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

Primary Purpose

Rhinosinusitis

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Budesonide

About this trial

This is an interventional treatment trial for Rhinosinusitis focused on measuring CRS, without polyposis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University Göttingen
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
University Munich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Buparid; Treatment A

Budes; Treatment B

Arm Description

Buparid 1mg budesonide/2 ml nebulizer solution

Budes Nasal Spray 50 µg budesonide/pump

Outcomes

Primary Outcome Measures

Change of Inflammation of the Nasal Mucosa and Paranasal Sinus

Inflammation of the nasal mucosa and paranasal sinus was assessed using the Lund-Mackay score based on magnetic resonance imaging. The score can take on values between 0 and 24 points, with higher values indicating more severe thickness of the mucosa or opacification. The outcome investigated is the intraindividual mean score of 2 independent raters assessing the same images.

Secondary Outcome Measures

Health-specific Quality of Life

Health-specific quality of life was assessed by means of the self-rated, 20-item Sino-Nasal Outcome Test (SNOT-20). The SNOT-20 total score has a (theoretical) range of 0 - 100 points, with higher scores indicating more severe impairment. Presented are the mean values of the SNOT-20 total score after 48 weeks minus value at day 0 (baseline).

Nasal Obstruction

Nasal obstruction was assessed using the method of rhinomanometry by measuring the positive nasal inspiratory flow (PNIF). For the assessment the subject had to inhale maximally through the nose three times and the highest value of flow rate was recorded after 4 weeks and 8 weeks of treatment.

Inflammation of the Nasal Mucosa and Paranasal Sinus

Determination of the thickness of the mucosa using Magnetic Resonance Imaging

Safety Assessment

Treatment-emergent adverse events

Full Information

NCT ID

NCT01955980

First Posted

September 30, 2013

Last Updated

February 14, 2022

Sponsor

Pari Pharma GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01955980

Brief Title

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

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

October 27, 2015 (Actual)

Primary Completion Date

September 27, 2018 (Actual)

Study Completion Date

July 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pari Pharma GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhinosinusitis

Keywords

CRS, without polyposis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Buparid; Treatment A

Arm Type

Experimental

Arm Description

Buparid 1mg budesonide/2 ml nebulizer solution

Arm Title

Budes; Treatment B

Arm Type

Active Comparator

Arm Description

Budes Nasal Spray 50 µg budesonide/pump

Intervention Type

Drug

Intervention Name(s)

Budesonide

Intervention Description

Inhalation

Intervention Type

Drug

Intervention Name(s)

Budesonide

Intervention Description

Nasal Spray

Primary Outcome Measure Information:

Title

Change of Inflammation of the Nasal Mucosa and Paranasal Sinus

Description

Time Frame

Change from Baseline to week 8

Secondary Outcome Measure Information:

Title

Health-specific Quality of Life

Description

Time Frame

change of SNOT-20 total score from baseline to week 48

Title

Nasal Obstruction

Description

Time Frame

4 weeks / 8 weeks

Title

Inflammation of the Nasal Mucosa and Paranasal Sinus

Description

Determination of the thickness of the mucosa using Magnetic Resonance Imaging

Time Frame

Changes from Baseline at Week 8

Title

Safety Assessment

Description

Treatment-emergent adverse events

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Canis, MD

Organizational Affiliation

University Goettingen

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Göttingen

City

Göttingen

ZIP/Postal Code

37099

Country

Germany

Facility Name

UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

University Munich

City

Munich

ZIP/Postal Code

81377

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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