Trial Outcomes & Findings for Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis With Polyposis Nasi (NCT NCT01946711)
NCT ID: NCT01946711
Last Updated: 2022-04-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Change from Baseline to Week 8
Results posted on
2022-04-12
Participant Flow
4 patients not randomised
Participant milestones
| Measure |
Buparid; Treatment A
Buparid 1 mg budesonide/2 ml nebuliser solution
Budesonide: Inhalation
|
Budes; Treatment B
Budes® Nasal Spray 50 µg budesonide/pump
Budesonide: Nasal spray
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Buparid; Treatment A
n=8 Participants
Buparid 1 mg budesonide/2 ml nebuliser solution
Budesonide: Inhalation
|
Budes; Treatment B
n=6 Participants
Budes® Nasal Spray 50 µg budesonide/pump
Budesonide: Nasal spray
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
14 Participants
n=14 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=14 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=8 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=8 Participants
|
3 Participants
n=6 Participants
|
8 Participants
n=14 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Germany
|
8 participants
n=8 Participants
|
6 participants
n=6 Participants
|
14 participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 8Inflammation 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.
Outcome measures
| Measure |
Buparid; Treatment A
n=8 Participants
Buparid 1 mg budesonide/2 ml nebuliser solution
Budesonide: Inhalation
|
Budes; Treatment B
n=6 Participants
Budes® Nasal Spray 50 µg budesonide/pump
Budesonide: Nasal spray
|
|---|---|---|
|
Change of Inflammation of the Nasal Mucosa and Paranasal Sinus
|
-2 units on a scale
Interval -3.5 to 2.5
|
-0.8 units on a scale
Interval -3.5 to 1.0
|
SECONDARY outcome
Timeframe: up to 26 weeksTreatment-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.
Outcome measures
| Measure |
Buparid; Treatment A
n=8 Participants
Buparid 1 mg budesonide/2 ml nebuliser solution
Budesonide: Inhalation
|
Budes; Treatment B
n=6 Participants
Budes® Nasal Spray 50 µg budesonide/pump
Budesonide: Nasal spray
|
|---|---|---|
|
Safety Assessment
|
5 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksHealth-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).
Outcome measures
| Measure |
Buparid; Treatment A
n=8 Participants
Buparid 1 mg budesonide/2 ml nebuliser solution
Budesonide: Inhalation
|
Budes; Treatment B
n=6 Participants
Budes® Nasal Spray 50 µg budesonide/pump
Budesonide: Nasal spray
|
|---|---|---|
|
Health-specific Quality of Life
|
23.6 score on a scale
Interval 19.7 to 27.6
|
14.4 score on a scale
Interval 9.8 to 18.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeks / 8 weeksNasal 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.
Outcome measures
| Measure |
Buparid; Treatment A
n=8 Participants
Buparid 1 mg budesonide/2 ml nebuliser solution
Budesonide: Inhalation
|
Budes; Treatment B
n=6 Participants
Budes® Nasal Spray 50 µg budesonide/pump
Budesonide: Nasal spray
|
|---|---|---|
|
Nasal Obstruction
Mean flow rate after 4 weeks
|
746 ml/sec
Interval 462.0 to 1031.0
|
574 ml/sec
Interval 267.0 to 881.0
|
|
Nasal Obstruction
Mean flow rate after 8 weeks
|
755 ml/sec
Interval 644.0 to 867.0
|
646 ml/sec
Interval 527.0 to 765.0
|
Adverse Events
Buparid; Treatment A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Budes; Treatment B
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Buparid; Treatment A
n=8 participants at risk
Buparid 1 mg budesonide/2 ml nebuliser solution
Budesonide: Inhalation
|
Budes; Treatment B
n=6 participants at risk
Budes® Nasal Spray 50 µg budesonide/pump
Budesonide: Nasal spray
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
12.5%
1/8 • Number of events 1 • 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.
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum Increased
|
0.00%
0/8 • 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.
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • 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.
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • Number of events 1 • 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.
|
0.00%
0/6 • 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.
|
|
Nervous system disorders
Parosmia
|
12.5%
1/8 • Number of events 1 • 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.
|
0.00%
0/6 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/8 • 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.
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • 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.
|
0.00%
0/6 • 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.
|
|
Psychiatric disorders
Depression
|
0.00%
0/8 • 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.
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Sensitive Skin
|
0.00%
0/8 • 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.
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Infections and infestations
Otitis media
|
0.00%
0/8 • 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.
|
16.7%
1/6 • Number of events 1 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
1/8 • Number of events 1 • 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.
|
16.7%
1/6 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place