Chronic Obstructive Pulmonary Disease (COPD)Phase 4NCT01243788
The Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Atropium/Albuterol in Patients COPD
A Phase 4 study testing Salmeterol/Fluticasone Propionate in people with Chronic Obstructive Pulmonary Disease (COPD), run by Fudan University at 11 sites in China.
Trial summary
To determine the efficacy and safety of Salmeterol/Fluticasone Propionate 50/500ug BID vs Ipratropium/Albuterol 36/206ug QID in Chinese patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Salmeterol/Fluticasone Propionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 11 sitesChina
- Study dates
- Jul 2009to Oct 2011
- Phase
- Phase 4
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese male or female outpatients aged 40 to 79 years, inclusive
- Patients with an established diagnosis of COPD, defined as GOLD guideline postbronchodilation FEV1/FVC ratio of <70%, AND Postbronchodilation FEV1% predicted ranged from ≥25 to ≤70.
- A cigarette smoking history of 10 pack-years
- Use of oral theophylline, or any other inhaled medications other than LABA, LAMA, or ICS for≥30 days (e.g. SABA, SAMA)
- Patients who are able to use Accuhaler device and relief medication
- Patients willing to give informed consent to participate in the study and comply to study protocol
- Eligible female on child-bearing potentia
Who cannot join
- Patients with concurrent respiratory disorders (e.g. asthma) other than COPD
- Patients with a requirement for regular or long term oxygen therapy (>12h/d)
- Patients who used inhaled or oral steroids within 30 days of screening
- Patients who had a respiratory tract infection requiring antibiotics within 14 days of screening
- Patients with a moderate-to-severe COPD exacerbation within 30 days of screening
- Patients with any significant medical condition or disease that would place patients at risk or interfere with the study evaluation.
- Patients who used some inhibitory agents (e.g. b blockers) within 14 days of screening
- Female patients who is pregnant or may be pregnant in the study duration
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020
Yingxiang Y Lin, Master, 8613611370119, linyx666@yahoo.com.cn
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Bei B HE, Bachlor, 8613910125933, puh3_hb@bjmu.edu.cn
- Recruiting
West China Hospital of Sichuan
Chengdu, Sichuan, 610041
Fuqiang F Wen, Doctor, 8613628040336, wenfuqiang@126.com
- Recruiting
Chongqing Xinqiao Hospital
Chongqing, Sichuan, 430007
Changzheng C Wang, Doctor, 8613983815706, czwang@netease.com
- Recruiting
Gguang Zhou Institute of Respiratory Disease
Guangzhou, Guangdong, 510120
Jingfang J Ma, Master, 8620-83062880, majf1216@163.com
- Recruiting
Affiliated Hospital of Anhui Medical College
Hefei, Anhui, 230022
Gengyun G Sun, Doctor, 8613966673211, sungengyun@tom.com
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210004
Mao M Huang, Doctor, 8613813886116, Hm6114@126.com
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Yutong Y GU, doctor, 8621-64041990 ext. 2425, gu.yutong@zs-hospital.sh.cn
- Recruiting
Shenyang Military General Hospital
Shenyang, Liaoning, 110016
Ping P Chen, Doctor, 8613309887193, HXNK2004@126.com
- Recruiting
Wuxi People's Hospital,
Wuxi, Jiangsu, 214002
Fuxing F Hui, Bachlor, 8613358111977, HFX110705@sina.com
- Recruiting
Henan Province Hospital
Zhengzhou, Henan, 450003
Lijun L Ma, Bachlor, 8613837115111, malijun0401@163.com
About this study
Official title: Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Ipratropium/Albuterolin Chinese Patients With Moderate-to-severe COPD.
To determine the efficacy and safety of Salmeterol/Fluticasone Propionate 50/500ug BID vs Ipratropium/Albuterol 36/206ug QID in Chinese patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD).
Read the detailed description
- This is a 12-week, multicentre,randomized,open-label,active-controlled, paralleled-group study.
- Chinese patients aged ≥40 years with moderate-to-severe COPD are eligible for this study.
- If satisfying the entry criteria, patients enter an 8 to 14 day run-in period,and replace previous bronchodilators with inhaled or nebulized Salbutamol.
