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Effects of Sublingual Immunotherapy on Grasspollen Allergy

Primary Purpose

Hayfever

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Oralgen
Nasal biopsy
Nasal washing
Peak nasal inspiratory flow
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hayfever focused on measuring nasal biopsy grasspollen sublingual immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 18 and older. Patients known in general practice with documented clinical history of grass pollen allergy with moderate disease intensity as retrospectively derived from the use of symptomatic allergy medication during the previous grass pollen season, i.e. regular use of cromoglycates as nasal spray and/or eye drops, and/or regular use of anti histamine tablets or sprays and/or limited use of local acting or systemically administered corticosteroids. Positive (ARTU) grass pollen specific skin prick test (despite negative RAST). Exclusion Criteria: Clinical history of severe asthmatic symptoms requiring inhalant therapy with daily pulmonary steroids during at least 3 months a year. Symptomatic perennial allergic rhinitis. Meaning perennial allergy is allowed if the allergen is not present in patients' daily life (especially one month prior to provocation) and if they have no apparent symptoms of this perennial allergy. Other seasonal allergic rhinitis are not allowed unless it is asymptomatic during the period of provocation. The intention to subject the patient to surgery of the nasal cavity in the course of the study. Previous immunotherapy. Negative (ARTU) grass pollen specific skin prick test (despite positive RAST). Contraindications to sublingual immunotherapy, i.e.: Malignancies and serious disorders of the oral cavity History of status asthmaticus and anaphylactic shock Aggressively developing asthmatic symptoms Serious chronic inflammations, chronic disorders associated with fever, particularly of the bronchial tubes Irreversible, secondary changes in reactive organs (emphysema, bronchiectasis) Auto immune diseases and immunodeficiency Concurrent therapy involving immunosuppressives Systemic and collagen diseases Tuberculosis of the lung and tuberculosis Serious psychological disorders Documented hypersensitivity to glycerol Pregnancy Serious cardiovascular disease Usage of b -blockers

Sites / Locations

  • Radboud university hospital

Outcomes

Primary Outcome Measures

Double blind placebo controlled evaluation of the immunological effects of SLIT on the nasal mucosal tissue of adult humans with sever

Secondary Outcome Measures

I. Correlating immunological effects to a retrospective subjective complaint reduction.
II. Rescue medication decrease through SLIT.
III. Determining the effects of SLIT on decongestion.
IV. Assessment of treatment compliance.

Full Information

First Posted
September 7, 2005
Last Updated
September 7, 2005
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00150514
Brief Title
Effects of Sublingual Immunotherapy on Grasspollen Allergy
Official Title
A Placebo Controlled, Double-Blind, Randomised Study to Assess Efficacy of Sublingual Immunotherapy in Patients With Grass Pollen Allergy Through Assessment of Its Immunological Effects on the Mucosal Tissue of the Nose.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2003
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center

4. Oversight

5. Study Description

Brief Summary
The objective of the study is to document the objective immunological effects of SLIT on the nasal mucosa. Better understanding of these immunological pathways, in which this widely practised clinical therapy is likely to work, can only benefit the overall outcome of this, more patient friendly, therapy and it will demonstrate the effects of SLIT on the allergic reaction, with objective parameters, in the nasal tissues showing it to be a true etiological treatment of allergy.
Detailed Description
Double blind placebo controlled evaluation of the immunological effects (decrease of IgE specific cells and the decrease of Th2 mediator release, respectively increase of Th1 mediator release) of SLIT on the nasal mucosal tissue of adult humans with severe rhinocunjunctivitis due to grass pollen allergy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hayfever
Keywords
nasal biopsy grasspollen sublingual immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
38 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Oralgen
Intervention Type
Procedure
Intervention Name(s)
Nasal biopsy
Intervention Type
Procedure
Intervention Name(s)
Nasal washing
Intervention Type
Procedure
Intervention Name(s)
Peak nasal inspiratory flow
Primary Outcome Measure Information:
Title
Double blind placebo controlled evaluation of the immunological effects of SLIT on the nasal mucosal tissue of adult humans with sever
Secondary Outcome Measure Information:
Title
I. Correlating immunological effects to a retrospective subjective complaint reduction.
Title
II. Rescue medication decrease through SLIT.
Title
III. Determining the effects of SLIT on decongestion.
Title
IV. Assessment of treatment compliance.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 and older. Patients known in general practice with documented clinical history of grass pollen allergy with moderate disease intensity as retrospectively derived from the use of symptomatic allergy medication during the previous grass pollen season, i.e. regular use of cromoglycates as nasal spray and/or eye drops, and/or regular use of anti histamine tablets or sprays and/or limited use of local acting or systemically administered corticosteroids. Positive (ARTU) grass pollen specific skin prick test (despite negative RAST). Exclusion Criteria: Clinical history of severe asthmatic symptoms requiring inhalant therapy with daily pulmonary steroids during at least 3 months a year. Symptomatic perennial allergic rhinitis. Meaning perennial allergy is allowed if the allergen is not present in patients' daily life (especially one month prior to provocation) and if they have no apparent symptoms of this perennial allergy. Other seasonal allergic rhinitis are not allowed unless it is asymptomatic during the period of provocation. The intention to subject the patient to surgery of the nasal cavity in the course of the study. Previous immunotherapy. Negative (ARTU) grass pollen specific skin prick test (despite positive RAST). Contraindications to sublingual immunotherapy, i.e.: Malignancies and serious disorders of the oral cavity History of status asthmaticus and anaphylactic shock Aggressively developing asthmatic symptoms Serious chronic inflammations, chronic disorders associated with fever, particularly of the bronchial tubes Irreversible, secondary changes in reactive organs (emphysema, bronchiectasis) Auto immune diseases and immunodeficiency Concurrent therapy involving immunosuppressives Systemic and collagen diseases Tuberculosis of the lung and tuberculosis Serious psychological disorders Documented hypersensitivity to glycerol Pregnancy Serious cardiovascular disease Usage of b -blockers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K Ingels, MD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Radboud university hospital
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500
Country
Netherlands

12. IPD Sharing Statement

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Effects of Sublingual Immunotherapy on Grasspollen Allergy

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