Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Early asthmatic response
研究概览
简要总结
Evaluate single dose (2 x 2.5mcg/puff; total dose 5mcg) effect of tiotropium administered 30 minutes prior to allergen challenge on allergen-induced EAR assessed as the maximal % fall in FEV1 after allergen inhalation compared to that of single dose (two puffs) matched placebo administered 30 minutes prior to allergen challenge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age (years) at least 18 years
- •no confounding health issue (i.e. no health conditions, other than asthma, that would put the participant at risk or affect data integrity as determined by the principal investigator)
- •baseline FEV1 ≥ 65% of predicted normal at Visit 1
- •evidence of atopy to an allergen suitable for inhalation challenge following skin prick testing such as house dust mite, grass, cat or horse
- •fall in FEV1 of ≥ 20% at a dose of methacholine ≤ 600mcg (methacholine PD20) at Visit 1
- •positive response to allergen inhalation challenge (fall in FEV1 of ≥ 15% after inhalation of allergen at a dilution 1:32 or more dillute.
- •absence of respiratory infection for at least 4 weeks prior to Visit 1
- •absence of significant worsening of asthma that requires health care intervention or prolonged change in medication due to allergen exposure (or other trigger) for at least 4 weeks prior to Visit 1
- •women of child-bearing potential shall not be pregnant or lactating
- •non-smoker (cigarettes, vaping); ex-smoker with <10 pack year history allowed; cannabis use will be evaluated on a case-by-case basis
- •if on as needed budesonide/formoterol therapy, no reported use within 3 weeks prior to allergen challenge
排除标准
- •Smoker >10 pack year history
研究组 & 干预措施
Tiotropium treatment
2 puffs tiotropium
干预措施: Tiotropium (Spiriva®) (Drug)
Placebo
2 puffs placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Early asthmatic response
时间窗: 2 hours post-allergen challenge
Evaluate single dose (2 x 2.5mcg/puff; total dose 5mcg) effect of tiotropium administered 30 minutes prior to allergen challenge on allergen-induced EAR assessed as the maximal % fall in FEV1 after allergen inhalation compared to that of single dose (two puffs) matched placebo administered 30 minutes prior to allergen challenge.
次要结局
- Inflammatory response(Five hours post-allergen challenge)
- FEV1(30 minutes)
研究者
Brianne Philipenko
MD FRCPC
University of Saskatchewan