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

NCT02288156 | Completed Phase 4 Results

• 1 other identifier: TBM
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analogue Scale for Major Nasal Symptoms

  patients score their main nasal complaints from 0 to 10 on a scale of 10, with 0 meaning no complaints and 10 meaning the worst complaints. This is done at baseline and after 4 weeks of treatment

  Baseline and week 4

Secondary Outcomes (5)

• Change in Visual Analogue Scale for Individual Nasal Symptoms

  Baseline, week 4

• Therapeutic Response in All Treatment Regimes

  week 4

• Change of Nasal Hyperreactivity in All Treatment Modalities.

  baseline, week 4

• Number of Adverse Events in All Treatment Groups

  week 4

• Number of Patients Without Improvement of Symptoms at the End of the Trial in All Treatment Modalities

  week 4, 12 and 26

Study Arms (4)

0.1mM

ACTIVE COMPARATOR

Drug: Capsaicin

0.01mM

EXPERIMENTAL

Drug: Capsaicin

0.001mM

EXPERIMENTAL

Drug: Capsaicin

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Capsaicin DRUG

via nasal spray

0.001mM; 0.01mM; 0.1mM

placebo DRUG

via nasal spray

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

ORL

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 32439432 DERIVED

MeSH Terms

Conditions

Common Cold

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: Prof. Dr. Hellings
• Organization: UZ Leuven

nkogh@uzleuven.be

016336340

Study Officials

• Peter Hellings, Prof. Dr.

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 11, 2014
• Study Start: July 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 22, 2021
• Results First Posted: January 12, 2021

Record last verified: 2021-05

Locations

BE (1)