Comparison of the efficacy and safety of the fixed-dose combination of xylometazoline and dexpanthenol in SeptaNazal® and xylometazoline in nasal congestion in patients after surgery in the nose and paranasal cavity and in patients with acute rhinitis – SeptaNazal DOUBLE clinical study.
- Conditions
- asal congestion in patients with acute rhinitis and in patients after surgery in the nose and paranasal cavityMedDRA version: 20.0Level: HLTClassification code 10028736Term: Nasal congestion and inflammationsSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2015-005155-27-HR
- Lead Sponsor
- KRKA-FARMA d.o.o.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 223
Patients with acute rhinitis (Group 1):
• Aged 18-60 years
• Diagnosed with acute rhinitis
• Can carry out intranasal administration of the investigational medicinal
product
• Signed Informed consent form
Patients after nasal surgery or nasal cavities surgery (Group 2):
• Aged 18-60 years
• Recent nasal surgery or nasal cavities surgery (patients with chronic
rinosinusitis with nasal polyps (CRSwNP) and patients with chronic
rinosinusitis without nasal polyps (CRSsNP)
• Can carry out intranasal administration of the investigational medicinal
product
• Signed Informed consent form
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 223
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Hypersensitivity to the active substances or to any of the excipients
• Dry nasal inflammation (rhinitis sicca)
• History of transsfenoidal hypophysectomy or other surgical procedures in which the dura mater was exposed
• Patients who are treated with drugs for local or systemic treatment of influenza, and sympathomimetic agents, which contain a medicament for the treatment for cough and/or cold
• Pregnancy or breast-feeding
• Patients with asthma who require treatment with corticosteroids
• Rhinitis medicamentosa
• Chronic rhinitis
• Patients treated with monoamine oxidase inhibitors (MAOIs) or other drugs that may raise blood pressure
• Patients with increased intraocular pressure, in particular with angle-closure glaucoma
• Patients with pheochromocytom
• Nose injury less than 3 months prior the first visit
• Current treatment with nasal decongestants
• Respiratory tract infection within 2 weeks prior the first visit (including otitis media), who required treatment with antibiotics
• Current smoker or ex-smoker less than 6 months prior the first visit
• Participation in another clinical trial within thirty days prior the first visit
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of the double blind, randomized trial is to compare the efficacy of the treatment between fixed combination of xylometazoline and dexpanthenol (Septanazal®), nasal spray, and xylometazoline, nasal spray, on nasal congestion and the healing effect of dexpanthenol in patients with acute rhinitis and in patients after surgery in the nose and paranasal cavity;Secondary Objective: Not applicable;Primary end point(s): To compare the efficiency of the treatment between fixed combination of<br>xylometazoline and dexpanthenol (Septanazal®), nasal spray, and<br>xylometazoline, nasal spray, on nasal congestion in the two groups of<br>patients: patients after nasal surgery or nasal cavities surgery<br>(CRSwNP and CRSsNP patients)<br> and patients diagnosed with acute rhinitis;Timepoint(s) of evaluation of this end point: After 7 days of treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): To compare the efficiency of the treatment between fixed combination of<br>xylometazoline and dexpanthenol (Septanazal®), nasal spray, and<br>xylometazoline, nasal spray, in the Group 1 and Group 2 in the following<br>parameters:<br>• swelling of the nasal mucosa<br>• dryness of the nasal mucosa<br>• burning feeling in the nose<br>• crust formation<br>• bleeding from nasal mucosa<br>• redness of the nasal mucosa and skin at nasal entrance<br>• sneezing<br>• nasal exudate<br>• nasal irritation<br><br>To compare the treatment duration and occurrence of rebound effect<br>between fixed combination of xylometazoline and dexpanthenol<br>(Septanazal®), nasal spray, and xylometazoline, nasal spray, in the<br>Group 1 and Group 2.<br><br>To compare the onset of action between fixed combination of<br>xylometazoline and dexpanthenol (Septanazal®), nasal spray, and<br>xylometazoline, nasal spray, in the Group 1 and Group 2.;Timepoint(s) of evaluation of this end point: After 7 days of treatment