Benralizumab Active treatment group delivered subcutaneously

Placebo treatment group delivered subcutaneously

Chronic Rhinosinusitis (Diagnosis)

Nasal Polyps

Eosinophilia

30mg Benralizumab will be delivered subcutaneously

Benralizumab

Placebo

Johns Hopkins University School of Medicine

Benralizumab Effect on Severe Chronic Rhinosinusitis With Eosinophilic Polyposis

Benralizumab Effect on Severe Chronic Rhinosinusitis With Eosinophilic Polyposis: A Phase II Randomized Placebo Controlled Trial

Reduction in endoscopic nasal polyp score after 6 months of treatment

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)

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.

UPSIT smell test. 40 questions with four choices each. Number of correct answers range 0-40.

Complete Blood Count (CBC) to determine absolute eosinophil count. Range 30-300/uL.

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 nasal polyp surgery. Measured in months starting after last injection.

Drop Out Rate. Calculated continuously throughout the study up to 24 weeks.

Johns Hopkins University

Patients assigned to this arm of the study will undergo the In Clinic Polypectomy Performed in Clinic

Patients assigned to this arm will undergo endoscopic sinus surgery (ESS),

Sinusitis

The experimental intervention is endoscopic polypectomy performed in clinic (EPIC) where nasal polyps are removed using a microdebrider under local and topical anesthesia in the outpatient clinic.

Endoscopic polypectomy in clinic (EPIC)

The control intervention is endoscopic sinus surgery (ESS), a minimally invasive procedure that is the current standard that involves polypectomy with a microdebrider as well as sinus ostia enlargement of the affected sinuses performed in the operating room under general anesthesia.

Endoscopic Sinus Surgery (ESS)

ESS will be performed under general anesthesia in the operating room

General Anesthesia

EPIC will be performed under topical and local anesthesia in a clinic setting

Local and topical anesthesia

Ottawa Hospital Research Institute

In-clinic Endoscopic Polypectomy for Chronic Sinusitis With Nasal Polyps

Endoscopic Polypectomy Performed In Clinic for Chronic Rhinosinusitis With Polyps: The EPIC Randomised Controlled Trial

Patient satisfaction with anesthesia for the treatment procedure

Work Impairment related to chronic rhinosinusitis

Endoscopic inflammation of the nose and paranasal sinuses after treatment

Canadian Institutes of Health Research (CIHR)

Medtronic

Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks

Placebo, capsules for oral administration, TID, for 8 weeks

Verapamil HCl, capsules for oral administration, 80mg, TID, for 1 year

Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.

Treatment

Placebo, capsules for oral administration, TID, for 8 weeks
Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.

Control

Verapamil HCl, capsules for oral administration, 80mg, TID, for 1 year
Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.

Open Label

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Minimum Score: 0 Maximum Score: 110 A higher score indicates a worse outcome

Subjective Sinonasal Symptoms on Sinonasal Outcomes Test-22(SNOT-22)

Minimum Score: 0 Maximum Score: 100 A higher score indicates a worse outcome.

Subjective Sinonasal Symptoms on 10cm Visual Analogue Scale(VAS)

Minimum Score: 0 Maximum Score: 12 Higher value represents worse outcome.

Objective Sinonasal Symptoms on Lund-Kennedy Score(LKS)

Minimum Score: 0 Maximum Score: 24 Higher value represents worse outcome.

Objective Sinonasal Symptoms on Lund-McKay Score(LMS)

Heart Rate

Systolic Blood Pressure

Diastolic Blood Pressure

Double-Blind Period

Open Label Period

Benjamin Bleier

Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.

Verapamil HCl

Capsule with the same characteristics (size, color, smell) as Verapamil HCl.

Massachusetts Eye and Ear Infirmary

Trial of Verapamil in Chronic Rhinosinusitis

Randomized Double Blind Placebo Controlled Trial of Verapamil in Chronic Rhinosinusitis

Principal Investigator

Xolair placebo 150-375 mg is administered subcutaneously (SC) every 2 or 4 weeks depending on the patient's baseline serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg) ). Doses of more than 150 mg are divided among more than one injection site to limit injections to not more than 150 mg per site.

Xolair (omalizumab) 150-375 mg is administered subcutaneously (SC) every 2 or 4 weeks depending on the patient's baseline serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Doses of more than 150 mg are divided among more than one injection site to limit injections to not more than 150 mg per site.

Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)

Xolair Placebo

Xolair (Omalizumab)

Ethnicity (NIH/OMB)

Improvement is defined as any decrease in sinus CT scores at end of study.
Quantification of polypoid mucosal thickening in the anterior ethmoid and maxillary sinuses on sinus CT scan (primary outcome variable):
A sinus CT scan will be performed on Day 0 and repeated on Day 112. The CT scans will be performed with consistent orientation of the patient's head and landmarks to assure that both the pretreatment and posttreatment scans are done with identical orientation and sections. The CT scans will be scored using the established scoring system known as the Zinreich modification of the Lund Mackay scoring system.. As an exploratory measure, a 3-dimensional scoring system developed with the radiology department of Massachusetts General Hospital may also be used.

Objective (a) the Effect on Polypoid Mucosal Thickening in the Anterior Ethmoid and Maxillary Sinuses as Measured on Sinus CT Scan.

Improvement is defined as any reduction in the total nasal polyp score. Using rhinoscopic evaluation, Nasal Polyp Score will be assessed on the right and on the left, and added together.
Scoring system:
Score Definition 0 No polyps
Polyp in middle meatus, not reaching below the inferior border of the middle turbinate
Polyp reaching below the inferior border of the middle turbinate but not touching the inferior turbinate
Polyp reaching below the inferior border of the middle turbinate and touching the inferior turbinate
Polyp reaching to or below the lower border of the inferior turbinate
Range: minimum 0 (better outcome), maximum 8 (worse outcome)

Objective (b) the Effect on Volume of Polypoid Mucosal Tissue in the Nose and Sinuses on Rhinoscopic Examination.

Overall Study

Dr. Ellen Dutta

Xolair placebo: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)

Xolair (omalizumab): two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)

Chronic Rhinosinusitis

two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)

nasal polyps/cefalàlgia

Benralizumab Effect on Severe Chronic Rhinosinusitis With Eosinophilic Polyposis

In-clinic Endoscopic Polypectomy for Chronic Sinusitis With Nasal Polyps

Trial of Verapamil in Chronic Rhinosinusitis

Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis

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