Status:
UNKNOWN
The Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Atropium/Albuterol in Patients COPD
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Shanghai Zhongshan Hospital
The First Affiliated Hospital of Guangzhou Medical University
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40-79 years
Phase:
PHASE4
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 D...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2011
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT01243788
Start Date
July 1 2009
End Date
October 1 2011
Last Update
November 19 2010
Active Locations (11)
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1
Affiliated Hospital of Anhui Medical College
Hefei, Anhui, China, 230022
2
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, China, 100020
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
4
Gguang Zhou Institute of Respiratory Disease
Guangzhou, Guangdong, China, 510120