Back to resultsAllergy Towards Grass and Bronchial Inflammation - Related to Immunotherapy and Exhaled Nitrogen Oxide
Primary Purpose
Asthma, Bronchial, Allergic Rhinitis, Hypersensitivity, Immediate
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Specific immunotherapy
Sponsored by
About this trial
This is an interventional prevention trial for Asthma, Bronchial focused on measuring Asthma, Allergic rhinitis, Atopy, Exhaled nitric oxide, Specific immunotherapy, Atopic diseases
Eligibility Criteria
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
Sites / Locations
- Bispebjerg HospitalRecruiting
Outcomes
Primary Outcome Measures
Skin prick test
Spirometry
Methacholine provocation of the pulmonary system
Exhaled nitric oxide
Immunoglobulin E (IgE) status
Sputum examination
Condensation of exhaled air
Secondary Outcome Measures
Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00312312
Brief Title
Allergy Towards Grass and Bronchial Inflammation - Related to Immunotherapy and Exhaled Nitrogen Oxide
Official Title
Does Specific Immunotherapy Possess Immunomodulative Effects at the Bronchial Mucosa Level Among Adults With Atopic Diseases?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Bronchial, Allergic Rhinitis, Hypersensitivity, Immediate
Keywords
Asthma, Allergic rhinitis, Atopy, Exhaled nitric oxide, Specific immunotherapy, Atopic diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Specific immunotherapy
Primary Outcome Measure Information:
Title
Skin prick test
Title
Spirometry
Title
Methacholine provocation of the pulmonary system
Title
Exhaled nitric oxide
Title
Immunoglobulin E (IgE) status
Title
Sputum examination
Title
Condensation of exhaled air
Secondary Outcome Measure Information:
Title
Questionnaire
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas B Knudsen, Medical student
Phone
+45 61 70 96 99
Email
thomas@uknet.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Vibeke Backer, M.D., M.D.Sci
Phone
+45 35 31 30 69
Email
backer@dadlnet.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vibeke Backer, M.D., M.D.Sci
Organizational Affiliation
Lungeforskningsenheden v/Bispebjerg hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400 NV
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas B Knudsen, Medical student
Phone
+45 61 70 96 99
Email
thomas@uknet.dk
First Name & Middle Initial & Last Name & Degree
Thomas B Knudsen, Medical student
12. IPD Sharing Statement
Learn more about this trial
Allergy Towards Grass and Bronchial Inflammation - Related to Immunotherapy and Exhaled Nitrogen Oxide
We'll reach out to this number within 24 hrs