NCT00519740

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 4, 2009

Status Verified

February 1, 2009

Enrollment Period

2 years

First QC Date

August 22, 2007

Last Update Submit

February 3, 2009

Conditions

Bronchial HyperreactivityHypersensitivityAllergyBronchial Asthma

Keywords

grass-pollenallergybronchial hyperreactivityasthma

Outcome Measures

Primary Outcomes (1)

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

    aug 2006 - feb 2007

Interventions

inhalative specific bronchial provocation with grass-pollenOTHER

Eligibility Criteria

Age12 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goethe University, Department of Pulmonology

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Publications (2)

  • 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.

    PMID: 511010RESULT

  • 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.

    PMID: 20637584DERIVED

MeSH Terms

Conditions

Bronchial HyperreactivityHypersensitivityAsthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesImmune System DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, Immediate

Study Officials

  • Stefan Zielen, M.D., Ph.D.

    Goethe University, Department of Pulmonology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2007

First Posted

August 23, 2007

Study Start

August 1, 2006

Primary Completion

August 1, 2008

Study Completion

December 1, 2008

Last Updated

February 4, 2009

Record last verified: 2009-02

Locations

DE(1)