Chronic Polyposis, Rhinosinusitis
Conditions
Keywords
CRS, polyposis
Brief 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. Ideally, the selected parameter should allow a correlation between an objective methodology and the clinical outcome of the study patients.
Interventions
DRUGBudesonide
Inhalation
Sponsors
Pari Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Inflammation of the Nasal Mucosa and Paranasal Sinus | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment | up to 26 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health-specific Quality of Life | 24 weeks | 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). |
| Nasal Obstruction | 4 weeks / 8 weeks | 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. |
Countries
Germany
Participant flow
Recruitment details
4 patients not randomised
Participants by arm
| Arm | Count |
|---|---|
| Buparid; Treatment A Buparid 1 mg budesonide/2 ml nebuliser solution
Budesonide: Inhalation | 8 |
| Budes; Treatment B Budes® Nasal Spray 50 µg budesonide/pump
Budesonide: Nasal spray | 6 |
| Total | 14 |
Baseline characteristics
| Characteristic | Budes; Treatment B | Total | Buparid; Treatment A |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 14 Participants | 8 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Germany | 6 participants | 14 participants | 8 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 6 |
| other Total, other adverse events | 5 / 8 | 4 / 6 |
| serious Total, serious adverse events | 0 / 8 | 0 / 6 |
Outcome results
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.
Time frame: Change from Baseline to Week 8
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Buparid; Treatment A | Change of Inflammation of the Nasal Mucosa and Paranasal Sinus | -2 units on a scale |
| Budes; Treatment B | Change of Inflammation of the Nasal Mucosa and Paranasal Sinus | -0.8 units on a scale |
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.
Time frame: up to 26 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buparid; Treatment A | Safety Assessment | 5 Participants |
| Budes; Treatment B | Safety Assessment | 4 Participants |
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).
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Buparid; Treatment A | Health-specific Quality of Life | 23.6 score on a scale |
| Budes; Treatment B | Health-specific Quality of Life | 14.4 score on a scale |
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.
Time frame: 4 weeks / 8 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Buparid; Treatment A | Nasal Obstruction | Mean flow rate after 4 weeks | 746 ml/sec |
| Buparid; Treatment A | Nasal Obstruction | Mean flow rate after 8 weeks | 755 ml/sec |
| Budes; Treatment B | Nasal Obstruction | Mean flow rate after 4 weeks | 574 ml/sec |
| Budes; Treatment B | Nasal Obstruction | Mean flow rate after 8 weeks | 646 ml/sec |