Effects of COPD Standardized Management on COPD Exacerbation

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04664491
• Other study ID #: 2019-41-K29
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2020
• Source: China-Japan Friendship Hospital
• Contact: Ting Yang, MD, Ph.D
• Phone: 13651380809
• Email: dryangting[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3456
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Standardized COPD management
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.

Other:
• Routine COPD management
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety evaluation	Mortality and safety outcomes: deaths, death causes and adverse events,	12 months from baseline
Primary	Annual rate of moderate and severe COPD exacerbations	Annual rate is an estimated mean number of exacerbations per patient per year	12 months from baseline
Secondary	Effective assessments for secondary outcomes	Exacerbation numbers and the first exacerbation, hospitalisation, cost-effectiveness, lung function and respiratory symptoms, improvement of self-management.	12 months from baseline