NCT00312312

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2006

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 12, 2007

Status Verified

September 1, 2006

First QC Date

April 5, 2006

Last Update Submit

June 11, 2007

Conditions

Asthma, BronchialAllergic RhinitisHypersensitivity, Immediate

Keywords

AsthmaAllergic rhinitisAtopyExhaled nitric oxideSpecific immunotherapyAtopic diseases

Outcome Measures

Primary Outcomes (7)

  • Skin prick test

  • Spirometry

  • Methacholine provocation of the pulmonary system

  • Exhaled nitric oxide

  • Immunoglobulin E (IgE) status

  • Sputum examination

  • Condensation of exhaled air

Secondary Outcomes (1)

  • Questionnaire

Interventions

Specific immunotherapyBIOLOGICAL

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Other diseases except atopic disease
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400 NV, Denmark

RECRUITING

MeSH Terms

Conditions

AsthmaRhinitis, AllergicHypersensitivity, Immediate

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivityImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Vibeke Backer, M.D., M.D.Sci

    Lungeforskningsenheden v/Bispebjerg hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas B Knudsen, Medical student

CONTACT

+45 61 70 96 99thomas@uknet.dk

Vibeke Backer, M.D., M.D.Sci

CONTACT

+45 35 31 30 69backer@dadlnet.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 5, 2006

First Posted

April 10, 2006

Study Start

March 1, 2006

Study Completion

December 1, 2008

Last Updated

June 12, 2007

Record last verified: 2006-09

Locations

DK(1)