Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis
Condition: Non-allergic Rhinitis
MeSH terms: Rhinitis; Common Cold
Intervention: Capsaicin; placebo
Intervention description: via nasal spray; via nasal spray
Intervention MeSH terms: Capsaicin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.