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临床试验/NCT00048022
NCT00048022已完成2 期

Inhaled Corticosteroid Replacement Study - Efficacy and Safety of Ro 27-2441 (Test Drug) in Moderate Persistent Asthma

Hoffmann-La Roche60 个研究点 分布在 1 个国家开始时间: 2002年10月25日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
试验地点
60

研究概览

简要总结

The primary objective of the study is to evaluate the anti-inflammatory action and safety of Ro 27-2441 (study drug) in asthmatic patients currently taking inhaled corticosteroids. The research is being conducted at up to 40 clinical research sites in the US. Study participants will have a number of visits to a research site over a 4-month period.

研究设计

研究类型
Interventional
主要目的
Treatment

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Persistent asthma for more than 1 year
  • Currently receiving treatment with a stable dose of inhaled corticosteroids for more than 3 months
  • In good health as demonstrated by medical history and physical exam
  • Negative urine pregnancy test
  • Commitment to use two forms of effective contraception simultaneously throughout the study duration and for 1 month after discontinuing therapy

排除标准

  • Hospitalization for treatment of asthma and/or treatment with oral/injectable corticosteroids within 3 months before the start of the study
  • Undergoing allergy shots unless on a stable maintenance dose for 3 months before the start of the study
  • History of chronic pulmonary diseases other than asthma
  • Treatment of conditions other than asthma with oral corticosteroids within 1 month of the start of the study
  • Current tobacco usage
  • Smoking history of greater than 10 pack-year history of cigarette smoking (number of packs smoked per day times the number of years smoked)
  • History or evidence of drug or alcohol abuse
  • Diagnosis or evidence of an infectious illness within one month of Visit 1
  • Clinically significant diseases as assessed by the study doctor
  • Participation in another clinical study with an experimental drug within one month of start of the study

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (60)

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