- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03083067
Salvational Intervention for Reducing AECOPD Under Severe Air Pollution (SIRCAP)
A Prospective Study of Salvational Intervention With ICS/LABA for Reducing Chronic Obstructive Pulmonary Disease Exacerbation Under Severe Air Pollution (SIRCAP) in Beijing
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100034
- Peking University First Hospital
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Beijing, Beijing, China
- Civil Aviation General Hospital
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Beijing, Beijing, China
- Peking University Shougang Hospital
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Beijing, Beijing, China
- Aerospace 731 Hospital
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Beijing, Beijing, China
- Beijing Changping Hospital
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Beijing, Beijing, China
- Beijing Jingmei Group General Hospital
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Beijing, Beijing, China
- BeiJing JiShuiTan Hospital
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Beijing, Beijing, China
- Beijing Luhe Hospital
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Beijing, Beijing, China
- Beijing Miyun Hospital
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Beijing, Beijing, China
- People's Hospital of Beijing Daxing District
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Beijing, Beijing, China
- The Hospital of Shunyi District Beijing
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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.
Study Plan
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
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Anticonvulsants
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Budesonide
- Tiotropium Bromide
- Bromides
- Formoterol Fumarate
Other Study ID Numbers
- SF2016-1-4071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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