E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Nasal congestion in patients after nasal surgery or nasal cavities surgery and in patients with acute rhinitis |
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E.1.1.1 | Medical condition in easily understood language |
Nasal congestion in patients after nasal surgery or nasal cavities surgery and in patients with acute rhinitis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10028736 |
E.1.2 | Term | Nasal congestion and inflammations |
E.1.2 | System Organ Class | 100000004855 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 7 days of treatment |
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E.5.2 | 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 7 days of treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |