Phase 2
N=19
Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis
Rhinosinusitis
Bottom Line
View on ClinicalTrials.gov: NCT01955980 ↗Enrolled (actual)
19
Serious AEs
5.3%
Results posted
Apr 2022
Primary outcome: Primary: Change of Inflammation of the Nasal Mucosa and Paranasal Sinus — 0; -0.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Budesonide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pari Pharma GmbH
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Inflammation of the Nasal Mucosa and Paranasal Sinus |
0; -0.8 | — |
| SECONDARY Health-specific Quality of Life |
17.1; 22.9 | — |
| SECONDARY Nasal Obstruction |
542.4; 582.0; 461.5; 551.5 | — |
| SECONDARY Inflammation of the Nasal Mucosa and Paranasal Sinus |
— | — |
| SECONDARY Safety Assessment |
6; 6 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT01955980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.