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A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy

Primary Purpose

Rhinoconjunctivitis Due to Grass Pollen Allergy

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Allergen specific immunotherapy
Sponsored by
University of Zurich
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinoconjunctivitis Due to Grass Pollen Allergy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Written informed consent
  • History of allergic rhino-conjunctivitis in spring and summer
  • Age 18 years to 65 years
  • Positive skin prick test to grass pollen

Exclusion criteria:

  • Blood donation within previous 30 days
  • Surgery within the previous 30 days
  • Use of investigational drugs within previous 90 days
  • Pregnancy or nursing
  • Mastocytosis
  • Significant cardiovascular disease
  • Hypertension
  • Active infectious disease
  • Significant hepatic disease
  • Significant renal disease
  • Significant hematological disorder
  • Significant pulmonary disease
  • Moderate or severe asthma
  • Autoimmune disease
  • History of malignancy.
  • Contraindicated medications were immunosuppressive agents, beta-blockers, ACE-inhibitors, and tricyclic antidepressants.

Sites / Locations

  • Clinic for Dermatology University Hospital of Zurich

Outcomes

Primary Outcome Measures

Safety efficacy and toxicity

Secondary Outcome Measures

Full Information

First Posted
May 4, 2007
Last Updated
December 2, 2015
Sponsor
University of Zurich
Collaborators
AlleCure
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1. Study Identification

Unique Protocol Identification Number
NCT00470457
Brief Title
A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy
Official Title
A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy in Grass and/or Tree Pollen Allergic Subjects by Intralymphatic Allergen Administration
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Zurich
Collaborators
AlleCure

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Allergen specific immunotherapy (SIT) is the only causative treatment of IgE-mediated allergies. The disadvantages of SIT, however, are the requirement of numerous allergen administrations over three to five years, and that the treatment itself causes frequent allergic reactions. We aim at enhancing grass pollen SIT in hay fever patients by injecting the allergen directly into subcutaneous lymph nodes. In a monocentric randomized trial safety and efficacy of intralymphatic immunotherapy (ILIT) with 3 low dose grass pollen extract injections over 2 months are compared to subcutaneous immunotherapy (SCIT) using 54 injections over 3 years. Trial with immunodulatory product / biological

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinoconjunctivitis Due to Grass Pollen Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Allergen specific immunotherapy
Primary Outcome Measure Information:
Title
Safety efficacy and toxicity
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Written informed consent History of allergic rhino-conjunctivitis in spring and summer Age 18 years to 65 years Positive skin prick test to grass pollen Exclusion criteria: Blood donation within previous 30 days Surgery within the previous 30 days Use of investigational drugs within previous 90 days Pregnancy or nursing Mastocytosis Significant cardiovascular disease Hypertension Active infectious disease Significant hepatic disease Significant renal disease Significant hematological disorder Significant pulmonary disease Moderate or severe asthma Autoimmune disease History of malignancy. Contraindicated medications were immunosuppressive agents, beta-blockers, ACE-inhibitors, and tricyclic antidepressants.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Studienregister MasterAdmins
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Study Director
Facility Information:
Facility Name
Clinic for Dermatology University Hospital of Zurich
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19001265
Citation
Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wuthrich B, Crameri R, Graf N, Johansen P, Kundig TM. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci U S A. 2008 Nov 18;105(46):17908-12. doi: 10.1073/pnas.0803725105. Epub 2008 Nov 10.
Results Reference
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A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy

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