Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
55 participants
INTERVENTIONAL
2007-11-30
2008-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Placebo group
Placebo
Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
2
rBet v 1 tablets
rBet 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
rBet 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.
Placebo
Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Quintiles, Inc.
INDUSTRY
Stallergenes Greer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Stallergenes S.A.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hans-Jorgen MALLING, Pr. MD
Role: PRINCIPAL_INVESTIGATOR
National University Hospital - Copenhagen - DENMARK
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National University Hospital - Allergy Unit 4222
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VO58.07 DK
Identifier Type: -
Identifier Source: org_study_id