Clinical trial NCT02288156: Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis
Official title: Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-allergic Rhinitis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Change in Visual Analogue Scale for Major Nasal Symptoms
timeFrame: Baseline and week 4
Secondary outcomes:
measure: Change in Visual Analogue Scale for Individual Nasal Symptoms
timeFrame: Baseline, week 4
measure: Therapeutic Response in All Treatment Regimes
timeFrame: week 4
measure: Change of Nasal Hyperreactivity in All Treatment Modalities.
timeFrame: baseline, week 4
measure: Number of Adverse Events in All Treatment Groups
timeFrame: week 4
measure: Number of Patients Without Improvement of Symptoms at the End of the Trial in All Treatment Modalities
timeFrame: week 4, 12 and 26
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: ORL
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Peter Hellings, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Gerven L, Steelant B, Cools L, Callebaut I, Backaert W, de Hoon J, Ampe E, Talavera K, Hellings PW. Low-dose capsaicin (0.01 mM) nasal spray is equally effective as the current standard treatment for idiopathic rhinitis: A randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2021 Jan;147(1):397-400.e4. doi: 10.1016/j.jaci.2020.04.054. Epub 2020 May 19. No abstract available.