EUCTR2009-014640-11-PL进行中（未招募）不适用
A Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate Tolerability, Safety and Efficacy of AKITA Inhaled Steroid Suspension for Inhalation (AICS) in Subjects with Asthma Requiring Chronic Oral Corticosteroid Treatment
Activaero GmbH0 个研究点目标入组 195 人开始时间: 2010年2月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 195
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
- •1. Written informed consent prior to the performance of any study-related procedures
- •2. Age = 18 and = 65 year of age
- •3. Diagnosis of asthma (ATS definition, either allergic or non-allergic) for = 6 months
- •4. Asthma treated for at least 3 months with inhaled (ICS) and oral corticosteroids (OCS) with a minimum of at least 5 mg/day oral corticosteroids, up to a maximum of 40 mg/day or 80mg/day if taken every other day. Exact baseline level of OCS and SABA will be measured during the screening period by subject diary entries.
- •5. FEV1 = 40% or = 79% predicted at the Screening or Baseline Visit
- •6. Documented increase of at least 12% in absolute FEV1 within 15-30 minutes after the use of inhaled Salbutamol at the Screening Visit or within 2 years prior to Screening.
- •7. Mandatory usage of long-acting ß-agonists
- •8. A negative pregnancy test must be available for any women of childbearing potential at screening and, in addition, a negative urine pregnancy test must be present at randomization (prior to randomization to one of the
- •treatment groups!)
- •9. Women of childbearing potential must agree to use a reliable method of contraception from the screening until 4 weeks after study completion or after study drug discontinuation in case study drug treatment is stopped prematurely. In this study, hormone-based contraceptives alone are not considered as reliable method (Effective hormonal methods of birth control with a pearl index <1 include prescription combined hormonal contraceptives, hormonal contraceptive injections, and hormonal intrauterine devices. Additionally accepted are male partner vasectomized or female subjects with a hysterectomy or bilateral tubal ligation.)
- •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
- •1. History of allergy or adverse experience with Budesonide
- •2. Pregnant women or nursing mothers
- •3. Upper respiratory tract infection within 4 weeks of Screening
- •4. Emergency room visit for treatment of asthma exacerbation within 4 weeks of Screening
- •5. Hospitalization for asthma within 3 months of Screening
- •6. Use of anti-IgE, methotrexate, oral gold, Dapsone, or IV gamma globulin within 3 months of Screening.
- •7. Treatment with other investigational asthma treatment within 30 days prior to Screening.
- •8. Evidence of chronic lung diseases other than asthma, including but not limited to: cystic fibrosis, allergic
- •bronchopulmonary aspergillosis (ABPA), COPD, chronic bronchitis and emphysema
- •9. History of medication noncompliance
- •10. History of significant medical illness or condition that in the Investigator’s opinion places the subject at undue
- •risk by participating in the study
- •11. Past episode of anaphylaxis with severe respiratory symptoms
- •12. Oral corticosteroid average daily dose of > 40mg/day or > 80mg/day if taken every other day
- •13. Currently smoking or history of smoking = 10 pack years
- •14. Taking oral or i.v. corticosteriods for any disease indication other than asthma
- •15. Abnormal lab values for chemistry tests at Screening that may indicate impaired ability to metabolize and/or excrete Budesonide:
- •LFTs (AST, ALT) > 3 times upper limit of normal range
- •Serum creatinine > 1.5 times upper limit of normal range
研究者
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A Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate Tolerability, Safety and Efficacy of AKITA Inhaled Steroid Suspension for Inhalation (AICS) in Subjects with Asthma Requiring Chronic Oral Corticosteroid TreatmenttSubjects with Asthma Requiring Chronic Oral Corticosteroid TreatmentMedDRA version: 12.0Level: LLTClassification code 10003555Term: Asthma bronchialEUCTR2009-014640-11-DEActivaero GmbH195
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