- Patients record daily severity ratings for daytime symptoms of shortness of breath, tiredness, activity limitation, frustration with symptoms, and night-time sleep symptoms on daily cards.
- Each symptom is rated using 0-100 visual analog scal (VAS). For overall assessment of daytime symptoms, a combined symptom score is obtained by adding VAS scores for shortness of breath, tiredness, activity limitation, frustration with symptoms.
- Patients are required to be symptomatic as demonstrated by a combined daytime symptom score of 120 on at least 4 of the 7 days prior to randomization. <!-- -->
- Eligible patients will be randomized (1:1) to the following 2 treatments for 12 weeks.
- Inhaled Salmeterol/Fluticasone propionate 50/500ug twice daily or inhaled IB/ALB 36/206ug QID.
- Salbutamol will be provided for relief of symptoms on an "as required" basis during the whole 12 weeks.
- A Follow-up visit will be conducted 2 weeks after completion of treatment/early withdrawal to assess for any adverse effects after discontinuing study treatment.
- Being tested
- Salmeterol/Fluticasone Propionate
- Keywords
- COPD, Seretide, Combivent, effect and safety, Twelve weeks
- 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.
Salmeterol/Fluticasone PropionateDrug
Also called Combivent, Salbutamol Aerosol
Salmeterol/Fluticasone 50/500ug twice daily Duration:12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ipratropium/Albuterol | Active comparator | Ipratropium/Albuterol 36/206ug QID Receives: Drug: Salmeterol/Fluticasone Propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre-broncholidator FEV1
Change from Baseline in pre-broncholidator FEV1 at 12 weeks
Measured: at 12 weeks
Secondary outcomes (6)
post-broncholidator FEV1
Change from Baseline in post-broncholidator FEV1 at 12 weeks
Measured: at 12 weeks
Morning PEF, inspiration capacity (IC) and Residual Volume (RV)
Change from Baseline in morning PEF, inspiration capacity (IC) and Residual Volume (RV)at 12 weeks
Measured: at 12 weeks
Overall daytime symptom score, reliever medication use,SGRQ and BODY index
Change from Baseline in overall daytime symptom score, reliever medication use,SGRQ and BODY index at 12 weeks
Measured: at 12 weeks
Percent of symptom-free nights, sleep symptoms, nighttime awakenings due to respiratory symptoms
Change from Baseline in percent of symptom-free nights, sleep symptoms, nighttime awakenings due to respiratory symptoms at 12 weeks
Measured: at 12 weeks
Biomarkers: serum Clara cell 16 (CC-16) protein and serum surfactant protein D (SPD)
Change from Baseline in biomarkers: serum Clara cell 16 (CC-16) protein and serum surfactant protein D (SPD) at 12 weeks
Measured: at 12 weeks
participants with adverse events and COPD exacerbations
Change from Baseline in number of participants with adverse events and COPD exacerbations at 12 weeks
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startJul 2009
- Primary completionFeb 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital with Nanjing Medical University, Guangzhou First People's Hospital, Peking Union Medical College Hospital, Beijing Chao Yang Hospital, Peking University Third Hospital, Liaoning Cancer Hospital & Institute, West China Hospital, Xinqiao Hospital of Chongqing, Qingdao University, Armed Police Medical college Affiliated Hospital, The First Affiliated Hospital of Anhui Medical University, Henan Provincial People's Hospital
- Investigators
- Chunxue C BAI, Doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243788
- Sponsor's protocol ID
- SCO113162
- Other IDs
- SCO113162
- Status last verified
- Oct 2008
- First submitted
- 18 Nov 2010
- Last updated
- 19 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Ipratropium/Albuterolin Chinese Patients With Moderate-to-severe COPD.
- ClinicalTrials.gov ID
- NCT01243788
- Acronym / sponsor ID
- SCO113162
- Keywords
- COPD, Seretide, Combivent, effect and safety, Twelve weeks
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital with Nanjing Medical University, Guangzhou First People's Hospital, Peking Union Medical College Hospital, Beijing Chao Yang Hospital, Peking University Third Hospital, Liaoning Cancer Hospital & Institute, West China Hospital, Xinqiao Hospital of Chongqing, Qingdao University, Armed Police Medical college Affiliated Hospital, The First Affiliated Hospital of Anhui Medical University, Henan Provincial People's Hospital
- Study start
- Jul 2009
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 19 Nov 2010 (estimated)
- 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.
