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临床试验/NCT01243788
NCT01243788Unknown4 期

Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Ipratropium/Albuterolin Chinese Patients With Moderate-to-severe COPD.

Fudan University11 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2009年7月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
450
试验地点
11
主要终点
pre-broncholidator FEV1
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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).

详细描述

  • 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.

  2. Inhaled Salmeterol/Fluticasone propionate 50/500ug twice daily or inhaled IB/ALB 36/206ug QID.

  3. Salbutamol will be provided for relief of symptoms on an "as required" basis during the whole 12 weeks.

  4. 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 79 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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 ≤
  • •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

排除标准

  • •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

研究组 & 干预措施

Ipratropium/Albuterol

Active Comparator

Ipratropium/Albuterol 36/206ug QID

干预措施: Salmeterol/Fluticasone Propionate (Drug)

结局指标

主要结局

pre-broncholidator FEV1

时间窗: at 12 weeks

Change from Baseline in pre-broncholidator FEV1 at 12 weeks

次要结局

  • post-broncholidator FEV1(at 12 weeks)
  • Morning PEF, inspiration capacity (IC) and Residual Volume (RV)(at 12 weeks)
  • 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(at 12 weeks)
  • Biomarkers: serum Clara cell 16 (CC-16) protein and serum surfactant protein D (SPD)(at 12 weeks)
  • participants with adverse events and COPD exacerbations(at 12 weeks)

研究者

申办方类型
Other

研究点 (11)

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