A Double-blind Randomized Controlled Trial of Inhaled Salbutamol vs Placebo for the Treatment of Acute Abdominal Pain From Food-induced IgE-mediated Reactions
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Time to resolution of moderate-to-severe abdominal pain
研究概览
简要总结
The goal of this study is to assess the efficacy of inhaled salbutamol to treat abdominal pain during food allergic reactions.
Patients experiencing abominal pain as a result of a food allergic reaction during a food challenge in the allergy clinic will be invited to participate to the study.
They will receive either 8 puffs of salbutamol (asthma inhaler) or 8 puffs of a placebo inhaler.
The abdominal pain will then be followed using a numeric scale to see if patients receiving the medication experienced a faster improvement compared to those receiving the placebo.
详细描述
This trial aims to compare the efficacy of inhaled salbutamol compared to placebo to decrease the duration of abdominal pain in children and adults with IgE-mediated food allergic reactions.
The population will be children and adults aged 6 to 55 presenting with moderate to severe IgE-mediated abdominal pain in the context of an oral food challenge or an oral immunotherapy dose increase at the allergy clinic.
Eligible participants will be randomized to receive an immediate treatement with either inhaled salbutamol 800 mcg or inhaled placebo, dispensed with a spacer, at a ratio of 1:1.
Participants will be asked to rate the evolution of their abdominal pain by the minute on the NRS-11 scale until it resolves completely or that they have been discharged.
Patients still presenting moderate to severe abdominal pain 30 minutes after the administration of the investigational product will receive an open-label treatment with 800 mcg of inhaled salbutamol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged between 6 to 55 years old.
- •Undergoing an oral food challenge or an oral immunotherapy up-dosing visit for the diagnosis or treatment of an IgE-mediated food allergy.
- •Previous confirmation of the food allergy by either skin prick tests (SPT) or serum specific IgE;
- •Able to express the intensity of their pain using the NRS-11;
- •Willing to comply with all study requirements.
排除标准
- •Previous adverse reactions to salbutamol;
- •Known hypersensitivity to salbutamol or placebo or any of their components;
- •Any condition that could be considered a relative contra-indication to the use of salbutamol according to the investigator (e.g. patient with a history of hyperglycemia, arrhythmia or hypokalemia);
- •Patients receiving beta-blockers or a daily / long-acting beta agonists;
- •Patients needing to pass an anti-doping test for high-level sport in the following 24h.
研究组 & 干预措施
Inhaled salbutamol
8 puffs of 100 mcg of inhaled salbutamol once
干预措施: Salbutamol (Drug)
Placebo
8 puffs of inhaled placebo once
干预措施: Placebo (Drug)
结局指标
主要结局
Time to resolution of moderate-to-severe abdominal pain
时间窗: From time of administation of investigational product, until the pain decreases to a point where the patient would not normally seek treatment, assessed up to 30 minutes
Time from treatment to an abdominal pain of less than moderate intensity, defined as a pain for which the patient would not normally seek treatment
次要结局
- Epinephrine use(From randomization to three days after randomization)
- Time to complete resolution of the abdominal pain(From time of administation of investigational product, until the pain is completely resolved, assessed up to 30 minutes)
- Time to any improvement in the abdominal pain(From time of administation of investigational product, until any decrease in the NRS-11, assessed up to 30 minutes)
- Adverse events(From randomization to three days after randomization)
研究者
Philippe Bégin
Associate professor
St. Justine's Hospital