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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Nebulized Dermatophagoides farina administered at following doses: 10AE, 20 AE, 40 AE, 80 160 AE, etc… until the FEV1 decreases 20% below the initial FEV1-value
Dermatophagoides farina will be administered in both nostrils
Nebulized metacholine will be administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg until the FEV1 decreases 20% below the initial FEV1-value
Klinik für Kinder- und Jugendmedizin Universitätsklinikum
Frankfurt am Main, Hesse, Germany
RECRUITINGDecrase of exhaled NO (eNO) after BAP
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.
Time frame: 4 weeks
Absolute levels eNO
Comparison of absolute levels eNO (ppb)at end of treatment between groups
Time frame: 4 weeks
Magnitude of EAR
Comparison of EAR (maximum decrease of FEV1) at end of treatment between groups
Time frame: 4 weeks
Magnitude of LAR
Comparison of LAR (maximum decrease of FEV1 in %) at end of treatment between groups
Time frame: 4 weeks
FEV1 after BAP
Comparison of FEV1 Levels 24 hours after BAP between groups
Time frame: 4 weeks
Comparison of methacholin levels
Comparison of methacholin (mg) Levels 24 hours after BAP between groups
Time frame: 4 weeks
Asthma control test (ACT)
Comparison of ACT score between Groups at end of treatment
Time frame: 4 weeks
Cumulative Salbutamol use
Cumulative Salbutamol use in the last 4 days of treatment during repetitive BAP between groups
Time frame: 4 days
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Comparison of peak nasal expiratory flow (PNIF) after NPT between groups
Lebel symptom score
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.
Time frame: 4 weeks
Peak nasal expiratory flow
Comparison of peak nasal expiratory flow (PNIF) after NPT between groups
Time frame: 4 weeks
Visual analog scala (VAS)-score after NPT
Comparison of VAS (mm) after NPT between groups
Time frame: 4 weeks
Visual analog scala (VAS)-score for nasal symptoms
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
Time frame: 5 days