Trial Outcomes & Findings for Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis (NCT NCT01955980)
NCT ID: NCT01955980
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 thickness of the mucosa or opacification. 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
19 participants
Primary outcome timeframe
Change from Baseline to week 8
Results posted on
2022-04-12
Participant Flow
Participant milestones
| Measure |
Buparid; Treatment A
Buparid 1mg budesonide/2 ml nebulizer solution
Budesonide: Inhalation Solution
|
Budes; Treatment B
Budes Nasal Spray 50 µg budesonide/pump
Budesonide: Nasal Spray
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
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=10 Participants
Buparid 1mg budesonide/2 ml nebulizer solution
Budesonide: Inhalation Solution
|
Budes; Treatment B
n=9 Participants
Budes Nasal Spray 50 µg budesonide/pump
Budesonide: Nasal Spray
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
19 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=19 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
5 Participants
n=9 Participants
|
10 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
4 Participants
n=9 Participants
|
9 Participants
n=19 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Germany
|
10 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
19 Participants
n=19 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 thickness of the mucosa or opacification. The outcome investigated is the intraindividual mean score of 2 independent raters assessing the same images.
Outcome measures
| Measure |
Buparid; Treatment A
n=10 Participants
Buparid 1mg budesonide/2 ml nebulizer solution
Budesonide: Inhalation
|
Budes; Treatment B
n=9 Participants
Budes Nasal Spray 50 µg budesonide/pump
Budesonide: Nasal Spray
|
|---|---|---|
|
Change of Inflammation of the Nasal Mucosa and Paranasal Sinus
|
0 score on a scale
Interval -2.0 to 5.5
|
-0.8 score on a scale
Interval -5.5 to 4.5
|
SECONDARY outcome
Timeframe: change of SNOT-20 total score from baseline to week 48Health-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).
Outcome measures
| Measure |
Buparid; Treatment A
n=10 Participants
Buparid 1mg budesonide/2 ml nebulizer solution
Budesonide: Inhalation
|
Budes; Treatment B
n=9 Participants
Budes Nasal Spray 50 µg budesonide/pump
Budesonide: Nasal Spray
|
|---|---|---|
|
Health-specific Quality of Life
|
17.1 score on a scale
Interval 5.5 to 28.7
|
22.9 score on a scale
Interval 10.5 to 35.3
|
SECONDARY 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=10 Participants
Buparid 1mg budesonide/2 ml nebulizer solution
Budesonide: Inhalation
|
Budes; Treatment B
n=9 Participants
Budes Nasal Spray 50 µg budesonide/pump
Budesonide: Nasal Spray
|
|---|---|---|
|
Nasal Obstruction
Mean flow rate after 4 weeks
|
542.4 ml/sec
Interval 521.0 to 664.0
|
582.0 ml/sec
Interval 447.0 to 717.0
|
|
Nasal Obstruction
Mean flow rate after 8 weeks
|
461.5 ml/sec
Interval 320.0 to 602.0
|
551.5 ml/sec
Interval 408.0 to 694.0
|
SECONDARY outcome
Timeframe: Changes from Baseline at Week 8Determination of the thickness of the mucosa using Magnetic Resonance Imaging
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksTreatment-emergent adverse events
Outcome measures
| Measure |
Buparid; Treatment A
n=10 Participants
Buparid 1mg budesonide/2 ml nebulizer solution
Budesonide: Inhalation
|
Budes; Treatment B
n=9 Participants
Budes Nasal Spray 50 µg budesonide/pump
Budesonide: Nasal Spray
|
|---|---|---|
|
Safety Assessment
|
6 Participants
|
6 Participants
|
Adverse Events
Buparid; Treatment A
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Budes; Treatment B
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Buparid; Treatment A
n=10 participants at risk
Buparid 1mg budesonide/2 ml nebulizer solution
Budesonide: Inhalation Solution
|
Budes; Treatment B
n=9 participants at risk
Budes Nasal Spray 50 µg budesonide/pump
Budesonide: Nasal Spray
|
|---|---|---|
|
Vascular disorders
Aneurysm
|
10.0%
1/10 • 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%
0/9 • 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.
|
Other adverse events
| Measure |
Buparid; Treatment A
n=10 participants at risk
Buparid 1mg budesonide/2 ml nebulizer solution
Budesonide: Inhalation Solution
|
Budes; Treatment B
n=9 participants at risk
Budes Nasal Spray 50 µg budesonide/pump
Budesonide: Nasal Spray
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • 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%
0/9 • 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
Nasal Dryness
|
0.00%
0/10 • 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.
|
11.1%
1/9 • 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
|
0.00%
0/10 • 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.
|
22.2%
2/9 • Number of events 2 • 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
|
0.00%
0/10 • 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.
|
11.1%
1/9 • 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.
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • 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%
0/9 • 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
Rhinitis
|
10.0%
1/10 • 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.
|
11.1%
1/9 • 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
Sinusitis
|
10.0%
1/10 • 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.
|
11.1%
1/9 • 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
Tonsillitis
|
10.0%
1/10 • 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%
0/9 • 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
Influenza
|
10.0%
1/10 • 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.
|
11.1%
1/9 • 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