Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005567

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005567
  •   2014/03/26
  •   2013/09/30
  •   no
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Secondary IDs

  •   NCT01955980  (ClinicalTrials.gov)
  •   12082.102  (Pari Pharma GmbH)
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Health Condition or Problem studied

  •   Rhinosinusitis
  •   J32 -  Chronic sinusitis
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Interventions/Observational Groups

  •   Drug: Budesonide
  •   Drug: Budesonide
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Avoidance or postponing of sinus surgery; time frame: From baseline to week 48; Time to surgery

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2015/04/30
  •   20
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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)

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Addresses

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    • Pari Pharma GmbH
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    • University Goettingen
    • Martin Canis, MD 
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    • University Goettingen
    • Martin Canis, MD 
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    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2018/12/04
* This entry means the parameter is not applicable or has not been set.