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

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).

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Salmeterol/Fluticasone Propionate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yutong Y GU, Doctor; Phone Number: 2445 8621-64041990; Email: gu.yutong@zs-hospital.sh.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • Recruiting
      • Affiliated Hospital of Anhui Medical College
      • Contact: Gengyun G Sun, Doctor; Phone Number: 8613966673211; Email: sungengyun@tom.com
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Bei B HE, Bachlor; Phone Number: 8613910125933; Email: puh3_hb@bjmu.edu.cn
    • Beijing, Beijing, China, 100020
      • Recruiting
      • Beijing ChaoYang Hospital
      • Contact: Yingxiang Y Lin, Master; Phone Number: 8613611370119; Email: linyx666@yahoo.com.cn
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Gguang Zhou Institute of Respiratory Disease
      • Contact: Jingfang J Ma, Master; Phone Number: 8620-83062880; Email: majf1216@163.com
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • Henan Province Hospital
      • Contact: Lijun L Ma, Bachlor; Phone Number: 8613837115111; Email: malijun0401@163.com
  • Jiangsu
    • Nanjing, Jiangsu, China, 210004
      • Recruiting
      • Jiangsu Province Hospital
      • Contact: Mao M Huang, Doctor; Phone Number: 8613813886116; Email: Hm6114@126.com
    • Wuxi, Jiangsu, China, 214002
      • Recruiting
      • Wuxi People's Hospital,
      • Contact: Fuxing F Hui, Bachlor; Phone Number: 8613358111977; Email: HFX110705@sina.com
  • Liaoning
    • Shenyang, Liaoning, China, 110016
      • Recruiting
      • Shenyang Military General Hospital
      • Contact: Ping P Chen, Doctor; Phone Number: 8613309887193; Email: HXNK2004@126.com
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital
      • Contact: Yutong Y GU, doctor; Phone Number: 2425 8621-64041990; Email: gu.yutong@zs-hospital.sh.cn
  • Sichuan
    • Chendu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital of Sichuan
      • Contact: Fuqiang F Wen, Doctor; Phone Number: 8613628040336; Email: wenfuqiang@126.com
    • Chongqing, Sichuan, China, 430007
      • Recruiting
      • Chongqing Xinqiao Hospital
      • Contact: Changzheng C Wang, Doctor; Phone Number: 8613983815706; Email: czwang@netease.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pre-broncholidator FEV1	Change from Baseline in pre-broncholidator FEV1 at 12 weeks	at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-broncholidator FEV1	Change from Baseline in post-broncholidator FEV1 at 12 weeks	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	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	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	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	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	at 12 weeks

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; The First Affiliated Hospital of Anhui Medical University; Peking Union Medical College Hospital; Shanghai Zhongshan Hospital; Peking University Third Hospital; West China Hospital; Guangzhou First People's Hospital; Qingdao University; Beijing Chao Yang Hospital; The First Affiliated Hospital of Guangzhou Medical University; Henan Provincial People's Hospital; Xinqiao Hospital of Chongqing; Liaoning Tumor Hospital & Institute; Armed Police Medical college Affiliated Hospital
• Investigators: Principal Investigator: Chunxue C BAI, Doctor, Fudan University

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): February 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: November 18, 2010
• First Submitted That Met QC Criteria: November 18, 2010
• First Posted (Estimate): November 19, 2010

Study Record Updates

• Last Update Posted (Estimate): November 19, 2010
• Last Update Submitted That Met QC Criteria: November 18, 2010
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: COPD; Seretide; Combivent; effect and safety; Twelve weeks
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Fluticasone; Xhance; Salmeterol Xinafoate
• Other Study ID Numbers: SCO113162 (Other Grant/Funding Number: GlaxoSmithKline)