Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

402

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach

1 country

11 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5 years study duration

First Submitted

Initial submission to the registry

March 3, 2017

Completed

14 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed

3 days until next milestone

Study Start

First participant enrolled

March 20, 2017

Completed

5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2022

Completed

Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

5 years

First QC Date

March 3, 2017

Last Update Submit

March 30, 2022

Conditions

COPD Exacerbation Air Pollution

Keywords

AECOPDair pollutionCOPDsalvational Intervention

Outcome Measures

Primary Outcomes (1)

the frequency of exacerbation of COPD per year
3 year

Secondary Outcomes (5)

the number of unplanned outpatient visits caused by exacerbation of COPD per year
3 years
the number of unplanned emergency medical visits caused by exacerbation of COPD per year
3 years
the number of unplanned hospitalization caused by exacerbation of COPD per year
3 years
the cost of unplanned medical expense caused by exacerbation of COPD per year
3 years
the number of unplanned mortality caused by exacerbation of COPD per year
3 years

Study Arms (2)

Salvational intervention(SI) group

EXPERIMENTAL

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

Drug: Budesonide/formoterolDrug: tiotropium bromide

Control(CT) group

ACTIVE COMPARATOR

CT group maintain the original treatment

Drug: tiotropium bromide

Interventions

Budesonide/formoterolDRUG

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.

Salvational intervention(SI) group

tiotropium bromideDRUG

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

Control(CT) groupSalvational intervention(SI) group

Eligibility Criteria

Age40 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

aged at 40-80 years old;
spirometry confirmed diagnose of COPD with at least once exacerbation before, and stable for at least three months;
quit smoking for more than six months;
be able to engage in daily activities;
have willing to participate in this study, follow the research program and have the ability to sign the informed consent;
Beijing residents;
can be contacted;

You may not qualify if:

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;
history of lobectomy and / or lung transplantation;
predicted life expectancy less than 3 years;
history of severe psychiatric illnesses, mental disorders, neurological disorders, malignant tumors, chronic liver disease, heart failure, autoimmune diseases, chronic kidney disease;
Never engage in outdoor activities;
plan to move out of Beijing in 3 years
Plan to carry out an indoor redecoration during the study;
Alcoholism, drug abuse or abuse of toxic solvents;
Allergic to the study drug or its ingredients, or have a clear contraindication of it;
Participation in another clinical trial;
Cannot finish long term follow-up or poor compliance;
Do not provide consent.

Contact the study team to confirm eligibility.

Study Sites (11)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Aerospace 731 Hospital