Chronic Rhinosinusitis (CRS) with polyposis nasi
Conditions
Interventions
Trade Name: Budes Nasenspray
Product Name: Budes Nasenspray
Product Code: N/A
Pharmaceutical Form: Nasal spray, suspension
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg
Sponsors
PARI Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: "Not applicable";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) ;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) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Germany
Contacts
Public ContactClinical Development Department
PARI Pharma GmbH
Outcome results
None listed