RhinosinusitisPhase 1/2NCT01946711
Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis With Polyposis Nasi
A Phase 1/2 study testing Budesonide in people with Rhinosinusitis and Chronic Polyposis, run by Pari Pharma GmbH at 4 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinosinusitis, Chronic Polyposis
- What is being tested?
- Budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 4 sitesGermany
- Study dates
- 28 Aug 2013to 21 Jun 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
University Göttingen
Göttingen, 37075
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, 55131
University LMU Munich
Munich, 81377
HNO-Zentrum Mangfall-Inn
Rosenheim, 83022
About this study
Official title: A Pilot Study to Investigate the Efficacy and Safety of Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis (CRS) With Polyposis Nasi in Adult Patients
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.
- Conditions
- Rhinosinusitis, Chronic Polyposis
- Being tested
- Budesonide
- Keywords
- CRS, polyposis
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Inhalation
BudesonideDrug
Nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Buparid; Treatment A | Experimental | Buparid 1 mg budesonide/2 ml nebuliser solution Receives: Drug: Budesonide |
| Budes; Treatment B | Active comparator | Budes® Nasal Spray 50 µg budesonide/pump Receives: Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 impairment. The outcome investigated is the intraindividual mean score of 2 independent raters assessing the same images.
Measured: Change from Baseline to Week 8
Secondary outcomes (1)
Safety Assessment
Treatment-emergent adverse events (AEs) Each participant has been monitored for adverse events up to 26 weeks. All patients withdrawn from the study will be followed-up for AEs or SAEs for further 2 weeks or 4 weeks, respectively.
Measured: up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study start28 Aug 2013
- Primary completion3 Feb 2020
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RhinosinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pari Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sven Becker, MD, Principal investigator, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946711
- Sponsor's protocol ID
- 12082.101
- Status last verified
- Feb 2022
- First submitted
- 4 Sep 2013
- Last updated
- 12 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate the Efficacy and Safety of Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis (CRS) With Polyposis Nasi in Adult Patients
- ClinicalTrials.gov ID
- NCT01946711
- Acronym / sponsor ID
- 12082.101
- Conditions
- Rhinosinusitis, Chronic Polyposis
- Keywords
- CRS, polyposis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Pari Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2013 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Posted 12 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buparid; Treatment A | Experimental | Drug: BudesonideBuparid 1 mg budesonide/2 ml nebuliser solution |
| Budes; Treatment B | Active comparator | Drug: BudesonideBudes® Nasal Spray 50 µg budesonide/pump |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BudesonideInhalation | Drug | Buparid; Treatment A |
| BudesonideNasal spray | Drug | Budes; Treatment B |
Primary outcome
Change of Inflammation of the Nasal Mucosa and Paranasal Sinus
Time frame: Change from Baseline to Week 8
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 impairment. The outcome investigated is the intraindividual mean score of 2 independent raters assessing the same images.
1 secondary outcome
Safety Assessment
Time frame: up to 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Rhinosinusitis
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RecruitingPhase 4
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A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
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Enrolling by invitationObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Becker, MD principal investigator
Johannes Gutenberg University Mainz
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Budesonide in people with Rhinosinusitis and Chronic Polyposis, run by Pari Pharma GmbH at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Inflammation of the Nasal Mucosa and Paranasal Sinus (time frame: Change from Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.