Olopatadin / Mometason (1) – Ryaltris®

• Clinical trials
  • The GSP301-PoC study is a single-centre, double-blind, 5-arm randomised controlled trial (RCT).

Adults and children aged 12 years and over with moderate to severe nasal symptoms associated with allergic rhinitis

• Additional benefit is not proven for the treatment of adults and adolescents aged 12 years and over with moderate to severe nasal symptoms associated with allergic rhinitis.
• Overall, for adults and children aged 12 years and over with moderate to severe nasal symptoms associated with allergic rhinitis, the additional benefit of olopatadine/mometasone compared with the appropriate comparator therapy is not proven.
• Overall assessment / Conclusion
  • In summary, the study submitted by the pharmaceutical manufacturer is not suitable for demonstrating any additional benefit of olopatadine/mometasone compared with the appropriate comparator therapy ‘intranasal glucocorticoid (INCS) in combination with an intranasal antihistamine (INAH)’.
  • The study duration of only 14 days is considered too short within the context of the randomised comparative study phase for early benefit assessment in a chronic condition.
  • Furthermore, it is unclear whether the results obtained under artificial induction can be extrapolated to the clinical setting under natural exposure.

Courtesy translation only, please refer to the German original.