The Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Atropium/Albuterol in Patients COPD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Shanghai Zhongshan Hospital
The First Affiliated Hospital of Guangzhou Medical University
Jiangsu Province Hospital
Guangzhou First Municipal People’s Hospital
Peking Union Medical College Hospital
Beijing Chao Yang Hospital
Peking University Third Hospital
Liaoning Province North Hospital
West China Hospital
Xinqiao Hospital of Chongqing
Qingdao University
Armed Police Medical college Affiliated Hospital
Anhui Medical University
Henan Provincial Hospital
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01243788
First received: November 18, 2010
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Salmeterol/Fluticasone Propionate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Ipratropium/Albuterolin Chinese Patients With Moderate-to-severe COPD.

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • pre-broncholidator FEV1 [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
    Change from Baseline in pre-broncholidator FEV1 at 12 weeks


Secondary Outcome Measures:
  • post-broncholidator FEV1 [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
    Change from Baseline in post-broncholidator FEV1 at 12 weeks

  • Morning PEF, inspiration capacity (IC) and Residual Volume (RV) [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
    Change from Baseline in morning PEF, inspiration capacity (IC) and Residual Volume (RV)at 12 weeks

  • Overall daytime symptom score, reliever medication use,SGRQ and BODY index [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
    Change from Baseline in overall daytime symptom score, reliever medication use,SGRQ and BODY index at 12 weeks

  • Percent of symptom-free nights, sleep symptoms, nighttime awakenings due to respiratory symptoms [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
    Change from Baseline in percent of symptom-free nights, sleep symptoms, nighttime awakenings due to respiratory symptoms at 12 weeks

  • Biomarkers: serum Clara cell 16 (CC-16) protein and serum surfactant protein D (SPD) [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
    Change from Baseline in biomarkers: serum Clara cell 16 (CC-16) protein and serum surfactant protein D (SPD) at 12 weeks

  • participants with adverse events and COPD exacerbations [ Time Frame: at 12 weeks ] [ Designated as safety issue: Yes ]
    Change from Baseline in number of participants with adverse events and COPD exacerbations at 12 weeks


Estimated Enrollment: 450
Study Start Date: July 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ipratropium/Albuterol
Ipratropium/Albuterol 36/206ug QID
Drug: Salmeterol/Fluticasone Propionate
Salmeterol/Fluticasone 50/500ug twice daily Duration:12 weeks
Other Names:
  • Combivent
  • Salbutamol Aerosol

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.

    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.
    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.
  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243788

Contacts
Contact: Yutong Y GU, Doctor 8621-64041990 ext 2445 gu.yutong@zs-hospital.sh.cn

Locations
China, Anhui
Affiliated Hospital of Anhui Medical College Recruiting
Hefei, Anhui, China, 230022
Contact: Gengyun G Sun, Doctor    8613966673211    sungengyun@tom.com   
China, Beijing
Beijing Chaoyang Hospital Recruiting
Beijing, Beijing, China, 100020
Contact: Yingxiang Y Lin, Master    8613611370119    linyx666@yahoo.com.cn   
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Contact: Bei B HE, Bachlor    8613910125933    puh3_hb@bjmu.edu.cn   
China, Guangdong
Gguang Zhou Institute of Respiratory Disease Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Jingfang J Ma, Master    8620-83062880    majf1216@163.com   
China, Henan
Henan Province Hospital Recruiting
Zhengzhou, Henan, China, 450003
Contact: Lijun L Ma, Bachlor    8613837115111    malijun0401@163.com   
China, Jiangsu
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China, 210004
Contact: Mao M Huang, Doctor    8613813886116    Hm6114@126.com   
Wuxi People's Hospital, Recruiting
Wuxi, Jiangsu, China, 214002
Contact: Fuxing F Hui, Bachlor    8613358111977    HFX110705@sina.com   
China, Liaoning
Shenyang Military General Hospital Recruiting
Shenyang, Liaoning, China, 110016
Contact: Ping P Chen, Doctor    8613309887193    HXNK2004@126.com   
China, Shanghai
Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Yutong Y GU, doctor    8621-64041990 ext 2425    gu.yutong@zs-hospital.sh.cn   
China, Sichuan
West China Hospital of Sichuan Recruiting
Chendu, Sichuan, China, 610041
Contact: Fuqiang F Wen, Doctor    8613628040336    wenfuqiang@126.com   
Chongqing Xinqiao Hospital Recruiting
Chongqing, Sichuan, China, 430007
Contact: Changzheng C Wang, Doctor    8613983815706    czwang@netease.com   
Sponsors and Collaborators
Fudan University
Shanghai Zhongshan Hospital
The First Affiliated Hospital of Guangzhou Medical University
Jiangsu Province Hospital
Guangzhou First Municipal People’s Hospital
Peking Union Medical College Hospital
Beijing Chao Yang Hospital
Peking University Third Hospital
Liaoning Province North Hospital
West China Hospital
Xinqiao Hospital of Chongqing
Qingdao University
Armed Police Medical college Affiliated Hospital
Anhui Medical University
Henan Provincial Hospital
Investigators
Principal Investigator: Chunxue C BAI, Doctor Fudan University
  More Information

No publications provided

Responsible Party: Chunxue BAI, Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01243788     History of Changes
Other Study ID Numbers: SCO113162, SCO113162
Study First Received: November 18, 2010
Last Updated: November 18, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
COPD
Seretide
Combivent
effect and safety
Twelve weeks

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Albuterol
Salmeterol
Ipratropium
Fluticasone
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 26, 2014