Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis
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ClinicalTrials.gov Identifier: NCT01955980 |
Recruitment Status
:
Active, not recruiting
First Posted
: October 8, 2013
Last Update Posted
: April 4, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rhinosinusitis | Drug: Budesonide | Phase 3 |
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 |

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
|
- Avoidance or postponing of sinus surgery [ Time Frame: From baseline to week 48 ]Time to surgery
- 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)
- Nasal obstruction [ Time Frame: 8 weeks ]Rhinomanometry
- 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
- Safety assessment [ Time Frame: 48 weeks ]Treatment-emergent adverse events

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01955980
Germany | |
University Göttingen | |
Göttingen, Germany, 37099 | |
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz | |
Mainz, Germany, 55131 | |
University Munich | |
Munich, Germany, 81377 |
Principal Investigator: | Martin Canis, MD | University Goettingen |
Responsible Party: | Pari Pharma GmbH |
ClinicalTrials.gov Identifier: | NCT01955980 History of Changes |
Other Study ID Numbers: |
12082.102 |
First Posted: | October 8, 2013 Key Record Dates |
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 |