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NCT00312312 Clinical Trial

Allergy Towards Grass and Bronchial Inflammation - Related to Immunotherapy and Exhaled Nitrogen Oxide

Allergic Rhinitis Clinical Trial

Official title:
Does Specific Immunotherapy Possess Immunomodulative Effects at the Bronchial Mucosa Level Among Adults With Atopic Diseases?

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00312312
Other study ID # SITNO
Secondary ID
Status Recruiting
Phase N/A
First received April 5, 2006
Last updated June 11, 2007
Start date March 2006
Est. completion date December 2008

Study information
Verified date September 2006
Source Bispebjerg Hospital
Contact Thomas B Knudsen, Medical student
Phone +45 61 70 96 99
Email thomas@uknet.dk
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the immunomodulatory effect of treatment of allergic rhinitis symptoms with specific immunotherapy by measurement of pulmonary inflammatory markers, and among others, exhaled nitric oxide.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Age 18-45 years old

- Skin prick test or RAS test and physical examination conclude that the patient will have a beneficial effect from specific immunotherapy

Exclusion Criteria:

- Other diseases except atopic disease

- Pregnancy

Study Design

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

Related Conditions & MeSH terms

Intervention

Biological:
• Specific immunotherapy

Locations
Country Name City State
Denmark Bispebjerg Hospital Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Skin prick test
Primary Spirometry
Primary Methacholine provocation of the pulmonary system
Primary Exhaled nitric oxide
Primary Immunoglobulin E (IgE) status
Primary Sputum examination
Primary Condensation of exhaled air
Secondary Questionnaire
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