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Effects of COPD Standardized Management on COPD Exacerbation

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standardized COPD management
Routine COPD management
Sponsored by
China-Japan Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Standardized Management, Maintenance Therapy, Follow-Up and Monitoring, Lung Function, COPD Symptoms

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged ≥40 years
  2. Newly diagnosed COPD patients with post-bronchodilator FEV1/FVC <70% or previously diagnosed of COPD by physicians and confirmed by PFT.
  3. Baseline COPD Assessment Test (CAT) score ≥10
  4. Local residents who will be accessible and available for follow-up during trial
  5. Written informed consent

Exclusion Criteria:

  1. Pregnancy, breastfeeding or potential pregnancy
  2. Primary diagnosis of asthma, including Asthma-COPD overlap syndrome.
  3. Having severe cognitive dysfunction
  4. Severely ill with less than 12-month life expectancy
  5. Patients with alcohol abuse history
  6. Have participated in similar trials or are undergoing other clinical trials
  7. Refuses or unable to give informed consent
  8. Planning to move
  9. Contraindicated to maintenance medicine
  10. Unstable cardiovascular conditions (eg., angina, myocardial infarction, ascending aortic aneurysm) that may predispose patients absolutely contraindicative to PFT during follow-up.
  11. Having pneumothorax currently or planning to undergo thoracic/abdominal, ophthalmic, or brain surgery that are relatively contraindicative to PFT within next 6 months.
  12. A recent exacerbation with antibiotics and/or oral or intravenous systemic glucocorticoids used within 30 days prior to screening.
  13. Having one or more exacerbations requiring hospitalization in the recent 30 days prior to screening.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Standardized management

    Usual care

    Arm Description

    Patients will be managed according to recommendations in GOLD guideline and China's guidelines for COPD care.

    Patients will undergo usual care according to current clinical practice in study sites.

    Outcomes

    Primary Outcome Measures

    Annual rate of moderate and severe COPD exacerbations
    Annual rate is an estimated mean number of exacerbations per patient per year

    Secondary Outcome Measures

    Effective assessments for secondary outcomes
    Exacerbation numbers and the first exacerbation, hospitalisation, cost-effectiveness, lung function and respiratory symptoms, improvement of self-management.

    Full Information

    First Posted
    December 6, 2020
    Last Updated
    December 6, 2020
    Sponsor
    China-Japan Friendship Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04664491
    Brief Title
    Effects of COPD Standardized Management on COPD Exacerbation
    Official Title
    Effect of Standardized Disease Management on Exacerbation of COPD in Primary Health Care in China: a Multicenter, Adjudicator-Blinded, Parallel, Cluster Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2021 (Anticipated)
    Primary Completion Date
    September 30, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China-Japan Friendship Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This is a multi-center, parallel-group,cluster randomised trial involving secondary hospitals across China. The objective is to evaluate the effect of COPD on reducing moderate-to-severe exacerbations during 12 months follow-up in primary-level medical institutions.
    Detailed Description
    COPD is the most common chronic respiratory disease in China and has caused significant economic and disease burden. An effective and standardized condition management strategy is urgently needed to reduce the incidence of acute exacerbation, improve the quality of patients' life, and avoid premature death caused by COPD. At present, management of COPD is mainly conducted in community-level health institutions. Implementing standardized management of COPD in primary care will help improve the level of COPD prevention and treatment in China. We will carry out a multicenter, adjudicator-blinded, parallel, cluster randomized clinical trial, involving 96 secondary hospitals across the country. Each hospital enrolls 36 patients with COPD. The hospitals will be randomly allocated into standardized management (SM) group and control group. In SM group, standardized COPD management based-on guidelines will be delivered to patients, including inhaler use for initial and maintenance therapy, regular follow-up, long-term monitoring of lung function and respiratory symptoms, patient education, and favorable lifestyle changes. In control group, patients will receive routine care as usual. In both groups, moderate and severe exacerbations will be collected within 12 months follow-up after randomization. Group difference in annual exacerbation rate will be examined to evaluate the effect of standardized management of COPD on acute exacerbation of COPD in primary care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease
    Keywords
    COPD, Standardized Management, Maintenance Therapy, Follow-Up and Monitoring, Lung Function, COPD Symptoms

