Status:
COMPLETED
Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Non-allergic Rhinitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02288156
Start Date
July 1 2015
End Date
December 1 2018
Last Update
June 22 2021
Active Locations (1)
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1
ORL
Leuven, Vlaams-Brabant, Belgium, 3000