Changes in Exhaled Breath Temperature During the Pollen Season in Subjects With Allergic Rhinoconjunctivitis Sensitized to Grasses and Effect of Sublingual Immunotherapy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes of exhaled breath temperature before and during the pollen season of subjects treated with 5 grass allergen extract sublingually and the untreated control patients.
研究概览
简要总结
The purpose of this study is to determine whether exhaled breath temperature, a surrogate marker of airway inflammation, rises during the pollen season in sensitized subjects with allergic rhinoconjucnctivitis with or without mild asthma. Sublingual Immunotherapy with respective allergens suppresses the seasonal increase of EBT. During the second year (2013) of the trial all patients will be treated with 5 grass allergen extract: carry over differences between the active and placebo arms from the previous year (2012) will be looked for.
详细描述
Patients with grass pollen allergy are most typical and best responding to sublingual immunotherapy. Their selection will be done in accordance with the criteria listed in Chapter 9 of the World Allergy Organization Position Paper on specific immunotherapy 2009 and in compliance with the rules for good clinical practice.
Proposed primary variable: the difference between the changes of exhaled breath temperature before and in the pollen season of subjects treated with grass-pollen sublingual immunotherapy and the untreated control patients.
Suggested secondary variables: changes over time of exhaled breath temperature in the two groups, difference in symptoms scores, methacholine responsiveness, rescue medication usage.
Statistical analysis
On the basis of the available data about the variability of exhaled breath changes and its changes upon flare up of airway inflammation or after anti-inflammatory treatment we have calculated a sample size of 20 subjects in each group to be sufficient to prove differences in the primary variable with a significance level <0.05. However, as this is "first time ever" type of pilot study on sublingual immunotherapy and exhaled breath temperature in grass-pollen patients, this estimate is relative. By all means this study will identify trends to be used for sample size calculations in future studies. During the second year of the study when all patients will be on active treatment with 5 grass allergen extract, carry over effects from the first year of treatment with 5 grass allergen extract or placebo on exhaled breath temperature will be explored.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 randomized patients from either sex
- •age range 5-55 years
- •included patients should have a proven grass pollen sensitization
排除标准
- •age under or above the stated
- •lack of any other concomitant allergen sensitivities that may blur the clinical course of the natural exacerbation due to pollen
研究组 & 干预措施
5 grass allergen extract
30 patients will receive the active component 5 grass allergen extract daily during the active pollen season (February-July)
干预措施: 5 grass allergen extract (Drug)
Placebo
30 patients will receive placebo
干预措施: 5 grass allergen extract (Drug)
结局指标
主要结局
Changes of exhaled breath temperature before and during the pollen season of subjects treated with 5 grass allergen extract sublingually and the untreated control patients.
时间窗: 6 months in year 1 (2012): baseline and at month 6; and 6 months in year 2 (2013): baseline and month 6.
The primary objective of the study is to evaluate the differences between the changes of exhaled breath temperature before and in the pollen season of subjects treated with 5 grass allergen extract applied sublingually and untreated control patients. Possible carry-over differences between the same two arms will be explored during the second year of the trial. Calculations will involve difference between assessment at month 6 and baseline for year 1 (2012) and in year 2 (2013) and comparisons between the two arms of the study will be made.
次要结局
- Effect of the treatment on symptoms and objective measurements in blood(6 months in year 1 (2012): baseline and at month 6; and 6 months in year 2 (2013): baseline and month 6.)
研究者
Prof. Todor Popov
Associate Professor
Association Asthma, Bulgaria