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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buparid; Treatment A | Experimental | Buparid 1mg budesonide/2 ml nebulizer solution |
|
| Budes; Treatment B | Active Comparator | Budes Nasal Spray 50 µg budesonide/pump |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug | Inhalation |
| |
| Budesonide |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline to week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | change of SNOT-20 total score from baseline to week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Canis, MD | University Goettingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Göttingen | Göttingen | 37099 | Germany | |||
| UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz |
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| ID | Title | Description |
|---|---|---|
| FG000 | Buparid; Treatment A | Buparid 1mg budesonide/2 ml nebulizer solution Budesonide: Inhalation Solution |
| FG001 | Budes; Treatment B | Budes Nasal Spray 50 µg budesonide/pump Budesonide: Nasal Spray |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Buparid; Treatment A | Buparid 1mg budesonide/2 ml nebulizer solution Budesonide: Inhalation Solution |
| BG001 | Budes; Treatment B | Budes Nasal Spray 50 µg budesonide/pump Budesonide: Nasal Spray |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | 95% Confidence Interval | score on a scale | Change from Baseline to week 8 |
|
Each participant has been monitored for adverse events up to 48 weeks. All patients withdrawn from the study will be followed-up for AEs or SAEs for further 2 weeks or 4 weeks, respectively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Buparid; Treatment A | Buparid 1mg budesonide/2 ml nebulizer solution Budesonide: Inhalation Solution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aneurysm | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Friedrich Gruber | PARI Pharma | +4989742846 | 10 | friedrich.gruber@pari.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 17, 2015 | Aug 27, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 27, 2020 | Aug 27, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000096825 | Rhinosinusitis |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012852 | Sinusitis |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
Nasal Spray |
|
| 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. | 4 weeks / 8 weeks |
| Inflammation of the Nasal Mucosa and Paranasal Sinus | Determination of the thickness of the mucosa using Magnetic Resonance Imaging | Changes from Baseline at Week 8 |
| Safety Assessment | Treatment-emergent adverse events | 48 weeks |
| Mainz |
| 55131 |
| Germany |
| University Munich | Munich | 81377 | Germany |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | change of SNOT-20 total score from baseline to week 48 |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | ml/sec | 4 weeks / 8 weeks |
|
|
|
| Secondary | Inflammation of the Nasal Mucosa and Paranasal Sinus | Determination of the thickness of the mucosa using Magnetic Resonance Imaging | Not Posted | Changes from Baseline at Week 8 | Participants |
| Secondary | Safety Assessment | Treatment-emergent adverse events | Posted | Count of Participants | Participants | 48 weeks |
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| 5 |
| 10 |
| EG001 | Budes; Treatment B | Budes Nasal Spray 50 µg budesonide/pump Budesonide: Nasal Spray | 0 | 9 | 0 | 9 | 6 | 9 |
| Nasal Dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
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| D010254 |
| Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |