跳至主要内容
临床试验/EUCTR2011-000939-86-SE
EUCTR2011-000939-86-SE进行中(未招募)不适用

An open-label single site single dose pilotstudy using mannitol challenge test with the purpose to explore treatment with fixed dose combinations in adult subjects with asthma in primary care in Sweden - Mannitol Pilot

Mundipharma AB0 个研究点开始时间: 2011年4月29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)

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. Males and females, age 18-65 years.
  • 2. Subjects diagnosed with asthma.
  • 3. Subjects with a baseline FEV1 of =50% of the predicted value.
  • 4. Outpatients at primary clinic.
  • 5. Subjects treated with a fixed dose combination for at least the last three months.
  • 6. Subjects who have withheld their asthma- and allergy medication according to individual instructions at the day of the challenge test.
  • 7. Subjects who are able to read and comprehend Swedish and are willing to sign an informed consent.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 100
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1. Subjects with evidence of any other respiratory and/or obstructive disease.
  • 2. Subjects treated with a oral corticosteroid within 4 weeks (28 days) prior to the day of the challenge test.
  • 3. Any history of hypersensitivity to mannitol challenge test.
  • 4. Any contraindications to use of the diagnostic study medication.
  • 5. Subjects who are unsuitable for other reason(s) in the opinion of the investigator.

研究者

相似试验

已完成
1 期
An open label, single dose, phase I pilot study to determine the pharmacokinetic, safety and tolerability profiles of oxymorphone delivered from a transdermal oxymorphone patchTo promote pain relief, tested in healthy volunteers.Anaesthesiology - Pain management
ACTRN12613000085774Phosphagenics Limited12
已完成
1 期
An open label, phase I single application study to determine the pharmacokinetic, safety and tolerability profiles of oxycodone delivered from a transdermal oxycodone patch.
ACTRN12613000398707Phosphagenics Limited12
已完成
1 期
Open-Label, Single Dose Study to Evaluate the Safety and Efficacy of Nivolumab With or Without GS 4774 for the Treatment of Chronic Hepatitis B patients who are currently receiving oral antiviral treatment
ACTRN12615001133527Gilead Sciences, Inc.24
进行中(未招募)
不适用
A phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and safety of Telbivudine (LdT) in Children and Adolescents with Chronic Hepatitis B Virus InfectioChronic Hepatitis BMedDRA version: 9.1Level: LLTClassification code 10008910Term: Chronic hepatitis B
EUCTR2007-006218-40-BGovartis Pharma Services AG28
已完成
1 期
Comparative assessment of the absorption of a generic formulation of atorvastatin oral spray against the innovator atorvastatin capsule conducted under fasting conditions in healthy male and female volunteersPilot pharmacokinetic study conducted in healthy volunteers comparing two formulations of atorvastatin (oral spray and capsule) with no health condition or problem studied. Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, atorvastatin is used as an adjunct to diet for the treatment of patients with hypercholesterolaemia.Pilot pharmacokinetic study conducted in healthy volunteers comparing two formulations of atorvastatin (oral spray and capsule) with no health condition or problem studied.Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, atorvastatin is used as an adjunct to diet for the treatment of patients with hypercholesterolaemia.Blood - Other blood disordersMetabolic and Endocrine - Other metabolic disorders
ACTRN12618000208202Zenith Technology Corp Ltd12