NCT00228475已完成4 期
An Open Single Centre Study to Assess the Concentration of Budesonide in Breast Milk From Asthmatic Women on Maintenance Treatment w/Pulmicort ® Turbuhaler ® at the Dose Levels 200/400 µg Bid
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- The concentration of budesonide in breast milk from asthmatic women
研究概览
简要总结
The purpose to measure the concentration of budesonide in breast milk of asthmatic mothers on their normal maintenance treatment with budesonide (Pulmicort Turbuhaler), and to estimate the exposure of budesonide to infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be willing and able to comply with study procedures and provide informed consent.
- •Be breast-feeding women, aged 18 to 45 years inclusive, and having infants aged 1 to 6 months.
- •Be asthmatics that have been on maintenance treatment with Pulmicort Turbuhaler 200 or 400 µg bid for at least 3 months prior to visit
排除标准
- •Clinically relevant abnormalities in physical examination, laboratory assessments, blood pressure or pulse as judged by the investigator.
- •Clinically relevant disease and/or abnormalities, which in the opinion of the investigator, may either put the patient or infant at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study.
- •A suspected/manifested infection of HIV, hepatitis B or C or other infection according to WHO Risk classification 2-4
结局指标
主要结局
The concentration of budesonide in breast milk from asthmatic women
on maintenance treatment with Pulmicort Turbuhaler
次要结局
- Level of budesonide to the infant from breast milk concentrations
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of the Pharmacokinetics, Safety and Tolerability of Single Doses of VR647 Inhalation Suspension Administered Using the VR647 Inhalation System in Children With Wheezing, Reactive Airway Disease or Mild AsthmaWheezingReactive Airway DiseaseMild AsthmaNCT03421730Vectura Limited17
已完成
1 期
A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating WomenHealthy ParticipantsNCT06720714UCB Biopharma SRL15
已完成
1 期
Study Evaluating The Excretion Of Moxidectin Into The Breast Milk Of Lactating, Non-Breastfeeding WomenInfectionNCT00751764Wyeth is now a wholly owned subsidiary of Pfizer12
已完成
4 期
Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's DiseaseColitis, UlcerativeCrohn's DiseaseNCT02559713Takeda11
已完成
1 期
A Study to Measure Daridorexant in Breast Milk of Healthy Lactating WomenHealthyNCT05632393Idorsia Pharmaceuticals Ltd.10