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

uzleuven0 个研究点目标入组 120 人开始时间: 2015年1月20日最近更新: 2020年12月14日

适应症

试验速览

暂无简介。

•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

•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.

发起方

uzleuven