Effect of a Dietary Fatty Acid Supplementation on Symptoms and Bronchial Inflammation in Patients With Asthma
NCT ID: NCT04109534
Last Updated: 2019-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-10-01
2020-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Bronchial allergen provocation (BAP)
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
Nasal provocation test (NPT)
Dermatophagoides farina will be administered in both nostrils
Methacholine test
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
Peak nasal expiratory flow (PNIF)
Comparison of peak nasal expiratory flow (PNIF) after NPT between groups
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
Bronchial allergen provocation (BAP)
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
Nasal provocation test (NPT)
Dermatophagoides farina will be administered in both nostrils
Methacholine test
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
Peak nasal expiratory flow (PNIF)
Comparison of peak nasal expiratory flow (PNIF) after NPT between groups
Interventions
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Bronchial allergen provocation (BAP)
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
Nasal provocation test (NPT)
Dermatophagoides farina will be administered in both nostrils
Methacholine test
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
Peak nasal expiratory flow (PNIF)
Comparison of peak nasal expiratory flow (PNIF) after NPT between groups
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
ALL
No
Sponsors
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Stefan Zielen
OTHER
Responsible Party
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Stefan Zielen
Professor
Principal Investigators
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Stefan Zielen, Professor
Role: PRINCIPAL_INVESTIGATOR
Klinik für Kinder- und Jugendmedizin Universitätsklinikum
Locations
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Klinik für Kinder- und Jugendmedizin Universitätsklinikum
Frankfurt am Main, Hesse, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19-263
Identifier Type: -
Identifier Source: org_study_id
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