EUCTR2006-003225-87-DE进行中（未招募）不适用
A randomized, multi-centre, double-blind, double dummy placebo controlled single-dose cross-over study to demonstrate that 12 and 24 µg of formoterol delivered byConcept1 has a bronchodilator efficacy which is equivalent to the same dose of formoterol delivered by Aerolizer® inadult and adolescent patients with persistent asthma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •Male and female adult and adolescent patients aged 13 years and over, who have signed an Informed Consent Form prior to initiation of any study-related procedure. In the case of patients below the legal age of consent, the Informed Consent Form should also be signed by the patient’s parent / guardian.
- •Patients with stable mild or moderate persistent asthma, diagnosed according to GINA guidelines [National Institutes of Health. National Heart, Lung and Blood Institute. (OCT 2005)] and who additionally meet the following criteria:
- •Patients receiving daily treatment with anti-inflammatory asthma medication, in a stable regimen for the month prior to Visit 1.
- •Patients whose FEV1 at Visit 2 is >= 60% of his/her predicted normal value. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6-hours during which no shortacting ß2-agonist has been inhaled, and 48 hours for a long-acting ß2-agonist .
- •Patients who demonstrate an increase of >=15% or 200ml in FEV1 over their pre-treatment value within 30 minutes after inhalation of 400 µg (4 x 100 µg inhalations) of salbutamol (the administration of salbutamol for the reversibility test has to be within 30 minutes of pre-treatment spirometry).Reversibility will have to be demonstrated at Visit 2 only, after a washout period of at least six hours prior to the evaluation for a short-acting ß2-agonist and 48 hours for a long-acting ß2- agonist.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- •History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- •History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)
- •Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, hysterectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap.
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