Birch Pollen-Related Rhinoconjunctivitis, Rhinitis, Allergic, Seasonal
Conditions
Keywords
rBet v 1, Birch pollen allergy, Sublingual Immunotherapy
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.
Interventions
BIOLOGICALPlacebo
Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
BIOLOGICALrBet v 1
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.
Sponsors
Quintiles, Inc.
Stallergenes Greer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local tolerability | Assessed every day over 2 weeks |
| Global safety | Assessed every day over 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Immunological markers (IgE and IgG4) | Between selection and follow-up visit |
Countries
Denmark
Outcome results
None listed