COPD ExacerbationSIRCAPNCT03083067
Salvational Intervention for Reducing AECOPD Under Severe Air Pollution
A study testing Budesonide/formoterol and tiotropium bromide in people with COPD Exacerbation and Air Pollution, run by Peking University First Hospital at 11 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD Exacerbation, Air Pollution
- What is being tested?
- Budesonide/formoterol and tiotropium bromide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 11 sitesChina
- Study dates
- 20 Mar 2017to 16 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Aerospace 731 Hospital
Beijing, Beijing Municipality
Beijing Changping Hospital
Beijing, Beijing Municipality
Beijing Jingmei Group General Hospital
Beijing, Beijing Municipality
Beijing Jishuitan Hospital
Beijing, Beijing Municipality
Beijing Luhe Hospital
Beijing, Beijing Municipality
Beijing Miyun Hospital
Beijing, Beijing Municipality
Civil Aviation General Hospital
Beijing, Beijing Municipality
Peking University Shougang Hospital
Beijing, Beijing Municipality
People's Hospital of Beijing Daxing District
Beijing, Beijing Municipality
The Hospital of Shunyi District Beijing
Beijing, Beijing Municipality
About this study
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
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.
Read the 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.
- Conditions
- COPD Exacerbation, Air Pollution
- Being tested
- Budesonide/formoterol, tiotropium bromide
- Keywords
- AECOPD, air pollution, COPD, salvational Intervention
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
tiotropium bromideDrug
Inhaled tiotropium bromide(18ug) will be used as routine medicine according to doctor's advice.
| Study group | Role | What they receive |
|---|---|---|
| Salvational intervention(SI) group | Experimental | Budesonide/formoterol（160ug/4.5ug）will be used as an intervention drug on the foundation of original treatment. Receives: Drug: Budesonide/formoterol; Drug: tiotropium bromide |
| Control(CT) group | Active comparator | CT group maintain the original treatment Receives: Drug: tiotropium bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
the frequency of exacerbation of COPD per year
Measured: 3 year
Secondary outcomes (5)
the number of unplanned outpatient visits caused by exacerbation of COPD per year
Measured: 3 years
the number of unplanned emergency medical visits caused by exacerbation of COPD per year
Measured: 3 years
the number of unplanned hospitalization caused by exacerbation of COPD per year
Measured: 3 years
the cost of unplanned medical expense caused by exacerbation of COPD per year
Measured: 3 years
the number of unplanned mortality caused by exacerbation of COPD per year
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start20 Mar 2017
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Shougang Hospital, People's Hospital of Beijing Daxing District, Beijing Jingmei Group General Hospital, Beijing Miyun Hospital, Beijing Shuyi Hospital, Beijing Luhe Hospital, Civil Aviation General Hospital, Beijing Jishuitan Hospital, Aerospace 731 Hospital, Beijing Changping Hospital
- Responsible party
- Principal investigator, Guangfa Wang, Peking University First Hospital
- Investigators
- Guangfa Wang, MD, Study chair, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083067
- Sponsor's protocol ID
- SF2016-1-4071
- Acronym
- SIRCAP
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2017
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou T, Zhong Y, Liao J, Wang G, Li X, Qian X, Xiang P, Chen X, Xu Z, Zhang F, Wang X, Wang S, Li X, Yu C, Zhang Y, Xia G, Dai L. A prospective study of salvational intervention with ICS/LABA for reducing chronic obstructive pulmonary disease exacerbation under severe air pollution (SIRCAP) in Beijing: protocol of a multi-center randomized controlled trial. BMC Pulm Med. 2019 Jan 25;19(1):22. doi: 10.1186/s12890-018-0771-9.
PubMed 30683080
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03083067
- Acronym / sponsor ID
- SIRCAP / SF2016-1-4071
- Conditions
- COPD Exacerbation, Air Pollution
- Keywords
- AECOPD, air pollution, COPD, salvational Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Peking University Shougang Hospital, People's Hospital of Beijing Daxing District, Beijing Jingmei Group General Hospital, Beijing Miyun Hospital, Beijing Shuyi Hospital, Beijing Luhe Hospital, Civil Aviation General Hospital, Beijing Jishuitan Hospital, Aerospace 731 Hospital, Beijing Changping Hospital
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salvational intervention(SI) group | Experimental | Drug: Budesonide/formoterol, Drug: tiotropium bromideBudesonide/formoterol（160ug/4.5ug）will be used as an intervention drug on the foundation of original treatment. |
| Control(CT) group | Active comparator | Drug: tiotropium bromideCT group maintain the original treatment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide/formoterolOn 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 | Salvational intervention(SI) group |
| tiotropium bromideInhaled tiotropium bromide(18ug) will be used as routine medicine according to doctor's advice. | Drug | Control(CT) group, Salvational intervention(SI) group |
Primary outcome
the frequency of exacerbation of COPD per year
Time frame: 3 year
5 secondary outcomes
the number of unplanned outpatient visits caused by exacerbation of COPD per year
Time frame: 3 years
the number of unplanned emergency medical visits caused by exacerbation of COPD per year
Time frame: 3 years
the number of unplanned hospitalization caused by exacerbation of COPD per year
Time frame: 3 years
the cost of unplanned medical expense caused by exacerbation of COPD per year
Time frame: 3 years
the number of unplanned mortality caused by exacerbation of COPD per year
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 30683080Zhou T, Zhong Y, Liao J, Wang G, Li X, Qian X, Xiang P, Chen X, Xu Z, Zhang F, Wang X, Wang S, Li X, Yu C, Zhang Y, Xia G, Dai L. A prospective study of salvational intervention with ICS/LABA for reducing chronic obstructive pulmonary disease exacerbation under severe air pollution (SIRCAP) in Beijing: protocol of a multi-center randomized controlled trial. BMC Pulm Med. 2019 Jan 25;19(1):22. doi: 10.1186/s12890-018-0771-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guangfa Wang, MD study chair
Peking University First Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Budesonide/formoterol and tiotropium bromide in people with COPD Exacerbation and Air Pollution, run by Peking University First Hospital at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the frequency of exacerbation of COPD per year (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03083067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.