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

This study has been completed.

First Received: August 22, 2007 Last Updated: February 3, 2009 History of Changes

Sponsor:	Johann Wolfgang Goethe University Hospitals
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00519740

Purpose

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.

Condition	Intervention
Bronchial Hyperreactivity Hypersensitivity Allergy Bronchial Asthma	Other: inhalative specific bronchial provocation with grass-pollen

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Influence of Nutrition on Nasal and Bronchial Affliction in Patients With Allergy on Grass-Pollen After Low-Dosed Specific Bronchial Provocation

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma

U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:

correlation of the blood fatty-acid level and bronchial hyperreactivity, measured as the exhaled NO. [ Time Frame: aug 2006 - feb 2007 ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	August 2006
Study Completion Date:	December 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	12 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519740

Locations

Germany, Hessen
Goethe University, Department of Pulmonology
Frankfurt, Hessen, Germany, 60590

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospitals

Investigators

Principal Investigator:

Stefan Zielen, M.D., Ph.D.

Goethe University, Department of Pulmonology

More Information

Publications:

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.

Responsible Party:	Goethe University, Childrens Hospital, Dept of Pulmonology & Allergy ( Prof Stefan Zielen )
Study ID Numbers:	214/06/FFM
Study First Received:	August 22, 2007
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00519740 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:

grass-pollen
allergy
bronchial hyperreactivity
asthma

Additional relevant MeSH terms:

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Bronchial Diseases
Immune System Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Bronchial Hyperreactivity
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 27, 2009