The Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Atropium/Albuterol in Patients COPD
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|ClinicalTrials.gov Identifier: NCT01243788|
Recruitment Status : Unknown
Verified October 2008 by Fudan University.
Recruitment status was: Recruiting
First Posted : November 19, 2010
Last Update Posted : November 19, 2010
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD)||Drug: Salmeterol/Fluticasone Propionate||Phase 4|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Ipratropium/Albuterolin Chinese Patients With Moderate-to-severe COPD.|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||February 2011|
|Estimated Study Completion Date :||October 2011|
Active Comparator: Ipratropium/Albuterol
Ipratropium/Albuterol 36/206ug QID
Drug: Salmeterol/Fluticasone Propionate
Salmeterol/Fluticasone 50/500ug twice daily Duration:12 weeks
- pre-broncholidator FEV1 [ Time Frame: at 12 weeks ]Change from Baseline in pre-broncholidator FEV1 at 12 weeks
- post-broncholidator FEV1 [ Time Frame: at 12 weeks ]Change from Baseline in post-broncholidator FEV1 at 12 weeks
- Morning PEF, inspiration capacity (IC) and Residual Volume (RV) [ Time Frame: at 12 weeks ]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 ]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 ]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 ]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 ]Change from Baseline in number of participants with adverse events and COPD exacerbations at 12 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Beijing Chaoyang Hospital||Recruiting|
|Beijing, Beijing, China, 100020|
|Contact: Yingxiang Y Lin, Master 8613611370119 firstname.lastname@example.org|
|Peking University Third Hospital||Recruiting|
|Beijing, Beijing, China, 100191|
|Contact: Bei B HE, Bachlor 8613910125933 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|