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
• 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
• 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

• Allergic Rhinitis
• Asthma
• Asthma, Bronchial
• Hypersensitivity
• Hypersensitivity, Immediate

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