Allergy Towards Grass and Bronchial Inflammation - Relate... | NCT00312312

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

NCT00312312

Sponsor

Bispebjerg Hospital

Status

Unknown status

Last Update Posted

Jun 12, 2007Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Asthma, Bronchial
Allergic Rhinitis
Hypersensitivity, Immediate

Interventions

Specific immunotherapy

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Not provided

Completion Date

Dec 2008Estimated

First Submitted Date

Apr 5, 2006

First Submission Date that Met QC Criteria

Apr 5, 2006

First Posted Date

Apr 10, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2007

Last Update Posted Date

Jun 12, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
Specific immunotherapy	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Questionnaire

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas B Knudsen, Medical student	Contact	+45 61 70 96 99		thomas@uknet.dk
Vibeke Backer, M.D., M.D.Sci	Contact	+45 35 31 30 69		backer@dadlnet.dk

Overall Officials

Name	Affiliation	Role
Vibeke Backer, M.D., M.D.Sci	Lungeforskningsenheden v/Bispebjerg hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bispebjerg Hospital	Recruiting	Copenhagen		2400 NV	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D065631	Rhinitis, Allergic
D006969	Hypersensitivity, Immediate

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided