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

Primary Purpose

Non-allergic Rhinitis

Status

Completed

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

Capsaicin

placebo

About this trial

This is an interventional treatment trial for Non-allergic Rhinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

0.1mM

0.01mM

0.001mM

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Visual Analogue Scale for Individual Nasal Symptoms

patients score all kinds of nasal symptoms 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

Therapeutic Response in All Treatment Regimes

Evaluation of the therapeutic response (TRE) on a scale from 1 (= no relief of symptoms) to 5 (= total relief of symptoms).

Change of Nasal Hyperreactivity in All Treatment Modalities.

change in the number of participants with nasal hyperreactivity in all treatment modalities

Number of Adverse Events in All Treatment Groups

All reported AEs were entered into the AE section so please see AE table for specifics.

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

Full Information

NCT ID

NCT02288156

First Posted

November 6, 2014

Last Updated

May 31, 2021

Sponsor

Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT02288156

Brief Title

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

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

December 2018 (Actual)

Study Completion Date

December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee

5. Study Description

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%.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.1mM

Arm Type

Active Comparator

Arm Title

0.01mM

Arm Type

Experimental

Arm Title

0.001mM

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Capsaicin

Intervention Description

via nasal spray

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

via nasal spray

Primary Outcome Measure Information:

Title

Change in Visual Analogue Scale for Major Nasal Symptoms

Description

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

Time Frame

Baseline and week 4

Secondary Outcome Measure Information:

Title

Change in Visual Analogue Scale for Individual Nasal Symptoms

Description

patients score all kinds of nasal symptoms 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

Time Frame

Baseline, week 4

Title

Therapeutic Response in All Treatment Regimes

Description

Evaluation of the therapeutic response (TRE) on a scale from 1 (= no relief of symptoms) to 5 (= total relief of symptoms).

Time Frame

week 4

Title

Change of Nasal Hyperreactivity in All Treatment Modalities.

Description

change in the number of participants with nasal hyperreactivity in all treatment modalities

Time Frame

baseline, week 4

Title

Number of Adverse Events in All Treatment Groups

Description

All reported AEs were entered into the AE section so please see AE table for specifics.

Time Frame

week 4

Title

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

Time Frame

week 4, 12 and 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Hellings, Prof. Dr.

Organizational Affiliation

UZ Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

ORL

City

Leuven

State/Province

Vlaams-Brabant

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

32439432

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.

Results Reference

derived

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

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