Allergic Asthma Clinical Trial
— LCPUFAOfficial title:
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
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Klinik für Kinder- und Jugendmedizin Universitätsklinikum | Frankfurt | Hessen |
Lead Sponsor | Collaborator |
---|---|
Stefan Zielen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Levels of LCPUFA | Levels of LCPUFA will be measured before and after Supplementation between groups | 4 weeks | |
Other | Levels of triglyceride and cholesterin | Levels of triglyceride and cholesterin will be measured before and after supplementation between groups | 4 weeks | |
Other | Levels of eosinophils | Levels of eosinophils will be measured after supplementation and 24 hours after BAP between groups | 4 weeks | |
Other | micro RNAs | Levels of micro RNAs will be measured before supplementation and before and 24 hours after BAP between groups | 4 weeks | |
Primary | Decrase 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. | 4 weeks | |
Secondary | Absolute levels eNO | Comparison of absolute levels eNO (ppb)at end of treatment between groups | 4 weeks | |
Secondary | Magnitude of EAR | Comparison of EAR (maximum decrease of FEV1) at end of treatment between groups | 4 weeks | |
Secondary | Magnitude of LAR | Comparison of LAR (maximum decrease of FEV1 in %) at end of treatment between groups | 4 weeks | |
Secondary | FEV1 after BAP | Comparison of FEV1 Levels 24 hours after BAP between groups | 4 weeks | |
Secondary | Comparison of methacholin levels | Comparison of methacholin (mg) Levels 24 hours after BAP between groups | 4 weeks | |
Secondary | Asthma control test (ACT) | Comparison of ACT score between Groups at end of treatment | 4 weeks | |
Secondary | Cumulative Salbutamol use | Cumulative Salbutamol use in the last 4 days of treatment during repetitive BAP between groups | 4 days | |
Secondary | 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. | 4 weeks | |
Secondary | Peak nasal expiratory flow | Comparison of peak nasal expiratory flow (PNIF) after NPT between groups | 4 weeks | |
Secondary | Visual analog scala (VAS)-score after NPT | Comparison of VAS (mm) after NPT between groups | 4 weeks | |
Secondary | 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 | 5 days |
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