry(FEV1/FVC<0.7, post-bronchodilator according to GOLD 2016)
Sign (or their legally-acceptable representatives must sign) and date the informed consent form indicating that they understand the purpose of and procedure required for the study and are willing to participate in the study.

Exclusion Criteria:

Participated in any interventional clinical trial during the last 30 days
With acute exacerbation within 4 weeks before enrolment
Not suitable for study observation judged by investigators.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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
The mean rate of COPD exacerbations Délai: within one year	The mean rate of COPD exacerbations (acute exacerbation number per patient per year).	within one year
The proportion of hospitalized patients Délai: within one year	The proportion of hospitalized patients due to the COPD exacerbations within one year；	within one year
The distribution of different severity of COPD exacerbations Délai: within one year	The distribution will be measured by percentage of patient on each level of severity of COPD exacerbations (mild: requiring an increase in rescue medication≥ 3 puffs / day for at least 2 consecutive days; moderate: requiring systemic glucocorticosteroids and/or antibiotics; severe: hospitalization, emergency room visit or leading to death), the calculation will be based on non-missing data.	within one year
The mean reduction value of available FEV1 Délai: within one year	The mean reduction value of available FEV1 after one year from baseline	within one year
The mean change in CAT Délai: within one year	The mean change in CAT total scores after one year from baseline; COPD assessment test (CAT) total score will be derived by summing up the score of all items. Total Scores range 0-40.The COPD influence on patients: 1 stage (mild): 0-10 points; 2 stage (moderate): 11-20 points; 3 stage (severe):21-30 points; 4 stage (very severe):31-40 points.	within one year
The mean change in mMRC Délai: within one year	The mean change in mMRC results after one year from baseline. Modified Medical Research Council Questionnaire (mMRC) will be assessed according to the severity of breathlessness as below: Grade 0 I only get breathless with strenuous exercise Grade 1 I get short of breath when hurrying on the level or walking up a slight hill Grade 2 I walk slower than people of the same age on the level because of breathlessness, or I have to stop for breath when walking on my own pace on the level Grade 3 I stop for breath after walking about 100 meters or after a few minutes on the level Grade 4 I am too breathless to leave the house or I am breathless when dressing or undressing	within one year
The mean change in COPD-Q Délai: within one year	The mean change in COPD patients' cognition questionnaire (COPD-Q) total scores after one year from baseline. COPD knowledge Questionnaire (COPD-Q) total score will be derived by summing up the scores from 13 items evaluating patients knowledge and understanding to COPD including 8 forward items: 1point (true), 0 point (false or not sure); 5 reverse items: 1 point (false), 0 point (true or not sure). Then get the total scores.	within one year
The mean rate of COPD exacerbations by different severity of COPD patients by airway limitation / by A/B/C/D at baseline. Délai: within one year	The mean rate of COPD exacerbations (acute exacerbation number per patient per year) by different severity of COPD patients by airway limitation / by A/B/C/D at baseline according to GOLD 2016.	within one year
The proportion of hospitalized patients by different severity of COPD patients by airway limitation / by A/B/C/D at baseline Délai: within one year	The proportion of hospitalized patients due to the COPD exacerbations by different severity of COPD patients by airway limitation / by A/B/C/D at baseline within one year according to GOLD 2016.	within one year
The mean reduction value of available FEV1 by different severity of COPD by airway limitation / by A/B/C/D patients after one year from baseline Délai: within one year	The mean reduction value of available FEV1 by different severity of COPD by airway limitation / by A/B/C/D patients according to GOLD 2016 after one year from baseline	within one year

