Chronic Rhinosinusitis (CRS)
Conditions
Interventions
Trade Name: Budes Nasenspray
Product Name: Budes Nasenspray
Product Code: N/A
Pharmaceutical Form: Nasal spray
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: µg microgram(s
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. Diagnosis is based on history of symptoms (nasal obstruction, running nose, postnasal drip, facial pain and hyposmia with a duration of > 3 months) and on MRT-imaging 2. Patient without alternative other than sinus surgery 3. Patient’s written informed consent obtained prior to any screening or study-specific procedure 4. Male or female, equal/over 18 years of age 5. Patient is able to undergo nasal therapy without restrictions 6. Capable to correctly use the PARI SINUS device 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 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 polyposis nasi grade I-IV 3. Patients with prior FESS (Functional Endosopic Sinus Surgery) 4. Pregnant or breastfeeding women 5. Any active invasive bacterial, viral or fungal infection within one week prior to first investigational medicinal product administration 6. No clinically relevant abnormal parameters of vital signs, blood biochemistry or renal/hepatic function 7. Unlikely to comply with visits, inhalation procedures or other measurements scheduled in the protocol 8. Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP 9. 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 10. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures 11. Drug or alcohol abuse 12. End-stage malignancies 13. Known hypersensitivity to Budesonide 14. Patients with oral steroid therapy within the last 3 months 15. Patients needing > 1 mg/day Budesonide (or steroidal equivalent) for therapy of asthma 16. Patients on therapy with leukotriene receptor antagonists, decongestants, antihistamines or antibiotics 17. Patients with frequent epistaxis (> 1 episode per week)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to analyse whether Buparid/PARI SINUS has a higher potential to avoid or postpone sinus surgery in adult patients with CRS than Standard of Care therapy with Budes® Nasal Spray. The results of this study are expected to provide estimates for a proper sample size calculation to conduct a pivotal study.;Secondary Objective: "Not applicable";Primary end point(s): Efficacy: Health-related quality of life Nasal obstruction Inflammation of nasal mucosa and paranasal sinus Clinical parameters Symptoms of rhinosinusitis Loss of taste/Loss of smell Avoidance or postponing of sinus surgery Customer satisfaction regarding the PARI SINUS device, if applicable Safety: Treatment-emergent adverse events (AEs);Timepoint(s) of evaluation of this end point: Efficacy: Health-related quality of life at Visit 0, 1, 2, 3, 4, 5 and 6 Nasal obstruction at Visit 0, 1, 2 and 3 Inflammation of the nasal mucosa and paranasal sinus at Visit 1 and Visit 3 Clinical parameters at Visit 0, 3 and 6 Symptoms of rhinosinusitis at Visit 0, 1, 2, 3, 4, 5 and 6 Loss of taste/Loss of smell at Visit 0, 1, 3 and 6 Avoidance or postponing of sinus surgery at Visit 3, 4, 5 and 6 Safety: During the whole study period | — |
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 Trial Manager
PARI Pharma GmbH
Outcome results
None listed