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

11 stycznia 2022 zaktualizowane przez: AstraZeneca

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.

This is a multi-centre, prospective, observational study to realize the current situation of COPD patients in China. About 5000 COPD patients will be enrolled from 50 participating sites around China and followed up for one year. During this study, patients will undergo clinical assessments and receive medical care as determined by their treating physician.

Przegląd badań

Status

Zakończony

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

5020

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Chiny
      • Beijing, Chiny, 100029
        • Research Site

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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.

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
The mean rate of COPD exacerbations
Ramy czasowe: within one year
The mean rate of COPD exacerbations (acute exacerbation number per patient per year).
within one year
The proportion of hospitalized patients
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: within one year
The mean reduction value of available FEV1 after one year from baseline
within one year
The mean change in CAT
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
The distribution of different severity of COPD patients
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

AstraZeneca

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

30 czerwca 2017

Zakończenie podstawowe (Rzeczywisty)

6 sierpnia 2020

Ukończenie studiów (Rzeczywisty)

6 sierpnia 2020

Daty rejestracji na studia

Pierwszy przesłany

20 marca 2017

Pierwszy przesłany, który spełnia kryteria kontroli jakości

24 kwietnia 2017

Pierwszy wysłany (Rzeczywisty)

27 kwietnia 2017

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 stycznia 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 stycznia 2022

Ostatnia weryfikacja

1 stycznia 2022

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • D2287R00114

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania 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.

Kryteria dostępu do udostępniania 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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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