Trial · NCT03450083
Benralizumab Effect on Severe Chronic Rhinosinusitis With Eosinophilic Polyposis
NCT03450083, Phase 2, Completed, Johns Hopkins University; results first posted 2021-01-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Benralizumab Effect on Severe Chronic Rhinosinusitis With Eosinophilic Polyposis. Trials, record NCT03450083. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03450083
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Benralizumab Effect on Severe Chronic Rhinosinusitis With Eosinophilic Polyposis
- NCT number
- NCT03450083
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Chronic Rhinosinusitis (Diagnosis), Nasal Polyps, Eosinophilia
- Interventions
- Benralizumab, Placebo
- First posted
- 2018-03-01
- Last updated
- 2021-02-11
- Results first posted
- 2021-01-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Nasal Polyp Score | Week 5 and Week 25 | Change in endoscopic nasal polyp score after 6 months of treatment. Nasal Polyp Score (NPS): the change in mean score from Screen visit (Week 5) bilateral endoscopic nasal polyp score as compared to score at end of treatment (Week 25). Higher scores indicate increase in number of polyps and/or polyp size. The score is the sum of the right and left nostril scores, as evaluated by nasal endoscopy. NPS score key: 0 = No visible polyps; 1 = Small amount of polypoid disease confined within the middle meatus; 2 = Multiple polyps occupying the middle meatus; 3 = Polyps extending beyond the middle meatus; 4 = Polyps completely obstructing the nasal cavity. Reported data is a difference in the NPS between Week 25 and Week 5. |
| Secondary | Change in Nasal Polyp Size as Assessed by the Lund Mackay Score | Week 5 and Week 25 | Computed Tomography (CT) scan of the sinus was performed at screening (Week 5) and then again at the end of treatment (Week 25). Sinus CT images were obtained to determine the Lund Mackay Score (LMS), a widely used method for radiologic staging of nasal polyposis. The mean change in the LMS was determined by comparing the scores from Week 5 to Week 25. Each sinus group is graded between 0 and 2 (0: no abnormality; 1: partial opacification; 2: total opacification). The ostiomeatal complex is scored as "0" not obstructed) or "2" (obstructed). Overall score range of 0-24. Higher scores indicate progression of nasal polyposis disease. Reported data is a difference in the LMS between Week 25 and Week 5. |
| Secondary | Change in Symptom Severity Score as Assessed by the Sino-nasal Outcome Test | Treatment Week 0 and Week 20 | The Sino-nasal Outcome Test (SNOT-22) is a condition-specific health-related quality of life assessment that captures patient-reported physical problems, functional limitations, and emotional consequences of sinonasal conditions for the 2 weeks prior to completing the test. Participants completed the SNOT-22 at treatment Week 0 and at Treatment Week 20. Patients rated their symptom severity and symptom impact over the previous 2 weeks using a 6-point scale (0- No Problem to 5- Problem as bad as it can be). The total score is the sum of individual item scores and has a range from 0 to 110. Higher scores indicate more severe symptoms. Outcome measure data shows change in SNOT-22 scores between treatment Week 20 and Week 0. |
| Secondary | Change in The University of Pennsylvania Smell Identification Test Score | Week 5 and Week 25 | The University of Pennsylvania Smell Identification Test (UPSIT) is a quantitative test of olfactory function that uses microencapsulated odorants that are released by scratching standardized odor-impregnated test booklets. Four booklets with 10 questions in each booklet on odor identification. Patients were asked to identify the odor by scratching the test area then selecting their answer using multiple-choice format that lists 4 different possible answers for each question. The mean change in the UPSIT was determined by comparing the score from Week 5 to the score in Week 25. The test is a forced-choice test meaning the patient is required to mark one of the four answers even if a smell is not perceived. Scores are based on number of correctly identified odors (score range 0 to 40). Higher scores indicate subject's ability to correctly identify odors. Reported data is a difference in the UPSIT score between Week 25 and Week 5. |
