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CompletedNCT00150514Updated Sep 8, 2005

Effects of Sublingual Immunotherapy on Grasspollen Allergy

A Phase 4 interventional study of Oralgen and Nasal biopsy in Hayfever, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2005-09-08.

Sponsored by Radboud University Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hayfever

Keywords

  • nasal biopsy grasspollen sublingual immunotherapy
03

In context

Rhinitis, Allergic, Seasonal

392 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 25 are open to participants now.

This study's enrollment of 38 is below the median of 136 across 356 interventional studies indexed under Rhinitis, Allergic, Seasonal.

Browse Rhinitis, Allergic, Seasonal studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
38 participants

Interventions

  • DrugOralgen
  • ProcedureNasal biopsy
  • ProcedureNasal washing
  • ProcedurePeak nasal inspiratory flow
06

What researchers measure

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

  1. I. Correlating immunological effects to a retrospective subjective complaint reduction.

  2. II. Rescue medication decrease through SLIT.

  3. III. Determining the effects of SLIT on decongestion.

  4. IV. Assessment of treatment compliance.

07

Study locations

1 site
  • Radboud university hospital
    Nijmegen, Gelderland 6500, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00150514
Lead sponsor
Radboud University Medical Center
First posted
Sep 8, 2005
Start date
Jan 2002
Completion
Dec 2006
Last update
Sep 8, 2005

Study contacts

K Ingels, MD
study chair · Radboud University Medical Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2003. You cannot join it, but the record below documents what was studied.

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