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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Pari Pharma GmbH
Sponsor:
Information provided by (Responsible Party):
Pari Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01955980
First received: September 30, 2013
Last updated: April 10, 2017
Last verified: April 2017
  Purpose
The study should create data for the selection of a clinically relevant endpoint to assess the potential of Buparid/PARI SINUS to postpone sinus surgery in patients with chronic Rhinosinusitis.

Condition Intervention Phase
Rhinosinusitis
Drug: Budesonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Pilot Study to Investigate the Potential of Buparid/PARI SINUS Versus Budes® Nasal Spray to Avoid or Postpone Sinus Surgery in Adult Patients With Chronic Rhinosinusitis

Resource links provided by NLM:


Further study details as provided by Pari Pharma GmbH:

Primary Outcome Measures:
  • Avoidance or postponing of sinus surgery [ Time Frame: From baseline to week 48 ]
    Time to surgery


Secondary Outcome Measures:
  • Changes in Health-related quality of life [ Time Frame: From baseline to week 48 ]
    Assessments will be done using the Sino-Nasal outcome Test 22 (SNOT 22)

  • Nasal obstruction [ Time Frame: 8 weeks ]
    Rhinomanometry

  • Inflammation of the nasal mucosa and paranasal sinus [ Time Frame: Changes from Baseline at Week 8 ]
    Determination of the thickness of the mucosa using Magnetic Resonance Imaging

  • Safety assessment [ Time Frame: 48 weeks ]
    Treatment-emergent adverse events


Estimated Enrollment: 20
Study Start Date: April 2015
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buparid; Treatment A
Buparid 1mg budesonide/2 ml nebulizer 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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  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: NCT01955980

Contacts
Contact: Stefanie Prante +49 89 742846 ext 830 stefanie.prante@pari.com

Locations
Germany
University Goettingen Recruiting
Goettingen, Germany, 37099
Contact: Martin Canis, MD    +49 551 39 ext 22801    martin.canis@med.uni-goettingen.de   
Principal Investigator: Martin Canis, MD         
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz Recruiting
Mainz, Germany, 55131
Contact: Sven Becker, MD    +49 (0) 6131 17 ext 2099    sven.becker@unimedizin-mainz.de   
Principal Investigator: Sven Becker, MD         
University Munich Recruiting
Munich, Germany, 81377
Contact: Mareike Haack    +49 89 4400 ext 0    mareike.haack@med.uni-muenchen.de   
Principal Investigator: Mareike Haack         
Sponsors and Collaborators
Pari Pharma GmbH
Investigators
Principal Investigator: Martin Canis, MD University Goettingen
  More Information

Responsible Party: Pari Pharma GmbH
ClinicalTrials.gov Identifier: NCT01955980     History of Changes
Other Study ID Numbers: 12082.102
Study First Received: September 30, 2013
Last Updated: April 10, 2017

Keywords provided by Pari Pharma GmbH:
CRS
without polyposis

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

ClinicalTrials.gov processed this record on May 23, 2017