Fish Oil and Asthma in House Dust Mite Allergy
Primary Purpose
Allergic Asthma, Bronchial Inflammation, House Dust Mite Allergy
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
polyunsatturated fatty acids (fish oil)
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Asthma focused on measuring polyunsatturated fatty acids, nutrition, low-dose allergen challenge, exhaled nitric oxide
Eligibility Criteria
Inclusion Criteria:
- allergic sensitization to house dust mite as proven by skin test and specific IgE
- normal lung function, episodic asthma
Exclusion Criteria:
- history of hypersensitization towards fish oil, chronic illness, pregnancy
Sites / Locations
Outcomes
Primary Outcome Measures
lung function, symptom score,exhalative nitric oxide, metacholine testing
Secondary Outcome Measures
sulfoleucotriens, eosinophilic cationic protein, sputum eosinophils, safety lab parameters (clinical chemistry, hematology, hemostasis)
Full Information
NCT ID
NCT00380926
First Posted
September 25, 2006
Last Updated
September 28, 2006
Sponsor
Johann Wolfgang Goethe University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00380926
Brief Title
Fish Oil and Asthma in House Dust Mite Allergy
Official Title
Anti-Inflammatory Effect of Polyunsaturated Fatty Acids in Allergic Asthma After Allergen Challenge
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Johann Wolfgang Goethe University Hospital
4. Oversight
5. Study Description
Brief Summary
Native populations consuming high amounts of fish suffer less from allergic diseases. The purpose of this study is to determine whether polyunsaturated fatty acids (fish oil) might have a disease modifying influence on asthmatics sensitized to house dust mite.
Detailed Description
Most asthmatics suffer from mild disease and non pharmacologic intervention would be beneficial for the majority of these subjects. We investigated the anti-inflammatory potential of polyunsaturated fatty acids (PUFA) in allergic asthma.
In our parallel, double-blinded study, 23 patients allergic to house dust mite were randomly assigned to dietary supplementation with a PUFA enriched fat blend or placebo for five weeks. The verum contained eicosapentaenoic acid (EPA) 450 mg/day, docosahexaenoic acid 180 mg/day, stearidonic acid 60mg/day, and gamma-linolenic acid 60 mg/day; the placebo consisted of mainly unsaturated and monosaturated fatty acids. After three weeks, the patients were challenged with low doses of inhalative house dust mite allergen for two weeks.
Following parameters were determined during low-dose allergen exposure in both groups: exhaled NO (eNO) as a marker of bronchial inflammation, clinical symptoms, FEV1, beta-agonist usage, and bronchial hyperreactivity, sputum eosinophils and sulfoleucotrienes. Compliance with the study protocol was controlled by the determination of PUFAs in plasma and erythrocytes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Asthma, Bronchial Inflammation, House Dust Mite Allergy
Keywords
polyunsatturated fatty acids, nutrition, low-dose allergen challenge, exhaled nitric oxide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
23 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
polyunsatturated fatty acids (fish oil)
Primary Outcome Measure Information:
Title
lung function, symptom score,exhalative nitric oxide, metacholine testing
Secondary Outcome Measure Information:
Title
sulfoleucotriens, eosinophilic cationic protein, sputum eosinophils, safety lab parameters (clinical chemistry, hematology, hemostasis)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
allergic sensitization to house dust mite as proven by skin test and specific IgE
normal lung function, episodic asthma
Exclusion Criteria:
history of hypersensitization towards fish oil, chronic illness, pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Stefan Zielen, M.D.
Organizational Affiliation
Goethe University, Dpt of Pulmonology/Allergy
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
Citation
Horrobin DF. Low prevalences of coronary heart disease (CHD), psoriasis, asthma and rheumatoid arthritis in Eskimos: are they caused by high dietary intake of eicosapentaenoic acid (EPA), a genetic variation of essential fatty acid (EFA) metabolism or a combination of both? Med Hypotheses. 1987; 22(4):421-8. Stephensen CB. Fish oil and inflammatory disease: is asthma the next target for n-3 fatty acid supplements? Nutr Rev 2004; 62:486-489 Woods RK, Thien FC, Abramson MJ. Dietary marine fatty acids (fish oil) for asthma in adults and children. Cochrane Database Syst Rev2002; CD001283 Dry J, Vincent D. Effect of a fish oil diet on asthma: results of a 1-year double-blind study. Int Arch Allergy Appl Immunol 1991; 95:156-157 Stenius-Aarniala B, Aro A, Hakulinen A, Ahola I, Seppala E, Vapaatalo H. Evening primrose oil and fish oil are ineffective as supplementary treatment of bronchial asthma. Ann Allergy 1989; 62:534-537 Mickleborough TD, Lindley MR, Ionescu AA, Fly AD. Protective effect of fish oil supplementation on exercise-induced bronchoconstriction in asthma. Chest 2006; 129:39-49
Results Reference
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Fish Oil and Asthma in House Dust Mite Allergy
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