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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01946711
Recruitment Status : Unknown
Verified April 2018 by Pari Pharma GmbH.
Recruitment status was:  Recruiting
First Posted : September 20, 2013
Last Update Posted : April 26, 2018
Information provided by (Responsible Party):
Pari Pharma GmbH

Tracking Information
First Submitted Date  ICMJE September 4, 2013
First Posted Date  ICMJE September 20, 2013
Last Update Posted Date April 26, 2018
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2013)
Change of inflammation of the nasal mucosa and paranasal sinus [ Time Frame: Change from Baseline at Week 8 ]
Magnetic Resonance Imaging
  • Thickness of mucosa
  • Lund-Mackay-Score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2013)
Safety assessment [ Time Frame: 26 weeks ]
Treatment-emergent adverse events (AEs)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 16, 2013)
  • Health-specific quality of life [ Time Frame: 26 weeks ]
    SNOT 22 (Sino-Nasal Outcome Test 22)
  • Nasal obstruction [ Time Frame: 8 weeks ]
  • Expansion of polyposis nasi [ Time Frame: Week 0 and Week 8 ]
    Endoscopy (classification according to Rasp et al. 2000)
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis With Polyposis Nasi
Official Title  ICMJE A Pilot Study to Investigate the Efficacy and Safety of Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis (CRS) With Polyposis Nasi in Adult Patients
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Rhinosinusitis
  • Chronic Polyposis
Intervention  ICMJE
  • Drug: Budesonide
  • Drug: Budesonide
    Nasal spray
Study Arms  ICMJE
  • Experimental: Buparid; Treatment A
    Buparid 1 mg budesonide/2 ml nebuliser solution
    Intervention: Drug: Budesonide
  • Active Comparator: Budes; Treatment B
    Budes® Nasal Spray 50 µg budesonide/pump
    Intervention: Drug: Budesonide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 16, 2013)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01946711
Other Study ID Numbers  ICMJE 12082.101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pari Pharma GmbH
Study Sponsor  ICMJE Pari Pharma GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sven Becker, MD Johannes Gutenberg University Mainz
PRS Account Pari Pharma GmbH
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP