Salvational Intervention for Reducing AECOPD Under Severe Air Pollution (SIRCAP)

March 30, 2022 updated by: Guangfa Wang, Peking University First Hospital

A Prospective Study of Salvational Intervention With ICS/LABA for Reducing Chronic Obstructive Pulmonary Disease Exacerbation Under Severe Air Pollution (SIRCAP) in Beijing

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

402

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing, China
        • Civil Aviation General Hospital
      • Beijing, Beijing, China
        • Peking University Shougang Hospital
      • Beijing, Beijing, China
        • Aerospace 731 Hospital
      • Beijing, Beijing, China
        • Beijing Changping Hospital
      • Beijing, Beijing, China
        • Beijing Jingmei Group General Hospital
      • Beijing, Beijing, China
        • BeiJing JiShuiTan Hospital
      • Beijing, Beijing, China
        • Beijing Luhe Hospital
      • Beijing, Beijing, China
        • Beijing Miyun Hospital
      • Beijing, Beijing, China
        • People's Hospital of Beijing Daxing District
      • Beijing, Beijing, China
        • The Hospital of Shunyi District Beijing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Salvational intervention(SI) group
Budesonide/formoterol(160ug/4.5ug)will be used as an intervention drug on the foundation of original treatment.
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.
Inhaled tiotropium bromide(18ug) will be used as routine medicine according to doctor's advice.
ACTIVE_COMPARATOR: Control(CT) group
CT group maintain the original treatment
Inhaled tiotropium bromide(18ug) will be used as routine medicine according to doctor's advice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the frequency of exacerbation of COPD per year
Time Frame: 3 year
3 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 20, 2017

Primary Completion (ACTUAL)

March 16, 2022

Study Completion (ACTUAL)

March 16, 2022

Study Registration Dates

First Submitted

March 3, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (ACTUAL)

March 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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