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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).
* 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.
Age
40 - 79 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
July 1, 2009
Primary Completion Date
February 1, 2011
Completion Date
October 1, 2011
Last Updated
November 19, 2010
450
ESTIMATED participants
Salmeterol/Fluticasone Propionate
DRUG
Lead Sponsor
Fudan University
Collaborators
NCT07477600
NCT07382258
NCT07195838
Data Source & Attribution
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