drugset / Trial / NCT02231307
SUBLIVAC FIX Birch Phase III Short-term Efficacy
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The aim of this phase III study is to asses if SUBLIVAC FIX Birch is safe and effective in reducing birch allergy induced symptoms and birch allergy medication usage.
Timeline
- Start
- 2014-09
- Primary completion
- 2015-07
- Completion
- 2015-11
Outcome
Met primary endpoint
paper significant (P < .0001) and clinically relevant (32%) reduction in the combined symptom and medication score compared with placebo PMID 30508538 ↗
Publications
- Fortescue R, Kew KM, Leung MST. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD011293. doi: 10.1002/14651858.CD011293.pub3.
- Pfaar O, Bachert C, Kuna P, Panzner P, Dzupinova M, Klimek L, van Nimwegen MJ, Boot JD, Yu D, Opstelten DJE, de Kam PJ. Sublingual allergen immunotherapy with a liquid birch pollen product in patients with seasonal allergic rhinoconjunctivitis with or without asthma. J Allergy Clin Immunol. 2019 Mar;143(3):970-977. doi: 10.1016/j.jaci.2018.11.018. Epub 2018 Nov 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SUBLIVAC FIX Birch | Unknown | 40000 unknown | Other |