Nasal congestion in patients after nasal surgery or nasal cavities surgery and in patients with acute rhinitis MedDRA version: 19.0 Level: HLT Classification code 10028736 Term: Nasal congestion and inflammations System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Septanazal for adults
Product Name: Septanazal for adults
Pharmaceutical Form: Nasal spray, solution
Product Name: Xylometazoline chloride
Pharmaceutical Form: Nasal spray, solution
Sponsors
Krka, d.d., Novo mesto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: • Group 1 - patients after nasal surgery or nasal cavities surgery (CRSwNP and CRSsNP patients) • Group 2 - patients diagnosed with acute rhinitis ;Timepoint(s) of evaluation of this end point: After 7 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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: • swelling of the nasal mucosa • dryness of the nasal mucosa • burning feeling in the nose • crust formation • bleeding from nasal mucosa • redness of the nasal mucosa and skin at nasal entrance • sneezing • nasal exudate • nasal irritation 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. 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. ;Timepoint(s) of evaluation of this end point: After 7 days of treatment | — |
Countries
Croatia, Slovenia
Contacts
Public ContactClinical Trials Information
Krka, d.d., Novo mesto
Outcome results
None listed