E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Rhinosinusitis (CRS) with polyposis nasi |
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E.1.1.1 | Medical condition in easily understood language |
Chronic Rhinosinusitis with nasal polys |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
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 objective of this study is to create data for the selection of a clinically relevant primary endpoint to assess the efficacy and safety of Buparid/PARI SINUS as compared to Budes Nasal Spray in the therapy of chronic rhinosinusitis (CRS) with polyposis nasi in adult patients. Ideally, the selected parameter should allow a correlation between an objective methodology and the clinical outcome of the study patients. |
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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 |
1.Patient with confirmed diagnosis of chronic rhinosinusitis (CRS), i.e. inflammation of nasal mucosa and paranasal sinus, with polyposis nasi grade I-III (according to Rasp et al. 2000). Diagnosis is based on history of symptoms (nasal obstruction, running nose, postnasal drip, facial pain and hyposmia with a duration of > 3 months (according to EPOS3) and on MRT-imaging using the Lund-Mackey Score)
2.Patient with a PNIF (positive nasal inspiratory flow) of > 7 l/min separated for left and right side of the nose
3.Patient’s written informed consent obtained prior to any screening or study-specific procedure
4.Male or female, equal and older 18 years of age
5.Patient is able to undergo nasal therapy without restrictions
6.Capable to correctly use the PARI SINUS device (closing of the soft palate) in accordance with the package insert
7.Capable of understanding the purpose and risk of the clinical trial
8.Female patients with childbearing potential must have a negative urine pregnancy test prior to first IMP administration. Both women and men must agree to use a medically acceptable method of contraception throughout the IMP treatment period and for 3 months after IMP discontinuation.
9.Patient is able to participate in the study according to Investigator’s opinion
10.Patient has completed correctly the diary during the Wash-in Phase
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E.4 | Principal exclusion criteria |
1.Patients with cystic fibrosis
2.Patients with CSR without polyposis nasi
3.Patients with polyposis nasi grade IV
4.Patients with prior sinonasal surgery (exemption: polypectomy)
5.Patients with primary ciliaritis
7.Pregnant or breastfeeding women
8.Patients with suspected active upper airway infection
9.Unlikely to comply with visits, inhalation procedures or other measurements scheduled in the protocol
10.Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
11.Any co-existing medical condition that in the Investigator’s judgement will substantially increase the risk associated with the patient’s participation in the clinical trial
12.Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures
13.Drug or alcohol abuse
14.End-stage malignancies
15.Known hypersensitivity to Budesonide
16.Patients with oral steroid therapy within the last 4 weeks
17.Patients with frequent epistaxis (> 2 per month)
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy
• Health-specific quality of life
• Nasal obstruction
• Inflammation of nasal mucosa and paranasal sinus
• Expansion of polyposis nasi
• Nasal inflammation
• Symptoms of rhinosinusitis
• Loss of taste/Loss of smell
• Requirement of surgery
• Customer satisfaction regarding the PARI SINUS device
Safety:
• Treatment-emergent adverse events (AEs)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Efficacy (at Visit 1, 2, 3 and 4):
• Health-specific quality of life
• Nasal obstruction
• Inflammation of nasal mucosa and paranasal sinus
• Expansion of polyposis nasi
• Nasal inflammation
• Symptoms of rhinosinusitis
• Loss of taste/Loss of smell
At Follow-up Visit 5 and 6:
• Health-specific quality of life
• Requirement of surgery
• Customer satisfaction regarding the PARI SINUS device
Safety (during the whole study period):
• Treatment-emergent adverse events (AEs)
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | No |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |