Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever
NCT ID: NCT00310466
Last Updated: 2013-05-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
226 participants
INTERVENTIONAL
2005-06-30
2007-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch
NCT01191359
A Study in Children and Adolescents With Birch Pollen-induced Rhinoconjunctivitis
NCT04878354
Open Label Safety Study of a Birch Pollen Allergen Extract
NCT00818181
Efficacy and Safety Study of a Sublingual Immunotherapy Solution to Treat Patients Suffering From Birch Pollen Allergic Rhinoconjunctivitis
NCT01731249
Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis
NCT00309062
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sublingual immunotherapy
sublingual immunotherapy with drops applied once daily by single dose containers (200 STU per dose)
Sublingual immunotherapy
once daily intake of sublingual drops
Placebo
placebo sublingual drops
Placebo
once daily intake of sublingual drops
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sublingual immunotherapy
once daily intake of sublingual drops
Placebo
once daily intake of sublingual drops
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
* Positive skin prick test to birch
* Positive conjunctival test to birch
* Positive specific Immunoglobulin E (IgE) to birch
Exclusion Criteria
* History of seasonal allergy interfering with study
* History of symptomatic perennial allergy
* History of emergency visit or admission for asthma in the previous 12 month
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ALK-Abelló A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hendrik Wolf, PhD
Role: STUDY_DIRECTOR
ALK-SCHERAX Arzneimittel GmbH
Margitta Worm, MD, Prof.
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Charité Klinik für Dermatologie, Venerologie und Allergologie
Berlin, State of Berlin, Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHX0712
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.