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Fish Oil and Asthma in House Dust Mite Allergy
This study has been completed.
Study NCT00380926   Information provided by Johann Wolfgang Goethe University Hospitals
First Received: September 25, 2006   Last Updated: September 28, 2006   History of Changes

September 25, 2006
September 28, 2006
April 2004
 
lung function, symptom score,exhalative nitric oxide, metacholine testing
Same as current
Complete list of historical versions of study NCT00380926 on ClinicalTrials.gov Archive Site
sulfoleucotriens, eosinophilic cationic protein, sputum eosinophils, safety lab parameters (clinical chemistry, hematology, hemostasis)
Same as current
 
Fish Oil and Asthma in House Dust Mite Allergy
Anti-Inflammatory Effect of Polyunsaturated Fatty Acids in Allergic Asthma After Allergen Challenge

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.

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.

Phase II, Phase III
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Allergic Asthma
  • Bronchial Inflammation
  • House Dust Mite Allergy
Drug: polyunsatturated fatty acids (fish oil)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
23
November 2004
 

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00380926
 
ZAFES-2004-07
Johann Wolfgang Goethe University Hospitals
 
Principal Investigator: Prof. Stefan Zielen, M.D. Goethe University, Dpt of Pulmonology/Allergy
Johann Wolfgang Goethe University Hospitals
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP