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

Tracking Information

First Received Date ^ICMJE

August 22, 2007

Last Updated Date

February 3, 2009

Start Date ^ICMJE

August 2006

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00519740 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Influence of Nutrition on Nasal and Bronchial Affliction in Patients With Allergy on Grass-Pollen After Low-Dosed Specific Bronchial Provocation

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Bronchial Hyperreactivity
Hypersensitivity
Allergy
Bronchial Asthma

Intervention ^ICMJE

Other: inhalative specific bronchial provocation with grass-pollen

Study Arms / Comparison Groups

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.

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

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

December 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00519740

Responsible Party

Prof Stefan Zielen, Goethe University, Childrens Hospital, Dept of Pulmonology & Allergy

Study ID Numbers ^ICMJE

214/06/FFM

Study Sponsor ^ICMJE

Johann Wolfgang Goethe University Hospitals

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

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

Goethe University, Department of Pulmonology

Information Provided By

Johann Wolfgang Goethe University Hospitals

Verification Date

February 2009

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