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

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ClinicalTrials.gov Identifier: NCT01955980
Recruitment Status : Unknown
Verified April 2018 by Pari Pharma GmbH.
Recruitment status was:  Active, not recruiting
First Posted : October 8, 2013
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Pari Pharma GmbH

Tracking Information
First Submitted Date  ICMJE September 30, 2013
First Posted Date  ICMJE October 8, 2013
Last Update Posted Date April 4, 2018
Study Start Date  ICMJE April 2015
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2013)
Avoidance or postponing of sinus surgery [ Time Frame: From baseline to week 48 ]
Time to surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis
Official Title  ICMJE 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
Brief Summary 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.
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
Intervention  ICMJE
  • Drug: Budesonide
    Inhalation
  • Drug: Budesonide
    Nasal Spray
Study Arms  ICMJE
  • Experimental: Buparid; Treatment A
    Buparid 1mg budesonide/2 ml nebulizer 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 7, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2019
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
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 NCT01955980
Other Study ID Numbers  ICMJE 12082.102
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: Martin Canis, MD University Goettingen
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