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

NCT ID: NCT02288156

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-12-31

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%.)

Conditions

Non-allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

0.1mM

Group Type: ACTIVE_COMPARATOR

Capsaicin

Intervention Type: DRUG

via nasal spray

0.01mM

Group Type: EXPERIMENTAL

Capsaicin

Intervention Type: DRUG

via nasal spray

0.001mM

Group Type: EXPERIMENTAL

Capsaicin

Intervention Type: DRUG

via nasal spray

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

via nasal spray

Interventions

Capsaicin

via nasal spray

Intervention Type: DRUG

placebo

via nasal spray

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Hellings, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

ORL

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 32439432 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TBM

Identifier Type: -

Identifier Source: org_study_id