Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1
A Phase I Study to Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Higher Multi Dose Regimens to Subjects Sensitised to Birch Pollen
1 other identifier
interventional
57
1 country
1
Brief Summary
To investigate the safety and tolerability of successive single rising doses of SLIT in subjects with allergic rhinitis and to investigate the safety and tolerability of multi high dose regimens of SLIT in subjects with allergic rhinitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2006
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 2, 2006
CompletedFirst Posted
Study publicly available on registry
November 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedJune 27, 2013
April 1, 2009
4 months
November 2, 2006
June 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Local tolerability
Assessed every day over 2 weeks
Global safety
Assessed every day over 2 weeks
Secondary Outcomes (1)
Immunological markers (IgE and IgG4)
Between selection and follow-up visit
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo group
Active group
EXPERIMENTALrBet v 1 tablets
Interventions
Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
Two tablets (1 placebo + 1 rBet v 1 or 2 rBet v 1) were administered every day over 2 weeks with a 2-day break for the week-end. Administered doses ranged from 50 to 300 µg rBet v 1.
Eligibility Criteria
You may qualify if:
- written consent
- Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years.
- Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) of at least Class 2 at screening.
- FEV1 at least of 80% of predicted values at screening.
You may not qualify if:
- Patient who previously received desensitization treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder…) or who plan to start desensitization treatment during this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stallergenes Greerlead
- Quintiles, Inc.collaborator
Study Sites (1)
National University Hospital - Allergy Unit 4222
Copenhagen, Denmark
Related Publications (1)
L. Winther, L.K. Poulsen, B. Robin, M. Mélac, H. Malling Safety and Tolerability of Recombinant Bet v 1 (rBet v 1) Tablets in Sublingual Immunotherapy (SLIT) The Journal of Allergy and Clinical Immunology February 2009 (Vol. 123, Issue 2, Page S215)
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hans-Jorgen MALLING, Professor
National University Hospital, Copenhagen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 2006
First Posted
November 6, 2006
Study Start
November 1, 2006
Primary Completion
March 1, 2007
Study Completion
June 1, 2007
Last Updated
June 27, 2013
Record last verified: 2009-04