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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 : Active, not recruiting
First Posted : October 8, 2013
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Pari Pharma GmbH

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rhinosinusitis Drug: Budesonide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Start Date : April 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arms and Interventions
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Arm Intervention/treatment
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


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


Secondary Outcome Measures :
  1. 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)

  2. Nasal obstruction [ Time Frame: 8 weeks ]
    Rhinomanometry

  3. 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

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01955980


Locations
Germany
University Göttingen
Göttingen, Germany, 37099
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
University Munich
Munich, Germany, 81377
Sponsors and Collaborators
Pari Pharma GmbH
Investigators
Principal Investigator: Martin Canis, MD University Goettingen
More Information
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Responsible Party: Pari Pharma GmbH
ClinicalTrials.gov Identifier: NCT01955980     History of Changes
Other Study ID Numbers: 12082.102
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

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