Effects of Sublingual Immunotherapy on Grasspollen Allergy

Hayfever Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150514
• Other study ID #: AB0103
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: September 7, 2005
• Start date: January 2002
• Est. completion date: December 2006

Study information

• Verified date: November 2003
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 and older.

2. 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.

3. Positive (ARTU) grass pollen specific skin prick test (despite negative RAST).

Exclusion Criteria:

1. Clinical history of severe asthmatic symptoms requiring inhalant therapy with daily pulmonary steroids during at least 3 months a year.

2. 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.

3. Other seasonal allergic rhinitis are not allowed unless it is asymptomatic during the period of provocation.

4. The intention to subject the patient to surgery of the nasal cavity in the course of the study.

5. Previous immunotherapy.

6. Negative (ARTU) grass pollen specific skin prick test (despite positive RAST).

7. 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hayfever

Intervention

Drug:
• Oralgen

Procedure:
• Nasal biopsy

• Nasal washing

• Peak nasal inspiratory flow

Locations

Country	Name	City	State
Netherlands	Radboud university hospital	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Double blind placebo controlled evaluation of the immunological effects of SLIT on the nasal mucosal tissue of adult humans with sever
Secondary	I. Correlating immunological effects to a retrospective subjective complaint reduction.
Secondary	II. Rescue medication decrease through SLIT.
Secondary	III. Determining the effects of SLIT on decongestion.
Secondary	IV. Assessment of treatment compliance.