RhinosinusitisPhase 1/2NCT01955980
Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis
A Phase 1/2 study testing Budesonide in people with Rhinosinusitis, run by Pari Pharma GmbH at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinosinusitis
- What is being tested?
- Budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesGermany
- Study dates
- 27 Oct 2015to 29 Jul 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
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University Göttingen
Göttingen, 37099
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, 55131
University Munich
Munich, 81377
About this study
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
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.
Read the 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.
- Conditions
- Rhinosinusitis
- Being tested
- Budesonide
- Keywords
- CRS, without 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 1mg budesonide/2 ml nebulizer 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 thickness of the mucosa or opacification. 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 (4)
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).
Measured: change of SNOT-20 total score from baseline to week 48
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.
Measured: 4 weeks / 8 weeks
Inflammation of the Nasal Mucosa and Paranasal Sinus
Determination of the thickness of the mucosa using Magnetic Resonance Imaging
Measured: Changes from Baseline at Week 8
Safety Assessment
Treatment-emergent adverse events
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study start27 Oct 2015
- Primary completion27 Sep 2018
- Study completion29 Jul 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pari Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Canis, MD, Principal investigator, University Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955980
- Sponsor's protocol ID
- 12082.102
- Status last verified
- Feb 2022
- First submitted
- 30 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 Potential of Buparid/PARI SINUS Versus Budes® Nasal Spray to Avoid or Postpone Sinus Surgery in Adult Patients With Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT01955980
- Acronym / sponsor ID
- 12082.102
- Conditions
- Rhinosinusitis
- Keywords
- CRS, without polyposis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Pari Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2015 (actual)
- Primary completion
- 27 Sep 2018 (actual)
- Study completion
- 29 Jul 2021 (actual)
- First posted
- 8 Oct 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 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.
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 1mg budesonide/2 ml nebulizer 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 (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
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 thickness of the mucosa or opacification. The outcome investigated is the intraindividual mean score of 2 independent raters assessing the same images.
4 secondary outcomes
Health-specific Quality of Life
Time frame: change of SNOT-20 total score from baseline to week 48
Nasal Obstruction
Time frame: 4 weeks / 8 weeks
Inflammation of the Nasal Mucosa and Paranasal Sinus
Time frame: Changes from Baseline at Week 8
Safety Assessment
Time frame: 48 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
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
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.
Martin Canis, MD principal investigator
University Goettingen
3 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, run by Pari Pharma GmbH at 3 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 9 inclusion and 17 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 3 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.