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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Salmeterol/Fluticasone Propionate
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Seretide, Combivent, effect and safety, Twelve weeks

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Affiliated Hospital of Anhui Medical CollegeRecruiting
  • Beijing Chaoyang HospitalRecruiting
  • Peking University Third HospitalRecruiting
  • Gguang Zhou Institute of Respiratory DiseaseRecruiting
  • Henan Province HospitalRecruiting
  • Jiangsu Province HospitalRecruiting
  • Wuxi People's Hospital,Recruiting
  • Shenyang Military General HospitalRecruiting
  • Zhongshan HospitalRecruiting
  • West China Hospital of SichuanRecruiting
  • Chongqing Xinqiao HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Ipratropium/Albuterol

Arm Description

Ipratropium/Albuterol 36/206ug QID

Outcomes

Primary Outcome Measures

pre-broncholidator FEV1
Change from Baseline in pre-broncholidator FEV1 at 12 weeks

Secondary Outcome Measures

post-broncholidator FEV1
Change from Baseline in post-broncholidator FEV1 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
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
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
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
participants with adverse events and COPD exacerbations
Change from Baseline in number of participants with adverse events and COPD exacerbations at 12 weeks

Full Information

First Posted
November 18, 2010
Last Updated
November 18, 2010
Sponsor
Fudan University
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 Tumor 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
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1. Study Identification

Unique Protocol Identification Number
NCT01243788
Brief Title
The Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Atropium/Albuterol in Patients COPD
Official Title
Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Ipratropium/Albuterolin Chinese Patients With Moderate-to-severe COPD.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fudan University
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 Tumor 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, Seretide, Combivent, effect and safety, Twelve weeks

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ipratropium/Albuterol
Arm Type
Active Comparator
Arm Description
Ipratropium/Albuterol 36/206ug QID
Intervention Type
Drug
Intervention Name(s)
Salmeterol/Fluticasone Propionate
Other Intervention Name(s)
Combivent, Salbutamol Aerosol
Intervention Description
Salmeterol/Fluticasone 50/500ug twice daily Duration:12 weeks
Primary Outcome Measure Information:
Title
pre-broncholidator FEV1
Description
Change from Baseline in pre-broncholidator FEV1 at 12 weeks
Time Frame
at 12 weeks
Secondary Outcome Measure Information:
Title
post-broncholidator FEV1
Description
Change from Baseline in post-broncholidator FEV1 at 12 weeks
Time Frame
at 12 weeks
Title
Morning PEF, inspiration capacity (IC) and Residual Volume (RV)
Description
Change from Baseline in morning PEF, inspiration capacity (IC) and Residual Volume (RV)at 12 weeks
Time Frame
at 12 weeks
Title
Overall daytime symptom score, reliever medication use,SGRQ and BODY index
Description
Change from Baseline in overall daytime symptom score, reliever medication use,SGRQ and BODY index at 12 weeks
Time Frame
at 12 weeks
Title
Percent of symptom-free nights, sleep symptoms, nighttime awakenings due to respiratory symptoms
Description
Change from Baseline in percent of symptom-free nights, sleep symptoms, nighttime awakenings due to respiratory symptoms at 12 weeks
Time Frame
at 12 weeks
Title
Biomarkers: serum Clara cell 16 (CC-16) protein and serum surfactant protein D (SPD)
Description
Change from Baseline in biomarkers: serum Clara cell 16 (CC-16) protein and serum surfactant protein D (SPD) at 12 weeks
Time Frame
at 12 weeks
Title
participants with adverse events and COPD exacerbations
Description
Change from Baseline in number of participants with adverse events and COPD exacerbations at 12 weeks
Time Frame
at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yutong Y GU, Doctor
Phone
8621-64041990
Ext
2445
Email
gu.yutong@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunxue C BAI, Doctor
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Anhui Medical College
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gengyun G Sun, Doctor
Phone
8613966673211
Email
sungengyun@tom.com
Facility Name
Beijing Chaoyang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingxiang Y Lin, Master
Phone
8613611370119
Email
linyx666@yahoo.com.cn
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bei B HE, Bachlor
Phone
8613910125933
Email
puh3_hb@bjmu.edu.cn
Facility Name
Gguang Zhou Institute of Respiratory Disease
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingfang J Ma, Master
Phone
8620-83062880
Email
majf1216@163.com
Facility Name
Henan Province Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijun L Ma, Bachlor
Phone
8613837115111
Email
malijun0401@163.com
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mao M Huang, Doctor
Phone
8613813886116
Email
Hm6114@126.com
Facility Name
Wuxi People's Hospital,
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuxing F Hui, Bachlor
Phone
8613358111977
Email
HFX110705@sina.com
Facility Name
Shenyang Military General Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping P Chen, Doctor
Phone
8613309887193
Email
HXNK2004@126.com
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yutong Y GU, doctor
Phone
8621-64041990
Ext
2425
Email
gu.yutong@zs-hospital.sh.cn
Facility Name
West China Hospital of Sichuan
City
Chendu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuqiang F Wen, Doctor
Phone
8613628040336
Email
wenfuqiang@126.com
Facility Name
Chongqing Xinqiao Hospital
City
Chongqing
State/Province
Sichuan
ZIP/Postal Code
430007
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changzheng C Wang, Doctor
Phone
8613983815706
Email
czwang@netease.com

12. IPD Sharing Statement

Learn more about this trial

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

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