- Oral presentation
- Open Access
Short and long-term safety of MP29-02*: a new therapy for the treatment of allergic rhinitis
Clinical and Translational Allergy volume 3, Article number: O15 (2013)
To evaluate the short- and long-term safety of MP29-02*.
4022 patients (>=12 years old) were randomized into 4, 14-day double-blind, placebo-controlled SAR trials to receive MP29-02*, AZE, FP or placebo nasal sprays (all given as 1 spray/nostril bid). 612 patients (>=12 years old) were randomized into a 1-year, open-label, active-controlled, parallel-group chronic rhinitis trial to receive MP29-02* (1 spray/nostril bid) or FP nasal spray (2 sprays/nostril qd). For all studies the total daily dose of AZE and FP was 548 g and 200 µg respectively. Safety was assessed by incidence, type, and severity of adverse events, vital signs and nasal examination.
In all SAR studies, the treatment-related adverse events (TRAEs) observed were those usually reported with AZE (dysgeusia) and FP (headache and epistaxis), did not exceed placebo in many instances (Table 1 shows results from a representative SAR study) and were 'mild' in the vast majority of cases. In the long-term study there was no evidence for an accumulation of TRAEs over time, any occurrence of late AEs and none were considered severe. < 3% of subjects discontinued from the study due to an AE. A SAE was reported by 3 MP29-02 subjects and 1 FP subject, but none were considered treatment-related. For all studies, changes in vital signs and nasal examinations were similar in all groups.
MP29-02* was well tolerated following 14 day's use in SAR patients with a similar safety profile as standard therapies and placebo. MP29-02* is also safe for long-term use.
Carr : JACI. 2012
Price : EAACI. 2012