Effects of Sublingual Immunotherapy on Grasspollen Allergy

NCT00150514 | Completed Phase 4

• 1 other identifier: AB0103
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Hayfever

Keywords

nasal biopsy grasspollen sublingual immunotherapy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• 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.

Interventions

Oralgen DRUG

Nasal biopsy PROCEDURE

Nasal washing PROCEDURE

Peak nasal inspiratory flow PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud university hospital

Nijmegen, Gelderland, 6500, Netherlands

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Nasal Lavage Fluid

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nasal Lavage; Therapeutic Irrigation; Investigative Techniques

Study Officials

• K Ingels, MD

  Radboud University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 8, 2005
• Study Start: January 1, 2002
• Study Completion: December 1, 2006
• Last Updated: September 8, 2005

Record last verified: 2003-11

Locations

NL (1)