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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-28

Study Completion Date

2021-06-21

Brief Summary

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The study should create data for the selection of a clinically relevant primary endpoint to assess the efficacy and safety of Buparid/PARI SINUS as compared to Budes Nasal Spray in the therapy of chronic rhinosinusitis (CRS) with polyposis nasi in adult patients. Ideally, the selected parameter should allow a correlation between an objective methodology and the clinical outcome of the study patients.

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Detailed Description

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Conditions

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Rhinosinusitis Chronic Polyposis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Buparid; Treatment A

Buparid 1 mg budesonide/2 ml nebuliser solution

Group Type EXPERIMENTAL

Budesonide

Intervention Type DRUG

Inhalation

Budes; Treatment B

Budes® Nasal Spray 50 µg budesonide/pump

Group Type ACTIVE_COMPARATOR

Budesonide

Intervention Type DRUG

Nasal spray

Interventions

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Budesonide

Inhalation

Intervention Type DRUG

Budesonide

Nasal spray

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient with confirmed diagnosis of chronic rhinosinusitis (CRS) with polyposis nasi grade I-III
* Patient with a PNIF of \> 7 l/min separated for left and right side of the nose
* Patient's written informed consent
* Male or female,\>= 18 years of age
* Patient is able to undergo nasal therapy without restrictions
* 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 has completed correctly the diary during the Wash-in Phase

Exclusion Criteria

* Patients with cystic fibrosis
* Patients with polyposis nasi grade IV
* Patients with prior sinonasal surgery (exemption: polypectomy)
* Patients with primary ciliaritis
* Pregnant or breastfeeding women
* Patients with suspected active upper airway infection
* Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
* Drug or alcohol abuse
* End-stage malignancies
* Known hypersensitivity to Budesonide
* Patients with oral steroid therapy within the last 4 weeks
* Patients with frequent epistaxis (\> 2 per month)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No