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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Pari Pharma GmbH
Sponsor:
Information provided by (Responsible Party):
Pari Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01946711
First received: September 4, 2013
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Rhinosinusitis
Chronic Polyposis
Drug: Budesonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pari Pharma GmbH:

Primary Outcome Measures:
  • Change of inflammation of the nasal mucosa and paranasal sinus [ Time Frame: Change from Baseline at Week 8 ] [ Designated as safety issue: No ]

    Magnetic Resonance Imaging

    • Thickness of mucosa
    • Lund-Mackay-Score


Secondary Outcome Measures:
  • Safety assessment [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
    Treatment-emergent adverse events (AEs)


Other Outcome Measures:
  • Health-specific quality of life [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    SNOT 22 (Sino-Nasal Outcome Test 22)

  • Nasal obstruction [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Rhinonanometry

  • Expansion of polyposis nasi [ Time Frame: Week 0 and Week 8 ] [ Designated as safety issue: No ]
    Endoscopy (classification according to Rasp et al. 2000)


Estimated Enrollment: 20
Study Start Date: April 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buparid; Treatment A
Buparid 1 mg budesonide/2 ml nebuliser solution
Drug: Budesonide
Inhalation
Active Comparator: Budes; Treatment B
Budes® Nasal Spray 50 µg budesonide/pump
Drug: Budesonide
Nasal spray

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with confirmed diagnosis of chronic rhinosinusitis (CRS) with polyposis nasi grade I-II
  • 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 III-IV
  • Patients with prior sinonasal surgery (exemption: polypectomy)
  • Patients with primary ciliaritis
  • Patients with asthma
  • Patients with active and symptomatic allergies against aeroallergens
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946711

Contacts
Contact: Stefanie Prante +49 89 742846 ext 830 s.prante@pari.de
Contact: Gerhard Boerner +49 89 742846 ext 59 g.boerner@pari.de

Locations
Germany
University Goettingen Recruiting
Goettingen, Germany, 37075
Contact: Martin Canis, Prof    +49 551 3989 ext 71    martin.canis@med.uni-goettingen.de   
Principal Investigator: Martin Canis, Prof         
University LMU Munich Recruiting
Munich, Germany, 81377
Contact: Sven Becker, MD    +49 89 7095 ext 0    sven.becker@med.uni-muenchen.de   
Principal Investigator: Sven Becker, MD         
Sponsors and Collaborators
Pari Pharma GmbH
Investigators
Principal Investigator: Sven Becker, MD Ludwig-Maximilians - University of Munich
  More Information

No publications provided

Responsible Party: Pari Pharma GmbH
ClinicalTrials.gov Identifier: NCT01946711     History of Changes
Other Study ID Numbers: 12082.101
Study First Received: September 4, 2013
Last Updated: July 18, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pari Pharma GmbH:
CRS
polyposis

Additional relevant MeSH terms:
Sinusitis
Nose Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Budesonide
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014