The Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Atropium/Albuterol in Patients COPD
NCT ID: NCT01243788
Last Updated: 2010-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
450 participants
INTERVENTIONAL
2009-07-31
2011-10-31
Brief Summary
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Detailed Description
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* Chinese patients aged ≥40 years with moderate-to-severe COPD are eligible for this study.
1. If satisfying the entry criteria, patients enter an 8 to 14 day run-in period,and replace previous bronchodilators with inhaled or nebulized Salbutamol.
2. 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.
3. 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.
4. 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.
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1. Eligible patients will be randomized (1:1) to the following 2 treatments for 12 weeks.
1. Inhaled Salmeterol/Fluticasone propionate 50/500ug twice daily or inhaled IB/ALB 36/206ug QID.
2. Salbutamol will be provided for relief of symptoms on an "as required" basis during the whole 12 weeks.
2. 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ipratropium/Albuterol
Ipratropium/Albuterol 36/206ug QID
Salmeterol/Fluticasone Propionate
Salmeterol/Fluticasone 50/500ug twice daily Duration:12 weeks
Interventions
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Salmeterol/Fluticasone Propionate
Salmeterol/Fluticasone 50/500ug twice daily Duration:12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
40 Years
79 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
The First Affiliated Hospital of Guangzhou Medical University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Guangzhou First People's Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Beijing Chao Yang Hospital
OTHER
Peking University Third Hospital
OTHER
Liaoning Cancer Hospital & Institute
OTHER
West China Hospital
OTHER
Xinqiao Hospital of Chongqing
OTHER
Qingdao University
OTHER
Armed Police Medical college Affiliated Hospital
UNKNOWN
The First Affiliated Hospital of Anhui Medical University
OTHER
Henan Provincial People's Hospital
OTHER
Fudan University
OTHER
Responsible Party
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Zhongshan Hospital
Principal Investigators
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Chunxue C BAI, Doctor
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Affiliated Hospital of Anhui Medical College
Hefei, Anhui, China
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Gguang Zhou Institute of Respiratory Disease
Guangzhou, Guangdong, China
Henan Province Hospital
Zhengzhou, Henan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Wuxi People's Hospital,
Wuxi, Jiangsu, China
Shenyang Military General Hospital
Shenyang, Liaoning, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan
Chengdu, Sichuan, China
Chongqing Xinqiao Hospital
Chongqing, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Gengyun G Sun, Doctor
Role: primary
Yingxiang Y Lin, Master
Role: primary
Bei B HE, Bachlor
Role: primary
Jingfang J Ma, Master
Role: primary
Lijun L Ma, Bachlor
Role: primary
Mao M Huang, Doctor
Role: primary
Fuxing F Hui, Bachlor
Role: primary
Ping P Chen, Doctor
Role: primary
Yutong Y GU, doctor
Role: primary
Fuqiang F Wen, Doctor
Role: primary
Changzheng C Wang, Doctor
Role: primary
Other Identifiers
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SCO113162
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SCO113162
Identifier Type: -
Identifier Source: org_study_id