Trial Outcomes & Findings for Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis (NCT NCT01066104)

Last Updated: 2017-06-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

4 months

Results posted on

2017-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Xolair Placebo Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)	Xolair (Omalizumab) Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
Overall Study STARTED	14	13
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Xolair Placebo Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)	Xolair (Omalizumab) Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
Overall Study Adverse Event	1	1
Overall Study Protocol Violation	1	0

Baseline Characteristics

2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 4 months

Outcome measures

Outcome measures
Measure	Xolair Placebo n=12 Participants Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)	Xolair (Omalizumab) n=12 Participants Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
Objective (a) the Effect on Polypoid Mucosal Thickening in the Anterior Ethmoid and Maxillary Sinuses as Measured on Sinus CT Scan.	-8.9 % Change Standard Deviation 28.2	4.2 % Change Standard Deviation 25.6

SECONDARY outcome

Timeframe: 4 months

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 1. Polyp in middle meatus, not reaching below the inferior border of the middle turbinate 2. Polyp reaching below the inferior border of the middle turbinate but not touching the inferior turbinate 3. Polyp reaching below the inferior border of the middle turbinate and touching the inferior turbinate 4. Polyp reaching to or below the lower border of the inferior turbinate Range: minimum 0 (better outcome), maximum 8 (worse outcome)

Outcome measures

Outcome measures
Measure	Xolair Placebo n=12 Participants Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)	Xolair (Omalizumab) n=12 Participants Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
Objective (b) the Effect on Volume of Polypoid Mucosal Tissue in the Nose and Sinuses on Rhinoscopic Examination.	.05 Change in Total polyp score Standard Deviation 2.27	-0.33 Change in Total polyp score Standard Deviation 2.1

Adverse Events

Xolair Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Xolair (Omalizumab)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Xolair Placebo n=14 participants at risk Xolair placebo: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)	Xolair (Omalizumab) n=13 participants at risk Xolair (omalizumab): two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
Skin and subcutaneous tissue disorders Hair thinning	0.00% 0/14 • 4 months	7.7% 1/13 • Number of events 1 • 4 months
Blood and lymphatic system disorders Bilateral hilar adenopathy	7.1% 1/14 • Number of events 1 • 4 months	0.00% 0/13 • 4 months

Additional Information

Dr. Ellen Dutta

MGH

Phone: 6177248256

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Xolair Placebo n=14 Participants Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)	Xolair (Omalizumab) n=13 Participants Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=14 Participants	0 Participants n=13 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=14 Participants	13 Participants n=13 Participants	27 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=14 Participants	0 Participants n=13 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	4 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	3 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	7 Participants n=24 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.
Sex: Female, Male Male	8 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	9 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	17 Participants n=24 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	1 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	3 Participants n=24 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	11 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	21 Participants n=24 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	0 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	0 Participants n=24 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	0 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	0 Participants n=24 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.
Race (NIH/OMB) Asian	0 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	0 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	0 Participants n=24 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	0 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	0 Participants n=24 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.
Race (NIH/OMB) Black or African American	3 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	1 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	4 Participants n=24 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.
Race (NIH/OMB) White	8 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	10 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	18 Participants n=24 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.
Race (NIH/OMB) More than one race	1 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	0 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	1 Participants n=24 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	1 Participants n=12 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.	1 Participants n=24 Participants • 2 subjects withdrew from the study due to adverse events. 1 Subject withdrew from the study due to protocol violation (concomitant medication that was not allowed). These 3 subjects did not complete the procedures to allow for analysis.