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