Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The study should create data for the selection of a clinically relevant endpoint to assess the potential of Buparid/PARI SINUS to postpone sinus surgery in patients with chronic Rhinosinusitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pari Pharma GmbH
• Treatments: Budesonide

Criteria

Inclusion Criteria:

• Patient with confirmed diagnosis of chronic rhinosinusitis

• Patient without alternative other than sinus surgery

• Patient's written informed consent obtained prior to any screening or study-specific procedure

• Male or female, ≥ 18 years of age

• Patient is able to undergo nasal therapy without restrictions

• Capable to correctly use the PARI SINUS device

• Capable of understanding the purpose and risk of the clinical trial

• Female patients with childbearing potential must have a negative urine pregnancy test prior to first IMP administration.

• Patient is able to participate in the study according to Investigator's opinion

Exclusion Criteria:

• Patients with cystic fibrosis

• Patients with polyposis nasi grade I-IV

• Patients with prior FESS (Functional Endoscopic Sinus Surgery)

• Pregnant or breastfeeding women

• Any active invasive bacterial, viral or fungal infection within one week prior to first investigational medicinal product (IMP) administration

• No clinically relevant abnormal parameters of vital signs, blood biochemistry or renal/hepatic function

• Unlikely to comply with visits, inhalation procedures or other measurements scheduled in the protocol

• Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP

• 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

• Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures

• Drug or alcohol abuse

• End-stage malignancies

• Known hypersensitivity to Budesonide

• Patients with oral steroid therapy within the last 3 months

• Patients needing > 1 mg/day Budesonide (or steroidal equivalent) for therapy of asthma

• Patients on therapy with leukotriene-receptor antagonists, decongestants, antihistamines or antibiotics

• Patients with frequent epistaxis (> 1 episode per week)