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临床试验/NCT01231230
NCT01231230已完成不适用

Interactive Acute Smooth Muscle Effects of Salmeterol and Fluticasone in the Airway

University of Miami0 个研究点目标入组 14 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
14
主要终点
Maximum Change From Baseline in Airway Blood Flow (Qaw)

研究概览

简要总结

The addition of an inhaled long-acting beta-adrenergic agonist to an inhaled glucocorticosteroid improves disease control in persistent asthma. This observation has supported the use of long-acting beta-adrenergic agonist/glucocorticosteroid combination preparations for the management of asthma. Currently, salmeterol/fluticasone and formoterol/budesonide are available for clinical use. The long-term beneficial clinical effects of the two drug classes seem to be synergistic, and several mechanisms of glucocorticoid-beta-adrenergic agonist interactions involving gene transcription have been invoked to explain this phenomenon.This study, wish to address the question whether glucocorticoids can acutely potentiate the bronchodilator response to a long-acting beta-adrenergic agonist.We expect that in patients with asthma, the short-term bronchodilator effect of salmeterol is enhanced by the addition of fluticasone, which by itself has no short-term bronchodilator effect. To test this premise, we will assess the respective short-term effects of salmeterol (50 µg), fluticasone (250 µg), salmeterol/fluticasone (50/250 µg), and placebo/placebo on spirometric parameters. Airway Blood flow will also be measured to ensure that vasoconstriction does not occur.

详细描述

Fourteen lifetime nonsmokers with a physician diagnosis of asthma will be recruited for the study. All subjects will be allowed to use short-acting beta-adrenergic agonists as rescue medication.

Inclusion criteria:

  1. Males and females, 18 to 65 years of age.
  2. FEV1 60-85% of predicted on the screening day.

Exclusion criteria:

  1. Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women.
  2. Cardiovascular disease and/or use of cardiovascular medications

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females, 18 to 65 years of age.
  • FEV1 60-85% of predicted on the screening day. -

排除标准

  • Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women.
  • Cardiovascular disease and/or use of cardiovascular medications
  • Subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance
  • Acute respiratory infection within four weeks prior to the study
  • Use, within two weeks prior to the study, of any anti-asthma medication not mentioned above

研究组 & 干预措施

fluticasone/salmeterol

Experimental

participants were treated fluticasone/salmeterol,

干预措施: fluticasone/salmeterol (Drug)

salmeterol

Experimental

participants were treated with salmeterol

干预措施: Salmeterol (Drug)

fluticasone

Experimental

participants were treated with fluticasone

干预措施: fluticasone (Drug)

placebo inhalation

Placebo Comparator

participants were treated with placebo

干预措施: placebo inhalation (Drug)

结局指标

主要结局

Maximum Change From Baseline in Airway Blood Flow (Qaw)

时间窗: maximum change in Qaw within 240 minutes post drug inhalation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam Wanner

Professor of Medicine

University of Miami

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