ANTONY, France, August 27 /PRNewswire-FirstCall/ --
- Oralair(R) Grasses 300IR Highly Positive Clinical Results in a Pharmacodynamic Study Conducted in an Allergen Challenge Chamber
Stallergenes S.A. announces the highly positive results of a new study conducted in an Allergen Challenge Chamber (ACC).
The study on Oralair(R) Grasses included 86 adult patients exposed to
grass pollen challenge with different treatment durations: 1 week, 1 month,
2 and 4 months without a titration phase. Use of rescue medication was not
The outcomes of this trial in line with the objectives were:
- An onset of action starting on the seventh day
(statistically significant at one month)
- An efficacy plateau reached on challenge at the first month
- A highly statistically significant effect of Oralair(R)
Grasses versus placebo (p=0.0003) on the average symptom score (RTSS).
The magnitude of efficacy (34%)1 was similar to the findings of the
Previous studies VO34 (in adults) and VO52 (in a paediatric population)
- A Cohen score of 0.79 corresponding to a large effect size
Safety results, with only well-known local adverse events, and efficacy results were consistent with the findings of Oralair(R) Grasses studies previously conducted in adults (VO34) and children (VO52) in phase III trials.
"This study has demonstrated a clear consistency with the outcomes of previous pivotal studies. It opens the way for ACC as a new tool for phase II studies reducing the unpredictability of pollination. Moreover, it confirms the therapeutic effect of Oralair(R) Grasses and the very fast onset of action on the symptoms," said Olivier de Beaumont.
1 on median scores
ABOUT THE STUDY
This was a randomised, double-blind, parallel-group,
placebo-controlled, single centre, phase I study to assess, subsequent to
allergen challenge in an allergen exposition chamber, the efficacy
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