Randomized Clinical Trial to Evaluate the Efficacy and Safety of Product CM9241GRU in Relieving Nasal Symptoms in Perennial Allergic Rhinitis (RESPIRE)

NCT06577077 Phase 3 NOT_YET_RECRUITING

To evaluate the efficacy and safety of CM9241GRU versus placebo in the treatment of perennial allergic rhinitis.

Details

Lead sponsor	Ache Laboratorios Farmaceuticos S.A.
Phase	Phase 3
Status	NOT_YET_RECRUITING
Enrolment	432
Start date	2024-09
Completion	2025-08

Conditions

• Rhinitis, Allergic, Perennial

Interventions

• Product CM9241GRU
• Placebo

Primary outcomes

• Absolute reduction in the evening reflective total nasal symptom score (rTNSS) — 14 days
  Absolute reduction in the evening reflective total nasal symptom score (rTNSS) evaluated 14 days after starting treatment compared to the baseline evening rTNSS.