elaboration of patient-friendly treatment strategy with capsaicin nasal spray in patients with idiopathic rhinitis

Conditions: Non-allergic Rhinitis

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%.)


Eligibility criteria:
inclusion criteria: * idiopathic rhinitis patients with at least 2 persistent (\> 12w) rhinological symptoms (nasal discharge, sneezing, nasal congestion) for an average of at least 1 h per day, * idiopathic rhinitis patients with a total nasal symptoms score (tns) of 5 or more on a visual analogue scale (vas). * age \> 18 and \< 65 years. * written informed consent. * willingness to adhere to visit schedules. * adequate contraceptive precautions in female patients with childbearing potential. exclusion criteria: * patients with concomitant allergic rhinitis, demonstrated by positive skin prick test (hal reagents) and/or immunoglobins e in blood. \* * patients with structural abnormalities: nasal polyps, severe septal deviation (septum reaching concha inferior or lateral nasal wall), septal perforation, hypertrophy of the inferior turbinates. * patients with local allergic rhinitis (lar) or entopy. * systemic steroid treatment less than 4 weeks before the inclusion in the study, nasal steroid spray less than 4 weeks before the inclusion, oral leukotriene antagonists or long-acting antihistamines less than 2 weeks before the inclusion. * inability of the patient to stop taking medication affecting nasal function like ß-blockers. * history of prolonged use or abuse of decongestant nasal spray like xylometazoline spray and/or use or abuse of decongestive oral medication. * evidence of infectious rhinitis/rhinosinusitis or common cold within 4 weeks prior to inclusion. * pregnancy or lactation. \*\* * any disorder of which might compromise the ability of a patient to give truly informed consent for participation in this study. * enrollment in other investigational drug trial(s) or receiving other investigational agent(s) for any other medical condition. * contra-indications for the use of local anesthesia (cocaine 5%). * smoking or occupational exposure to irritants (like hypochlorite, persulfates, isocyanates). * nasal malignancies or severe comorbidity like granulomatosis or vasculitis.