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
The distribution of different severity of COPD patients Délai: within one year	The distribution will be measured by the percentage of patient on each level of severity of COPD patients by airway limitation / by A/B/C/D patients at baseline and after one year. The calculation will be based on non-missing data.	within one year
Distribution of stable COPD medications in mono in total population by drug class Délai: within one year	The distribution will be measured by the percentage of patient on each kind of stable COPD medications in mono in total population by drug class (ICS[inhaled corticosteroid], LABA[long-acting beta2-agonist], ICS/LABA[combination long-acting beta2-agonists plus corticosteroids in one inhaler], SABA[short-acting beta2-agonist], SAMA[short-acting muscarinic antagonist], SABA/SAMA [combination short-acting beta2-agonist plus anticholinergic], LAMA[long-acting muscarinic antagonist], methylxanthines, mucolytic, traditional Chinese medicine and others [antibiotics, systemic corticosteroids, vaccines, antioxidant agents, etc]) at baseline and after one year. The calculation will be based on non-missing data.	within one year
Distribution of stable COPD medications by drug class according to the severity by airway limitation / by A/B/C/D patients Délai: within one year	The distribution will be measured by the percentage of stable COPD medications by drug class (ICS[inhaled corticosteroid], LABA[long-acting beta2-agonist], ICS/LABA[combination long-acting beta2-agonists plus corticosteroids in one inhaler], SABA[short-acting beta2-agonist], SAMA[short-acting muscarinic antagonist], SABA/SAMA [combination short-acting beta2-agonist plus anticholinergic], LAMA[long-acting muscarinic antagonist], methylxanthines, mucolytic, traditional Chinese medicine and others [antibiotics, systemic corticosteroids, vaccines, antioxidant agents, etc]) according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year. The calculation will be based on non-missing data.	within one year
Distribution of medications for COPD exacerbations by drug class including hospital prescribed and pharmacy bought Délai: within one year	The distribution will be measured by the percentage of patient on each kind of medications for COPD exacerbations by drug (short-acting bronchodilators, corticosteroids, antibiotics and others) including hospital prescribed and pharmacy bought. The calculation will be based on non-missing data.	within one year
Distribution of non-drug treatments Délai: within one year	The distribution will be measured by the percentage of patient on each kind of non-drug treatments (health education, smoking cessation, exercise of respiratory function and vaccine injection) during the study. The calculation will be based on non-missing data.	within one year
Patients drug compliance Délai: within one year	Patients drug compliance (actual drug taken days/actually prescribed days, and actual drug taken dosage/actually prescribed dosage)	within one year
Mean total direct COPD cost Délai: within one year	Mean total direct COPD cost of the whole year per patient including the stable COPD management cost (medications and non-drug treatments) and the COPD exacerbations cost.	within one year
Distribution of prescribed stable COPD medications by drug class at each usual visit. Délai: within one year	The distribution will be measured by the percentage of patient on each kind of prescribed stable COPD medications by drug class (ICS[inhaled corticosteroid], LABA[long-acting beta2-agonist], ICS/LABA[combination long-acting beta2-agonists plus corticosteroids in one inhaler], SABA[short-acting beta2-agonist], SAMA[short-acting muscarinic antagonist], SABA/SAMA [combination short-acting beta2-agonist plus anticholinergic], LAMA[long-acting muscarinic antagonist], methylxanthines, mucolytic, traditional Chinese medicine and others [antibiotics, systemic corticosteroids, vaccines, antioxidant agents, etc]) on each usual care visit. The calculation will be based on non-missing data.	within one year
Distribution of stable COPD dosage by drug class according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year. Délai: Within one year	The distribution will be measured by the percentage of patient on each kind of stable COPD dosage by drug class according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year. The calculation will be based on non-missing data.	Within one year
Distribution of stable COPD frequency by drug class according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year. Délai: Within one year	The distribution will be measured by the percentage of patient on each level of stable COPD frequency by drug class ( same as above) according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year. The calculation will be based on non-missing data.	Within one year
Patients visit compliance Délai: Within one year	Patients visit compliance (the mean usual care visit times per patient per year, and the dropout rate at each visit including V0, V1 and TC visits)	Within one year
Distribution of stable COPD medications in combination in total population by drug class Délai: Within one year	The distribution will be measured by the percentage of patient on each kind of stable COPD medications in combination in total population by drug class (ICS[inhaled corticosteroid], LABA[long-acting beta2-agonist], ICS/LABA[combination long-acting beta2-agonists plus corticosteroids in one inhaler], SABA[short-acting beta2-agonist], SAMA[short-acting muscarinic antagonist], SABA/SAMA [combination short-acting beta2-agonist plus anticholinergic], LAMA[long-acting muscarinic antagonist], methylxanthines, mucolytic, traditional Chinese medicine and others [antibiotics, systemic corticosteroids, vaccines, antioxidant agents, etc]) at baseline and after one year. The calculation will be based on non-missing data.	Within one year

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

AstraZeneca

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

This is a CSR Synopsis.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

30 juin 2017

Achèvement primaire (Réel)

6 août 2020

Achèvement de l'étude (Réel)

6 août 2020

Dates d'inscription aux études

Première soumission

20 mars 2017

Première soumission répondant aux critères de contrôle qualité

24 avril 2017

Première publication (Réel)

27 avril 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 janvier 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 janvier 2022

Dernière vérification

1 janvier 2022

Plus d'information

Termes liés à cette étude

Mots clés

MPOC

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

D2287R00114

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Délai de partage IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Critères d'accès au partage IPD

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Type d'informations de prise en charge du partage d'IPD

PROTOCOLE D'ÉTUDE
SÈVE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Realize the Current Situation of COPD Patients in China (REAL)

REALizing and Improving Management of Stable COPD in China--A Multi-centre, Prospective, Observational Study to Realize the Current Situation of COPD Patients in China.