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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Rhinosinusitis	Drug: Budesonide	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	20 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	April 2015
Estimated Primary Completion Date :	November 2018
Estimated Study Completion Date :	January 2019

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Buparid; Treatment A; Buparid 1mg budesonide/2 ml nebulizer solution	Drug: Budesonide; Inhalation
Active Comparator: Budes; Treatment B; Budes Nasal Spray 50 µg budesonide/pump	Drug: Budesonide; Nasal Spray

Outcome Measures

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Primary Outcome Measures :

1. Avoidance or postponing of sinus surgery [ Time Frame: From baseline to week 48 ]
   Time to surgery

Secondary Outcome Measures :

1. 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)
2. Nasal obstruction [ Time Frame: 8 weeks ]
   Rhinomanometry
3. 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
4. Safety assessment [ Time Frame: 48 weeks ]
   Treatment-emergent adverse events

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

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Locations

Germany
University Göttingen
Göttingen, Germany, 37099
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
University Munich
Munich, Germany, 81377

Sponsors and Collaborators

Pari Pharma GmbH

Investigators

Principal Investigator:	Martin Canis, MD	University Goettingen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Pari Pharma GmbH
ClinicalTrials.gov Identifier:	NCT01955980 History of Changes
Other Study ID Numbers:	12082.102
First Posted:	October 8, 2013
Last Update Posted:	April 4, 2018
Last Verified:	April 2018

Keywords provided by Pari Pharma GmbH:

CRS; without polyposis

Additional relevant MeSH terms:

Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Otorhinolaryngologic Diseases; Budesonide; Anti-Inflammatory Agents; Bronchodilator Agents	Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists