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.
- Conditions
- Acute rhinitisAdults aged =18years old suffering from acute rhinitis with symptoms present for up to 72h. The purpose of this study is to demonstrate the efficacy and compare safety and tolerability of Medical Device class I Rhinaction® as well as its non-inferiority when compared to Medical Product Olynth® 0.1% in cases of acute rhinitis in adults up to 8 days of administrationTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2015-002796-23-CZ
- Lead Sponsor
- aboratoire de la Mer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Area under the curve for the overall severity of cold symptoms score from the Wisconsin Upper Respiratory Symptom Survey (WURSS 21) questionnaire <br>during the patient illness, but up to the maximum of 8 days of observation.<br>;Timepoint(s) of evaluation of this end point: last patient last visit (up to 8 days of patient´s observation);Main Objective: Demonstrate the non-inferiority of Medical Device class I Rhinaction®, an osmotic decongestant nasal spray containing essential oils compared to Medical Product Olynth® 0.1%, a vasoactive substance in acute rhinitis symptoms relief.;Secondary Objective: Assess:<br>•Tolerability<br>•Safety<br>•Impact on Quality of Life<br>•Effect on illness severity <br>•Onset of action<br>•Lasting effect<br>•Product acceptability (adherence)<br>•Overall satisfaction <br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary endpoints: <br>•Individual WURSS-21 items<br>•WURSS-21 symptoms domains<br>•WURSS-21 functional impairments domain<br>•Tolerability (nasal burning, nasal irritation, nasal itching, nasal bleeding (epistaxis), nasal dryness, crusts, bad taste and other are) assessed on a 7-level scale (not at all, very acceptable, acceptable, rather acceptable, rather unacceptable, unacceptable, very unacceptable)<br>•Product satisfaction (overall satisfaction, overall perceived efficacy, perceived sensation during and after application, willingness to reuse the product if needed, willingness to recommend this product) assessed by 7 level scale questionnaire and acceptability assessed by Morisky questionnaire<br>•Onset of action and lasting effect assessed by questionnaire ;Timepoint(s) of evaluation of this end point: last patient last visit (up to 8 days of patient´s observation)