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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
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 25, 2006
    Last Updated
    September 28, 2006
    Sponsor
    Johann Wolfgang Goethe University Hospital
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    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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