EUCTR2009-010434-22-DK进行中（未招募）不适用
A SINGLE-DOSE, OPEN-LABEL, 2-WAY CROSS-OVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 50/6 HFA pMDI (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 50µg PLUS FORMOTEROL FUMARATE 6 µg ) USING THE AEROCHAMBER PLUS™ SPACER DEVICE VERSUS THE FREE COMBINATION OF BECLOMETHASONE HFA pMDI AND FORMOTEROL HFA pMDI AVAILABLE ON THE MARKET USING THE AEROCHAMBER PLUS™ SPACER DEVICE IN ASTHMATIC CHILDRE
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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 obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting) prior to any study-related procedures.
- •2. Male/female children with asthma stable enough, according the paediatrician opinion, to allow a wash out period from steroids of 3 days before study treatments.
- •3.Male/female children with asthma on regular treatment with ICS or using short-acting inhaled beta2-agonist as reliever to control asthma symptoms
- •4. Age 5 -11y (about 50% of the children in the age range 5-8 years old)
- •5. Children with a forced expiratory volume in one second (FEV1) > 70% of predicted values (% pred).
- •6. A cooperative attitude and ability to be trained about the proper use of pMDI with a spacer device and compliant to study procedures.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •Exclusion Criteria
- •The presence of any of the following will exclude a subject from study enrolment:
- •1. Past or present diagnoses of cardiovascular, renal or liver disease
- •2. Known hypersensitivity to the active treatments
- •3. Exacerbation of asthma symptoms within the previous 4 weeks
- •4. Inability to perform the required breathing technique and blood sampling
- •5. Hospitalization due to exacerbation of asthma within 1 month prior to inclusion
- •6. Lower respiratory tract infection within 1 month prior to inclusion
- •7. Disease (other than asthma) which might influence the outcome of the study
- •8. Obesity, i.e. > 97% weight percentile by local standards
研究者
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