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 after nasal surgery or nasal cavities surgery and in patients with acute rhinitisMedDRA version: 19.0Level: HLTClassification code 10028736Term: Nasal congestion and inflammationsSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2015-005155-27-SI
- Lead Sponsor
- Krka, d.d., Novo mesto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 194
Patients after nasal surgery or nasal cavities surgery (Group 1):
• 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
Patients with acute rhinitis (Group 2):
• Aged 18-60 years
• Diagnosed with acute rhinitis
• 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 270
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 after nasal surgery or nasal cavities surgery and patients with acute rhinitis.;Secondary Objective: Not applicable;Primary end point(s): To compare the efficiency of the treatment between fixed combination of xylometazoline and dexpanthenol (Septanazal®), nasal spray, and xylometazoline, nasal spray, on nasal congestion in the two groups of patients:<br>• Group 1 - patients after nasal surgery or nasal cavities surgery (CRSwNP and CRSsNP patients)<br>• Group 2 - patients diagnosed with acute rhinitis<br>;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 xylometazoline and dexpanthenol (Septanazal®), nasal spray, and xylometazoline, nasal spray, in the Group 1 and Group 2 in the following 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 between fixed combination of xylometazoline and dexpanthenol (Septanazal®), nasal spray, and xylometazoline, nasal spray, in the Group 1 and Group 2.<br><br>To compare the onset of action between fixed combination of xylometazoline and dexpanthenol (Septanazal®), nasal spray, and xylometazoline, nasal spray, in the Group 1 and Group 2.<br>;Timepoint(s) of evaluation of this end point: After 7 days of treatment