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

Launched by PARI PHARMA GMBH · Sep 16, 2013

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient with confirmed diagnosis of chronic rhinosinusitis (CRS) with polyposis nasi grade I-III
• • Patient with a PNIF of \> 7 l/min separated for left and right side of the nose
• • Patient's written informed consent
• • Male or female,\>= 18 years of age
• • Patient is able to undergo nasal therapy without restrictions
• • 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 has completed correctly the diary during the Wash-in Phase
• Exclusion Criteria:
• • Patients with cystic fibrosis
• • Patients with polyposis nasi grade IV
• • Patients with prior sinonasal surgery (exemption: polypectomy)
• • Patients with primary ciliaritis
• • Pregnant or breastfeeding women
• • Patients with suspected active upper airway infection
• • Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
• • Drug or alcohol abuse
• • End-stage malignancies
• • Known hypersensitivity to Budesonide
• • Patients with oral steroid therapy within the last 4 weeks
• • Patients with frequent epistaxis (\> 2 per month)