E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Nasal congestion in patients with acute rhinitis and in patients after surgery in the nose and paranasal cavity |
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E.1.1.1 | Medical condition in easily understood language |
Nasal congestion in patients with acute rhinitis and in patients after surgery in the nose and paranasal cavity |
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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 | 20.0 |
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 with acute rhinitis and in patients after surgery in the nose and paranasal cavity |
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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 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
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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: patients after nasal surgery or nasal cavities surgery
(CRSwNP and CRSsNP patients)
and patients diagnosed with acute rhinitis |
|
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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |