EUCTR2006-004187-32-GB进行中（未招募）1 期
Efficacy and safety of AVT-01 5 mg once daily over 7 days in patients with moderate persistent atopic asthma – A double-blind, randomized, placebo-controlled clinical study
Avontec GmbH0 个研究点目标入组 48 人开始时间: 2008年2月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
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
- Male
入选标准
- •- Written informed consent by the patient for study participation, prior to protocol specific procedures·
- •- Male outpatients aged 18 - 65·
- •- Atopic asthma defined as:
- •The patients have to suffer from allergic complaints caused by clinically relevant sensitisation against house dust mites. The IgE mediated sensitisation has to be verified by:
- •suggestive medical history;
- •a positive skin prick test for house dust mites, resulting in a wheal diameter of at least 3 mm > negative control reaction;
- •or '++' versus histamine
- •Patients with co-allergies (e.g. trees, grasses) may only be included before or after the respective pollen season
- •- Moderate persistent asthma acc. GINA classification 2005:
- •FEV1 = 60 to 80%predicted
- •PC20 methacholine = 4 mg / ml
- •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
- •Intake of any of the following medications within the last 2 weeks prior to screening:
- •- Systemic antibiotics
- •- Systemic or inhaled glucocorticosteroids
- •- Systemic or inhaled long-acting beta-agonists
- •- Leukotriene modifiers
- •- Nedocromil
- •Intake of any of the following medications during the entire study:
- •- Systemic antibiotics
- •- Systemic or inhaled glucocorticosteroids
- •- Systemic or inhaled long-acting beta-agonists
- •- Leukotriene modifiers
- •- Nedocromil
- •- Cromolyn sodium
- •- Immunosuppressant agents
- •- Antihistamines
- •Medical history or presence of any of the following organic diseases:
- •- Acute respiratory infection (including common cold”) in the past 4 weeks prior to screening and during the entire study
- •- Chronic obstructive pulmonary disease (COPD)
- •- Acute episode of COPD
- •- Clinically relevant chronic cardiovascular disease
- •- Chronic kidney disease
- •- Gastrointestinal or liver diseases, such as:
- •active peptic gastric ulcer
- •malabsorption
- •hypersecretion of bile acido
- •- Malignant growth
- •- Severe somatopathic, neurological and/or psychiatric disease
- •- Aortic aneurysm
- •- Myasthenia gravis
- •- Parallel participation in another study, participation in a study within less than 6 weeks prior to study entry, or previous participation in this same study
- •- Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
- •- Patients who have difficulties in understanding the language in which the patient information is given
- •- Any vulnerable patient (patient who is or could be dependent on the investigator, e.g. spouse of the investigator, nurses, members of the site staff, persons who are officially/legally admitted to an institution, persons with a terminal illness, persons living in a nursing home, homeless persons, patients in emergency situations, prisoners, persons incapable of consenting)
- •- Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, history of or [and] known drug abuse, known to be non-compliant or presenting an unstable psychiatric history).
- •- Patients in custody by juridical or official order
- •- Evidence of an uncooperative attitude
- •- A patient who is at the same time the investigator
研究者
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