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

Launched by PARI PHARMA GMBH · Oct 7, 2013

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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)