The Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Atropium/Albuterol in Patients COPD
Recruitment status was Recruiting
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).
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Salmeterol/Fluticasone Propionate
|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.|
- pre-broncholidator FEV1 [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]Change from Baseline in pre-broncholidator FEV1 at 12 weeks
- 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
|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)|
Active Comparator: Ipratropium/Albuterol
Ipratropium/Albuterol 36/206ug QID
Drug: Salmeterol/Fluticasone Propionate
Salmeterol/Fluticasone 50/500ug twice daily Duration:12 weeks
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243788
|Contact: Yutong Y GU, Doctor||8621-64041990 ext firstname.lastname@example.org|
|Affiliated Hospital of Anhui Medical College||Recruiting|
|Hefei, Anhui, China, 230022|
|Contact: Gengyun G Sun, Doctor 8613966673211 email@example.com|
|Peking University Third Hospital||Recruiting|
|Beijing, Beijing, China, 100191|
|Contact: Bei B HE, Bachlor 8613910125933 firstname.lastname@example.org|
|Beijing Chaoyang Hospital||Recruiting|
|Beijing, Beijing, China, 100020|
|Contact: Yingxiang Y Lin, Master 8613611370119 email@example.com|
|Gguang Zhou Institute of Respiratory Disease||Recruiting|
|Guangzhou, Guangdong, China, 510120|
|Contact: Jingfang J Ma, Master 8620-83062880 firstname.lastname@example.org|
|Henan Province Hospital||Recruiting|
|Zhengzhou, Henan, China, 450003|
|Contact: Lijun L Ma, Bachlor 8613837115111 email@example.com|
|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|
|Shenyang Military General Hospital||Recruiting|
|Shenyang, Liaoning, China, 110016|
|Contact: Ping P Chen, Doctor 8613309887193 HXNK2004@126.com|
|Shanghai, Shanghai, China, 200032|
|Contact: Yutong Y GU, doctor 8621-64041990 ext 2425 firstname.lastname@example.org|
|West China Hospital of Sichuan||Recruiting|
|Chendu, Sichuan, China, 610041|
|Contact: Fuqiang F Wen, Doctor 8613628040336 email@example.com|
|Chongqing Xinqiao Hospital||Recruiting|
|Chongqing, Sichuan, China, 430007|
|Contact: Changzheng C Wang, Doctor 8613983815706 firstname.lastname@example.org|
|Principal Investigator:||Chunxue C BAI, Doctor||Fudan University|