Drugs / Oralair
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT00418379 | Dec 2006 → Aug 2010 | allergic disease | Stallergenes Greer | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT02014623 | Feb 2014 → Nov 2019 | allergic rhinitis | Bayside Health | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2018-11-14 | Stallergenes Greer | Regulatory Stallergenes Greer Announces U.S. FDA Approval of Pediatric Indication Extension for Oralair® Sublingual Immunotherapy Tablet for the Treatment of Grass Pollen Allergy stallergenesgreer.com ↗ |
| 2018-05-29 | Stallergenes Greer | Results Stallergenes Greer plc: Two New Real-World Evidence Studies Show Long-Term Benefits of Sublingual Allergy Immunotherapy stallergenesgreer.com ↗
This retrospective analysis is based on four years’ worth of prescription data from 28,574 patients in France and demonstrated the statistically significant long-term benefit of grass pollen AIT sublingual tablets, including Stallergenes Greer’s Oralair®, on grass pollen-induced allergic rhinitis compared to only symptomatic treatments. |
| 2017-06-19 | Stallergenes Greer | Results First real-world evidence shows long term benefits of sublingual immunotherapy to control allergic rhinitis and potentially prevent allergic asthma stallergenesgreer.com ↗
Study results showed that grass pollen SLIT tablets significantly improved control of allergic rhinitis and may have a preventive effect on allergic asthma onset and worsening compared to symptomatic treatments. |
All press releases naming this drug 3 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Oralair | “OBJECTIVES: We sought to evaluate the sustained efficacy of 2 dosing regimens of a pre- and coseasonal treatment with 300 IR (index of reactivity) 5-grass-pollen SLIT tablets...” PMID 21802126 ↗ Jul 20111“The investigators propose conducting a longitudinal open label study to investigate the immunological changes that occur with the 5 grass pollen sublingual immunotherapy tablet...” NCT02014623 ↗ |
| Modality | Other / unclassified | “300 IR grass pollen allergen extract tablet” NCT00418379 ↗ |