Benralizumab Effect on Severe Chronic Rhinosinusitis With Eosinophilic Polyposis
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|ClinicalTrials.gov Identifier: NCT03450083|
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : March 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Rhinosinusitis (Diagnosis) Nasal Polyps Eosinophilia||Drug: Benralizumab Drug: Placebo||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 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|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Active Comparator: Benralizumab treatment group
Benralizumab Active treatment group delivered subcutaneously
30mg Benralizumab will be delivered subcutaneously
Placebo Comparator: Placebo group
Placebo treatment group delivered subcutaneously
Subcutaneous placebo injection
- Nasal Polyp Size [ Time Frame: 24 weeks ]Reduction in endoscopic nasal polyp score after 6 months of treatment
- Nasal polyp size by CT [ Time Frame: 24 weeks ]
Lund-Mackay (LM) CT scan of sinus will be used to determine nasal polyp size. Each of four sinuses are graded 0-3 on each side (total range 0-24).
0 (no abnormality)
- (partial opacification) or
- (complete opacification)
- Clinical Survey [ Time Frame: 24 weeks ]Sino-nasal Outcome Test (SNOT-22) nasal symptoms score. 22 questions each scored 0-5 (no problem - as bad as it can be) for a total range of 0-110.
- Smell Test [ Time Frame: 24 weeks ]UPSIT smell test. 40 questions with four choices each. Number of correct answers range 0-40.
- Blood Test [ Time Frame: 24 weeks ]Complete Blood Count (CBC) to determine absolute eosinophil count. Range 30-300/uL.
- Rescue Medication Use [ Time Frame: Up to 24 weeks ]Rescue Medication Score. Rescue medications include triamcinolone twice daily, and Prednisone 20mg for five days which will be given only as needed periodically. Score ranges from 0-20. (0=none, 5=triamcinolone nasal daily, 10=triamcinolone nasal BID, 20=prednisone 20mg for five days)
- Time to Surgery [ Time Frame: 24 weeks ]Time to nasal polyp surgery. Measured in months starting after last injection.
- Drop Out Rate [ Time Frame: Up to 24 weeks ]Drop Out Rate. Calculated continuously throughout the study up to 24 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
|Contact: Jeanne Hoddinott, RNfirstname.lastname@example.org|
|Contact: Tammy Fallis||410-550-2301|
|United States, Maryland|
|Johns Hopkins University School of Medicine||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Jeanne Hoddinott, RN 410-550-8017 email@example.com|
|Contact: Tammy Fallis 410-550-2301|