Salvational Intervention for Reducing AECOPD Under Severe Air Pollution

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-20

Study Completion Date

2022-03-16

Brief Summary

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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.

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Detailed Description

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This is a multi-center, prospective, randomized and standard treatment parallel control clinical trial. A total of 764 stable COPD patients with history of exacerbation according to GOLD will be recruited and equally divided into two parallel groups, salvational intervention group (SI group) and control group (CT group). The randomization is stratified by medical center and the random code is designed in a 1:1 ratio. The Department of Respiratory and Critical Care of Peking University First Hospital is responsible for this research. Other 10 units participating in the study include Peking University Shougang Hospital, People's Hospital of Beijing Daxing District, Beijing Jingmei Group General Hospital, Beijing Miyun Hospital, Beijing Changping Hospital, The Hospital of Shunyi District Beijing, Beijing Luhe Hospital Capital Medical University, Civil Aciation General Hospital, Beijing Jishuitan Hospital and Aerospace 731 Hospital. These 11 centers approximately cover area from urban to suburbs in Beijing.

Inhaled tiotropium bromide(18ug), budesonide/formoterol（160ug/4.5ug）or tiotropium bromide(18ug)+ budesonide/formoterol （160ug/4.5ug）will be used as basic medicine. On the foundation of basic medicine, inhaled budesonide/formoterol（160ug/4.5ug）will be used as an intervention drug for patients in SI group. When air quality index (AQI) is above 200, they will temporary add one inhalation of budesonide/formoterol（160ug/4.5ug）twice a day until the third day after AQI drops below 200. CT group maintains the original treatment. Besides baseline, patients will be formally visited 4 or 5 times during this trial: before randomization (for those who need pharmacological washout) and every six months after randomization.

Primary outcome is the frequency of AECOPD per year, which is defined as the frequency of AECOPD/the number of patients/year. Secondary outcomes include the number of unplanned outpatient visits, emergency medical visits, hospitalization, medical expense and mortality caused by AECOPD per year.

The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2016\[1032\]). Any protocol modifications will be submitted for the IRB review and approval.

Conditions

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COPD Exacerbation Air Pollution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Salvational intervention(SI) group

Budesonide/formoterol（160ug/4.5ug）will be used as an intervention drug on the foundation of original treatment.

Group Type EXPERIMENTAL

Budesonide/formoterol

Intervention Type DRUG

On the foundation of basic treatment strategies, inhaled budesonide/formoterol（160ug/4.5ug）will be used as an intervention drug for patients in PIC group. When air quality index (AQI) is above 200, they will temporary add one inhalation of budesonide/formoterol（160ug/4.5ug）twice a day until the third day after AQI drops below 200.

tiotropium bromide

Intervention Type DRUG

Inhaled tiotropium bromide(18ug) will be used as routine medicine according to doctor's advice.

Control(CT) group

CT group maintain the original treatment

Group Type ACTIVE_COMPARATOR

tiotropium bromide

Intervention Type DRUG

Inhaled tiotropium bromide(18ug) will be used as routine medicine according to doctor's advice.

Interventions

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Budesonide/formoterol

On the foundation of basic treatment strategies, inhaled budesonide/formoterol（160ug/4.5ug）will be used as an intervention drug for patients in PIC group. When air quality index (AQI) is above 200, they will temporary add one inhalation of budesonide/formoterol（160ug/4.5ug）twice a day until the third day after AQI drops below 200.

Intervention Type DRUG

tiotropium bromide

Inhaled tiotropium bromide(18ug) will be used as routine medicine according to doctor's advice.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Guangfa Wang

Prof. & MD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guangfa Wang, MD

Role: STUDY_CHAIR

Peking University First Hospital

Locations

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