Birch Pollen-Related Rhinoconjunctivitis, Rhinitis, Allergic, Seasonal
Conditions
Keywords
rBet v 1, Birch pollen allergy, Sublingual Immunotherapy
Brief summary
The purpose of this study is to determine the safety and tolerability of several doses of r Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.
Interventions
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 12.5 to 100 µg rBet v 1.
BIOLOGICALPlacebo
Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
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 * Male or female subject from 18 to 60 years old and in general good health * For woman of child bearing potential: * 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) \>0.70 kU/L at screening. * FEV1 at least of 80% of predicted values at screening. * Subject accepting to comply fully with the protocol.
Exclusion criteria
* Past or current disease which as judged by the Investigator, may affect the outcome of this study. * History of life-threatening asthma, * Asthma requiring daily treatment (whatever the pharmaceutical class). * Pregnant or lactating woman. * Subject being treated with inhaled steroids within 4 weeks prior to screening visit or within 12 weeks prior to screening visit. * Subject who previously received desensitisation treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder) or who plan to start desensitisation treatment during this study. * Symptoms during the treatment phase due to a sensitivity to a second allergen. * Subjects treated with ongoing immunotherapy with another allergen
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 (up to 18 weeks) |
Countries
Denmark
Outcome results
None listed