Investigation of the Effect of a Dietary Fatty Acid Supplementation on Symptoms and Bronchial Inflammation in Patients With Asthma and House Dust Mite Allergy After Repeated Allergen Challenge
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Decrase of exhaled NO (eNO) after BAP
研究概览
简要总结
The proposed study will investigate the effect of a polyunsaturated fatty acid / lipid mixture (LCPUFAs) on the clinical symptoms, bronchial inflammation and lung function in allergic asthma in a bronchial allergen provocation (BAP) model. For this purpose, patients with stable episodic asthma and dust mite allergy will underwent BAP before and after supplementation with LCPUFAs. The clinical symptoms, bronchial inflammation, exhaled NO increase and lung function decline (FEV1) will be analyzed.
详细描述
Asthma is a chronic lung disease, which is characterized by recurrent obstruction, a hypersensitivity and a chronic inflammation of the airway. It is known that LCPUVAs could reduce the production of inflammatory mediators. In addition, LCPUVAs can improve pulmonary function, with a concurrent reduction in bronchodilator use in patients with asthma. Subjects suffering from episodic asthma and house dust mite (HDM) allergy usually have a normal lung function testing at rest and show a decrease in lung function when they are exposed to HDM. Bronchial allergen provocation models are well established in asthma research and allow the evaluation of anti-allergic and anti-asthmatic agents in relatively small sample sizes. In a previous study the investigators could show, that LCPUVAs could reduce exhaled NO after repeated BAP with HDM.
In this study the investigators will investigate the protective effect of LCPUVAs in a repeated BAP model. Clinical symptoms (nasal and bronchial), exhaled NO, decrease in lung function the early asthmatic reaction (EAR), the late asthmatic reaction (LAR) and blood parameters (Triglyceride and Cholesterin and mircro RNAs) will be measured before and after LCPUVA supplementation.
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
- Double (Participant, Investigator)
盲法说明
LCPUVAS and Placebo are provided in sealed bags
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Patients: aged ≥18 and 45 years
- •known allergen induced asthma and HDM-Allergy
- •basic lung function FVC ≥ 80%, FEV1 ≥ 75%
- •decrease in FEV1 after BAP ≥ 20%
- •30% increase of NO after BAP
排除标准
- •lung function Forced vital capacity (FVC) <80% and Forced expiratory volume in 1 second (FEV1) <75%
- •chronic diseases or infections (e.g. HIV, Tbc)
- •pregnancy
- •systemic corticosteroid-treatment
- •inhalative corticosteroid therapy or leukotriene antagonists
- •alcohol, substance or drug abuse
- •current smokers
- •inability to capture extend and consequences of the study
研究组 & 干预措施
Placebo
Placebo comparator 20 patients aged 18-45 years with a diagnosis of HDM induced allergic asthma and an increase of exhaled NO of 30% after BAP will be randomized to the Placebo Comparator
干预措施: Bronchial allergen provocation (BAP) (Diagnostic Test)
Placebo
Placebo comparator 20 patients aged 18-45 years with a diagnosis of HDM induced allergic asthma and an increase of exhaled NO of 30% after BAP will be randomized to the Placebo Comparator
干预措施: Nasal provocation test (NPT) (Diagnostic Test)
Placebo
Placebo comparator 20 patients aged 18-45 years with a diagnosis of HDM induced allergic asthma and an increase of exhaled NO of 30% after BAP will be randomized to the Placebo Comparator
干预措施: Methacholine test (Diagnostic Test)
Placebo
Placebo comparator 20 patients aged 18-45 years with a diagnosis of HDM induced allergic asthma and an increase of exhaled NO of 30% after BAP will be randomized to the Placebo Comparator
干预措施: Peak nasal expiratory flow (PNIF) (Diagnostic Test)
Verum
PUFAS: 2640 mg of middle-chain and polyunsaturated fatty acids 20 patients aged 18-45 years with a diagnosis of HDM induced allergic asthma and an increase of exhaled NO of 30% after BAP will be randomized to the Active Comparator
干预措施: Bronchial allergen provocation (BAP) (Diagnostic Test)
Verum
PUFAS: 2640 mg of middle-chain and polyunsaturated fatty acids 20 patients aged 18-45 years with a diagnosis of HDM induced allergic asthma and an increase of exhaled NO of 30% after BAP will be randomized to the Active Comparator
干预措施: Nasal provocation test (NPT) (Diagnostic Test)
Verum
PUFAS: 2640 mg of middle-chain and polyunsaturated fatty acids 20 patients aged 18-45 years with a diagnosis of HDM induced allergic asthma and an increase of exhaled NO of 30% after BAP will be randomized to the Active Comparator
干预措施: Methacholine test (Diagnostic Test)
Verum
PUFAS: 2640 mg of middle-chain and polyunsaturated fatty acids 20 patients aged 18-45 years with a diagnosis of HDM induced allergic asthma and an increase of exhaled NO of 30% after BAP will be randomized to the Active Comparator
干预措施: Peak nasal expiratory flow (PNIF) (Diagnostic Test)
结局指标
主要结局
Decrase of exhaled NO (eNO) after BAP
时间窗: 4 weeks
After BAP with HDM the decrease of eNO will be compared between placebo and active comparator. A relevant decrease is defined as a drop of 30% of exhaled NO.
次要结局
- Asthma control test (ACT)(4 weeks)
- Magnitude of LAR(4 weeks)
- Magnitude of EAR(4 weeks)
- Absolute levels eNO(4 weeks)
- Cumulative Salbutamol use(4 days)
- Lebel symptom score(4 weeks)
- Visual analog scala (VAS)-score for nasal symptoms(5 days)
- FEV1 after BAP(4 weeks)
- Comparison of methacholin levels(4 weeks)
- Peak nasal expiratory flow(4 weeks)
- Visual analog scala (VAS)-score after NPT(4 weeks)
研究者
Stefan Zielen
Professor
Johann Wolfgang Goethe University Hospital