Rhinitis, Allergic, Seasonal Clinical Trial
Official title:
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
Verified date | April 2009 |
Source | Stallergenes |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Medicines Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 57 |
Est. completion date | June 2007 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | National University Hospital - Allergy Unit 4222 | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Stallergenes | Quintiles, Inc. |
Denmark,
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)
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Local tolerability | Assessed every day over 2 weeks | Yes | |
Primary | Global safety | Assessed every day over 2 weeks | Yes | |
Secondary | Immunological markers (IgE and IgG4) | Between selection and follow-up visit | No |
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