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

This study has been completed.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00519740
First received: August 22, 2007
Last updated: February 3, 2009
Last verified: February 2009
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
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:
Responsible Party: Prof Stefan Zielen, Goethe University, Childrens Hospital, Dept of Pulmonology & Allergy
ClinicalTrials.gov Identifier: NCT00519740     History of Changes
Other Study ID Numbers: 214/06/FFM
Study First Received: August 22, 2007
Last Updated: February 3, 2009
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:
Hypersensitivity
Asthma
Bronchial Hyperreactivity
Immune System Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on July 22, 2014