drugset / Trial / NCT02288156

Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis

NCT02288156

Phase 4 Completed 80 enrolled Universitaire Ziekenhuizen KU Leuven
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Chronic rhinitis is affecting more than 200 million people worldwide. Its prevalence is estimated to be as high as 30% of the Western population. Rhinitis is defined as symptomatic inflammation of the inner lining of the nose and is characterized by the following symptoms: rhinorrhea, nasal blockage, nasal itching and/or sneezing. The cut-off point for defining rhinitis as chronic rhinitis is considered to be persisting symptoms for over more than twelve weeks Chronic rhinitis can be divided into three major subgroups; based on the knowledge of the major etiological factor: infectious rhinitis, allergic rhinitis and non-allergic, non-infectious rhinitis, in literature also referred to as nonallergic rhinitis. Non-inferiority in efficacy of the two novel treatment regimes i.e. capsaicin nasal spray 0,01mM (2puffs/nostril/day) during 4 weeks and capsaicin nasal spray 0,001mM (2puffs/nostril/day) during 4 weeks compared to the current treatment of capsaicin nasal spray 0,1mM (5/day administered on a single day) with regard to the change from baseline in VAS for major nasal symptom on week 4. (Estimated placebo effect is 25%.)

Timeline

Start
2015-07
Primary completion
2018-12
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Capsaicin Small molecule 0.001 unknown Intranasal
Subject Capsaicin Small molecule 0.01 unknown Intranasal
Subject Capsaicin Small molecule 0.1 unknown Intranasal

Indications