To determine the efficacy and safety of Salmeterol/Fluticasone Propionate 50/500ug BID vs Ipratropium/Albuterol 36/206ug QID in Chinese patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD).
Detailed description
- This is a 12-week, multicentre,randomized,open-label,active-controlled, paralleled-group study.
- Chinese patients aged ≥40 years with moderate-to-severe COPD are eligible for this study.
- If satisfying the entry criteria, patients enter an 8 to 14 day run-in period,and replace previous bronchodilators with inhaled or nebulized Salbutamol.
- Patients record daily severity ratings for daytime symptoms of shortness of breath, tiredness, activity limitation, frustration with symptoms, and night-time sleep symptoms on daily cards.
- Each symptom is rated using 0-100 visual analog scal (VAS). For overall assessment of daytime symptoms, a combined symptom score is obtained by adding VAS scores for shortness of breath, tiredness, activity limitation, frustration with symptoms.
- Patients are required to be symptomatic as demonstrated by a combined daytime symptom score of 120 on at least 4 of the 7 days prior to randomization. <!-- -->
- Eligible patients will be randomized (1:1) to the following 2 treatments for 12 weeks.
- Inhaled Salmeterol/Fluticasone propionate 50/500ug twice daily or inhaled IB/ALB 36/206ug QID.
- Salbutamol will be provided for relief of symptoms on an "as required" basis during the whole 12 weeks.
- A Follow-up visit will be conducted 2 weeks after completion of treatment/early withdrawal to assess for any adverse effects after discontinuing study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ipratropium/Albuterol | Active comparator | Drug: Salmeterol/Fluticasone PropionateIpratropium/Albuterol 36/206ug QID |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chinese male or female outpatients aged 40 to 79 years, inclusive
- Patients with an established diagnosis of COPD, defined as GOLD guideline postbronchodilation FEV1/FVC ratio of <70%, AND Postbronchodilation FEV1% predicted ranged from ≥25 to ≤70.
- A cigarette smoking history of 10 pack-years
- Use of oral theophylline, or any other inhaled medications other than LABA, LAMA, or ICS for≥30 days (e.g. SABA, SAMA)
- Patients who are able to use Accuhaler device and relief medication
Key exclusion criteria (8 listed)
- Patients with concurrent respiratory disorders (e.g. asthma) other than COPD
- Patients with a requirement for regular or long term oxygen therapy (>12h/d)
- Patients who used inhaled or oral steroids within 30 days of screening
- Patients who had a respiratory tract infection requiring antibiotics within 14 days of screening
- Patients with a moderate-to-severe COPD exacerbation within 30 days of screening
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 |
|---|---|---|
| Salmeterol/Fluticasone PropionateAlso: Combivent, Salbutamol AerosolSalmeterol/Fluticasone 50/500ug twice daily Duration:12 weeks | Drug | Ipratropium/Albuterol |
Primary outcome
pre-broncholidator FEV1
Time frame: at 12 weeks
Change from Baseline in pre-broncholidator FEV1 at 12 weeks
6 secondary outcomes
post-broncholidator FEV1
Time frame: at 12 weeks
Morning PEF, inspiration capacity (IC) and Residual Volume (RV)
Time frame: at 12 weeks
Overall daytime symptom score, reliever medication use,SGRQ and BODY index
Time frame: at 12 weeks
Percent of symptom-free nights, sleep symptoms, nighttime awakenings due to respiratory symptoms
Time frame: at 12 weeks
Biomarkers: serum Clara cell 16 (CC-16) protein and serum surfactant protein D (SPD)
Time frame: at 12 weeks
participants with adverse events and COPD exacerbations
Time frame: at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2010.
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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.
Chunxue C BAI, Doctor principal investigator
Fudan University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Salmeterol/Fluticasone Propionate in people with Chronic Obstructive Pulmonary Disease (COPD), run by Fudan University 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 8 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: status not confirmed, as of the sponsor's last update on 19 Nov 2010. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yutong Y GU, Doctor (8621-64041990 ext. 2445, gu.yutong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pre-broncholidator FEV1 (time frame: at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2010.