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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buparid; Treatment A | Experimental | Buparid 1 mg budesonide/2 ml nebuliser 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 impairment. 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 |
|---|---|---|
| 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 All patients withdrawn from the study will be followed-up for AEs or SAEs for further 2 weeks or 4 weeks, respectively. | up to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Health-specific Quality of Life | Health-specific quality of life was assessed by means of the self-rated, 22-item Sino-Nasal Outcome Test (SNOT-22). The SNOT-22 total score has a (theoretical) range of 0 - 110 points, with higher scores indicating more severe impairment. Presented are the mean values of the SNOT-22 total score after 24 weeks minus value at day 0 (baseline). | 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sven Becker, MD | Johannes Gutenberg University Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Göttingen | Göttingen | 37075 | Germany | |||
| UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz |
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4 patients not randomised
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| ID | Title | Description |
|---|---|---|
| FG000 | Buparid; Treatment A | Buparid 1 mg budesonide/2 ml nebuliser solution Budesonide: Inhalation |
| 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 1 mg budesonide/2 ml nebuliser solution Budesonide: Inhalation |
| 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 impairment. The outcome investigated is the intraindividual mean score of 2 independent raters assessing the same images. | Posted | Median | 95% Confidence Interval | units 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 1 mg budesonide/2 ml nebuliser solution Budesonide: Inhalation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal Dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Friedrich gruber | Pari Pharma | +4989742846 | 76 | 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 | Feb 10, 2015 | Jul 14, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 27, 2020 | Jul 14, 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 |
| Mainz |
| 55131 |
| Germany |
| University LMU Munich | Munich | 81377 | Germany |
| HNO-Zentrum Mangfall-Inn | Rosenheim | 83022 | 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 | Number | participants |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | up to 26 weeks |
|
|
|
| Other Pre-specified | Health-specific Quality of Life | Health-specific quality of life was assessed by means of the self-rated, 22-item Sino-Nasal Outcome Test (SNOT-22). The SNOT-22 total score has a (theoretical) range of 0 - 110 points, with higher scores indicating more severe impairment. Presented are the mean values of the SNOT-22 total score after 24 weeks minus value at day 0 (baseline). | Posted | Mean | 95% Confidence Interval | score on a scale | 24 weeks |
|
|
|
| Other Pre-specified | 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 |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 5 |
| 8 |
| EG001 | Budes; Treatment B | Budes® Nasal Spray 50 µg budesonide/pump Budesonide: Nasal spray | 0 | 6 | 0 | 6 | 4 | 6 |
| Sputum Increased | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Parosmia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Oropharyngeal Pain | 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 |
|
| Sensitive Skin | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Nasopharyngitis | 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 |