Multicenter, parallel, randomized, single-blind trial comparing the efficacy and tolerability of Rhinaction®, an osmotic decongestant nasal spray containing essential oils versus Olynth® 0.1%, a vasoconstrictor, in the relief of acute rhinitis symptoms in adults. - RHINO

aboratoire de la Mer0 个研究点开始时间: 2015年7月9日最近更新: 2016年12月5日

适应症

试验速览

暂无简介。

•Adults (male or female) aged =18years old.
•Willingness to provide written informed consent prior to performance of any study-related procedure.
•Diagnosis of common cold: Jackson score of two (2) or higher; symptoms severity rated as 0=absent, 1=mild, 2=moderate, and 3=severe for each of the 8 Jackson symptoms: sneezing, nasal discharge, nasal obstruction, sore throat, cough, headache, malaise and chilliness. At least one (1) of the first four cold-specific Jackson symptoms is required on the day of screening (=randomization).
•Symptoms expressed for up to 72 hours prior to the screening visit.
•Negative urine pregnancy test in women of childbearing potential.
•Topical vasoactive (for ex. Nasivin, Sanorin etc.) and antiseptic substances (for ex. Pinosol) can be used before the trial, no washout period is needed.
•Subjects agreeing to stop current use of topical vasoactive and/or topical antiseptic substances at randomization.
•Subjects not participating in any other clinical trial.
•Subjects screened only once in this clinical trial.
•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 500
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•Current or past history of allergy combined with eye/nose itching or sneezing (such as allergic rhinitis).
•Current or past history of asthma bronchiale with cough, wheezing or shortness of breath.
•Prospective participants or enrollers feeling that any current symptoms are due to allergy, asthma or other non-URI cause.
•Other inflammatory disease than common cold.
•Secondary infection such as purulent acute otitis media and/or acute bacterial rhinosinusitis and/or lower respiratory tract bacterial infection.
•Known immunodeficiency.
•Symptoms of common cold present for more than 72 hours.
•Subjects with contraindication to vasoactive treatment.
•Known allergy to essential oils.
•Use of other cold medicine prior to inclusion (except topical vasoactives and/or topical antiseptics that will be discontinued):
•-topical and/or inhaled antihistaminics, corticoids and antibiotics before inclusion are forbidden;
•-per os taken vasoactives, antihistaminics, corticoids and antibiotics before inclusion are forbidden.
•Presence of chronic disease that may interfere with cold treatment and/or symptoms reporting (such as chronic rhinosinusitis).
•Pregnant and breastfeeding women.

发起方

aboratoire de la Mer