EUCTR2007-005094-54-GB进行中（未招募）不适用
A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, CROSSOVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 14-DAY INHALED TPI ASM8 IN SUBJECTS WITH ASTHMA
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Men and women 18 to 65 years of age; non-smoking, steroid-naive, (i.e.. those who are not currently on corticosteroid or those who have not taken any oral/ inhaled/ ophthalmic or injectable corticosteroid within 60 days prior to start of the study); and generally in good health;
- •Intermittent or persistent mild to moderate allergic asthma as defined by ATS/ ERS criteria ((American Thoracic Society Lung function testing, 1991);
- •History of episodic wheeze and shortness of breath;
- •Forced expiratory volume in 1 second (FEV1) at baseline at least 70% of the predicted value;
- •Able to comprehend and follow all required study procedures;
- •Willing and able to sign an REB/IEC-approved informed consent form;
- •Subjects must not be taking any other regular anti-asthmatic medication except for the short-acting B2-agonist bronchodilator (e.g. salbutamol/albuterol) on an as needed basis;
- •Positive 5’AMP challenge at baseline (AMP-PC20 = 60 mg/mL);
- •Positive skin-prick test to at least one of common aeroallergens (including cat fur and dander, house dust mite, mixed grass pollen);
- •Positive allergen-induced early (fall equal to or greater than 20% in FEV1 at 0-3 hrs following allergen challenge) and late (fall in FEV1 equal to or greater than 15% at 3-7 hrs) airway response (Dual responders).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Significant acute or chronic medical, neurologic, cardiovascular or psychiatric illness;
- •Known coagulopathy;
- •Asthma exacerbation or respiratory infection in the preceding 6 weeks;
- •Use of oral / injectable corticosteroids within the last 60 days or currently on any anti-asthmatic drugs, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants. (Intermittent doses of short-acting ß2-agonist are allowed);
- •Investigational drug use within 30 days;
- •Any clinically significant abnormality on physical examination or on screening laboratory determinations;
- •A >20% fall in FEV1 or FVC with baseline saline in the first AMP challenge during the screening period (Day –14).
- •Blood draws of 100 mL or more within 45 days prior to enrolment in the study.
- •Ongoing use of tobacco products of any kind or previous usage within the past 12 months or past history of greater than or equal to 10 pack years
- •Pregnant or lactating women; women actively seeking pregnancy or who are unwilling to use adequate contraception.
研究者
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