Clinical trial NCT01955980: Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Rhinosinusitis
Keywords: CRS
without polyposis
Lead sponsor: Pari Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: The objective of this study is to analyse whether Buparid/PARI SINUS has a higher potential to avoid or postpone sinus surgery in adult patients with CRS than Standard of Care therapy with Budes® Nasal Spray. The results of this study are expected to provide estimates for a proper sample size calculation to conduct a pivotal study.

Eligibility 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)

Primary outcomes:
measure: Change of Inflammation of the Nasal Mucosa and Paranasal Sinus
timeFrame: Change from Baseline to week 8
Secondary outcomes:
measure: Health-specific Quality of Life
timeFrame: change of SNOT-20 total score from baseline to week 48
measure: Nasal Obstruction
timeFrame: 4 weeks / 8 weeks
measure: Inflammation of the Nasal Mucosa and Paranasal Sinus
timeFrame: Changes from Baseline at Week 8
measure: Safety Assessment
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Göttingen
city: Mainz
country: Germany
facility: UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
city: Munich
country: Germany
facility: University Munich
Study officials:
affiliation: University Goettingen
name: Martin Canis, MD
role: PRINCIPAL_INVESTIGATOR
References: