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Influence of Nutrition on Nasal and Bronchial Affliction in Patients With Allergy on Grass-Pollen

Primary Purpose

Bronchial Hyperreactivity, Hypersensitivity, Allergy

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
inhalative specific bronchial provocation with grass-pollen
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bronchial Hyperreactivity focused on measuring grass-pollen, allergy, bronchial hyperreactivity, asthma

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age >12 and <45 years
  • informed consent
  • Known allergy on grass-pollen

Exclusion Criteria:

  • age <12 and >45 years
  • Clinical asthma requiring regular inhalation
  • vital capacity >80%
  • FEV1 < 75%
  • Chronic disease
  • pregnancy
  • Inhalative or systemic steroid use
  • substance abuse
  • incapability of understanding the study's purpose and performance

Sites / Locations

  • Goethe University, Department of Pulmonology

Outcomes

Primary Outcome Measures

correlation of the blood fatty-acid level and bronchial hyperreactivity, measured as the exhaled NO.

Secondary Outcome Measures

Full Information

First Posted
August 22, 2007
Last Updated
February 3, 2009
Sponsor
Johann Wolfgang Goethe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00519740
Brief Title
Influence of Nutrition on Nasal and Bronchial Affliction in Patients With Allergy on Grass-Pollen
Official Title
Influence of Nutrition on Nasal and Bronchial Affliction in Patients With Allergy on Grass-Pollen After Low-Dosed Specific Bronchial Provocation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Johann Wolfgang Goethe University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is meant to observe the influence of nutrition on nasal and bronchial discomfort in patients with allergy on grass pollen after specific bronchial provocation. Therefore, the investigators will record the patients' nutrition habits and measure the blood level of long chained polyunsaturated fatty-acids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Hyperreactivity, Hypersensitivity, Allergy, Bronchial Asthma
Keywords
grass-pollen, allergy, bronchial hyperreactivity, asthma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
inhalative specific bronchial provocation with grass-pollen
Primary Outcome Measure Information:
Title
correlation of the blood fatty-acid level and bronchial hyperreactivity, measured as the exhaled NO.
Time Frame
aug 2006 - feb 2007

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age >12 and <45 years informed consent Known allergy on grass-pollen Exclusion Criteria: age <12 and >45 years Clinical asthma requiring regular inhalation vital capacity >80% FEV1 < 75% Chronic disease pregnancy Inhalative or systemic steroid use substance abuse incapability of understanding the study's purpose and performance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Zielen, M.D., Ph.D.
Organizational Affiliation
Goethe University, Department of Pulmonology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Goethe University, Department of Pulmonology
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
511010
Citation
Dyerberg J, Bang HO. Lipid metabolism, atherogenesis, and haemostasis in Eskimos: the role of the prostaglandin-3 family. Haemostasis. 1979;8(3-5):227-33. doi: 10.1159/000214314.
Results Reference
result
PubMed Identifier
20637584
Citation
Kitz R, Rose MA, Schubert R, Beermann C, Kaufmann A, Bohles HJ, Schulze J, Zielen S. Omega-3 polyunsaturated fatty acids and bronchial inflammation in grass pollen allergy after allergen challenge. Respir Med. 2010 Dec;104(12):1793-8. doi: 10.1016/j.rmed.2010.06.019. Epub 2010 Jul 15.
Results Reference
derived

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Influence of Nutrition on Nasal and Bronchial Affliction in Patients With Allergy on Grass-Pollen

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