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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03083067
Recruitment Status : Recruiting
First Posted : March 17, 2017
Last Update Posted : November 22, 2017
Sponsor:
Collaborators:
Peking University Shougang Hospital
People's Hospital of Beijing Daxing District
Beijing Jingmei Group General Hospital
Beijing Miyun Hospital
The Hospital of Shunyi District Beijing
Beijing Luhe Hospital
Civil Aviation General Hospital
Beijing Jishuitan Hospital
Aerospace 731 Hospital
Beijing Changping Hospital
Information provided by (Responsible Party):
Guangfa Wang, Peking University First Hospital

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.

Condition or disease Intervention/treatment Phase
COPD Exacerbation Air Pollution Drug: Budesonide/formoterol Drug: tiotropium bromide Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 764 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective Study of Salvational Intervention With ICS/LABA for Reducing Chronic Obstructive Pulmonary Disease Exacerbation Under Severe Air Pollution (SIRCAP) in Beijing
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Air Pollution

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.
Drug: 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.

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




Primary Outcome Measures :
  1. the frequency of exacerbation of COPD per year [ Time Frame: 3 year ]

Secondary Outcome Measures :
  1. the number of unplanned outpatient visits caused by exacerbation of COPD per year [ Time Frame: 3 years ]
  2. the number of unplanned emergency medical visits caused by exacerbation of COPD per year [ Time Frame: 3 years ]
  3. the number of unplanned hospitalization caused by exacerbation of COPD per year [ Time Frame: 3 years ]
  4. the cost of unplanned medical expense caused by exacerbation of COPD per year [ Time Frame: 3 years ]
  5. the number of unplanned mortality caused by exacerbation of COPD per year [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083067


Contacts
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Contact: Guangfa Wang, MD +86 13810644029 wangguangfa@hotmail.com
Contact: Tianyu Zhou, PhD +86 18813186274 zty2712@hotmail.com

Locations
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China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Tianyu Zhou, PhD       zty2712@hotmail.com   
Contact: Yijue Zhong, PhD       zhongyijue1985@163.com   
Aerospace 731 Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Fengzhen Zhang       zfz731hx@163.com   
Beijing Changping Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Xiangxin Li       13691008082@163.com   
Beijing Jingmei Group General Hospital Recruiting
Beijing, Beijing, China
Contact: Chunxiao Yu       13811384503@163.com   
Beijing Jishuitan Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Guoguang Xia       guoguangxia1958@sina.com   
Beijing Luhe Hospital Recruiting
Beijing, Beijing, China
Contact: Zhenyang Xu       azhenyang@sina.com   
Beijing Miyun Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Senlin Wang       13701387739@163.com   
Civil Aviation General Hospital Recruiting
Beijing, Beijing, China
Contact: Xiaosen Qian       qian186@sohu.com   
Peking University Shougang Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Pingchao Xiang       xpcemail@163.com   
People's Hospital of Beijing Daxing District Recruiting
Beijing, Beijing, China
Contact: Yongxiang Zhang       zyx8669@163.com   
The Hospital of Shunyi District Beijing Not yet recruiting
Beijing, Beijing, China
Contact: Xisheng Chen       syhx2011@163.com   
Sponsors and Collaborators
Peking University First Hospital
Peking University Shougang Hospital
People's Hospital of Beijing Daxing District
Beijing Jingmei Group General Hospital
Beijing Miyun Hospital
The Hospital of Shunyi District Beijing
Beijing Luhe Hospital
Civil Aviation General Hospital
Beijing Jishuitan Hospital
Aerospace 731 Hospital
Beijing Changping Hospital
Investigators
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Study Chair: Guangfa Wang, MD Peking University First Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guangfa Wang, Prof. & MD., Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03083067    
Other Study ID Numbers: SF2016-1-4071
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Guangfa Wang, Peking University First Hospital:
AECOPD
air pollution
COPD
salvational Intervention
Additional relevant MeSH terms:
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Budesonide
Bromides
Formoterol Fumarate
Tiotropium Bromide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Anticonvulsants