NL-OMON50523已完成3 期
Randomized,double-blind,placebo-controlled study comparing formoterol-beclometason 12/200 mcg BID versus placebo to evaluate the improvement of coughing and quality of life in subjects with bronchiectasis. - FORZA study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •· Age >= 18 years;
- •· Symptomatic patient (wheezing, cough and dyspnoea);
- •· Proven and documented diagnosis of BE by high resolution computed tomography
- •· Stable pulmonary status as indicated by FEV1 (percent of predicted) >=30%
- •· Stable clinically phase (ie, subjects free from acute exacerbation for at
- •least 6 weeks prior to the start of the study);
- •· Stable regimen of standard treatment if used as chronic treatment for BE, at
- •least for the past 4 weeks prior to screening. And/or macrolides if used as
- •chronic treatment for BE at least for the past 6 months prior to screening;
- •· Coughing on the majority of days.
排除标准
- •Possible asthma according to the definition of the Global Initiative for Asthma
- •(GINA) with:
- •o Positive bronchodilator reversibility test (increase in FEV1 of >12% and
- •>200 mL from baseline, 10-15 minutes after 200-400 mcg salbutamol or equivalent)
- •o Positive bronchial challenge test (fall in FEV1from baseline of >=20% with
- •standard doses of methacholine or histamine)
- •- Known intolerance for ICS or LABA.
- •- Current ICS use
- •- Other cardiopulmonary conditions (other than bronchiectasis) that could
- •modify spirometric valeus.
- •- Women who are pregnant, lactating, or in whom pregnancy cannot be excluded;
- •- Cigarette smoking history of > 10 pack-years and/or current smokers;
- •- Expected to die within 72 hours after enrolment
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