Interactive Acute Smooth Muscle Effects of Salmeterol and Fluticasone in the Airway
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:
- Males and females, 18 to 65 years of age.
- FEV1 60-85% of predicted on the screening day.
Exclusion criteria:
- 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
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
- 否
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
participants were treated fluticasone/salmeterol,
干预措施: fluticasone/salmeterol (Drug)
salmeterol
participants were treated with salmeterol
干预措施: Salmeterol (Drug)
fluticasone
participants were treated with fluticasone
干预措施: fluticasone (Drug)
placebo inhalation
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
Adam Wanner
Professor of Medicine
University of Miami