| Secondary | Change in Absolute Eosinophil Count | Assessed at Treatment Week 0 and Week 20 | Complete Blood Count (CBC) to determine change in absolute eosinophil count. Normal Range 30-300 cells/uL. |
| Secondary | Utilization of Prednisone as a Rescue Medication | 20 weeks | Use of Prednisone as a rescue medication during the treatment phase (week 0 through week 20) was measured in total milligrams (mg) that were taken by participant. |
| Secondary | Time to Surgery | 24 weeks | |
| Secondary | Number of Participants Who Dropped Out | Up to 29 weeks | Number of participants who dropped out monitored continuously throughout the study up to 29 weeks. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Nasal Polyp Score | Week 5 and Week 25 | score on a scale | MEAN | |
| SECONDARY | Change in Nasal Polyp Size as Assessed by the Lund Mackay Score | Week 5 and Week 25 | score on a scale | MEAN | |
| SECONDARY | Change in Symptom Severity Score as Assessed by the Sino-nasal Outcome Test | Treatment Week 0 and Week 20 | score on a scale | MEAN | |
| SECONDARY | Change in The University of Pennsylvania Smell Identification Test Score | Week 5 and Week 25 | score on a scale | MEAN | |
| SECONDARY | Change in Absolute Eosinophil Count | Assessed at Treatment Week 0 and Week 20 | cells/uL | MEAN | |
| SECONDARY | Utilization of Prednisone as a Rescue Medication | 20 weeks | mg | MEAN | |
| SECONDARY | Time to Surgery | 24 weeks | Time to nasal polyp surgery post treatment was not assessed and no data was collected. | ||
| SECONDARY | Number of Participants Who Dropped Out | Up to 29 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Nasal Polyp Score | Benralizumab Treatment Group | .9 | Full Range 0 to 3 | score on a scale | |
| Change in Nasal Polyp Score | Placebo Group | .3 | Full Range -1 to 2 | score on a scale | |
| Change in Nasal Polyp Size as Assessed by the Lund Mackay Score | Benralizumab Treatment Group | -4.2 | Standard Error 1.1 | score on a scale | |
| Change in Nasal Polyp Size as Assessed by the Lund Mackay Score | Placebo Group | -1.6 | Standard Error 1.2 | score on a scale | |
| Change in Symptom Severity Score as Assessed by the Sino-nasal Outcome Test | Benralizumab Treatment Group | -19.2 | Standard Deviation 2.6 | score on a scale | |
| Change in Symptom Severity Score as Assessed by the Sino-nasal Outcome Test | Placebo Group | -14.6 | Standard Deviation 20.1 | score on a scale | |
| Change in The University of Pennsylvania Smell Identification Test Score | Benralizumab Treatment Group | 6.6 | Standard Error 2.2 | score on a scale | |
| Change in The University of Pennsylvania Smell Identification Test Score | Placebo Group | 4.3 | Standard Error 2.5 | score on a scale | |
| Change in Absolute Eosinophil Count | Benralizumab Treatment Group | 678 | Standard Error 119 | cells/uL | |
| Change in Absolute Eosinophil Count | Placebo Group | 196.7 | Standard Error 171 | cells/uL |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Benralizumab Treatment Group | 12 | |
| Overall Study | STARTED | Placebo Group | 12 | |
| Overall Study | COMPLETED | Benralizumab Treatment Group | 12 | |
| Overall Study | COMPLETED | Placebo Group | 12 | |
| Overall Study | NOT COMPLETED | Benralizumab Treatment Group | 0 | |
| Overall Study | NOT COMPLETED | Placebo Group | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Upper Respiratory Infection (URI) | General disorders | Benralizumab Treatment Group | 1 | 12 | 1 |
| other | Upper Respiratory Infection (URI) | General disorders | Placebo Group | 2 | 12 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Benralizumab Treatment Group | 0 | 12 |
| Total, all-cause mortality | Placebo Group | 0 | 12 |
| Total, other adverse events | Benralizumab Treatment Group | 1 | 12 |
| Total, other adverse events | Placebo Group | 2 | 12 |
| Total, serious adverse events | Benralizumab Treatment Group | 0 | 12 |
| Total, serious adverse events | Placebo Group | 0 | 12 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Benralizumab Treatment Group vs Placebo Group: Number of Participants Who Dropped Out | Trial comparisons |
| Benralizumab Treatment Group vs Placebo Group: deaths from any cause | Trial comparisons |
| Benralizumab Treatment Group vs Placebo Group: 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/NCT03450083
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