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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00519740
Other study ID # 214/06/FFM
Secondary ID
Status Completed
Phase N/A
First received August 22, 2007
Last updated February 3, 2009
Start date August 2006
Est. completion date December 2008

Study information

Verified date February 2009
Source Johann Wolfgang Goethe University Hospitals
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 2008
Est. primary completion date August 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 45 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Other:
inhalative specific bronchial provocation with grass-pollen


Locations

Country Name City State
Germany Goethe University, Department of Pulmonology Frankfurt Hessen

Sponsors (1)

Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary correlation of the blood fatty-acid level and bronchial hyperreactivity, measured as the exhaled NO. aug 2006 - feb 2007 No
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