NCT00760838已完成4 期
The AZIthromycin in Severe ASThma (AZISAST) Study: a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy, Safety and Cost-effectiveness of Azithromycin as add-on Therapy in Adult Subjects With Severe Persistent Asthma, Who Remain Inadequately Controlled Despite GINA (2006) Step 4 or 5 Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 7
- 主要终点
- Proportion of Participants With Severe Asthma Exacerbations
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain inadequately controlled despite GINA (2006) step 4 or 5 therapy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who have given written informed consent
- •males or females of any race
- •18-75 years of age
- •with the diagnosis of persistent asthma ≥ 1 year duration at screening and a history consistent with GINA step 4 or 5 clinical features
- •receiving high dose ICS plus inhaled LABA for at least 6 months prior to screening
- •patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations within the previous 12 months
- •patients must be never-smokers or ex-smokers with a smoking history of ≤ 10 pack-years.
排除标准
- •females who are pregnant or who are breastfeeding
- •patients with severe bronchiectasis
- •patients with active tuberculosis or non-tuberculous mycobacterial infections (NTM)
- •patients with significant underlying medical conditions (e.g. infection, hematological disease, malignancy, neurologic, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinologic or gastrointestinal disease) within the previous 3 months
- •who are unable to perform spirometry or complete a patient diary or complete questionnaires
- •patients with known hypersensitivity to azithromycin or other macrolide antibiotics
- •patients who's heart rate corrected QT interval is prolonged
- •patients who have - in the judgement of the investigator - a clinically relevant laboratory abnormality
- •patients currently treated with macrolide antibiotics or recent macrolide treatment (in the past twelve weeks)
- •anti-IgE treatment
研究组 & 干预措施
placebo
Placebo Comparator
Placebo
1x/day during 5 days 3x/week afterwards
干预措施: Placebo (Drug)
Azithromycin
Experimental
Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards
干预措施: Azithromycin 250 mg (Drug)
结局指标
主要结局
Proportion of Participants With Severe Asthma Exacerbations
时间窗: from baseline to week 26
Severe asthma exacerbations are defined as severe asthma episodes for which a treatment with antibiotics or cortisone is administered for a minimum of 3 days.
次要结局
- Proportion of Participants Using Rescue Medication From Baseline to Week 26(from baseline to week 26)
- Change in Forced Expiratory Volume in 1 Second(from baseline to week 26)
- Change in Total Score on Asthma Control Questionnaire (ACQ)(from baseline to week 26)
- Change in Total Score on the Asthma-related Quality of Life (AQLQ)(from baseline to week 26)
- Peakflow Measurements(from baseline to week 26)
研究者
研究点 (7)
Loading locations...
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