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

P

Pari Pharma

Status and phase

Completed
Phase 2
Phase 1

Conditions

Rhinosinusitis
Chronic Polyposis

Treatments

Drug: Budesonide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01946711
12082.101

Details and patient eligibility

About

The study should 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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

14 participants in 2 patient groups

Buparid; Treatment A
Experimental group
Description:
Buparid 1 mg budesonide/2 ml nebuliser solution
Treatment:
Drug: Budesonide
Drug: Budesonide
Budes; Treatment B
Active Comparator group
Description:
Budes® Nasal Spray 50 µg budesonide/pump
Treatment:
Drug: Budesonide
Drug: Budesonide

Trial documents
2

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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