Trial · NCT01955980
Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis
NCT01955980, Phase 1, Phase 2, Completed, Pari Pharma GmbH; results first posted 2022-04-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis. Trials, record NCT01955980. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01955980
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis
- NCT number
- NCT01955980
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Pari Pharma GmbH
- Conditions
- Rhinosinusitis
- Interventions
- Budesonide, Budesonide
- First posted
- 2013-10-08
- Last updated
- 2022-04-12
- Results first posted
- 2022-04-12
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 thickness of the mucosa or opacification. The outcome investigated is the intraindividual mean score of 2 independent raters assessing the same images. |
| Secondary | Health-specific Quality of Life | change of SNOT-20 total score from baseline to week 48 | 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). |
| Secondary | 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. |
| Secondary | Inflammation of the Nasal Mucosa and Paranasal Sinus | Changes from Baseline at Week 8 | Determination of the thickness of the mucosa using Magnetic Resonance Imaging |
| Secondary | Safety Assessment | 48 weeks | Treatment-emergent adverse events |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change of Inflammation of the Nasal Mucosa and Paranasal Sinus | Change from Baseline to week 8 | score on a scale | MEDIAN | |
| SECONDARY | Health-specific Quality of Life | change of SNOT-20 total score from baseline to week 48 | score on a scale | MEAN | |
| SECONDARY | Nasal Obstruction | 4 weeks / 8 weeks | ml/sec | MEAN | |
| SECONDARY | Inflammation of the Nasal Mucosa and Paranasal Sinus | Changes from Baseline at Week 8 | |||
| SECONDARY | Safety Assessment | 48 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change of Inflammation of the Nasal Mucosa and Paranasal Sinus | Buparid; Treatment A | 0 | 95% Confidence Interval -2 to 5.5 | score on a scale | |
| Change of Inflammation of the Nasal Mucosa and Paranasal Sinus | Budes; Treatment B | -0.8 | 95% Confidence Interval -5.5 to 4.5 | score on a scale | |
| Health-specific Quality of Life | Buparid; Treatment A | 17.1 | 95% Confidence Interval 5.5 to 28.7 | score on a scale | |
| Health-specific Quality of Life | Budes; Treatment B | 22.9 | 95% Confidence Interval 10.5 to 35.3 | score on a scale | |
| Nasal Obstruction | Buparid; Treatment A | Mean flow rate after 4 weeks | 542.4 | 95% Confidence Interval 521 to 664 | ml/sec |
| Nasal Obstruction | Budes; Treatment B | Mean flow rate after 4 weeks | 582.0 | 95% Confidence Interval 447 to 717 | ml/sec |
| Nasal Obstruction | Buparid; Treatment A | Mean flow rate after 8 weeks | 461.5 | 95% Confidence Interval 320 to 602 | ml/sec |
| Nasal Obstruction | Budes; Treatment B | Mean flow rate after 8 weeks | 551.5 | 95% Confidence Interval 408 to 694 | ml/sec |
| Safety Assessment | Buparid; Treatment A | 6 | Participants | ||
| Safety Assessment | Budes; Treatment B | 6 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Buparid; Treatment A | 10 | |
| Overall Study | STARTED | Budes; Treatment B | 9 | |
| Overall Study | COMPLETED | Buparid; Treatment A | 10 | |
| Overall Study | COMPLETED | Budes; Treatment B | 9 | |
| Overall Study | NOT COMPLETED | Buparid; Treatment A | 0 | |
| Overall Study | NOT COMPLETED | Budes; Treatment B | 0 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cough | Respiratory, thoracic and mediastinal disorders | Buparid; Treatment A | 1 | 10 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Budes; Treatment B | 0 | 9 | 0 |
| other | Nasal Dryness | Respiratory, thoracic and mediastinal disorders | Buparid; Treatment A | 0 | 10 | 0 |
| other | Nasal Dryness | Respiratory, thoracic and mediastinal disorders | Budes; Treatment B | 1 | 9 | 1 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Buparid; Treatment A | 0 | 10 | 0 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Budes; Treatment B | 2 | 9 | 2 |
| other | Headache | Nervous system disorders | Buparid; Treatment A | 0 | 10 | 0 |
| other | Headache | Nervous system disorders | Budes; Treatment B | 1 | 9 | 1 |
| other | Depression | Psychiatric disorders | Buparid; Treatment A | 1 | 10 | 1 |
| other | Depression | Psychiatric disorders | Budes; Treatment B | 0 | 9 | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Buparid; Treatment A | 0 | 10 |
| Total, all-cause mortality | Budes; Treatment B | 0 | 9 |
| Total, other adverse events | Buparid; Treatment A | 5 | 10 |
| Total, other adverse events | Budes; Treatment B | 6 | 9 |
| Total, serious adverse events | Buparid; Treatment A | 1 | 10 |
| Total, serious adverse events | Budes; Treatment B | 0 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Buparid; Treatment A vs Budes; Treatment B: Safety Assessment | Trial comparisons |
| Buparid; Treatment A vs Budes; Treatment B: deaths from any cause | Trial comparisons |
| Buparid; Treatment A vs Budes; Treatment B: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01955980
GET https://conductscience.org/api/trials/v1/NCT01955980/registered