Effect of a Dietary Fatty Acid Supplementation on Symptoms and Bronchial Inflammation in Patients With Asthma
- Conditions
- Allergy to House Dust MiteAllergic Asthma
- Interventions
- Diagnostic Test: Bronchial allergen provocation (BAP)Diagnostic Test: Nasal provocation test (NPT)Diagnostic Test: Methacholine testDiagnostic Test: Peak nasal expiratory flow (PNIF)
- Registration Number
- NCT04109534
- Lead Sponsor
- Stefan Zielen
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Nasal provocation test (NPT) 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 Placebo Methacholine test 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 Placebo Bronchial allergen provocation (BAP) 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 Verum Nasal provocation test (NPT) 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 Verum Peak nasal expiratory flow (PNIF) 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 Placebo Peak nasal expiratory flow (PNIF) 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 Verum Methacholine test 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 Verum Bronchial allergen provocation (BAP) 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
- Primary Outcome Measures
Name Time Method Decrase of exhaled NO (eNO) after BAP 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.
- Secondary Outcome Measures
Name Time Method Asthma control test (ACT) 4 weeks Comparison of ACT score between Groups at end of treatment
Magnitude of LAR 4 weeks Comparison of LAR (maximum decrease of FEV1 in %) at end of treatment between groups
Magnitude of EAR 4 weeks Comparison of EAR (maximum decrease of FEV1) at end of treatment between groups
Absolute levels eNO 4 weeks Comparison of absolute levels eNO (ppb)at end of treatment between groups
Cumulative Salbutamol use 4 days Cumulative Salbutamol use in the last 4 days of treatment during repetitive BAP between groups
Lebel symptom score 4 weeks Comparison of Lebel symptom score after nasal provocation test (NPT), before and after supplementation between groups. A lebel score of 0-4 is negative, a lebel score \>5 positive, the maximum result is 12.
Visual analog scala (VAS)-score for nasal symptoms 5 days Comparison of cumulative VAS-score for 4 nasal symptoms (Total mm each symptom) in the last 5 days of treatment during repetitive BAP between groups
FEV1 after BAP 4 weeks Comparison of FEV1 Levels 24 hours after BAP between groups
Comparison of methacholin levels 4 weeks Comparison of methacholin (mg) Levels 24 hours after BAP between groups
Peak nasal expiratory flow 4 weeks Comparison of peak nasal expiratory flow (PNIF) after NPT between groups
Visual analog scala (VAS)-score after NPT 4 weeks Comparison of VAS (mm) after NPT between groups
Trial Locations
- Locations (1)
Klinik für Kinder- und Jugendmedizin Universitätsklinikum
🇩🇪Frankfurt, Hessen, Germany