Effects of Sublingual Immunotherapy on Grasspollen Allergy

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00150514
First received: September 7, 2005
Last updated: NA
Last verified: November 2003
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hayfever
Drug: Oralgen
Procedure: Nasal biopsy
Procedure: Nasal washing
Procedure: Peak nasal inspiratory flow
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Radboud University:

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.

Estimated Enrollment: 38
Study Start Date: January 2002
Estimated Study Completion Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150514

Locations
Netherlands
Radboud university hospital
Nijmegen, Gelderland, Netherlands, 6500
Sponsors and Collaborators
Radboud University
Investigators
Study Chair: K Ingels, MD Radboud University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00150514     History of Changes
Other Study ID Numbers: AB0103
Study First Received: September 7, 2005
Last Updated: September 7, 2005
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
nasal biopsy grasspollen sublingual immunotherapy

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Hypersensitivity
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014