Benralizumab Effect on Severe Chronic Rhinosinusitis With Eosinophilic Polyposis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03450083|
Recruitment Status : Completed
First Posted : March 1, 2018
Results First Posted : January 22, 2021
Last Update Posted : February 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Rhinosinusitis (Diagnosis) Nasal Polyps Eosinophilia||Drug: Benralizumab Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Benralizumab Effect on Severe Chronic Rhinosinusitis With Eosinophilic Polyposis: A Phase II Randomized Placebo Controlled Trial|
|Actual Study Start Date :||July 1, 2017|
|Actual Primary Completion Date :||January 1, 2020|
|Actual Study Completion Date :||February 1, 2020|
Active Comparator: Benralizumab treatment group
Benralizumab Active treatment group delivered subcutaneously
30mg Benralizumab will be delivered subcutaneously
Other Name: Fasenra
Placebo Comparator: Placebo group
Placebo treatment group delivered subcutaneously
Subcutaneous placebo injection
- Change in Nasal Polyp Score [ Time Frame: 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.
- Change in Nasal Polyp Size as Assessed by the Lund Mackay Score [ Time Frame: 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.
- Change in Symptom Severity Score as Assessed by the Sino-nasal Outcome Test [ Time Frame: 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.
- Change in The University of Pennsylvania Smell Identification Test Score [ Time Frame: 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.
- Change in Absolute Eosinophil Count [ Time Frame: 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.
- Utilization of Prednisone as a Rescue Medication [ Time Frame: 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.
- Time to Surgery [ Time Frame: 24 weeks ]
- Number of Participants Who Dropped Out [ Time Frame: Up to 29 weeks ]Number of participants who dropped out monitored continuously throughout the study up to 29 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450083
|United States, Maryland|
|Johns Hopkins University School of Medicine|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Jody Tversky, MD||Johns Hopkins University|