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    3456 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standardized management
    Arm Type
    Experimental
    Arm Description
    Patients will be managed according to recommendations in GOLD guideline and China's guidelines for COPD care.
    Arm Title
    Usual care
    Arm Type
    Other
    Arm Description
    Patients will undergo usual care according to current clinical practice in study sites.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standardized COPD management
    Other Intervention Name(s)
    COPD management according to GOLD and China's guidelines for COPD care
    Intervention Description
    In standardized management group, patients will receive a multifaceted and integrated disease management that follows recommendations in GOLD 2020 and China Guideline on COPD care. It contains the components below. Maintenance therapy after initial treatment. In this study, patients' initial therapy is the prescribed inhalers at baseline. Maintenance therapy is the medications (LABA, LAMA, or ICS) prescribed for regular or long-term use after initial therapy. Long-term follow-up and routine monitoring of symptoms measured by CAT, mMRC and SGRQ. Regular pulmonary function testing for lung function monitoring Strengthened COPD education Behavioral modification, eg. encouragement of influenza/pneumococcal vaccination, providing smoking cessation counseling and pulmonary rehabilitation.
    Intervention Type
    Other
    Intervention Name(s)
    Routine COPD management
    Intervention Description
    Patients will undergo usual care according to current clinical practice in study sites. Usual care is the routine care provided to patients. Prescription and dispense of medicine for COPD initial and maintenance therapy will be at the discretion of doctors.
    Primary Outcome Measure Information:
    Title
    Annual rate of moderate and severe COPD exacerbations
    Description
    Annual rate is an estimated mean number of exacerbations per patient per year
    Time Frame
    12 months from baseline
    Secondary Outcome Measure Information:
    Title
    Effective assessments for secondary outcomes
    Description
    Exacerbation numbers and the first exacerbation, hospitalisation, cost-effectiveness, lung function and respiratory symptoms, improvement of self-management.
    Time Frame
    12 months from baseline
    Other Pre-specified Outcome Measures:
    Title
    Safety evaluation
    Description
    Mortality and safety outcomes: deaths, death causes and adverse events,
    Time Frame
    12 months from baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged ≥40 years Newly diagnosed COPD patients with post-bronchodilator FEV1/FVC <70% or previously diagnosed of COPD by physicians and confirmed by PFT. Baseline COPD Assessment Test (CAT) score ≥10 Local residents who will be accessible and available for follow-up during trial Written informed consent Exclusion Criteria: Pregnancy, breastfeeding or potential pregnancy Primary diagnosis of asthma, including Asthma-COPD overlap syndrome. Having severe cognitive dysfunction Severely ill with less than 12-month life expectancy Patients with alcohol abuse history Have participated in similar trials or are undergoing other clinical trials Refuses or unable to give informed consent Planning to move Contraindicated to maintenance medicine Unstable cardiovascular conditions (eg., angina, myocardial infarction, ascending aortic aneurysm) that may predispose patients absolutely contraindicative to PFT during follow-up. Having pneumothorax currently or planning to undergo thoracic/abdominal, ophthalmic, or brain surgery that are relatively contraindicative to PFT within next 6 months. A recent exacerbation with antibiotics and/or oral or intravenous systemic glucocorticoids used within 30 days prior to screening. Having one or more exacerbations requiring hospitalization in the recent 30 days prior to screening.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ting Yang, MD, Ph.D
    Phone
    13651380809
    Email
    dryangting@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chen Wang, MD, Ph.D
    Organizational Affiliation
    China-Japan Friendship Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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