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NCT04664491 | RECRUITING | Chronic Obstructive Pulmonary Disease

Effects of COPD Standardized Management on COPD Exacerbation
Sponsor:

China-Japan Friendship Hospital

Information provided by (Responsible Party):

Chen Wang

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.

Condition or disease

Chronic Obstructive Pulmonary Disease

Intervention/treatment

Standardized COPD management

Routine COPD management

Phase

NA

Detailed Description:

COPD is the most common chronic respiratory disease in China. An effective and standardized condition management strategy is urgently needed to prevent acute exacerbation, improve the quality of life, and avoid premature death due to COPD. COPD management is mainly performed in community-level health institutions. Implementing COPD standardized management in primary care will help improve the level of COPD prevention and treatment in China. The investigators will carry out a multicenter, adjudicator-blinded, parallel, cluster randomized clinical trial. An estimated number of 96 secondary hospitals across the country will be involved. Each hospital plans to enroll 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 3456 participants
Masking : SINGLE
Masking Description : Statisticians and outcome assessors will be blinded
Primary Purpose : PREVENTION
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
Actual Study Start Date : 2023-02-04
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2027-04-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Aged ≥40 years
  • 2. Post-bronchodilator FEV1/FVC \<70%
  • 3. Baseline CAT score ≥10 or history of exacerbation in previous 12 months, defined as any use of oral antibiotics and/or oral or nebulized corticosteroids for increased cough, sputum and dyspnea, or exacerbation requiring hospitalization/ emergency admission.
  • 4. Local residents who live nearby and can be followed up throughout study period
  • 5. Written informed consent
Exclusion Criteria
  • 1. Pregnancy, breastfeeding, or potential pregnancy
  • 2. Primary diagnosis of asthma
  • 3. Having severe cognitive dysfunction
  • 4. Severely ill with less than 12-month life expectancy
  • 5. Patients with alcohol abuse history are excluded as alcoholic individuals may have low adherence to the study. Alcohol abuse is defined as an average alcohol intake \>80 g per day within recent two weeks, or daily intake of ≥40 g alcohol in men, and ≥20 g alcohol in women for more than 5 years.
  • 6. Have participated in similar trials or are undergoing other clinical trials
  • 7. Refuses or unable to give informed consent
  • 8. Plan to move
  • 9. Contraindicated to maintenance medicine.
  • 10. Unstable cardiovascular conditions (e.g., angina, myocardial infarction, ascending aortic aneurysm) that may prevent patients performing spirometry.
  • 11. Relative contraindications to spirometry, including current pneumothorax or planning to undergo thoracic/abdominal, ophthalmic or brain surgeries within next 6 months.
  • 12. Comorbid lung disease including bronchiectasis and tuberculosis, or undergoing anti-tuberculosis treatment
  • 13. Recent exacerbation treated with antibiotics and/or oral or nebulized corticosteroids within 30 days prior to enrolment.
  • 14. Exacerbation requiring emergency admission or hospitalization within 30 days prior to enrolment.
Effects of COPD Standardized Management on COPD Exacerbation

Location Details

NCT04664491

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Locations

RECRUITING

China, Beijing

China-Japan Friendship Hospital

Beijing, Beijing, China, 100029