ELABORATION OF A PATIENT-FRIENDLY TREATMENT STRATEGY WITH CAPSAICIN NASAL SPRAY IN PATIENTS WITH IDIOPATHIC RHINITIS

Phase 1

• Conditions: idiopathic rhinitis; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2014-003914-10-BE
• Lead Sponsor: uzleuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-20
• Last Update Posted: 14 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

•IR patients with at least 1 persistent (> 12w) rhinological symptoms (nasal discharge, sneezing, nasal congestion) for an average of at least 1 h per day,
•IR patients with a total nasal symptoms score (TNS) of 5 or more on a visual analogue scale (VAS).
•Age > 18 and < 60 years.
•Written informed consent.
•Willingness to adhere to visit schedules.
•Adequate contraceptive precautions in female patients with childbearing potential.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients with concomitant allergic rhinitis, demonstrated by positive skin prick test (Hal reagents) and/or IgE 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 anaesthesia (cocaïne 5%).
•Smoking or occupational exposure to irritants (like hypochlorite, persulfates, isocyanates).
•Nasal malignancies or severe comorbidity like granulomatosis or vasculitis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To evaluate if the two novel treatment modalities show non-inferiority compared to the current treatment modality of capsaicin nasal treatment in 120 patients with IR. The gathered data of this single center trial can be used to guide the decision on the set-up and the design of a larger multi-center trial being powered to prove non-inferiority.;Secondary Objective: •To confirm the validity of CDA challenge and challenge with hyperosmolar discs as a clinical tool for the demonstration of the reduction of NHR by capsaicin nasal spray.<br>•To evaluate the occurrence of adverse events and recurrence of symptoms and NHR in the different treatment groups at week 4 and 12.<br>;Primary end point(s): •Comparison of VAS for major nasal symptom at week 4 in all treatments modalities. The region of equivalence of the compared treatment modalities is defined as a difference in VAS of less than 1. ;Timepoint(s) of evaluation of this end point: after 4 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Comparison of VAS for total and individual nasal symptoms at week 4 in all treatments modalities.<br>•Comparison of TRE in all treatment regimes at week 4.<br>•Comparison of the reduction of NHR (measured by CDA challenge and hyperosmolar discs) in all treatment modalities.<br>•Evaluation of appearance of adverse events in all treatment groups at week 4 and 12.<br>•Evaluation of recurrence of symptoms in all treatment modalities at week 4, 12 and 26.<br>;Timepoint(s) of evaluation of this end point: after 4, 12 and 26 weeks of treatment