Salvational Intervention for Reducing AECOPD Under Severe Air Pollution

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, prospective, randomized and standard treatment parallel control clinical trial.A total of 764 stable COPD patients according to GOLD will be recruited and equally divided into two parallel groups, salvational intervention group (SI group) and control group (CT group).On the foundation of basic medicine, inhaled ICS/LABA will be used as an intervention drug for patients in SI group on severe air pollution days. It is aimed to evaluate whether this novel treatment strategy will decrease the frequency of AECOPD per year.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University First Hospital
• Collaborators: Aerospace 731 Hospital; Beijing Changping Hospital; Beijing Jingmei Group General Hospital; Beijing Jishuitan Hospital; Beijing Luhe Hospital; Beijing Miyun Hospital; Civil Aviation General Hospital; Peking University Shougang Hospital; People's Hospital of Beijing Daxing District; People’s Hospital of Beijing Daxing District; The Hospital of Shunyi District Beijing
• Treatments: Bromides; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate; Tiotropium Bromide

Criteria

Inclusion Criteria:

1. aged at 40-80 years old;

2. spirometry confirmed diagnose of COPD with at least once exacerbation before, and stable for at least three months;

3. quit smoking for more than six months;

4. be able to engage in daily activities;

5. have willing to participate in this study, follow the research program and have the ability to sign the informed consent;

6. Beijing residents;

7. can be contacted;

Exclusion Criteria:

1. history of asthma, lung cancer, active pulmonary tuberculosis, bronchiectasis, diffuse lung disease (interstitial pneumonia, pulmonary sarcoidosis, occupational lung disease, sarcoidosis et al) and pleural disease;

2. history of lobectomy and / or lung transplantation;

3. predicted life expectancy less than 3 years;

4. history of severe psychiatric illnesses, mental disorders, neurological disorders, malignant tumors, chronic liver disease, heart failure, autoimmune diseases, chronic kidney disease;

5. Never engage in outdoor activities;

6. plan to move out of Beijing in 3 years

7. Plan to carry out an indoor redecoration during the study;

8. Alcoholism, drug abuse or abuse of toxic solvents;

9. Allergic to the study drug or its ingredients, or have a clear contraindication of it;

10. Participation in another clinical trial;

11. Cannot finish long term follow-up or poor compliance;

12. Do not provide consent.